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Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices

Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary... Hindawi Journal of Interventional Cardiology Volume 2020, Article ID 8216831, 10 pages https://doi.org/10.1155/2020/8216831 Research Article Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices 1 1 1 2 1 Tsuyoshi Isawa , Kazunori Horie, Taku Honda, Masataka Taguri, and Norio Tada Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan Department of Data Science, Yokohama City University School of Data Science, Yokohama, Japan Correspondence should be addressed to Tsuyoshi Isawa; isa_tsuyo@yahoo.co.jp Received 27 May 2020; Revised 26 July 2020; Accepted 3 August 2020; Published 14 August 2020 Academic Editor: Leonardo De Luca Copyright © 2020 Tsuyoshi Isawa et al. +is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. A Glidesheath slender (Terumo, Tokyo, Japan) and a sheathless Eaucath guiding catheter (Asahi Intecc, Nagoya, Japan) are two major slender devices utilized in percutaneous coronary intervention (PCI). +is study aimed to investigate the differences in access-site complications between these devices in PCI for acute coronary syndrome (ACS). A total of 1108 consecutive patients who underwent transradial PCI for ACS were enrolled. Transradial PCI was performed using either a 7-Fr Glidesheath slender/7- Fr guiding catheter combination (Glidesheath group) or a 7.5-Fr sheathless guiding catheter (Sheathless group); 1 :1 propensity score matching was performed, and 728 patients (364 in each group) were included in the propensity-matched population. In the matched patients, univariate analysis revealed that the Glidesheath group had less radial artery occlusion (RAO) at 30 days (Glidesheath: 1.4% vs. Sheathless: 4.1%, odds ratio (OR) � 0.33, 95% confidence interval (CI) � 0.12–0.91, p � 0.039), whereas no significant between-group differences were observed in severe radial spasm (Glidesheath: 1.4% vs. Sheathless: 1.9%, OR � 0.71, 95% CI � 0.23–2.22, p � 0.58) or access-site major bleeding (Glidesheath: 1.4% vs. Sheathless: 1.6%, OR � 0.83, 95% CI � 0.26–2.71, p � 1.00). Multivariate analysis revealed that the choice for Glidesheath was significantly associated with less RAO (OR � 0.32, 95% CI � 0.11–0.93, p � 0.036). In conclusion, 7-Fr Glidesheath slender/7-Fr guiding catheter combination is obviously more advantageous than 7.5-Fr sheathless guiding catheters for decreased risk of RAO. +e potential low risk of RAO in our findings supports the adoption of the 7-Fr Glidesheath slender sheath/7-Fr guiding catheter combination in transradial PCI for ACS. catheter system without a conventional sheath [4–6]. Re- 1. Introduction garding the device profile, difference in the outer diameter +e standard treatment for acute coronary syndrome (ACS) between a 7-Fr Glidesheath slender and 7.5-Fr sheathless is transradial percutaneous coronary intervention (PCI), guiding catheter is 0.30 mm (Figure 1). +e outer diameters which has considerably better outcomes than transfemoral of the 7.5-Fr sheathless guiding catheter and the 7-Fr Gli- PCI [1]. Although the default approach for PCI is via radial desheath slender are smaller than, or almost equal to, that of access, access-site complications, like radial artery occlusion the conventional 6-Fr sheath, which is currently used as the (RAO) [2] and radial spasm [3], are still encountered due to mainstream sheath in transradial PCI. During preparation overstretch and injury of the radial artery. Several slender for PCI for ACS, it is reasonable to select either a 7-Fr (downsized) devices have been developed based on the Glidesheath slender system or 7.5-Fr sheathless guiding hypothesis that smaller guiding catheters or sheaths reduce system. +ey provide better backup support than the con- the risk of access-site complications. Two such devices are ventional 6-Fr system, and they are sufficiently downsized Glidesheath slender sheath (Terumo, Tokyo, Japan), which is and consequently may lead to less or equal radial overstretch a thin-walled radial sheath, and a sheathless Eaucath guiding and injury than the conventional 6-Fr system. +e rates of catheter (Asahi Intecc, Nagoya, Japan), which is a guiding RAO associated with 7-Fr Glidesheath slender sheaths or 2 Journal of Interventional Cardiology 7.5-Fr Sheathless 6-Fr conventional sheath 7-Fr Glidesheath slender 7-Fr conventional sheath 2.49 2.70 2.79 3.00 OD, mm (6-Fr guide) (7-Fr guide) ) ID, mm 2.06 1.78 2.06 2.06 Figure 1: Comparison of the outer diameter and inner lumen diameters among the Glidesheath slender sheath, sheathless guiding catheter, and conventional sheath (illustration prepared by the authors with reference to the Glidesheath slender sheath and Sheathless Eaucath ® ® information brochures). “Glidesheath slender” denotes a Glidesheath slender sheath, and “Sheathless” denotes a sheathless guiding catheter. ID, inner lumen diameter; OD, outer diameter. 7.5-Fr sheathless guiding catheters are expected to be lower Hyperion guiding catheter (Asahi Intecc) combination, (iii) than, or almost equal to, those of the 6-Fr conventional refusal to participate, and (iv) loss of follow-up. Conse- sheath. Furthermore, they are better than the conventional quently, we retrospectively evaluated 1108 patients who 6-Fr system for optimal aspiration of thrombus. Larger underwent transradial PCI using 7-Fr Glidesheath slender caliber devices can aspirate a larger volume of thrombus as a sheath/7-Fr Hyperion guiding catheter combination (Gli- result of the increased proximal cross-sectional area of the desheath group) (n � 397) or 7.5-Fr sheathless Eaucath aspiration device. Although routine thrombus aspiration is guiding catheter (Sheathless group) (n � 711). not recommended, in cases of a large residual thrombus burden after opening the vessel with a guidewire or a bal- 2.2. PCI Procedure and Radial Ultrasound Study. After ad- loon, thrombus aspiration is still considered [7]. Previous ministration of nitroglycerin oral spray (0.3 mg; Myocor reports have demonstrated access-site complications in Spray; Toaeiyo, Tokyo, Japan) to patients with ACS, other transradial PCI using Glidesheath slender sheaths (RAO than those with Killip class IV, the radial artery was 0.8%–4.8% and radial spasm 2.3%–11.0%) and using punctured 2 cm proximal to the radius styloid process using sheathless guiding catheters (RAO 0.0%–3.2% and radial the Seldinger technique (posterior wall puncture) with 18- spasm 0.7%–5.0%) [5, 6, 8–10]. However, no previous study Ga puncture needles (Supercath; Medikit, Tokyo, Japan) has compared the 7-Fr Glidesheath slender/7-Fr guiding under local anesthesia. +e choice of guiding system (7.5-Fr catheter combination with the 7.5-Fr sheathless guiding sheathless guiding catheter or 7-Fr Glidesheath slender catheter in terms of the access-site complications in a large sheath/7-Fr guiding catheter combination) was at the op- sample of patients with ACS treated with transradial PCI. erator’s discretion. In cases where a 16 cm-long 7-Fr Gli- +erefore, we aimed to investigate the differences between desheath slender sheath was selected, after coronary the 7-Fr Glidesheath slender sheath/7-Fr guiding catheter angiography using a 4-Fr diagnostic catheter with a 7-Fr combination and 7.5-Fr sheathless Eaucath guiding system Glidesheath slender sheath, a 7-Fr Hyperion guiding cath- in terms of access-site complications in transradial PCI for eter equipped with an inner dilator (5.5-Fr STA Angiog- ACS, using propensity score matching analysis. raphy Catheter; Medikit, Tokyo, Japan) was inserted into the radial artery via the Glidesheath slender. In this study, a 2. Materials and Methods 16 cm-long 7-Fr Glidesheath slender was used, while a 10 cm-long one was not available. In all patients who un- 2.1. Patient Selection. +is was a single-center retrospective derwent PCI using 7-Fr Glidesheath slender sheaths, 7-Fr study that included patients with ACS who underwent Hyperion guiding catheters were used for coronary intu- transradial PCI in which either the 7-Fr Glidesheath slender/ bation. In cases where the 7.5-Fr sheathless guiding catheter 7-Fr guiding catheter or 7.5-Fr sheathless guiding catheter was selected, a sheath-cum-sheathless technique was used. was used. Figure 2 shows a flowchart of the study design and After coronary angiography using a 4-Fr diagnostic catheter patient selection criteria. We screened 1562 consecutive with a 4-Fr conventional sheath, a 4-Fr conventional sheath patients who underwent PCI for ACS, including ST-eleva- was subsequently exchanged for a 7.5-Fr sheathless guiding tion myocardial infarction and non-ST-elevation ACS, at the catheter connected to a supplied central dilator over a Sendai Kousei Hospital between January 2015 and February J-tipped 0.035-inch guidewire and inserted into the radial 2019. +e exclusion criteria were as follows: (i) PCI via artery (Figure 3). All PCI procedures were performed after femoral or brachial access, (ii) transradial PCI using guiding intra-arterial heparin administration (10,000 U). +e acti- catheter systems other than 7.5-Fr sheathless Eaucath vated clotting time (ACT) was noted 3 min after the first guiding catheters or 7-Fr Glidesheath slender sheaths/7-Fr administration of heparin and every 1 h thereafter. Heparin Journal of Interventional Cardiology 3 Consecutive patients with ACS undergoing PCI at our hospital (n = 1562) Exclusion (i) Transfemoral or transbrachial PCI (n = 206) (ii) Use of 6.5-Fr sheathless guiding catheter or 6-Fr sheath system (n = 198) (iii) Refusal to participate or loss of follow-up (n = 50) Eligible patients included in the study (n = 1108) 7-Fr Glidesheath slender/7-Fr guiding catheter (n = 397) 7.5-Fr sheathless guiding catheter (n = 711) 1 : 1 propensity score matching Glidesheath group (n = 364) Sheathless group (n = 364) Figure 2: Flowchart of study design and patient selection criteria. ACS, acute coronary syndrome; PCI, percutaneous coronary intervention. Figure 3: Sheathless transradial percutaneous coronary intervention procedure. (a) A central dilator is introduced into a guiding catheter. (b) A 4-Fr conventional sheath is inserted into the radial artery. (c) Following introduction, the sheath is exchanged for a sheathless guiding catheter connected to a supplied central dilator over a 0.035-inch wire. (d) A silicon-based stopper is linked to the proximal shaft of the sheathless guiding catheter and anchored to a surgical drape using forceps to avoid slippage. was administered additionally to maintain an ACTof≥300 s. sealed with a compression device (TOMETA KUN; Zeon End-procedural ACT was immediately measured before Medical, Tokyo, Japan) [11] and pressurized up to the ref- removing the guiding catheter at the end of the procedure. erence pressure (defined as ≥20 mmHg over the systolic After removing the sheathless guiding catheter or the Gli- blood pressure at the time of