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Safety and Long-Term Efficacy of Drug-Coated Balloon Angioplasty following Rotational Atherectomy for Severely Calcified Coronary Lesions Compared with New Generation Drug-Eluting Stents

Safety and Long-Term Efficacy of Drug-Coated Balloon Angioplasty following Rotational Atherectomy... Hindawi Journal of Interventional Cardiology Volume 2019, Article ID 9094178, 10 pages https://doi.org/10.1155/2019/9094178 Research Article Safety and Long-Term Efficacy of Drug-Coated Balloon Angioplasty following Rotational Atherectomy for Severely Calcified Coronary Lesions Compared with New Generation Drug-Eluting Stents 1 1 1 2 Katsumi Ueno , Norihiko Morita, Yoshinobu Kojima, Hiroshi Takahashi, 3 4 1 3 3 Masanori Kawasaki, Ryuta Ito, Hiroki Kondo, Shingo Minatoguchi, Tamami Yoshida, 1 1 1 Yasumasa Hashimoto, Tomohiko Tatsumi, and Tomoya Kitamura Department of Cardiology, Matsunami General Hospital, Gifu, Japan Department of Nephrology, Fujita Health University School of Medicine, Aichi, Japan Department of Cardiology, Gifu University Graduate School of Medicine, Gifu, Japan Department of Cardiology, Nagoya Kyoritsu Hospital, Aichi, Japan Correspondence should be addressed to Katsumi Ueno; nicebogey@yk.commufa.jp Received 12 August 2018; Accepted 11 February 2019; Published 13 March 2019 Academic Editor: Joseph Dens Copyright © 2019 Katsumi Ueno et al. This 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. Objectives. iTh s study sought to assess the safety and long-term efficacy of drug-coated balloons (DCB) following aggressive intracoronary image-guided rotational atherectomy (iRA) for severe coronary artery calcification (CAC), and to compare this strategy with new generation drug-eluting stents (nDES) following iRA. Background. Ischemic events following the treatment of CAC is still relatively high. us Th , more innovative strategies are required. Methods. We evaluated 123 consecutive patients (166 lesions) with de novo CAC undergoing an iRA (burr size; 0.7 of the mean reference diameter by intracoronary imaging) followed by DCB (DCB-iRA; 54 patients, 68 lesions) or nDES (nDES-iRA; 69 patients, 98 lesions). Follow-up angiography was obtained at> 6 months. Results. eTh target vessels (right coronary and circumflex), bifurcation (67.6% versus 47.9%), reference diameter (2.28mm versus 2.49mm), and lesion length (11.89mm versus 18.78mm) were significantly different between the two groups. eTh median follow-up was 732 days. TLR and TVR in DCB-iRA and nDES-iRA at 3 years were similar: 15.6% versus 16.3% (P=0.99) and 15.6% versus 23.3% (P=0.38). In 41 well-matched lesion pairs aer ft propensity score analysis, the cumulative incidence of TLR and TVR in DCB-iRA and nDES-iRA at 3 years was 12.9% versus 16.3% (P=0.70) and 12.9% versus 26.1% (P=0.17), respectively. On QCA analysis, although the acute gain was smaller in DCB-iRA (0.85 mm versus 1.53 mm, P<0.001), the minimum lumen diameter at follow-up was similar (1.69 mm versus 1.87 mm, P=0.29). The late lumen loss was lower (0.09 mm versus 0.52 mm, P=0.009) in DCB-iRA. Conclusions. DCB-iRA is feasible for CAC. 1. Introduction lesions via single balloon inflation to prevent restenosis, with nothing implanted in the coronary artery tree [4]. A recent Despite the improved outcomes of new generation drug- study that compared outcomes of the treatment of de novo eluting stents (nDES) [1], a previous report shows that coronary artery lesions with DCB and nDES showed similar there are still more ischemic events and higher bleeding safety and long-term efficacy [5, 6]. In addition, we recently complications with the treatment of patients with severe reported that the clinical outcomes after DCB treatment of coronary artery calcicfi ation (CAC) [2]. moderate or severe calcified lesions and noncalcified lesions Innovative strategies are required for the treatment of were similar [7]. CAC [3]. Drug-coated balloons (DCB) are one of the leading- However, CAC is associated with larger dissections edge devices that transfer antiproliferative drugs into the aer ft high-pressure balloon dilatation, with more stents 2 Journal of Interventional Cardiology consequently required for bailout or due to unsatisfactory into the guiding catheter. An “oscillating ablation technique” results [8]. us, Th aggressive lesion debulking with rotational [14] was used that slowly and gently engaged the lesion atherectomy (RA) is occasionally performed to avoid large with the rotating burr, which was then slowly retracted (not dissections followed by subsequent high-pressure balloon pecking quickly) to limit the rotational speed from baseline dilatation [9], although the use of a large burr has not been (<5,000 rpm) during any run (<15 seconds). The operators recommended due to high complications [10]. were highly recommended to advance the burr as slowly On the other hand, the efficacy of intravascular imaging and smoothly as possible, by 1-2mm under u fl oroscopy, devices in PCI was recently reported [11] and these imaging while discerning lesion contours