guiding catheter removal). desheath slender sheath, the punctured radial artery was +irty minutes after removal, the pressure was dropped by 4 Journal of Interventional Cardiology 2.4. Statistical Analysis. Continuous variables are expressed 20 mmHg every 1 h until it reached 20 mmHg. +e com- pression device was removed 8–9 h after the procedure. In all as median (interquartile range (IQR)), and categorical variables are expressed as frequency (%). Continuous var- patients, hemostasis was performed according to the aforementioned protocol, which was an occlusive hemo- iables were compared using the Mann–Whitney U test, while stasis technique. categorical variables were compared using Fisher’s exact test. Ultrasound measurements of the radial artery were taken For alleviating potential selection bias between the two 30 days after the index PCI. A single experienced vascular groups, a propensity score was estimated using a multi- sonographer, who had no knowledge of the techniques and variate logistic regression model. +e co-variables included the devices used for PCI, performed all ultrasonography in the model were selected based on the results of the univariate analysis/clinical perspective including age, sex, examinations using Doppler ultrasonography with the Toshiba Aplio XG SSA-790A (Toshiba Medical Systems body mass index, diabetes mellitus, hypertension, dyslipi- demia, current smoking, peripheral artery disease, history of Corporation, Otawara, Japan) and a PLT-1204AT (2D, 12 MHz) or a PLT-1204BT (2D, 12 MHz) probe or with the previous bleeding requiring hospitalization or transfusion, history of stroke and myocardial infarction, previous PCI, Aplio i800 (Canon Medical Systems, Tustin, CA) with an i24LX8 (2D, 24 MHz) probe. +e measurements were made previous coronary artery bypass grafting, use of oral anti- 2 cm proximal to the styloid process of the radius. +e ar- coagulants, Killip class on admission, estimated glomerular terial puncture site and subsequent sheath insertion site were filtration rate, arterial access site (left or right radial artery identified by visual confirmation using the skin scar at the approach), and the number of previous ipsilateral trans- sheath insertion site as a landmark. +us, arterial puncture, radial coronary angiography or intervention attempts sheath insertion, and ultrasound measurement were done at [2, 14]. Notably, these co-variables only included those that would be known at the time of the point of catheter selection. the same site. +e radial artery diameter was defined as the distance from the leading edge of the near wall to the leading +e C-statistic for the propensity score model was 0.62, and 1 :1 matching on the propensity score was performed using edge of the far wall of the artery along a line perpendicular to the long axis of the artery. nearest neighbor matching with a maximum caliper of 0.05 of the propensity score. In both groups, clinical outcomes within 30 days were compared using the Cox proportional 2.3.DefinitionofEndpoints. +e endpoints were RAO at 30 hazard models and Kaplan–Meier method. A two-tailed days, severe radial spasm during PCI, access-site major p value of <0.05 was considered statistically significant. All bleeding within 30 days as defined by the Bleeding Ac- statistical analyses were performed using JMP software ademic Research Consortium (BARC) type 3 or 5 criteria (version 14, SAS Institute Inc., Cary, NC, USA). +e initial [12], coronary ostial dissection by the guiding catheters, sample size calculation was performed to detect a 4% dif- procedural success, and clinical outcomes within 30 days. ference in the incidences of RAO (Sheathless group: 0.8%; RAO was defined as severely reduced or absent blood flow Glidesheath group: 4.8%) with a power of 80% and type I at the puncture site as revealed by Doppler studies. +e error of 5%. A sample size of 632 patients (316 in each group) Doppler criteria for diagnosing RAO were based on a was required [5, 6]. At the time of planning the study, the previous study [13]. If the Doppler measurement could data on the incidence of RAO with 7.5-Fr sheathless guiding not identify any residual flow, the radial flow was graded catheters in patients with ACS were not available. We, as 0. +is meant that the radial artery had occluded therefore, presumed that the incidence of RAO would be completely. If it indicated severely reduced antegrade flow close to that of the 6-Fr Glidesheath slender, which has an in comparison to the contralateral side, the radial flow was outer diameter of 2.45 mm, as the outer diameter of the 7.5- graded as 1. +is meant that the radial artery was pulseless. Fr sheathless guiding catheter is similar, at 2.49 mm. In our study, RAO was defined as severely reduced (grade 1) or absent blood flow (grade 0) at the puncture site as 2.5. Ethics Approval. +e study was approved by the In- revealed by Doppler studies. Severe radial spasm was stitutional Research Committee of the Sendai Kousei defined as severe local pain and discomfort during Hospital (approval no: 1-97). All procedures performed in catheter movement that prompted the operator to stop the this study were in accordance with the ethical standards of procedure and crossover to the other route (grade 3) or the Institutional Research Committee and the 1964 Helsinki severe local pain and discomfort associated with catheter Declaration and its later amendments or comparable ethical trapping (grade 4) [3]. For better objectivity, two expe- standards. rienced research staff members, as independent observers, judged the incidence and severity of radial spasm based on the patients’ complaints and medical records on the day of 3. Results the PCI procedure. Procedural success was defined as the successful completion of transradial PCI that reached a +e study sample included 1108 patients who underwent postprocedural thrombolysis in myocardial infarction transradial PCI for ACS (Glidesheath group, n = 397; grade 3 flow and <30% coronary residual stenosis. +irty- Sheathless group, n = 711). Following propensity score day clinical outcomes included all-cause death, myocar- matching, 728 patients treated with PCI using a 7-Fr Gli- dial infarction, stent thrombosis, target-lesion revascu- desheath slender sheath/7-Fr guiding catheter combination larization (TLR), and stroke. or a 7.5-Fr sheathless guiding catheter were included in the Journal of Interventional Cardiology 5 matched population (Glidesheath group, n = 364; Sheathless groups, with no significant differences between them except group, n = 364). Key baseline clinical and procedural char- for RAO. acteristics of the study population are summarized in Ta- First, in the matched comparison, compared with that bles 1 and 2. In the unmatched patients, the Glidesheath observed with a sheathless guiding catheter, the incidence of group exhibited a significantly higher percentage of patients ultrasound-diagnosed postprocedural RAO at 30 days was with current smoking, previous PCI, left circumflex artery significantly less frequent when a Glidesheath slender lesions, and heavily calcified lesions and significantly less sheath/guiding catheter combination was used, although the previous ipsilateral transradial angiography attempts than outer diameter of the 7-Fr Glidesheath slender is larger than the Sheathless group. After propensity score matching, the that of the 7.5-Fr sheathless guiding catheter by 0.30 mm and baseline clinical and procedural characteristics were well a larger-bore device causes more RAO [2]. +e reason why balanced between the groups, except for the frequency of left we found the reverse might be due to more injury to radial circumflex artery lesions, the guiding catheter types used to artery by exchanging the 4-Fr conventional sheath for a perform PCI for left anterior descending or diagonal artery, sheathless guiding catheter. +at is, exchanging a 4-Fr sheath for a sheathless guiding catheter over a 0.035-inch guidewire and the rate of thrombus aspiration. +e procedural outcomes are shown in Table 3. In the may cause more extensive dissection of radial artery, matched patients, the procedural success rates were high for resulting in more RAO incidence. +is speculation is sup- the Glidesheath and Sheathless groups, with no significant ported by a recent study using optical coherence tomog- differences between them. +e total fluoro time was sig- raphy imaging, revealing that sheathless guiding system was nificantly longer in the Glidesheath group than in the not related to reduced radial injury and caused more medial Sheathless group (median [IQR], Glidesheath; 22.3 min dissection when compared to conventional sheath/guiding [15.3–31.5] vs. Sheathless; 18.7 min [13.8–29.5], p � 0.002). system [15]. In our opinion, the different nature of radial +e median number of catheters used per procedure was one artery injury at the puncture site might have caused the in each group. significantly different incidences of RAO between the two +e periprocedural access-site complications are pre- groups: a 7-Fr Glidesheath slender with a dilator directly tracking on a guidewire after radial puncture versus graded sented in Table 4. In the matched patients, the Glidesheath group was significantly less likely to develop ultrasound- injury by a 4-Fr sheath, followed by a 7.5-Fr sheathless diagnosed RAO at 30 days compared to the Sheathless group guiding catheter on the dilator. Studies have shown that a (Glidesheath: 1.4% vs. Sheathless: 4.1%, odds ratio (OR) 0.33, larger-bore device causes more RAO, and the outer diameter 95% confidence interval (CI) 0.12–0.91; p � 0.039), whereas of the 7-Fr Glidesheath slender is larger than that of the 7.5- the incidences of severe radial spasm and access-site major Fr sheathless guiding catheter by 0.30 mm. However, more bleeding defined by BARC type 3 or 5 criteria were not local damage to the puncture site by exchanging the 4-Fr significantly different between the two groups. Multivariate conventional sheath for a sheathless guiding catheter may logistic regression analysis of the matched patients to de- explain why we found the reverse in our study. In contrast, termine predictors of RAO at 30 days revealed that the the role of the length of the sheathless guiding system (outer choice for Glidesheath was significantly associated with less diameter 2.49 mm all the way to the coronary artery) as RAO at 30 days (OR 0.32, 95% CI 0.11–0.93; p � 0.036). compared to the 16 cm-long Glidesheath slender system Conversely, end-procedural ACT and total fluoro time were (outer diameter 2.79 mm for the length of the sheath) may not significantly associated with RAO at 30 days (Table 5). have had little impact on the incidences of RAO because +e 30-day clinical outcomes are presented in Table 6. +ere when a 16 cm-long 7-Fr Glidesheath slender sheath is in- were no significant between-group differences in the inci- troduced into the radial artery, the tip of the sheath will dences