and borders by contrast devices are recently used to guide RA (intravascular image- injection. The operator monitored pitch changes, advancer guided RA: iRA) [3, 12]. knob resistance and drive shaft vibration. The operators also The aim of this study was to assess the safety of aggressive controlled the guidewire bias to avoid excessive load on the burr and rpm decreases, setting the optimal ablation vector debulking with iRA and the long-term efficacy of DCB angioplasty following iRA. Furthermore, we compared DCB of the burr by retracting the guidewire to a proximal position with nDES aer ft iRA in patients with CAC. or using a burr of smaller size, if needed. Although selection of DCB or nDES after an iRA was left to the discretion of the operator, the decision was made before iRA to investigate a 2. Methods crossover between the strategies. 2.1. Study Population. From April, 2014,toApril,2017, The only brand of DCB used was the SeQuentPlease 123 consecutive patients (166 lesions) were evaluated with (B. Braun, Berlin, Germany). In the nDES-RA group, the severely calciefi d de novo coronary artery lesions who under- stents implanted included 39 Xience (Abbott Laboratories, went an iRA followed by DCB angioplasty (DCB-iRA group: Abbott Park,IL),23 Ultimaster/ 3 Nobori(Terumo Corp.), 54 patients, 68 lesions) or nDES implantation (nDES-iRA 12 Premiere / 4 Synergy (Boston Scientific) and 17 Resolute group: 69 patients, 98 lesions) at Matsunami General Hospital (Medtronic Inc., Santa Rosa, California). (Gifu, Japan). 2.3. Burr Selection: Lesion Preparation with iRA before The patients included in this study had CAC that ap- peared on angiography as radio-opaque regions without car- DCB Angioplasty. A stepped-burr approach was used, with the maximum burr size determined by IVUS or OFDI diac motion before contrast injection and generally involved images (not by angiography), while considering guidewire both sides of the arterial wall. Only lesions were included in this study that met one of the following criteria: (1) the lesion bias. The target maximum burr size was set at 0.7 of the mean reference diameter (MRDI) obtained by intra- was not crossable by the smallest balloon or by intravascular coronary imaging. After every rotablation, intracoronary ultrasound (IVUS) or optical frequency domain imaging imaging was performed to decide whether to use a larger (OFDI) (70 lesions); (2) the lesion could not be dilated with a burr. high-pressure balloon or a scoring balloon (27 lesions); or (3) the lesions had extensive intimal deposition of calcium ( the Then, DCB was inflated at low pressure (1-4 atm) for 30 to 60 seconds to avoid major dissections, while confirming by arc of calcium> 270 ) assessed by an imaging catheter [13] angiographytoensurethattheballoonwasincontactwiththe (69 lesions). Patients with acute coronary syndrome, restenotic le- vessel luminal wall as well as estimated by changes in the ST segment of ECG. In order to ensure sufficient contact of the sions, thrombotic lesions, in-stent restenosis and bypass graft balloon surface with the vessel luminal wall at low pressure, lesions were excluded. All patients provided written informed the balloon diameter was the same or≥0.25 mm of the MRDI, consent. The study complied with the Declaration of Helsinki and the balloon length exceeded the target lesion at both sides for investigation in human beings and was approved by the by at least 2mm. institutional ethics committee of our institution. 2.4. Burr Selection: Lesion Preparation with iRA before nDES 2.2. Intravascular Image-Guided RA and the Choice of Adjunc- Implantation. A maximum burr size was also set at 0.7 of tive eTh rapy aeft r RA. Patients were pretreated with daily the MRDI. Before stenting after an iRA, the lesion was doses of 100mg of aspirin and 75mg of clopidogrel or 3.75mg dilated with a high-pressure balloon or a scoring balloon of prasugrel. A 300-mg loading dose of clopidogrel or a 20- until full expansion of the balloons was achieved at 12-22atm. mg loading dose of prasugrel was administered before the If necessary, high-pressure balloon dilatation was further procedure if patients had not been pretreated at least 4 days undertaken to treat stent underexpansion. earlier. Heparin was administered to maintain an activated clotting time of > 300 seconds during the procedure. All cases were treated with IVUS guidance (View IT, 35MHz and 2.5. Outcomes. The study end points were target lesion revas- AltaView, 40MHz; Terumo Corp. Tokyo, Japan or Opticross: cularization (TLR) and target vessel revascularization (TVR). Boston Scientific, Natick, MA, USA) or OFDI guidance Acute procedural success, defined as residual stenosis <50% (FastView and LUNAWAVE,Terumo Corp.). and stenosis reduction of at least 20% den fi ed by angiography, RA (Rotablator system, Boston Scientific) was performed procedural complications, death and major adverse cardiac by experienced operators. The baseline burr rotational speed events (MACE) were also investigated. All end points were defined according to the Academic Research Consortium was set at 195,000rpm for a 1.25mm burr and 175,000 rpm for larger burrs (1.5mm - 2.25mm burr) before passing the burr (ARC) definitions [15]. Journal of Interventional Cardiology 3 2.6. Quantitative Coronary Angiography. The latest coronary 3.3. Clinical Follow-Up. The median (IQR) follow-up was 732 angiograms, which were obtained at 6 months or later after (484-1,030) days. The cumulative incidence rates of TLR at PCI, were analyzed to obtain follow-up data. The angiograms 1, 2, and 3 years were not significantly different between the DCB-iRA and nDES-iRA group (9.3% versus 6.2% and 15.6% before and aeft r PCI and at follow-up were analyzed using the QAngio XA Version 7.3 (MEDIS Medical Imaging Systems versus 12.9%, and 15.6% versus 16.3%, respectively, P=0.99) BV, Leiden, the Netherlands). (HR 1.01, 95%CI 0.41-2.50, P=0.99). In addition, there was no significant difference between the DCB-iRA group and 2.7. Statistical Analysis. Continuous variables are presented nDES-iRA group in the cumulative incidence rates of TVR at as mean and standard deviation (SD) or median and 1, 2 and 3 years (9.3% versus 10.0%, 15.6% versus 18.0% and interquartile range (IQR) and categorical variables as counts 15.6% versus 23.3%, respectively, P=0.38) (HR 0.69, 95%CI and percentages. Student’s t-test and Chi-squared test were 0.30-1.60, P=0.39) (Figure 1). used for comparisons. A P value of< 0.05 was considered The propensity score was calculated from target vessel, significant. ostial lesion, bifurcation lesion, reference diameter, and lesion The cumulative incidence rates of TLR and TVR in the length as covariates with P< 0.05 in univariate analysis as well two groups were derived from Kaplan–Meier analyses, and as CTO and MLD before the procedure. In the propensity the log-rank test was used to compare the differences between score-matched group (41 lesions in each group, Table 4), the groups. Cox proportional hazard models were used to there was still no significant difference between the DCB-iRA compare the unadjusted outcomes between the groups, and group and nDES-iRA group in the cumulative incidence rates the results are presented as hazard ratios (HR) with 95% of TLR at 1, 2, and 3 years (7.5% versus 9.3% and 12.9% versus confidence intervals (CI). To adjust for differences in baseline 16.3% and 12.9% versus 16.3%, respectively, P=0.70) (HR 0.77, characteristics between the two procedures, propensity score 95%CI 0.21-2.88, P=0.70). The cumulative incidence rates of matching was performed with a greedy matching algorithm. TVR at 1, 2, and 3 years in the DCB-iRA group (7.5%, 12.9%, The matching algorithm used a multivariate logistic regres- and 12.9%, respectively) were also not different from those in sion model that included baseline covariates with P< 0.05 in the nDES-iRA group (19.2%, 26.1%, and 26.1%, respectively, univariate analysis as well as chronic total occlusion (CTO) P=0.17) (HR 0.44, 95% CI 0.13-1.47, P=0.18) (Figure 2). and the minimum lumen diameter (MLD) before procedure During the follow-up period, there were 10 cardiac deaths as established predictors [16]. All statistical analysis was (2/54, 3.7% in the DCB-iRA group and 8/69, 11.6% in the performed by R software version 3.4.1(2017-06-30). nDES-iRA group) and 9 noncardiac deaths (6/54, 11.1% in the DCB-iRA group and 3/69, 4.3% in the nDES-iRA group). At 1, 2, and 3 years, there were no significant differences 3. Results between the DCB-iRA group and the nDES-iRA group in 3.1. Characteristics of Patients and Lesions. The baseline the cumulative rates of all-cause mortality (7.6% versus 13.1%, characteristics of the patients and lesions are summarized in 10.5% versus 14.9% and 20.9% versus 14.9%, P=0.95), cardiac Table 1. The right coronary artery was the target vessel more death (1.9% versus 8.8%, 1.9% versus 10.7% and 9.4% versus oeft n in the nDES-iRA group, whereas the left circumefl x 10.7%, respectively, P=0.18), and MACE (15.1% versus 23.3%, coronary artery was more oeft n in the DCB-iRA group. Ostial 21.7% versus 28.2% and 31.6% versus 30.2%, respectively, lesions and bifurcation lesions were more frequent in the P=0.47). DCB-iRA group. The reference diameter was significantly There were no definite cases of vessel or stent thrombosis smaller in the DCB-iRA group (2.28± 0.58 mm versus 2.49 in either group, although one case of possible stent thrombo- ± 0.55 mm, respectively, P=0.019) and the lesion length was sis(1/69, 1.4%) and 2 casesofprobable stent thrombosis (2/69, significantly shorter in the DCB-iRA group (11.89 ± 6.41 mm 2.9%) were observed only in the nDES-iRA group. versus 18.78± 7.91 mm, respectively, P<0.001). 