of all-cause death, myocardial infarction, stent reach the very proximal radial artery or the brachial artery. thrombosis, and TLR. Kaplan–Meier curve analysis results As a result, both the sheathless guiding catheter and Gli- for individual components of 30-day clinical outcomes desheath slender sheath are placed along the entire length of according to the type of guiding system are shown in the radial artery. Both would, therefore, damage the entire Supplementary Figures 1–5. radial artery similarly. Notably, unlike a sheathless guiding catheter, a Glidesheath slender sheath does not require exchange of sheaths in performing PCI, which may con- 4. Discussion tribute to avoiding extensive radial injury at the sheath insertion site. In case of exchanging the guiding catheter for To our knowledge, the present study is one of the first studies to compare the 7-Fr Glidesheath slender sheath/7-Fr guiding a larger/smaller size, more injury to radial artery is not expected in the Glidesheath group; the guiding catheters catheter combination with a 7.5-Fr sheathless Eaucath guiding catheter in a large cohort of patients undergoing pass inside the 16 cm-long Glidesheath slender sheath and transradial PCI for ACS. One of the strengths of the study is do not cause more damage to radial artery at the sheath the assessment of RAO incidence using ultrasound exami- insertion point. +erefore, the number of catheters used per nation 30 days after the procedure. +e main findings were procedure may not be related to the radial injury in the (i) incidence of RAO at 30 days was significantly less fre- Glidesheath group and we did not include it in the multi- quent when a Glidesheath slender/guiding catheter com- variate analysis to determine predictors of RAO. Never- theless, the two slender devices revealed low incidences of bination was used and (ii) overall incidences of access-site complications were low in the Glidesheath and Sheathless postprocedural RAO in our study (1.4% for Glidesheath and 6 Journal of Interventional Cardiology Table 1: Baseline clinical characteristics of the study population. Total population Propensity-matched population Variables Glidesheath n � 397 Sheathless n � 711 p Glidesheath n � 364 Sheathless n � 364 p Age, y 68.0 (58.0–77.0) 68.0 (58.0–77.0) 0.89 67.5 (57.3–76.0) 67.0 (57.0–75.0) 0.69 Sex (male), n (%) 318 (80.1) 554 (77.9) 0.44 292 (80.2) 289 (79.4) 0.85 Height, cm 165.0 (160.0–170.0) 164.5 (158.0–170.0) 0.068 165.7 (160.0–170.0) 165.0 (158.0–170.0) 0.23 Weight, kg 67.0 (58.0–76.0) 65.0 (57.0–74.0) 0.12 67.6 (58.0–77.0) 66.8 (58.0–75.5) 0.54 Body mass index, kg/m 24.6 (22.3–27.2) 24.3 (22.4–26.8) 0.51 24.6 (22.4–27.3) 24.6 (22.6–27.4) 0.64 Diabetes mellitus, n (%) 167 (42.1) 259 (36.4) 0.071 150 (41.2) 157 (43.1) 0.65 Hypertension, n (%) 315 (79.4) 557 (78.3) 0.76 286 (78.6) 282 (77.5) 0.79 Dyslipidemia, n (%) 270 (68.0) 475 (66.8) 0.69 243 (66.8) 247 (67.9) 0.81 Current smoker, n (%) 171 (43.1) 240 (33.8) 0.002 151 (41.5) 152 (41.8) 1.00 Peripheral artery disease, n (%) 11 (2.8) 24 (3.4) 0.72 9 (2.5) 12 (3.3) 0.66 Previous history of bleeding, n (%) 32 (8.1) 59 (8.3) 1.0 31 (8.5) 32 (8.8) 1.00 Previous history of heart failure, n (%) 25 (6.3) 36 (5.1) 0.41 18 (5.0) 21 (5.8) 0.74 Previous stroke, n (%) 21 (5.3) 45 (6.3) 0.51 20 (5.5) 23 (6.3) 0.75 Previous MI, n (%) 27 (6.8) 70 (9.9) 0.096 25 (6.9) 28 (7.7) 0.78 Previous PCI, n (%) 52 (13.1) 133 (18.7) 0.019 46 (12.6) 46 (12.6) 1.00 Previous CABG, n (%) 3 (0.8) 3 (0.4) 0.67 3 (0.8) 2 (0.6) 1.00 Oral anticoagulants, n (%) 39 (9.9) 75 (10.6) 0.76 34 (9.3) 35 (9.6) 1.00 Killip IV on admission, n (%) 13 (3.3) 14 (2.0) 0.22 9 (2.5) 10 (2.8) 1.00 eGFR, ml/min/1.73 m 74.6 (59.3–91.0) 75.1 (60.6–86.9) 0.87 75.4 (60.1–91.5) 77.3 (62.8–88.8) 0.72 Data are presented as median (interquartile range) or n (%), unless otherwise indicated. “Glidesheath” denotes 7-Fr Glidesheath slender/7-Fr guiding catheter combination group, and “Sheathless” denotes 7.5-Fr sheathless guiding catheter group. +e asterisk denotes a statistically significant difference between the two groups. CABG, coronary artery bypass grafting; eGFR, estimated glomerular filtration rate; MI, myocardial infarction; PCI, percutaneous coronary intervention. Table 2: Procedural characteristics of the study population. Total population Propensity-matched population Variables Glidesheath Sheathless Glidesheath Sheathless p p N � 397 N � 711 N � 364 N � 364 LAD/diagonal, n (%) 196 (49.4) 318 (44.7) 0.15 179 (49.2) 170 (46.7) 0.55 ∗ ∗ LCX/marginal, n (%) 37 (9.3) 144 (20.3) <0.001 33 (9.1) 72 (19.8) <0.001 RCA, n (%) 139 (35.0) 217 (30.5) 0.14 132 (36.3) 109 (30.0) 0.08 LMCA, n (%) 25 (6.3) 32 (4.5) 0.20 20 (5.5) 13 (3.6) 0.29 Guiding catheter type 143 (73.0)/51 263 (82.7)/54 132 (73.7)/46 144 (84.7)/26 ∗ ∗ LAD/diagonal (JL/EBU/others), n (%) 0.025 0.033 (26.0)/2 (1.0) (17.0)/1 (0.3) (25.7)/1 (0.6) (15.3)/0 (0) 13 (35.1)/23 79 (54.9)/65 12 (36.4)/20 42 (58.3)/30 LCX/marginal (JL/EBU/others), n (%) 0.019 0.050 (62.2)/1 (2.7) (45.1)/0 (0) (60.6)/1 (3.0) (41.7)/0 (0) 101 (72.7)/30 157 (72.4)/58 97 (73.5)/28 81 (74.3)/26 RCA (JR/AL/others), n (%) 0.018 0.22 (21.6)/8 (5.7) (26.7)/2 (0.9) (21.2)/7 (5.3) (23.9)/2 (1.8) 15 (60.0)/9 28 (87.5)/3 14 (70.0)/6 12 (92.3)/1 LMCA (JL/EBU/others), n (%) 0.0046 0.12 (36.0)/1 (4.0) (9.4)/1 (3.1) (30.0)/0 (0) (7.7)/0 (0) True bifurcation lesion, n (%) 67 (16.9) 99 (13.9) 0.19 58 (15.9) 51 (14.0) 0.53 In-stent restenosis/occlusion, n (%) 26 (6.6) 39 (5.5) 0.58 24 (6.6) 18 (5.0) 0.43 Diffuse lesion, n (%) 264 (66.5) 434 (61.0) 0.080 246 (67.6) 228 (62.6) 0.19 Heavily calcified lesion, n (%) 13 (3.3) 10 (1.4) 0.047 12 (3.3) 5 (1.4) 0.14 ∗ ∗ +rombus aspiration, n (%) 218 (54.9) 253 (35.6) <0.001 203 (55.8) 135 (37.1) <0.001 Rotablation, n (%) 8 (2.0) 6 (0.8) 0.16 7 (1.9) 2 (0.6) 0.18 Arterial access site Left radial, n (%) 373 (94.0) 679 (95.5) 0.26 344 (94.5) 343 (94.2) 1.00 No. of previous iTRA attempts, median 0 (0–9) 0 (0–11) 0.002 0 (0–9) 0 (0–11) 0.17 (min–max) No. of previous iTRI attempts, median 0 (0–7) 0 (0–7) 0.059 0 (0–7) 0 (0–7) 0.36 (min–max) Data are presented as median (interquartile range) or n (%), unless otherwise indicated. “Glidesheath” denotes 7-Fr Glidesheath slender/7-Fr guiding catheter combination group, and “Sheathless” denotes 7.5-Fr sheathless guiding catheter group. +e asterisk denotes a statistically significant difference between the two groups. AL, Amplatz type; EBU, extra backup type; iTRA, ipsilateral transradial coronary angiography; iTRI, ipsilateral transradial coronary intervention; JL, Judkins Left type; JR, Judkins Right type; LAD, left anterior descending coronary artery; LCX, left circumflex coronary artery; LMCA, left main coronary artery; RCA, right coronary artery. Journal of Interventional Cardiology 7 Table 3: Procedural outcomes. Total population Propensity-matched population Variables Glidesheath Sheathless Glidesheath Sheathless OR (95% CI) p OR (95% CI) p N � 397 N � 711 N � 364 N � 364 Procedural success, n 1.00 0.99 392 (98.7) 702 (98.7) 1.0 359 (98.6) 361 (99.2) 0.73 (%) (0.99–1.01) (0.98–1.01) Coronary ostial 1.86 0.50 3 (0.8) 10 (1.4) 0.40 3 (0.8) 6 (1.7) 0.51 dissection, n (%) (0.52–6.72) (0.13–1.98) Access-site crossover from radial to femoral, n 1 (0.3) 0 (0) n/a 0.36 1 (0.3) 0 (0) n/a 1.00 (%) Total fluoroscopy time, 22.4 18.2 22.3 18.7 ∗ ∗ <0.001 0.002 min (15.3–31.5) (13.9–28.0) (15.3–31.5) (13.8–29.5) 127 133 Contrast used, ml 128 (100–160) 0.67 128 (100–160) 0.11 (103–160) (105–165) No. of catheters used, ∗ ∗ 1 (1–5) 1 (1–4) <0.001 1 (1–5) 1 (1–4) 0.016 median (min–max) Data are presented as median (interquartile range) or n (%), unless otherwise indicated. “Glidesheath” denotes 7-Fr Glidesheath slender/7-Fr guiding catheter combination group, and “Sheathless” denotes 7.5-Fr sheathless guiding catheter group. +e asterisk denotes a statistically significant difference between the two groups. CI, confidence interval; n/a, not applicable; OR, odds ratio. Table 4: Periprocedural access-site complications. Total population Propensity-matched population Variables Glidesheath Sheathless Glidesheath Sheathless OR (95% CI) p OR (95% CI) p N � 397 N � 711 N � 364 N � 364 RAD at 30 days, mm 2.0 (1.8–2.3) 2.1 (1.8–2.4) 0.15 2.0 (1.8–2.3) 2.1 (1.8–2.4) 0.06 End-procedural ACT, 301 289 ∗ ∗ 273 (231–312) <0.001 273 (229–310) <0.001 s (250–376) (250–372) 0.43 0.33 RAO at 30 days, n (%) 6 (1.5) 25 (3.5) 0.058 5 (1.4) 15 (4.1) 0.039 (0.18–1.04) (0.12–0.91) Severe radial spasm, n 1.46 0.71 9 (2.3) 11 (1.6) 0.48 5 (1.4) 7 (1.9) 0.58 (%) (0.61–3.49) (0.23–2.22) Access-site major bleeding within 30 days BARC type 3 or 5, n 0.99 0.83 5 (1.3) 9 (1.3) 1.00 5 (1.4) 6 (1.6) 1.00 (%) (0.34–2.95) (0.26–2.71) 0.99 0.83 BARC type 3, n (%) 5 (1.3) 9 (1.3) 1.00 5 (1.4) 6 (1.6) 1.00 (0.34–2.95) (0.26–2.71) BARC type 5, n (%) 0 (0) 0 (0) n/a n/a 0 (0) 0 (0) n/a n/a Data are presented as median (interquartile range) or n (%), unless otherwise indicated. “Glidesheath” denotes 7-Fr Glidesheath slender/7-Fr guiding catheter combination group, and “Sheathless” denotes 7.5-Fr sheathless guiding catheter group. +e asterisk denotes a statistically significant difference between the two groups. ACT; activated clotting time; BARC, Bleeding Academic Research Consortium; CI, confidence interval; n/a, not applicable; OR, odds ratio; RAD, radial artery diameter; RAO, radial artery occlusion. 4.1% for Sheathless). Notably, with both the slender devices, size is usually larger than that of Japanese patients [16], the incidences of RAO were lower than or almost equal to resulting in less postprocedural RAO. Notably, in the Gli- those of conventional 6-Fr sheaths/guiding catheters. +ese desheath group, we only documented six cases of RAO in the results were reasonable, considering that the outer diameters total population and five in the propensity-matched pop- of these two devices are almost equal or smaller than those of ulation, yielding the incidences of RAO of 1.5% and 1.4%, conventional 6-Fr sheaths. By comparison, the incidences of respectively, which are lower than the incidence previously RAO of conventional 6-Fr sheaths are reportedly 3.5%– reported for a 7-Fr Glidesheath slender sheath (4.8%) [5]. 