3.4. Quantitative Angiographic Analysis. Follow-up angiog- 3.2. Characteristics of the Procedural Devices and Acute Pro- raphy was performed for 38 patients (71.7%) with 51 lesions cedural Results. The DCB-iRA group had a significantly (76.1%) in the DCB-iRA group and 46 patients (66.7%) with higher mean maximum burr size (1.74± 0.28 mm versus 1.66 62 lesions (63.3%) in the nDES-iRA group. ± 0.22 mm, respectively, P=0.038) and a higher angiographic The results of quantitative coronary angiography are burr/artery ratio (B/A ratio) (0.79± 0.17 versus 0.69± 0.13, shown in Table 5. Aeft r propensity matching, the DCB-iRA respectively, P<0.001) (Table 2). group and the nDES-iRA group had a similar reference diam- eter (2.46± 0.64 mm versus 2.37± 0.39 mm, respectively, Theacutesuccess rates werehighand major complica- tions were rare in both groups. The incidence of coronary P=0.53), lesion length (15.01± 6.67 mm versus 15.77± 7.25 flow disturbance after rotablation was 14.8% in the DCB- mm, respectively, P=0.70), and B/A ratio (0.74± 0.11 versus iRA group and 11.6% in the nDES-iRA group (P=0.12). 0.72± 0.11, respectively, P=0.45). However, most coronary flow disturbances were due to TIMI At intervention, the acute gain (AG) in lumen diameter 2 slow ow fl despite a high B/A ratio. Crossover and major was smaller in the propensity matched DCB-iRA group than dissections were rare; one patient (1.9%) in the DCB-iRA in the nDES-iRA group (0.85 ± 0.37 mm versus 1.53 ± group experienced major dissection (NHLBI type E) just 0.43mm, respectively, P<0.001), and the post-PCI percent aeft r rotablation (B/A ratio, 0.83) and crossover to DES diameter stenosis was larger in the propensity matched DCB- (Table 3). iRA group than in the nDES-iRA group (24.10 ± 10.0% 4 Journal of Interventional Cardiology Table 1: Baseline characteristics of patients and lesions. DCB-iRA lesions nDES-iRA lesions Variables P value (n=68) (n=98) Number of patients 54 69 Age (years) 71±971±90.75 Male (%) 38 (70.4) 45 (65.2) 0.57 Smoking (%) 10 (18.5) 20 (29.0) 0.21 Diabetes (%) 33 (61.1) 39 (56.5) 0.71 Hypertension (%) 38 (70.4) 53 (76.8) 0.54 Hyperlipidemia (%) 38 (70.4) 43 (62.3) 0.44 Chronic kidney disease (%) 19 (35.2) 28 (40.6) 0.58 Hemodialysis patients (%) 12 (22.2) 19 (27.5) 0.54 Previous MI (%) 17 (31.5) 20 (29.0) 0.84 Previous CABG (%) 7 (13.0) 6 (8.7) 0.56 PAD (%) 15 (27.8) 21 (30.4) 0.84 Target vessel, n (%) LMT 2 (2.9) 5 (5.1) 0.001 LAD 38 (55.9) 47 (48.0) RCA 9 (13.2) 35 (35.7) LCX 19 (27.9) 11 (11.2) Lesion anatomy Type B2/C (%) 67 (98.6) 95 (96.9) 0.62 Ostial (%) 19 (27.9) 14 (14.3) 0.047 Bifurcation (%) 46 (67.6) 46 (47.9) 0.016 CTO (%) 3 (4.4) 11 (11.2) 0.16 Quantitative angiography Reference diameter (mm) 2.28±0.58 2.49±0.55 0.019 Lesion length (mm) 11.89±6.41 18.78±7.91 <0.001 MLD Pre-intervention (mm) 0.87±0.35 0.90±0.41 0.65 Percent diameter stenosis Pre-intervention (%) 60.9±12.5 64.5±16.3 0.12 CABG, coronary artery bypass graft surgery; CTO, chronic total occlusion; DCB, drug-coated balloon; LAD, left anterior descending artery; LMT, left main trunk; LCX, left circumflex artery; MI, myocardial infarction; MLD, minimun lumen diameter; nDES, new generation drug-eluting stents; PAD, peripher al artery diseases; RCA, right coronary artery; SD, standard deviation. versus 9.80 ± 6.46%, respectively, P<0.001). However, at On this hypothesis, the prospective randomized trial follow-up, the minimum lumen diameter (1.69± 0.57 mm (STRATAS) was performed to investigate the outcome of versus 1.87± 0.60 mm, respectively, P=0.29) and the percent 500 patients randomized to either an aggressive rotablation diameter stenosis (29.52 ± 17.62% versus 23.81 ± 20.52%, strategy (maximum burr/artery ratio >0.7 followed by no respectively, P=0.29) were similar between the two propensity angioplasty, or angioplasty≤1 atm) versus routine rotablation matched groups, and the late lumen loss (LLL) and loss index (maximum burr/artery ratio≤0.7, followed by routine bal- (LLL/AG) in the DCB-iRA group was significantly lower than loon angioplasty≥4 atm) [9]. MACE and emergent CABG that in the nDES-iRA group (0.09± 0.48 mm versus 0.52± were less in aggressive RA than in routine RA (2.0% versus 0.63 mm, respectively, P=0.009, and 0.03± 0.52 versus 0.32± 4.0%), coronary perforation occurred only in the routine 0.39, respectively, P=0.026). group, and severe ow fl disturbance occurred in only 1.2% in the aggressive RA. Nonetheless the aggressive rotational atherectomy strategy offered no advantage over more routine 4. Discussion burr sizing plus routine angioplasty in MLD at follow-up, The method in the present study is based on the hypothesis loss index (0.62 for the aggressive strategy versus 0.54 for the routine strategy) and restenosis rate. Therefore, since the that sufficient plaque debulking without barotrauma is a better approach for complex lesions [9, 17]. advent of the rfi st-generation DES, a B/A ratio has been Journal of Interventional Cardiology 5 Table 2: Device characteristics. DCB-iRA lesions (n=68) nDES-iRA lesions (n=98) P value Number of patients n=54 n=69 Sheath size, French(F) 6F (%) 32 (59.3) 53 (76.8) 0.11 7F (%) 10 (18.5) 9 (13.0) 8F (%) 12 (22.2) 7 (10.1) Approach via radial artery (%) 36 (66.7) 44 (63.8) 0.67 via brachial artery (%) 0 (0.0) 2 (2.9) via femoral artery (%) 18 (33.3) 23 (33.3) Maximum burr size (%) 1.25mm 5 (7.4) 8 (8.2) 0.18 1.5mm 19 (27.9) 34 (34.7) 1.75mm 27 (39.7) 45 (45.9) 2.0mm 7 (10.3) 7 (7.1) 2.15mm 1 (1.5) 1 (1.0) 2.25mm 9 (13.2) 3 (3.1) Mean burr size, mm 1.74±0.28 1.66±0.22 0.038 B/A ratio 0.79±0.17 0.69±0.13 <0.001 B/A ratio, burr-to-artery ratio. 1.0 1.0 TVR TLR 0.8 0.8 0.6 0.6 0.4 0.4 0.2 0.2 0.0 0.0 0 200 400 600 800 1000 0 200 400 600 800 1000 Time aer t ft he procedure (days) Time aer t ft he procedure (days) Number at risk Number at risk DCB-iRA 67 61 49 32 21 11 DCB-iRA 67 61 49 32 21 11 nDES-iRA 98 81 72 59 48 23 nDES-iRA 98 81 69 55 43 20 DCB-iRA DCB-iRA nDES-iRA nDES-iRA Figure 1: Cumulative Kaplan–Meier estimates of the incidence of target lesion revascularization (TLR) (left panel) and target vessel revascularization (TVR) (right panel), using the crude cohorts of 68 lesions treated with drug-coated balloons (DCB) aer ft intravascular image-guided rotational atherectomy (iRA) (DCB-iRA) and 98 lesions treated with new generation drug-eluting stents (nDES) aeft r iRA (nDES-iRA). recommended to be set at 0.5 to 0.6 before implantation of To the best of our knowledge, this is the rfi st report to DES [3]. assess the effect of DCB angioplasty at low pressure avoiding However, even in new generation DES era, CAC has barotrauma aer ft an aggressive rotablation of severely calci- been reported to be associated with higher procedural fied lesions. complications and an increased risk of MACE in patients The acute results of aggressive iRA in the present study undergoing not only PCI but also CABG [2, 18]. More showed that this procedure was safe, with less complication and less bailout stenting. Although the targeted maximum innovative strategies are required for the treatment of CAC. bur size was set at 0.7 of MRDI and a high B/A ratio Cumulative incidence of target lesion revascularization (TLR) Cumulative incidence of target vessel revascularization (TVR) 6 Journal of Interventional Cardiology Table 3: Acute procedural outcomes. DCB-iRA patients nDES-iRA patients P value (n=54) (n=69) Procedure success (%) 53 (98.1) 68 (98.6) 1.0 Patient success (%) 54 (100) 68 (98.6) Crossover (%) 1 (1.9) 0 1.0 Major complications 1.0 Death (%) 0 1 (1.4) MI (%) 0 1 (1.4) CABG (%) 0 0 Congestive heart failure (%) 0 2 (2.9) Minor complications 1.0 Ventricular fibrillation (%) 0 1 (1.4) Side branch occlusions (%) 0 1 (1.4) RA complications Perforation (%) 0 0 1.0 TIMI 0 slow flow (%) 0 2 (2.9) 0.12 TIMI 1 slow flow (%) 0 2 (2.9) TIMI 2 slow flow (%) 8 (14.8) 4 (5.8) Dissection; NHLBI classification A(%) 1 (1.9) 0 0.08 C(%) 1 (1.9) 0 E(%) 1 (1.9) 0 CABG, coronary artery bypass graft surgery; MI, myocardial infarction; RA rotational atherectomy. 1.0 1.0 TVR TLR 0.8 0.8 0.6 0.6 0.4 0.4 0.2 0.2 0.0 0.0 0 200 400 600 800 1000 0 200 400 600 800 1000 Time aer t ft he procedure (days) Time aer t ft he procedure (days) Number at risk Number at risk DCB-iRA DCB-iRA 41 37 30 18 11 6 41 37 30 18 11 6 nDES-iRA 41 33 27 24 21 11 nDES-iRA 41 33 24 21 18 9 DCB-iRA DCB-iRA nDES-iRA nDES-iRA Figure 2: Cumulative Kaplan–Meier estimates of the incidence of target lesion revascularization (TLR) (left panel) and target vessel revascularization (TVR) (right panel), using the propensity matched cohorts of 41 lesions treated with drug-coated balloons (DCB) after intravascular image-guided rotational atherectomy (iRA) (DCB-iRA) and 41 lesions treated with new generation drug-eluting stents (nDES) after iRA (nDES-iRA). Cumulative incidence of target lesion revascularization (TLR) Cumulative incidence of target vessel revascularization (TVR) Journal of Interventional Cardiology 7 Table 4: Baseline characteristics of patients and lesions in the propensity-matched cohorts. DCB-iRA lesions nDES-iRA lesions Variables P value (n=41) (n=41) Number of patients 34 35 Age (years) 70±872±90.63 Male (%) 24 (70.6) 20(57.1) 0.32 Smoking (%) 6 (17.6) 10 (28.6) 0.39 Diabetes (%) 22 (64.7) 17 (48.6) 0.23 Hypertension (%) 24(70.6) 28 (80.0) 0.41 Hyperlipidemia (%) 22 (64.7) 22(62.9) 1.00 Chronic kidney disease (%) 13 (38.2) 14 (40.0) 1.00 Hemodialysis patients (%) 10 (29.4) 12 (34.3) 0.80 Previous MI (%) 11 (32.4) 7 (20.0) 0.28 Previous CABG (%) 3 (8.8) 1(2.9) 0.36 PAD (%) 10 (29.4) 12 (34.3) 0.80 Target vessel LMT (%) 2(4.9) 2(4.9) 0.79 LAD (%) 23 (56.1) 21 (51.2) RCA (%) 9(22.0) 13(31.7 LCX (%) 7 (17.1) 5 (12.2) Lesion anatomy Type B2/C (%) 41(100) 39 (95.1) 0.60 Ostial (%) 10 (24.4) 10(24.4) 1.0 Bifurcation (%) 24 (58.5) 23 (56.1) 1.0 CTO (%) 3 (7.3) 5 (12.2) 0.71 Quantitative angiography Reference diameter (mm) 2.44±0.63 2.39±0.42 0.66 Lesion length (mm) 14.29±6.84 14.67±6.00 0.79 MLD Pre-intervention (mm) 0.93±0.39 0.87±0.35 0.43 Percent diameter stenosis Pre-intervention (%) 61.43±14.47 64.67±15.34 0.33 Mean burr size (mm) 1.78±0.32 1.66±0.18 0.028 B/A ratio 0.76±0.14 0.71±0.12 0.10 Abbreviations are the same for Table 1. In the SeQuentPlease World Wide Registry, the TLR was obtained, procedural complications were rare and only one crossover from DCB to DES was observed (1.9%). A rate aer ft DCB only for de novo lesions was similar to that severe flow disturbance (TIMI 0) was observed in only 2 aer ft DCB plus bare metal stents (BMS) (1.0% versus 2.4%, cases (1.6%). Since the