15.2% at ≥2 days after PCI [2]. +erefore, our data suggest Factors like intraprocedural anticoagulation of maintaining that using both the 7-Fr Glidesheath slender sheath and 7.5- an ACTof 300 s or longer might have contributed to this low Fr sheathless guiding catheter have equal or lower risk of incidence of RAO. Second, the overall incidences of access-site complica- RAO compared to conventional 6-Fr sheaths. Our study population was limited to Japanese patients; therefore, we do tions were low in the Glidesheath and Sheathless groups with not know whether these results can be generalized to other no significant differences between them except for RAO; the populations. However, these slender devices may be better in incidence of severe radial spasm during PCI was low, but not European or American patients because their radial artery significantly different between both them in the present 8 Journal of Interventional Cardiology Table 5: Multivariate logistic regression analysis to determine predictors of radial artery occlusion at 30 days. Variables Adjusted OR (95% CI) p Treatment modality (Glidesheath/Sheathless) 0.32 (0.11–0.93) 0.036 End-procedural ACT, per s 1.00 (0.99–1.00) 0.30 Total fluoroscopy time, per min 1.02 (1.00–1.04) 0.055 “Glidesheath” denotes 7-Fr Glidesheath slender/7-Fr guiding catheter combination group, and “Sheathless” denotes 7.5-Fr sheathless guiding catheter group. Of note, the number of catheters used per procedure was not included in the multivariate analysis. ACT, activated clotting time; CI, confidence interval; OR, odds ratio. Table 6: +irty-day clinical outcomes by Cox proportional hazard ratio model analysis. Cumulative events at 30 days (%) Variables Hazard ratio (95% CI) p Glidesheath Sheathless Total population All-cause death 4 (1.1) 1 (0.2) 7.30 (1.08–142.74) 0.075 Myocardial infarction 0 (0) 2 (0.3) 0.83 (0.04–8.67) 0.88 Stent thrombosis 4 (1.0) 1 (0.1) 8.94 (1.44–171.24) 0.046 TLR 0 (0) 1 (0.1) 1.68 (0.07–42.61) 0.71 Stroke 2 (0.5) 1 (0.1) 5.12 (0.65–103.56) 0.16 Propensity-matched population All-cause death 4 (1.2) 1 (0.3) 4.06 (0.60–79.31) 0.21 Myocardial infarction 0 (0) 1 (0.3) 0.87 (0.03–22.09) 0.92 Stent thrombosis 3 (0.8) 1 (0.3) 3.98 (0.59–77.80) 0.22 TLR 0 (0) 1 (0.3) 0.99 (0.86–1.15) 0.96 Stroke 2 (0.6) 0 (0) n/a n/a “Glidesheath” denotes the 7-Fr Glidesheath slender/7-Fr guiding catheter combination group and “Sheathless” denotes the 7.5-Fr sheathless guiding catheter group. +e asterisk denotes a statistically significant difference between the two groups. CI, confidence interval; n/a, not applicable; TLR, target-lesion revascularization. study. +is is not consistent with our previous study on characteristics and not the choice of the sheathless guiding elective transradial PCI using a 6.5-Fr sheathless guiding catheter because in our study, most dissections occurred in catheter vs. a 6-Fr Glidesheath slender [9]. +e advanced RCAs with moderate ostial stenosis. +erefore, in patients hydrophilic surface coating, which is common to both the with moderate ostial stenosis of the RCA, caution should be devices, might have made the detection of slight difference exercised during positioning and coaxial alignment of the difficult. Moreover, the assessment of radial spasm based on guiding catheters with the artery, irrespective of the catheter the subjective feelings of patients and subjective observa- type. tions by operators may also have led to inconsistent results. Access-site major bleeding events were not significantly 5. Study Limitations different between the two groups. +is is contradictory to a previous meta-analysis that demonstrated that a 5-Fr system +ere are several limitations to our study. First, this was a in transradial PCI significantly reduces bleeding frequency retrospective observational single-center study, and there- compared to a 6-Fr system [17]; the difference in outer fore, unknown associated factors in access-site complica- sheath size between the 5-Fr and 6-Fr sheaths was ap- tions may have been unequally distributed between the proximately 0.4 mm. +is suggested that the difference in groups. Second, the baseline clinical and the procedural outer sheath size between 7-Fr Glidesheath slender and 7.5- characteristics of the study population may not have been Fr sheathless guiding catheter (0.3 mm) was too small to sufficiently adjusted despite propensity score matching. As a cause a significant difference in the incidence of access-site result, more difficult cases might have been included in the major bleeding events between the two groups. Glidesheath group, which would explain the significantly Finally, the rates of catheter-induced coronary dissection longer fluoroscopy time. +e shorter fluoroscopy time in the were not significantly different between the two groups. In Sheathless group, interpreted differently, may indicate our study (n � 1108), coronary ostial dissection occurred in higher operator confidence, preference, and familiarity with 13 patients. Of note, 9 patients experienced right coronary the sheathless guiding system because the co-variables re- artery (RCA) ostial dissection (2.8% (6/217) for the garding propensity score matching did not include operator- Sheathless group and 2.2% (3/139) for the Glidesheath related factors. +ird, a randomized controlled trial would group, p � 0.75, respectively). One of the greatest concerns be needed to further validate our findings. Fourth, data with the use of sheathless guiding catheters in PCI is the risk pertaining to the pre-PCI Doppler evaluation were not of catheter-induced coronary dissection due to the greater obtained. Indeed, assessing the radial artery diameter 30 tip stiffness of their double-braiding design. In our opinion, days after PCI would have likely only introduced a slight RCA dissections may have been directly related to the lesion error in the measurement of radial artery size because the Journal of Interventional Cardiology 9 lumen of the radial artery at the puncture site remained denotes 7.5-Fr sheathless guiding catheter group; PCI, unchanged during follow-up, except for the distal part of the percutaneous coronary intervention. Supplementary Fig- puncture site [18]. +e variables that might have influenced ure 2: Kaplan–Meier curve analysis of myocardial infarction the size of the preprocedure radial artery, including sex and at 30 days according to the type of guiding system. “Gli- body mass index [16], were well balanced after propensity desheath” denotes 7-Fr Glidesheath slender/7-Fr guiding score matching. However, in reality, we do not know catheter combination group and “Sheathless” denotes 7.5-Fr whether or not the preprocedure radial artery diameter of sheathless guiding catheter group. Supplementary Figure 3: the Sheathless group was the same as that of the Glidesheath Kaplan–Meier curve analysis of stent thrombosis at 30 days group. Fifth, radial artery diameter is influenced by smoking according to the type of guiding system. “Glidesheath” [19]. We have no data on how many patients had quit denotes 7-Fr Glidesheath slender/7-Fr guiding catheter smoking at 30-day follow-up; however, many of them would combination group and “Sheathless” denotes 7.5-Fr have quit smoking because we advised all our patients to quit sheathless guiding catheter group. Supplementary Figure 4: smoking during hospitalization. Consequently, the pre- Kaplan–Meier curve analysis of TLR at 30 days according to procedure radial artery diameter could have been slightly the type of guiding system. “Glidesheath” denotes 7-Fr different from the postprocedure diameter. Sixth, despite Glidesheath slender/7-Fr guiding catheter combination statistical significance, the wide confidence interval of the group and “Sheathless” denotes 7.5-Fr sheathless guiding RAO result indicates that information needs to be collected catheter group; TLR, target-lesion revascularization. Sup- from a larger sample of patients with ACS to strengthen the plementary Figure 5: Kaplan–Meier curve analysis of stroke association. Lastly, morphology of acute radial artery in- at 30 days according to the type of guiding system. “Gli- juries after PCI was not assessed by optical coherence to- desheath” denotes 7-Fr Glidesheath slender/7-Fr guiding mography, and therefore, radial injury by sheath exchange catheter combination group and “Sheathless” denotes 7.5-Fr could not be completely identified as the immediate cause of sheathless guiding catheter group. Supplementary Figure 6: more frequency of RAO in the Sheathless group. graphical abstract. (Supplementary Materials) 6. Conclusions References We conducted a propensity score-based comparison of 7.5- [1] G. Ando` and D. Capodanno, “Radial versus femoral access in Fr sheathless guiding catheters vs. 7-Fr Glidesheath slender invasively managed patients with acute coronary syndrome,” sheaths/7-Fr guiding catheter combination in PCI for ACS. Annals of Internal Medicine, vol. 163, no. 12, pp. 932–940, We found that 7-Fr Glidesheath slender sheaths/7-Fr guiding catheter combination significantly reduced RAO, [2] M. Rashid, C. S. Kwok, S. Pancholy et al., “Radial artery occlusion after transradial interventions: A systematic review while maintaining a low incidence of severe radial spasm or and meta-analysis,” Journal of the American Heart Associa- access-site major bleeding and keeping an acceptable pro- tion, vol. 5, no. 1, Article ID e002686, 2016. cedural success rate, with no significant differences between [3] A. Goldsmit, F. Kiemeneij, I. C. Gilchrist et al., “Radial artery the groups. Our data suggest a greater advantage of Gli- spasm associated with transradial cardiovascular procedures: desheath slender sheaths over sheathless guiding catheters Results from the RAS registry,” Catheterization and Cardio- for decreased risk of RAO and inspire the expansion of the vascular Interventions, vol. 83, no. 1, pp. E32–E36, 2014. “slender sheath-first” approach in transradial PCI for ACS. [4] M. A. Mamas, F. Fath-Ordoubadi, and D. G. Fraser, “Atraumatic complex transradial intervention using large Data Availability bore sheathless guide catheter,” Catheterization and Cardio- vascular Interventions, vol. 72, no. 3, pp. 357–364, 2008. +e data used to support the findings of this study are [5] A. Aminian, J. F. Iglesias, C. Van Mieghem et al., “First available from the corresponding author upon request. prospective multicenter experience with the 7 French Gli- desheath slender for complex transradial coronary inter- Conflicts of Interest ventions,” Catheterization and Cardiovascular Interventions, vol. 89, no. 6, pp. 1014–1020, 2017. +e authors declare that they have no conflicts of interest. [6] A. Aminian, D. Dolatabadi, P. Lefebvre et al., “Initial expe- rience with the Glidesheath Slender for transradial coronary Acknowledgments angiography and intervention: A feasibility study with pro- spective radial ultrasound follow-up,” Catheterization and We would like to thank Manami Kumagai, Ai Saito, Shizuka Cardiovascular Interventions, vol. 84, no. 3, pp. 436–442, 2014. Ito, Keisuke Ishida, and Toru Okuzono at the Sendai Kousei [7] I. Borja, S. James, S. Agewall et al., “2017 ESC guidelines for Hospital for helping with the work and collection of data. the management of acute myocardial infarction in patients presenting with ST-segment elevation: +e task force for the Supplementary Materials management of acute myocardial infarction in patients pre- senting with ST-segment elevation of the European Society of Supplementary Figure 1: Kaplan–Meier curve analysis of all- Cardiology (ESC),” European Heart Journal, vol. 39, cause death at 30 days according to the type of guiding pp. 119–177, 2018. system. “Glidesheath” denotes 7-Fr Glidesheath slender/7-Fr [8] M. Mamas, S. D’Souza, C. Hendry