incidence of flow disturbance was respectively), whereas the TVR rate after DCB only tended reported to be 0-3.8% with a contemporary approach [3, 12], to be smaller than that of DCB plus BMS (1.0% versus it is reasonable to suppose that aggressive iRA (oscillating 3.6%, respectively, P=0.09) [19]. However, this tendency for ablation technique by the burr of 0.7MRDI) is as safe as a difference in the TVR rate was not found in the present rotablation when the B/A ratio is set at 0.5 to 0.6 by study (12.9% in the DCB-iRA versus 26.1% in the nDES-iRA, angiography. P=0.17). In addition, with respect to long-term efficacy, the loss Of note, Rissanen et al. recently reported that a stentless index in the DCB-iRA group in the present study was smaller strategy with DCB following balloon dilatation or cutting than that in the aggressive RA-low pressure POBA group balloon dilatation aeft r RA for CAC was safe and eeff ctive in the STRATAS trial (0.08 versus 0.62, respectively) [9]. (TLR / MACE at 1 and 2 years were 1.5% / 14% and 3.1% Furthermore, it was found that the DCB-iRA group has an / 20%, respectively) [20]. Compared with their results, the equivalent TLR and TVR rate to the nDES-iRA group, as well TLR rates in our study were higher although MACE was as after propensity matching. similar (9.3% / 15.1% and 15.6% / 21.7%, respectively). This 8 Journal of Interventional Cardiology Table 5: Pre- and postprocedural quantitative angiographic characteristics in the crude and matched cohorts. DCB-iRA lesions nDES-iRA lesions P value Crude cohorts n=51 n=62 At PCI Reference diameter (mm) 2.33±0.63 2.50±0.57 0.14 Lesion length (mm) 11.56±6.19 18.57±7.98 <0.001 MLD (mm) Pre-intervention (mm) 0.86±0.38 0.91±0.40 0.49 Post-intervention (mm) 1.75±0.50 2.57±0.51 <0.001 Percent diameter stenosis Pre-intervention (%) 62.27±13.31 64.70±15.39 0.38 Post-intervention (%) 22.86±10.11 9.59±6.10 <0.001 Acute Gain (mm) 0.90±0.39 1.66±0.53 <0.001 Rotablator burr size Mean burr size (mm) 1.74±0.28 1.68±0.21 0.21 B/A ratio 0.78±0.17 0.70±0.14 0.006 At follow-up MLD (mm) 1.68±0.63 2.03±0.84 0.015 % diameter stenosis (%) 29.01±20.25 25.12±23.56 0.36 Late lumen loss (mm) 0.08±0.43 0.54±0.80 <0.001 Loss index 0.05±0.48 0.33±0.45 0.002 Matched cohorts n=26 n=26 At PCI Reference diameter (mm) 2.46±0.64 2.37±0.39 0.53 Lesion length (mm) 15.01±6.67 15.77±7.25 0.70 MLD (mm) Pre-intervention 0.94±0.36 0.86±0.34 0.42 Post-intervention 1.78±0.42 2.38±0.34 <0.001 Acute Gain (mm) 0.85±0.37 1.53±0.43 <0.001 Percent diameter stenosis Pre-intervention (%) 60.78±13.27 65.48±15.44 0.24 Post-intervention (%) 24.10±10.00 9.80±6.46 <0.001 Rotablator burr size Mean burr size (mm) 1.78±0.32 1.67±0.20 0.16 B/A ratio 0.74±0.11 0.72±0.11 0.45 At follow-up MLD (mm) 1.69±0.57 1.87±0.60 0.29 % diameter stenosis (%) 29.52±17.62 23.81±20.52 0.29 Late lumen loss (mm) 0.09±0.48 0.52±0.63 0.009 Loss index 0.03±0.52 0.32±0.39 0.026 B/A ratio, burr-to-artery ratio; MLD, minimum lumen diameter; SD, standard deviation; PCI, percutaneous coronary intervention. Loss index; Late lumen loss / Acute gain. is attributed to the fact that the target lesions were in larger bailout stent (1.9% of the patients) was needed in the present vessels in their study, and routine noninvasive testing and study. follow-up angiographies were not performed. In contrast, Although there was no difference between the two groups the reference diameter in our study was smaller (2.28±0.58 in the reference diameter or B/A ratio after propensity match- mm). Moreover, 61.1% were diabetic mellitus patients and ing, the results of acute angiography showed that the DCB- 27.9% of the lesions were ostial lesions in our study. Since the iRA group had significantly less acute gain, lower post-PCI predictors of restenosis are a history of diabetes mellitus, a MLD, and higher residual stenosis. The differences in acute small reference diameter, and ostial lesions [21], the outcome gain and residual stenosis between the groups are attributed obtained is considered to be clinically acceptable. In addition, to the expansion of the lumen during stenting. In contrast, it should be noted that bailout stent was needed in 10% of at follow-up angiography, there was no difference between the groups in residual stenosis or MLD. The reason for this the procedures in their study, while alternatively only one Journal of Interventional Cardiology 9 was a signicfi antly larger late lumen loss (LLL) in the nDES- Acknowledgments iRA group than in the DCB-iRA group (0.52 mm versus 0.09 We would like to express our deepest gratitude to Gregory mm, respectively, P=0.009). The LLL in the stented group was A. Braden M.D. who taught us his masterful rotablator larger than what has been reported previously for the stenting technique and the fundamentals that this study was based of noncalcified lesions [22]. We speculate that this is due upon. We would also like to thank Takeshi Fukuda R.T. and to residual calcium causing damage to the stent polymer or Leigh Childs who gave us invaluable comments and warm chronic stent recoil, even after