et al., “Use of the sheathless guiding catheter combination group and “Sheathless” guide catheter during routine transradial percutaneous 10 Journal of Interventional Cardiology coronary intervention: A feasibility study,” Catheterization and Cardiovascular Interventions, vol. 75, no. 4, pp. 596–602, [9] K. Horie, N. Tada, T. Isawa et al., “A randomised comparison of incidence of radial artery occlusion and symptomatic radial artery spasm associated with elective transradial coronary intervention using 6.5 Fr SheathLess Eaucath guiding Cath- eter vs. 6.0 Fr Glidesheath slender,” EuroIntervention, vol. 13, no. 17, pp. 2018–2025, 2018. [10] S. Noble, E. Tessitore, B. Gencer et al., “A randomized study of sheathless vs standard guiding catheters for transradial per- cutaneous coronary interventions,” Canadian Journal of Cardiology, vol. 32, no. 12, pp. 1425–1432, 2016. [11] T. Sakatani, T. Kawasaki, M. Hadase, T. Kamitani, S. Kawasaki, and H. Sugihara, “Novel application of the he- mostatic device TOMETA KUN,” Circulation Journal, vol. 67, no. 10, pp. 895–897, 2003. [12] R. Mehran, S. V. Rao, D. L. Bhatt et al., “Standardized bleeding definitions for cardiovascular clinical trials,” Circulation, vol. 123, no. 23, pp. 2736–2747, 2011. [13] S. Saito, H. Ikei, G. Hosokawa, and S. Tanaka, “Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary in- tervention,” Catheterization and Cardiovascular Interven- tions, vol. 46, no. 2, pp. 173–178, 1999. [14] G. Hahalis, G. Tsigkas, N. Kounis et al., “Prevention of radial artery occlusions following coronary procedures: Forward and backward steps in improving radial artery patency rates,” Angiology, vol. 69, no. 9, pp. 755–762, 2018. [15] D. J. van der Heijden, M. A. H. van Leeuwen, S. L. Brinckman et al., “+e impact on radial injury of sheathless versus conventional access for transradial interventions: A ran- domized trial,” EuroIntervention, 2019. [16] M. A. Kotowycz, K. W. Johnston, J. Ivanov et al., “Predictors of radial artery size in patients undergoing cardiac cathe- terization: insights from the Good Radial Artery Size Pre- diction (GRASP) study,” Canadian Journal of Cardiology, vol. 30, no. 2, pp. 211–216, 2014. [17] A. Polimeni, F. Passafaro, S. De Rosa et al., “Clinical and procedural outcomes of 5-French versus 6-French sheaths in transradial coronary interventions,” Medicine, vol. 94, no. 52, Article ID e2170, 2015. [18] F. Costa, M. A. van Leeuwen, J. Daemen et al., “+e Rotterdam radial access research: Ultrasound-based radial artery evalu- ation for diagnostic and therapeutic coronary procedures,” Circulation: Cardiovascular Interventions, vol. 9, no. 2, Article ID e003129, 2016. [19] M. Failla, A. Grappiolo, S. Carugo, I. Calchera, C. Giannattasio, and G. Mancia, “Effects of cigarette smoking on carotid and radial artery distensibility,” Journal of Hy- pertension, vol. 15, no. 12, pp. 1659–1664, 1997. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Interventional Cardiology Hindawi Publishing Corporation

Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices

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Hindawi Journal of Interventional Cardiology Volume 2020, Article ID 8216831, 10 pages https://doi.org/10.1155/2020/8216831 Research Article Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices 1 1 1 2 1 Tsuyoshi Isawa , Kazunori Horie, Taku Honda, Masataka Taguri, and Norio Tada Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan Department of Data Science, Yokohama City University School of Data Science, Yokohama, Japan Correspondence should be addressed to Tsuyoshi Isawa; isa_tsuyo@yahoo.co.jp Received 27 May 2020; Revised 26 July 2020; Accepted 3 August 2020; Published 14 August 2020 Academic Editor: Leonardo De Luca Copyright © 2020 Tsuyoshi Isawa et al. +is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. A Glidesheath slender (Terumo, Tokyo, Japan) and a sheathless Eaucath guiding catheter (Asahi Intecc, Nagoya, Japan) are two major slender devices utilized in percutaneous coronary intervention (PCI). +is study aimed to investigate the differences in access-site complications between these devices in PCI for acute coronary syndrome (ACS). A total of 1108 consecutive patients who underwent transradial PCI for ACS were enrolled. Transradial PCI was performed using either a 7-Fr Glidesheath slender/7- Fr guiding catheter combination (Glidesheath group) or a 7.5-Fr sheathless guiding catheter (Sheathless group); 1 :1 propensity score matching was performed, and 728 patients (364 in each group) were included in the propensity-matched population. In the matched patients, univariate analysis revealed that the Glidesheath group had less radial artery occlusion (RAO) at 30 days (Glidesheath: 1.4% vs. Sheathless: 4.1%, odds ratio (OR) � 0.33, 95% confidence interval (CI) � 0.12–0.91, p � 0.039), whereas no significant between-group differences were observed in severe radial spasm (Glidesheath: 1.4% vs. Sheathless: 1.9%, OR � 0.71, 95% CI � 0.23–2.22, p � 0.58) or access-site major bleeding (Glidesheath: 1.4% vs. Sheathless: 1.6%, OR � 0.83, 95% CI � 0.26–2.71, p � 1.00). Multivariate analysis revealed that the choice for Glidesheath was significantly associated with less RAO (OR � 0.32, 95% CI � 0.11–0.93, p � 0.036). In conclusion, 7-Fr Glidesheath slender/7-Fr guiding catheter combination is obviously more advantageous than 7.5-Fr sheathless guiding catheters for decreased risk of RAO. +e potential low risk of RAO in our findings supports the adoption of the 7-Fr Glidesheath slender sheath/7-Fr guiding catheter combination in transradial PCI for ACS. catheter system without a conventional sheath [4–6]. Re- 1. Introduction garding the device profile, difference in the outer diameter +e standard treatment for acute coronary syndrome (ACS) between a 7-Fr Glidesheath slender and 7.5-Fr sheathless is transradial percutaneous coronary intervention (PCI), guiding catheter is 0.30 mm (Figure 1). +e outer diameters which has considerably better outcomes than transfemoral of the 7.5-Fr sheathless guiding catheter and the 7-Fr Gli- PCI [1]. Although the default approach for PCI is via radial desheath slender are smaller than, or almost equal to, that of access, access-site complications, like radial artery occlusion the conventional 6-Fr sheath, which is currently used as the (RAO) [2] and radial spasm [3], are still encountered due to mainstream sheath in transradial PCI. During preparation overstretch and injury of the radial artery. Several slender for PCI for ACS, it is reasonable to select either a 7-Fr (downsized) devices have been developed based on the Glidesheath slender system or 7.5-Fr sheathless guiding hypothesis that smaller guiding catheters or sheaths reduce system. +ey provide better backup support than the con- the risk of access-site complications. Two such devices are ventional 6-Fr system, and they are sufficiently downsized Glidesheath slender sheath (Terumo, Tokyo, Japan), which is and consequently may lead to less or equal radial overstretch a thin-walled radial sheath, and a sheathless Eaucath guiding and injury than the conventional 6-Fr system. +e rates of catheter (Asahi Intecc, Nagoya, Japan), which is a guiding RAO associated with 7-Fr Glidesheath slender sheaths or 2 Journal of Interventional Cardiology 7.5-Fr Sheathless 6-Fr conventional sheath 7-Fr Glidesheath slender 7-Fr conventional sheath 2.49 2.70 2.79 3.00 OD, mm (6-Fr guide) (7-Fr guide) ) ID, mm 2.06 1.78 2.06 2.06 Figure 1: Comparison of the outer diameter and inner lumen diameters among the Glidesheath slender sheath, sheathless guiding catheter, and conventional sheath (illustration prepared by the authors with reference to the Glidesheath slender sheath and Sheathless Eaucath ® ® information brochures). “Glidesheath slender” denotes a Glidesheath slender sheath, and “Sheathless” denotes a sheathless guiding catheter. ID, inner lumen diameter; OD, outer diameter. 7.5-Fr sheathless guiding catheters are expected to be lower Hyperion guiding catheter (Asahi Intecc) combination, (iii) than, or almost equal to, those of the 6-Fr conventional refusal to participate, and (iv) loss of follow-up. Conse- sheath. Furthermore, they are better than the conventional quently, we retrospectively evaluated 1108 patients who 6-Fr system for optimal aspiration of thrombus. Larger underwent transradial PCI using 7-Fr Glidesheath slender caliber devices can aspirate a larger volume of thrombus as a sheath/7-Fr Hyperion guiding catheter combination (Gli- result of the increased proximal cross-sectional area of the desheath group) (n � 397) or 7.5-Fr sheathless Eaucath aspiration device. Although routine thrombus aspiration is guiding catheter (Sheathless group) (n � 711). not recommended, in cases of a large residual thrombus burden after opening the vessel with a guidewire or a bal- 2.2. PCI Procedure and Radial Ultrasound Study. After ad- loon, thrombus aspiration is still considered [7]. Previous ministration of nitroglycerin oral spray (0.3 mg; Myocor reports have demonstrated access-site complications in Spray; Toaeiyo, Tokyo, Japan) to patients with ACS, other transradial PCI using Glidesheath slender sheaths (RAO than those with Killip class IV, the radial artery was 0.8%–4.8% and radial spasm 2.3%–11.0%) and using punctured 2 cm proximal to the radius styloid process using sheathless guiding catheters (RAO 0.0%–3.2% and radial the Seldinger technique (posterior wall puncture) with 18- spasm 0.7%–5.0%) [5, 6, 8–10]. However, no previous study Ga puncture needles (Supercath; Medikit, Tokyo, Japan) has compared the 7-Fr Glidesheath slender/7-Fr guiding under local anesthesia. +e choice of guiding system (7.5-Fr catheter combination with the 7.5-Fr sheathless guiding sheathless guiding catheter or 7-Fr Glidesheath slender catheter in terms of the access-site complications in a large sheath/7-Fr guiding catheter combination) was at the op- sample of patients with ACS treated with transradial PCI. erator’s discretion. In cases where a 16 cm-long 7-Fr Gli- +erefore, we aimed to investigate the differences between desheath slender sheath was selected, after coronary the 7-Fr Glidesheath slender sheath/7-Fr guiding catheter angiography using a 4-Fr diagnostic catheter with a 7-Fr combination and 7.5-Fr sheathless Eaucath guiding system Glidesheath slender sheath, a 7-Fr Hyperion guiding cath- in terms of access-site complications in transradial PCI for eter equipped with an inner dilator (5.5-Fr STA Angiog- ACS, using propensity score matching analysis. raphy Catheter; Medikit, Tokyo, Japan) was inserted into the radial artery via the Glidesheath slender. In this study, a 2. Materials and Methods 16 cm-long 7-Fr Glidesheath slender was used, while a 10 cm-long one was not available. In all patients who un- 2.1. Patient Selection. +is was a single-center retrospective derwent PCI using 7-Fr Glidesheath slender sheaths, 7-Fr study that included patients with ACS who underwent Hyperion