preparation of the lesions with encouragements. Finally, we would like to thank radiology rotablation. Additionally, further barotrauma was incurred nurses, radiology technicians, medical technologists, and by the high-pressure balloons. clinical engineering technologists in our cath lab for their On the other hand, given that the SeQuentPlease balloon continuous contribution and their warm support. is folded, a majority of the drug is protected by the folds during delivery to the calcified lesions. The reported washout of a delivered and retracted noninflated balloon is 6% [23]. References With appropriate drug delivery during balloon inflation, drug [1] A. E. Rodriguez, O. Santaera, M. Larribau et al., “ERACI IV uptake into the lesion is sufficient to inhibit LLL and reduce Investigators. Second vs. first-generation drug-eluting stents in the TLR rate. complex lesions subsets: 3 years’ follow-up of ERACI IV study,” Several potential advantages of stentless strategy using Minerva Cardioangiol,vol.65, no. 1,pp. 81–90,2017. DCB over stenting have been suggested [5, 19]: (1) a short [2] P. Gen ´ er ´ eux, B. Redfors, B. Witzenbichler et al., “Two-year duration of dual antiplatelet therapy (DAPT) of 1 month outcomes aer ft percutaneous coronary intervention of calcified is feasible, and DAPT can be discontinued at any time lesions with drug-eluting stents,” International Journal of Cardi- if there are bleeding events; (2) the absence of a metal ology, vol.231,pp.61–67, 2017. scaffold to deliver antiproliferative drug maintains vaso- [3] M. I. Tomey, A. S. Kini, and S. K. Sharma, “Current status motion and may prevent neoatherosclerosis in the treated of rotational atherectomy,” JACC: Cardiovascular Interventions, artery; (3) finally and most important, stentless PCI with vol. 7, no. 4, pp. 345–353, 2014. low pressure DCB dilation is often simpler and less time [4] C. Herdeg, M. Oberhoff, A. Baumbach et al., “Local paclitaxel consuming, especially for complex anatomy such as cal- delivery for the prevention of restenosis: Biological eeff cts and cified ostial lesions, bifurcation lesions and diffuse long efficacy in vivo,” Journal of the American College of Cardiology, lesions. vol. 35, no. 7, pp. 1969–1976, 2000. [5] D. Venetsanos, S. S. Lawesson, G. Panayi et al., “Long-term 4.1. Study Limitations. There are several limitations in this efficacy of drug coated balloons compared with new generation study. First, the two procedures were assigned in a nonran- drug-eluting stents for the treatment of de novo coronary artery domized manner. We conducted propensity score match- lesions,” Catheterization and Cardiovascular Interventions,vol. ing to minimize the difference in patient characteristics. 92, no. 5, pp. E317–E326, 2018. However, there may still be residual selection bias and [6] R.V.Jeger, A.Farah, M. A.Ohlow, N. Mangner etal., “Drug- confounding, and the number of propensity matched QCA coated balloons for small coronary artery disease (BASKET- pairs was small. Second, this study was a retrospective, small SMALL 2): an open-label randomised non-inferiority trial,” Lancet,vol.392,pp.849–856, 2018. study performed at a single center. Since a relatively small number of the patients were enrolled and only a small [7] R. Ito, K. Ueno, T. Yoshida et al., “Outcomes aer ft drug-coated number of events occurred due to small sample size, the balloon treatment for patients with calcified coronary lesions,” Journal of Interventional Cardiology, vol.31, no.4, pp. 436–441, present study may have been underpowered to determine the relationship between the incidence of TLR/TVR and DCB treatment aer ft iRA. A study in a larger popula- [8] T. Dill, U. Dietz, C. W. Hamm et al., “A randomized comparison of balloon angioplasty versus rotational atherectomy in complex tion is needed to definitively define the effects of DCB coronary lesions (COBRA study),” European Heart Journal,vol. angioplasty. 21, no. 21, pp. 1759–1766, 2000. [9] P.L. Whitlow,T. A.Bass, R. M. Kipperman et al.,“Results of 4.2. Conclusion. For severely calcified coronary lesions, a the study to determine rotablator and transluminal angioplasty stentless strategy utilizing DCB angioplasty at low pressure strategy (STRATAS),” American Journal of Cardiology,vol.87, following iRA is feasible and effective. no. 6, pp. 699–705, 2001. [10] R. D. Safian, T. Feldman, D. W. M. Muller et al., “Coro- nary Angioplasty and Rotablator Atherectomy Trial (CARAT): Data Availability Immediateand late results ofaprospectivemulticenter ran- domized trial,” Catheterization and Cardiovascular Interven- The data used to support the findings of this study are tions,vol.53,no.2, pp. 213–220,2001. available from the corresponding author upon request. [11] B. E. Claessen, R. Mehran, G. S. Mintz et al., “Impact of intravascular ultrasound imaging on early and late clinical outcomes following percutaneous coronary intervention with Conflicts of Interest drug-eluting stents,” JACC: Cardiovascular Interventions,vol. 4, The authors have no conflicts of interest to declare. no. 9, pp. 974–981, 2011. 