guiding catheters were used for coronary intu- transradial PCI in which either the 7-Fr Glidesheath slender/ bation. In cases where the 7.5-Fr sheathless guiding catheter 7-Fr guiding catheter or 7.5-Fr sheathless guiding catheter was selected, a sheath-cum-sheathless technique was used. was used. Figure 2 shows a flowchart of the study design and After coronary angiography using a 4-Fr diagnostic catheter patient selection criteria. We screened 1562 consecutive with a 4-Fr conventional sheath, a 4-Fr conventional sheath patients who underwent PCI for ACS, including ST-eleva- was subsequently exchanged for a 7.5-Fr sheathless guiding tion myocardial infarction and non-ST-elevation ACS, at the catheter connected to a supplied central dilator over a Sendai Kousei Hospital between January 2015 and February J-tipped 0.035-inch guidewire and inserted into the radial 2019. +e exclusion criteria were as follows: (i) PCI via artery (Figure 3). All PCI procedures were performed after femoral or brachial access, (ii) transradial PCI using guiding intra-arterial heparin administration (10,000 U). +e acti- catheter systems other than 7.5-Fr sheathless Eaucath vated clotting time (ACT) was noted 3 min after the first guiding catheters or 7-Fr Glidesheath slender sheaths/7-Fr administration of heparin and every 1 h thereafter. Heparin Journal of Interventional Cardiology 3 Consecutive patients with ACS undergoing PCI at our hospital (n = 1562) Exclusion (i) Transfemoral or transbrachial PCI (n = 206) (ii) Use of 6.5-Fr sheathless guiding catheter or 6-Fr sheath system (n = 198) (iii) Refusal to participate or loss of follow-up (n = 50) Eligible patients included in the study (n = 1108) 7-Fr Glidesheath slender/7-Fr guiding catheter (n = 397) 7.5-Fr sheathless guiding catheter (n = 711) 1 : 1 propensity score matching Glidesheath group (n = 364) Sheathless group (n = 364) Figure 2: Flowchart of study design and patient selection criteria. ACS, acute coronary syndrome; PCI, percutaneous coronary intervention. Figure 3: Sheathless transradial percutaneous coronary intervention procedure. (a) A central dilator is introduced into a guiding catheter. (b) A 4-Fr conventional sheath is inserted into the radial artery. (c) Following introduction, the sheath is exchanged for a sheathless guiding catheter connected to a supplied central dilator over a 0.035-inch wire. (d) A silicon-based stopper is linked to the proximal shaft of the sheathless guiding catheter and anchored to a surgical drape using forceps to avoid slippage. was administered additionally to maintain an ACTof≥300 s. sealed with a compression device (TOMETA KUN; Zeon End-procedural ACT was immediately measured before Medical, Tokyo, Japan) [11] and pressurized up to the ref- removing the guiding catheter at the end of the procedure. erence pressure (defined as ≥20 mmHg over the systolic After removing the sheathless guiding catheter or the Gli- blood pressure at the time of guiding catheter removal). desheath slender sheath, the punctured radial artery was +irty minutes after removal, the pressure was dropped by 4 Journal of Interventional Cardiology 2.4. Statistical Analysis. Continuous variables are expressed 20 mmHg every 1 h until it reached 20 mmHg. +e com- pression device was removed 8–9 h after the procedure. In all as median (interquartile range (IQR)), and categorical variables are expressed as frequency (%). Continuous var- patients, hemostasis was performed according to the aforementioned protocol, which was an occlusive hemo- iables were compared using the Mann–Whitney U test, while stasis technique. categorical variables were compared using Fisher’s exact test. Ultrasound measurements of the radial artery were taken For alleviating potential selection bias between the two 30 days after the index PCI. A single experienced vascular groups, a propensity score was estimated using a multi- sonographer, who had no knowledge of the techniques and variate logistic regression model. +e co-variables included the devices used for PCI, performed all ultrasonography in the model were selected based on the results of the univariate analysis/clinical perspective including age, sex, examinations using Doppler ultrasonography with the Toshiba Aplio XG SSA-790A (Toshiba Medical Systems body mass index, diabetes mellitus, hypertension, dyslipi- demia, current smoking, peripheral artery disease, history of Corporation, Otawara, Japan) and a PLT-1204AT (2D, 12 MHz) or a PLT-1204BT (2D, 12 MHz) probe or with the previous bleeding requiring hospitalization or transfusion, history of stroke and myocardial infarction, previous PCI, Aplio i800 (Canon Medical Systems, Tustin, CA) with an i24LX8 (2D, 24 MHz) probe. +e measurements were made previous coronary artery bypass grafting, use of oral anti- 2 cm proximal to the styloid process of the radius. +e ar- coagulants, Killip class on admission, estimated glomerular terial puncture site and subsequent sheath insertion site were filtration rate, arterial access site (left or right radial artery identified by visual confirmation using the skin scar at the approach), and the number of previous ipsilateral trans- sheath insertion site as a landmark. +us, arterial puncture, radial coronary angiography or intervention attempts sheath insertion, and ultrasound measurement were done at [2, 14]. Notably, these co-variables only included those that would be known at the time of the point of catheter selection. the same site. +e radial artery diameter was defined as the distance from the leading edge of the near wall to the leading +e C-statistic for the propensity score model was 0.62, and 1 :1 matching on the propensity score was performed using edge of the far wall of the artery along a line perpendicular to the long axis of the artery. nearest neighbor matching with a maximum caliper of 0.05 of the propensity score. In both groups, clinical outcomes within 30 days were compared using the Cox proportional 2.3.DefinitionofEndpoints. +e endpoints were RAO at 30 hazard models and Kaplan–Meier method. A two-tailed days, severe radial spasm during PCI, access-site major p value of <0.05 was considered statistically significant. All bleeding within 30 days as defined by the Bleeding Ac- statistical analyses were performed using JMP software ademic Research Consortium (BARC) type 3 or 5 criteria (version 14, SAS Institute Inc., Cary, NC, USA). +e initial [12], coronary ostial dissection by the guiding catheters, sample size calculation was performed to detect a 4% dif- procedural success, and clinical outcomes within 30 days. ference in the incidences of RAO (Sheathless group: 0.8%; RAO was defined as severely reduced or absent blood flow Glidesheath group: 4.8%) with a power of 80% and type I at the puncture site as revealed by Doppler studies. +e error of 5%. A sample size of 632 patients (316 in each group) Doppler criteria for diagnosing RAO were based on a was required [5, 6]. At the time of planning the study, the previous study [13]. If the Doppler measurement could data on the incidence of RAO with 7.5-Fr sheathless guiding not identify any residual flow, the radial flow was graded catheters in patients with ACS were not available. We, as 0. +is meant that the radial artery had occluded therefore, presumed that the incidence of RAO would be completely. If it indicated severely reduced antegrade flow close to that of the 6-Fr Glidesheath slender, which has an in comparison to the contralateral side, the radial flow was outer diameter of 2.45 mm, as the outer diameter of the 7.5- graded as 1. +is meant that the radial artery was pulseless. Fr sheathless guiding catheter is similar, at 2.49 mm. In our study, RAO was defined as severely reduced (grade 1) or absent blood flow (grade 0) at the puncture site as 2.5. Ethics Approval. +e study was approved by the In- revealed by Doppler studies. Severe radial spasm was stitutional Research Committee of the Sendai Kousei defined as severe local pain and discomfort during Hospital (approval no: 1-97). All procedures performed in catheter movement that prompted the operator to stop the this study were in accordance with the ethical standards of procedure and crossover to the other route (grade 3) or the Institutional Research Committee and the 1964 Helsinki severe local pain and discomfort associated with catheter Declaration and its later amendments or comparable ethical trapping (grade 4) [3]. For better objectivity, two expe- standards. rienced research staff members, as independent observers, judged the incidence and severity of radial spasm based on the patients’ complaints and medical records on the day of 3. Results the PCI procedure. Procedural success was defined as the successful completion of transradial PCI that reached a +e study sample included 1108 patients who underwent postprocedural thrombolysis in myocardial infarction transradial PCI for ACS (Glidesheath group, n = 397; grade 3 flow and <30% coronary residual stenosis. +irty- Sheathless group, n = 711). Following propensity score day clinical outcomes included all-cause death, myocar- matching, 728 patients treated with PCI using a 7-Fr Gli- dial infarction, stent thrombosis, target-lesion revascu- desheath slender sheath/7-Fr guiding catheter combination larization (TLR), and stroke. or a 7.5-Fr sheathless guiding catheter were included in the Journal of Interventional Cardiology 5 matched population (Glidesheath group, n = 364; Sheathless groups, with no significant differences between them except group, n = 364). Key baseline clinical and procedural char- for RAO. acteristics of the study population are summarized in Ta- First, in the matched comparison, compared with that bles 1 and 2. In the unmatched patients, the Glidesheath observed with a sheathless guiding catheter, the incidence of group exhibited a significantly higher percentage of patients ultrasound-diagnosed postprocedural RAO at 30 days was with current smoking, previous PCI, left circumflex artery significantly less frequent when a Glidesheath slender lesions, and heavily calcified lesions and significantly less sheath/guiding catheter combination was used, although the previous ipsilateral transradial angiography attempts than outer diameter of the 7-Fr Glidesheath slender is larger than the Sheathless group. After propensity score matching, the that of the 7.5-Fr sheathless guiding catheter by 0.30 mm and baseline clinical and procedural characteristics were well a larger-bore device causes more RAO [2]. +e reason why balanced between the groups, except for the frequency of left we found the reverse might be due to more injury to radial circumflex artery lesions, the guiding catheter types used to artery by exchanging the 4-Fr conventional sheath for a perform PCI for left anterior descending or diagonal artery, sheathless guiding catheter. +at is, exchanging a 4-Fr sheath for a sheathless guiding catheter over a 0.035-inch guidewire and the rate of thrombus aspiration. +e procedural outcomes are shown in Table 3. In the may cause more extensive dissection of radial artery, matched patients, the procedural success rates were high for resulting in more RAO incidence. +is speculation is sup- the Glidesheath and Sheathless groups, with no significant ported by a recent study using optical coherence tomog- differences between them. +e total fluoro time was sig- raphy imaging, revealing that sheathless guiding system was nificantly longer in the Glidesheath group than in the not related to reduced radial injury and caused more medial Sheathless group (median [IQR], Glidesheath; 22.3 min dissection when compared to conventional sheath/guiding [15.3–31.5] vs. Sheathless; 18.7 min [13.8–29.5], p � 0.002). system [15]. In our opinion, the different nature of radial +e median number of catheters used per procedure was one artery injury at the puncture site might have caused the in each group. significantly different incidences of RAO between the two +e periprocedural access-site complications are pre- groups: a 7-Fr Glidesheath slender with a dilator directly tracking on a guidewire after radial puncture versus graded sented in Table 4. In the matched patients, the Glidesheath group was significantly less likely to develop ultrasound- injury by a 4-Fr sheath, followed by a 7.5-Fr sheathless diagnosed RAO at 30 days compared to the Sheathless group guiding catheter on the dilator. Studies have shown that a (Glidesheath: 1.4% vs. Sheathless: 4.1%, odds ratio (OR) 0.33, larger-bore device causes more RAO, and the outer diameter 95% confidence interval (CI) 0.12–0.91; p � 0.039), whereas of the 7-Fr Glidesheath slender is larger than that of the 7.5- the incidences of severe radial spasm and access-site major Fr sheathless guiding catheter by 0.30 mm. However, more bleeding defined by BARC type 3 or 5 criteria were not local damage to the puncture site by exchanging the 4-Fr significantly different between the two groups. Multivariate conventional sheath for a sheathless guiding catheter may logistic regression analysis of the matched patients to de- explain why we found the reverse in our study. In contrast, termine predictors of RAO at 30 days revealed that the the role of the length of the sheathless guiding system (outer choice for Glidesheath was significantly associated with less diameter 2.49 mm all the way to the coronary artery) as RAO at 30 days (OR 0.32, 95% CI 0.11–0.93; p � 0.036). compared to the 16 cm-long Glidesheath slender system Conversely, end-procedural ACT and total fluoro time were (outer diameter 2.79 mm for the length of the sheath) may not significantly associated with RAO at 30 days (Table 5). have had little impact on the incidences of RAO because +e 30-day clinical outcomes are presented in Table 6. +ere when a 16 cm-long 7-Fr Glidesheath slender sheath is in- were no significant between-group differences in the inci- troduced into the radial artery, the tip of the sheath will dences of all-cause death, myocardial infarction, stent reach the very proximal radial artery or the brachial artery. thrombosis, and TLR. Kaplan–Meier curve analysis results As a result, both the sheathless guiding catheter and Gli- for individual components of 30-day clinical outcomes desheath slender sheath are placed along the entire length of according to the type of guiding system are shown in the radial artery. Both would, therefore, damage the entire Supplementary Figures 1–5. radial artery similarly. Notably, unlike a sheathless guiding catheter, a Glidesheath slender sheath does not require exchange of sheaths in performing PCI, which may con- 4. Discussion tribute to avoiding extensive radial injury at the sheath insertion site. In case of exchanging the guiding catheter for To our knowledge, the present study is one of the first studies to compare the 7-Fr Glidesheath slender sheath/7-Fr guiding a larger/smaller size, more injury to radial artery is not expected in the Glidesheath group; the guiding catheters catheter combination with a 7.5-Fr sheathless Eaucath guiding catheter in a large cohort of patients undergoing pass inside the 16 cm-long Glidesheath slender sheath and transradial PCI for ACS. One of the strengths of the study is do not cause more damage to radial artery at the sheath the assessment of RAO incidence using ultrasound exami- insertion point. +erefore, the number of catheters used per nation 30 days after the procedure. +e main findings were procedure may not be related to the radial injury in the (i) incidence of RAO at 30 days was significantly less fre- Glidesheath group and we did not include it in the multi- quent when a Glidesheath slender/guiding catheter com- variate analysis to determine predictors of RAO. Never- theless, the two slender devices revealed low incidences of bination was used and (ii) overall incidences of access-site complications were low in the Glidesheath and Sheathless postprocedural RAO in our study (1.4% for Glidesheath and 6 Journal of Interventional Cardiology Table 1: Baseline clinical characteristics of the study population. Total population Propensity-matched population Variables Glidesheath n � 397 Sheathless n � 711 p Glidesheath n � 364 Sheathless n � 364 p Age, y 68.0 (58.0–77.0) 68.0 (58.0–77.0) 0.89 67.5 (57.3–76.0) 67.0 (57.0–75.0) 0.69 Sex (male), n (%) 318 (80.1) 554 (77.9) 0.44 292 (80.2) 289 (79.4) 0.85 Height, cm 165.0 (160.0–170.0) 164.5 (158.0–170.0) 0.068 165.7 (160.0–170.0) 165.0 (158.0–170.0) 0.23 Weight, kg 67.0 (58.0–76.0) 65.0 (57.0–74.0) 0.12 67.6 (58.0–77.0) 66.8 (58.0–75.5) 0.54 Body mass index, kg/m 24.6 (22.3–27.2) 24.3 (22.4–26.8) 0.51 24.6 (22.4–27.3) 24.6 (22.6–27.4) 0.64 Diabetes mellitus, n (%) 167 (42.1) 259 (36.4) 0.071 150 (41.2) 157 (43.1) 0.65 Hypertension, n (%) 315 (79.4) 557 (78.3) 0.76 286 (78.6) 282 (77.5) 0.79 Dyslipidemia, n (%) 270 (68.0) 475 (66.8) 0.69 243 (66.8) 247 (67.9) 0.81 Current smoker, n (%) 171 (43.1) 240 (33.8) 0.002 151 (41.5) 152 (41.8) 1.00 Peripheral artery disease, n (%) 11 (2.8) 24 (3.4) 0.72 9 (2.5) 12 (3.3) 0.66 Previous history of bleeding, n (%) 32 (8.1) 59 (8.3) 1.0 31 (8.5) 32 (8.8) 1.00 Previous history of heart failure, n (%) 25 (6.3) 36 (5.1) 0.41 18 (5.0) 21 (5.8) 0.74 Previous stroke, n (%) 21 (5.3) 45 (6.3) 0.51 20 (5.5) 23 (6.3) 0.75 Previous MI, n (%) 27 (6.8) 70 (9.9) 0.096 25 (6.9) 28 (7.7) 0.78 Previous PCI, n (%) 52 (13.1) 133 (18.7) 0.019 46 (12.6) 46 (12.6) 1.00 Previous CABG, n (%) 3 (0.8) 3 (0.4) 0.67 3 (0.8) 2 (0.6) 1.00 Oral anticoagulants, n (%) 39 (9.9) 75 (10.6) 0.76 34 (9.3) 35 (9.6) 1.00 Killip IV on admission, n (%) 13 (3.3) 14 (2.0) 0.22 9 (2.5) 10 (2.8) 1.00 eGFR, ml/min/1.73 m 74.6 (59.3–91.0) 75.1 (60.6–86.9) 0.87 75.4 (60.1–91.5) 77.3 (62.8–88.8) 0.72 Data are presented as median (interquartile range) or n (%), unless otherwise indicated. “Glidesheath” denotes 7-Fr Glidesheath slender/7-Fr guiding catheter combination group, and “Sheathless” denotes 7.5-Fr sheathless guiding catheter group. +e asterisk denotes a statistically significant difference between the two groups. CABG, coronary artery bypass grafting; eGFR, estimated glomerular filtration rate; MI, myocardial infarction; PCI, percutaneous coronary intervention. Table 2: Procedural characteristics of the study population. Total population Propensity-matched population Variables Glidesheath Sheathless Glidesheath Sheathless p p N � 397 N � 711 N � 364 N � 364 LAD/diagonal, n (%) 196 (49.4) 318 (44.7) 0.15 179 (49.2) 170 (46.7) 0.55 ∗ ∗ LCX/marginal, n (%) 37 (9.3) 144 (20.3) <0.001 33 (9.1) 72 (19.8) <0.001 RCA, n (%) 139 (35.0) 217 (30.5) 0.14 132 (36.3) 109 (30.0) 0.08 LMCA, n (%) 25 (6.3) 32 (4.5) 0.20 20 (5.5) 13 (3.6) 0.29 Guiding catheter type 143 (73.0)/51 263 (82.7)/54 132 (73.7)/46 144 (84.7)/26 ∗ ∗ LAD/diagonal (JL/EBU/others), n (%) 0.025 0.033 (26.0)/2 (1.0) (17.0)/1 (0.3) (25.7)/1 (0.6) (15.3)/0 (0) 13 (35.1)/23 79 (54.9)/65 12 (36.4)/20 42 (58.3)/30 LCX/marginal (JL/EBU/others), n (%) 0.019 0.050 (62.2)/1 (2.7) (45.1)/0 (0) (60.6)/1 (3.0) (41.7)/0 (0) 101 (72.7)/30 157 (72.4)/58 97 (73.5)/28 81 (74.3)/26 RCA (JR/AL/others), n (%) 0.018 0.22 (21.6)/8 (5.7) (26.7)/2 (0.9) (21.2)/7 (5.3) (23.9)/2 (1.8) 15 (60.0)/9 28 (87.5)/3 14 (70.0)/6 12 (92.3)/1 LMCA (JL/EBU/others), n (%) 0.0046 0.12 (36.0)/1 (4.0) (9.4)/1 (3.1) (30.0)/0 (0) (7.7)/0 (0) True bifurcation lesion, n (%) 67 (16.9) 99 (13.9) 0.19 58 (15.9) 51 (14.0) 0.53 In-stent restenosis/occlusion, n (%) 26 (6.6) 39 (5.5) 0.58 24 (6.6) 18 (5.0) 0.43 Diffuse lesion, n (%) 264 (66.5) 434 (61.0) 0.080 246 (67.6) 228 (62.6) 0.19 Heavily calcified lesion, n (%) 13 (3.3) 10 (1.4) 0.047 12 (3.3) 5 (1.4) 0.14 ∗ ∗ +rombus aspiration, n (%) 218 (54.9) 253 (35.6) <0.001 203 (55.8) 135 (37.1) <0.001 Rotablation, n (%) 8 (2.0) 6 (0.8) 0.16 7 (1.9) 2 (0.6) 0.18 Arterial access site Left radial, n (%) 373 (94.0) 679 (95.5) 0.26 344 (94.5) 343 (94.2) 1.00 No. of previous iTRA attempts, median 0 (0–9) 0 (0–11) 0.002 0 (0–9) 0 (0–11) 0.17 (min–max) No. of previous iTRI attempts, median 0 (0–7) 0 (0–7) 0.059 0 (0–7) 0 (0–7) 0.36 (min–max) Data are presented as median (interquartile range) or n (%), unless otherwise indicated. “Glidesheath” denotes 7-Fr Glidesheath slender/7-Fr guiding catheter combination group, and “Sheathless” denotes 7.5-Fr sheathless guiding catheter group. +e asterisk denotes a statistically significant difference between the two groups. AL, Amplatz type; EBU, extra backup type; iTRA, ipsilateral transradial coronary angiography; iTRI, ipsilateral transradial coronary intervention; JL, Judkins Left type; JR, Judkins Right type; LAD, left anterior descending coronary artery; LCX, left circumflex coronary artery; LMCA, left main coronary artery; RCA, right coronary artery. Journal of Interventional Cardiology 7 Table 3: Procedural outcomes. Total population Propensity-matched population Variables Glidesheath Sheathless Glidesheath Sheathless OR (95% CI) p OR (95% CI) p N � 397 N � 711 N � 364 N � 364 Procedural success, n 1.00 0.99 392 (98.7) 702 (98.7) 1.0 359 (98.6) 361 (99.2) 0.73 (%) (0.99–1.01) (0.98–1.01) Coronary ostial 1.86 0.50 3 (0.8) 10 (1.4) 0.40 3 (0.8) 6 (1.7) 0.51 dissection, n (%) (0.52–6.72) (0.13–1.98) Access-site crossover from radial to femoral, n 1 (0.3) 0 (0) n/a 0.36 1 (0.3) 0 (0) n/a 1.00 (%) Total fluoroscopy time, 22.4 18.2 22.3 18.7 ∗ ∗ <0.001 0.002 min (15.3–31.5) (13.9–28.0) (15.3–31.5) (13.8–29.5) 127 133 Contrast used, ml 128 (100–160) 0.67 128 (100–160) 0.11 (103–160) (105–165) No. of catheters used, ∗ ∗ 1 (1–5) 1 (1–4) <0.001 1 (1–5) 1 (1–4) 0.016 median (min–max) Data are presented as median (interquartile range) or n (%), unless otherwise indicated. “Glidesheath” denotes 7-Fr Glidesheath slender/7-Fr guiding catheter combination group, and “Sheathless” denotes 7.5-Fr sheathless guiding catheter group. +e asterisk denotes a statistically significant difference between the two groups. CI, confidence interval; n/a, not applicable; OR, odds ratio. Table 4: Periprocedural access-site complications. Total population Propensity-matched population Variables Glidesheath Sheathless Glidesheath Sheathless OR (95% CI) p OR (95% CI) p N � 397 N � 711 N � 364 N � 364 RAD at 30 days, mm 2.0 (1.8–2.3) 2.1 (1.8–2.4) 0.15 2.0 (1.8–2.3) 2.1 (1.8–2.4) 0.06 End-procedural ACT, 301 289 ∗ ∗ 273 (231–312) <0.001 273 (229–310) <0.001 s (250–376) (250–372) 0.43 0.33 RAO at 30 days, n (%) 6 (1.5) 25 (3.5) 0.058 5 (1.4) 15 (4.1) 0.039 (0.18–1.04) (0.12–0.91) Severe radial spasm, n 1.46 0.71 9 (2.3) 11 (1.6) 0.48 5 (1.4) 7 (1.9) 0.58 (%) (0.61–3.49) (0.23–2.22) Access-site major bleeding within 30 days BARC type 3 or 5, n 0.99 0.83 5 (1.3) 9 (1.3) 1.00 5 (1.4) 6 (1.6) 1.00 (%) (0.34–2.95) (0.26–2.71) 0.99 0.83 BARC type 3, n (%) 5 (1.3) 9 (1.3) 1.00 5 (1.4) 6 (1.6) 1.00 (0.34–2.95) (0.26–2.71) BARC type 5, n (%) 0 (0) 0 (0) n/a n/a 0 (0) 0 (0) n/a n/a Data are presented as median (interquartile range) or n (%), unless otherwise indicated. “Glidesheath” denotes 7-Fr Glidesheath slender/7-Fr guiding catheter combination group, and “Sheathless” denotes 7.5-Fr sheathless guiding catheter group. +e asterisk denotes a statistically significant difference between the two groups. ACT; activated clotting time; BARC, Bleeding Academic Research Consortium; CI, confidence interval; n/a, not applicable; OR, odds ratio; RAD, radial artery diameter; RAO, radial artery occlusion. 4.1% for Sheathless). Notably, with both the slender devices, size is usually larger than that of Japanese patients [16], the incidences of RAO were lower than or almost equal to resulting in less postprocedural RAO. Notably, in the Gli- those of conventional 6-Fr sheaths/guiding catheters. +ese desheath group, we only documented six cases of RAO in the results were reasonable, considering that the outer diameters total population and five in the propensity-matched pop- of these two devices are almost equal or smaller than those of ulation, yielding the incidences of RAO of 1.5% and 1.4%, conventional 6-Fr sheaths. By comparison, the incidences of respectively, which are lower than the incidence previously RAO of conventional 6-Fr sheaths are reportedly 3.5%– reported for a 7-Fr Glidesheath slender sheath (4.8%) [5]. 15.2% at ≥2 days after PCI [2]. +erefore, our data suggest Factors like intraprocedural anticoagulation of maintaining that using both the 7-Fr Glidesheath slender sheath and 7.5- an ACTof 300 s or longer might have contributed to this low Fr sheathless guiding catheter have equal or lower risk of incidence of RAO. Second, the overall incidences of access-site complica- RAO compared to conventional 6-Fr sheaths. Our study population was limited to Japanese patients; therefore, we do tions were low in the Glidesheath and Sheathless groups with not know whether these results can be generalized to other no significant differences between them except for RAO; the populations. However, these slender devices may be better in incidence of severe radial spasm during PCI was low, but not European or American patients because their radial artery significantly different between both them in the present 8 Journal of Interventional Cardiology Table 5: Multivariate logistic regression analysis to determine predictors of radial artery occlusion at 30 days. Variables Adjusted OR (95% CI) p Treatment modality (Glidesheath/Sheathless) 0.32 (0.11–0.93) 0.036 End-procedural ACT, per s 1.00 (0.99–1.00) 0.30 Total fluoroscopy time, per min 1.02 (1.00–1.04) 0.055 “Glidesheath” denotes 7-Fr Glidesheath slender/7-Fr guiding catheter combination group, and “Sheathless” denotes 7.5-Fr sheathless guiding catheter group. Of note, the number of catheters used per procedure was not included in the multivariate analysis. ACT, activated clotting time; CI, confidence interval; OR, odds ratio. Table 6: +irty-day clinical outcomes by Cox proportional hazard ratio model analysis. Cumulative events at 30 days (%) Variables Hazard ratio (95% CI) p Glidesheath Sheathless Total population All-cause death 4 (1.1) 1 (0.2) 7.30 (1.08–142.74) 0.075 Myocardial infarction 0 (0) 2 (0.3) 0.83 (0.04–8.67) 0.88 Stent thrombosis 4 (1.0) 1 (0.1) 8.94 (1.44–171.24) 0.046 TLR 0 (0) 1 (0.1) 1.68 (0.07–42.61) 0.71 Stroke 2 (0.5) 1 (0.1) 5.12 (0.65–103.56) 0.16 Propensity-matched population All-cause death 4 (1.2) 1 (0.3) 4.06 (0.60–79.31) 0.21 Myocardial infarction 0 (0) 1 (0.3) 0.87 (0.03–22.09) 0.92 Stent thrombosis 3 (0.8) 1 (0.3) 3.98 (0.59–77.80) 0.22 TLR 0 (0) 1 (0.3) 0.99 (0.86–1.15) 0.96 Stroke 2 (0.6) 0 (0) n/a n/a “Glidesheath” denotes the 7-Fr Glidesheath slender/7-Fr guiding catheter combination group and “Sheathless” denotes the 7.5-Fr sheathless guiding catheter group. +e asterisk denotes a statistically significant difference between the two groups. CI, confidence interval; n/a, not applicable; TLR, target-lesion revascularization. study. +is is not consistent with our previous study on characteristics and not the choice of the sheathless guiding elective transradial PCI using a 6.5-Fr sheathless guiding catheter because in our study, most dissections occurred in catheter vs. a 6-Fr Glidesheath slender [9]. +e advanced RCAs with moderate ostial stenosis. +erefore, in patients hydrophilic surface coating, which is common to both the with moderate ostial stenosis of the RCA, caution should be devices, might have made the detection of slight difference exercised during positioning and coaxial alignment of the difficult. Moreover, the assessment of radial spasm based on guiding catheters with the artery, irrespective of the catheter the subjective feelings of patients and subjective observa- type. tions by operators may also have led to inconsistent results. Access-site major bleeding events were not significantly 5. Study Limitations different between the two groups. +is is contradictory to a previous meta-analysis that demonstrated that a 5-Fr system +ere are several limitations to our study. First, this was a in transradial PCI significantly reduces bleeding frequency retrospective observational single-center study, and there- compared to a 6-Fr system [17]; the difference in outer fore, unknown associated factors in access-site complica- sheath size between the 5-Fr and 6-Fr sheaths was ap- tions may have been unequally distributed between the proximately 0.4 mm. +is suggested that the difference in groups. Second, the baseline clinical and the procedural outer sheath size between 7-Fr Glidesheath slender and 7.5- characteristics of the study population may not have been Fr sheathless guiding catheter (0.3 mm) was too small to sufficiently adjusted despite propensity score matching. As a cause a significant difference in the incidence of access-site result, more difficult cases might have been included in the major bleeding events between the two groups. Glidesheath group, which would explain the significantly Finally, the rates of catheter-induced coronary dissection longer fluoroscopy time. +e shorter fluoroscopy time in the were not significantly different between the two groups. In Sheathless group, interpreted differently, may indicate our study (n � 1108), coronary ostial dissection occurred in higher operator confidence, preference, and familiarity with 13 patients. Of note, 9 patients experienced right coronary the sheathless guiding system because the co-variables re- artery (RCA) ostial dissection (2.8% (6/217) for the garding propensity score matching did not include operator- Sheathless group and 2.2% (3/139) for the Glidesheath related factors. +ird, a randomized controlled trial would group, p � 0.75, respectively). One of the greatest concerns be needed to further validate our findings. Fourth, data with the use of sheathless guiding catheters in PCI is the risk pertaining to the pre-PCI Doppler evaluation were not of catheter-induced coronary dissection due to the greater obtained. Indeed, assessing the radial artery diameter 30 tip stiffness of their double-braiding design. In our opinion, days after PCI would have likely only introduced a slight RCA dissections may have been directly related to the lesion error in the measurement of radial artery size because the Journal of Interventional Cardiology 9 lumen of the radial artery at the puncture site remained denotes 7.5-Fr sheathless guiding catheter group; PCI, unchanged during follow-up, except for the distal part of the percutaneous coronary intervention. Supplementary Fig- puncture site [18]. +e variables that might have influenced ure 2: Kaplan–Meier curve analysis of myocardial infarction the size of the preprocedure radial artery, including sex and at 30 days according to the type of guiding system. “Gli- body mass index [16], were well balanced after propensity desheath” denotes 7-Fr Glidesheath slender/7-Fr guiding score matching. However, in reality, we do not know catheter combination group and “Sheathless” denotes 7.5-Fr whether or not the preprocedure radial artery diameter of sheathless guiding catheter group. Supplementary Figure 3: the Sheathless group was the same as that of the Glidesheath Kaplan–Meier curve analysis of stent thrombosis at 30 days group. Fifth, radial artery diameter is influenced by smoking according to the type of guiding system. “Glidesheath” [19]. We have no data on how many patients had quit denotes 7-Fr Glidesheath slender/7-Fr guiding catheter smoking at 30-day follow-up; however, many of them would combination group and “Sheathless” denotes 7.5-Fr have quit smoking because we advised all our patients to quit sheathless guiding catheter group. Supplementary Figure 4: smoking during hospitalization. Consequently, the pre- Kaplan–Meier curve analysis of TLR at 30 days according to procedure radial artery diameter could have been slightly the type of guiding system. “Glidesheath” denotes 7-Fr different from the postprocedure diameter. Sixth, despite Glidesheath slender/7-Fr guiding catheter combination statistical significance, the wide confidence interval of the group and “Sheathless” denotes 7.5-Fr sheathless guiding RAO result indicates that information needs to be collected catheter group; TLR, target-lesion revascularization. Sup- from a larger sample of patients with ACS to strengthen the plementary Figure 5: Kaplan–Meier curve analysis of stroke association. Lastly, morphology of acute radial artery in- at 30 days according to the type of guiding system. “Gli- juries after PCI was not assessed by optical coherence to- desheath” denotes 7-Fr Glidesheath slender/7-Fr guiding mography, and therefore, radial injury by sheath exchange catheter combination group and “Sheathless” denotes 7.5-Fr could not be completely identified as the immediate cause of sheathless guiding catheter group. Supplementary Figure 6: more frequency of RAO in the Sheathless group. graphical abstract. (Supplementary Materials) 6. Conclusions References We conducted a propensity score-based comparison of 7.5- [1] G. Ando` and D. 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Published: Aug 14, 2020

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