10 Journal of Interventional Cardiology [12] W. Tian, M. Mahmoudi, T. Lhermusier et al., “Clinical outcomes of first- and second-generation drug-eluting stents in patients undergoing rotational atherectomy for heavily calcified coro- nary lesions,” Cardiovascular Revascularization Medicine,vol. 16, no. 3, pp. 147–150, 2015. [13] M.Mosseri,L.F.Satler,A.D.Pichard,andR.Waksman,“Impact of vessel calcification on outcomes after coronary stenting,” Cardiovascular Revascularization Medicine, vol.6,no. 4,pp. 147–153, 2005. [14] M. Reisman, Guide to Rotational Atherectomy, Physicians’ Press, Birmingham, Mich, USA, 1997. [15] D. E. Cutlip, S. Windecker, R. Mehran et al., “Clinical end points in coronary stent trials: a case for standardized definitions,” Circulation,vol.115,no.17,pp.2344–2351, 2007. [16] P. Rubartelli, E. Verna, L. Niccoli et al., “Coronary stent implantation is superior to balloon angioplasty for chronic coronary occlusions: Six-year clinical follow-up of the GISSOC trial,” Journal of the American College of Cardiology,vol. 41, no. 9, pp. 1488–1492, 2003. [17] F. Otsuka, M. Nakano, K. Sakakura, E. Ladich, F. D. Kolodgie, and R. Virmani, “Unique demands of the femoral anatomy and pathology and the need for unique interventions,” Journal of Cardiovascular Surgery, vol.54,no. 2,pp.191–210, 2013. [18] M. V. Madhavan, M. Tarigopula, G. S. Mintz, A. Maehara, G. W. Stone, and P. Gen ´ er ´ eux, “Coronary artery calcification: patho- genesis and prognostic implications,” Journal of the American College of Cardiology,vol.63,no.17, pp. 1703–1714, 2014. [19] J. Wo¨hrle, M. Zadura, S. Mob ¨ ius-Winkler et al., “SeQuent- Please World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospec- tive registry study,” Journal of the American College of Cardiol- ogy,vol.60,no. 18, pp.1733–1738, 2012. [20] T. T. Rissanen, S. Uskela, A. Siljander et al., “Percutaneous coro- nary intervention of complex calcified lesions with drug-coated balloon after rotational atherectomy,” Journal of Interventional Cardiology,vol.30,no. 2,pp.139–146, 2017. [21] P. A. Lemos, A. Hoye, D. Goedhart et al., “Clinical, angio- graphic, and procedural predictors of angiographic restenosis aer ft sirolimus-eluting stent implantation in complex patients: an evaluation from the rapamycin-eluting stent evaluated at rotterdam cardiology hospital (research) study,” Circulation, vol. 109, no. 11, pp. 1366–1370, 2004. [22] S. J. Brener, A. J. Prasad, Z. Khan, and T. J. Sacchi, “eTh rela- tionship between late lumen loss and restenosis among various drug-eluting stents: A systematic review and meta-regression analysis of randomized clinical trials,” Atherosclerosis,vol.214, no. 1, pp. 158–162, 2011. [23] B. Scheller, U. Speck, C. Abramjuk, U. Bernhardt, M. Bohm, ¨ and G. Nickenig, “Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis,” Circulation, vol. 110, no.7,pp.810–814,2004. 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Safety and Long-Term Efficacy of Drug-Coated Balloon Angioplasty following Rotational Atherectomy for Severely Calcified Coronary Lesions Compared with New Generation Drug-Eluting Stents

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Copyright © 2019 Katsumi Ueno et al. This 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.
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Hindawi Journal of Interventional Cardiology Volume 2019, Article ID 9094178, 10 pages https://doi.org/10.1155/2019/9094178 Research Article Safety and Long-Term Efficacy of Drug-Coated Balloon Angioplasty following Rotational Atherectomy for Severely Calcified Coronary Lesions Compared with New Generation Drug-Eluting Stents 1 1 1 2 Katsumi Ueno , Norihiko Morita, Yoshinobu Kojima, Hiroshi Takahashi, 3 4 1 3 3 Masanori Kawasaki, Ryuta Ito, Hiroki Kondo, Shingo Minatoguchi, Tamami Yoshida, 1 1 1 Yasumasa Hashimoto, Tomohiko Tatsumi, and Tomoya Kitamura Department of Cardiology, Matsunami General Hospital, Gifu, Japan Department of Nephrology, Fujita Health University School of Medicine, Aichi, Japan Department of Cardiology, Gifu University Graduate School of Medicine, Gifu, Japan Department of Cardiology, Nagoya Kyoritsu Hospital, Aichi, Japan Correspondence should be addressed to Katsumi Ueno; nicebogey@yk.commufa.jp Received 12 August 2018; Accepted 11 February 2019; Published 13 March 2019 Academic Editor: Joseph Dens Copyright © 2019 Katsumi Ueno et al. This 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. Objectives. iTh s study sought to assess the safety and long-term efficacy of drug-coated balloons (DCB) following aggressive intracoronary image-guided rotational atherectomy (iRA) for severe coronary artery calcification (CAC), and to compare this strategy with new generation drug-eluting stents (nDES) following iRA. Background. Ischemic events following the treatment of CAC is still relatively high. us Th , more innovative strategies are required. Methods. We evaluated 123 consecutive patients (166 lesions) with de novo CAC undergoing an iRA (burr size; 0.7 of the mean reference diameter by intracoronary imaging) followed by DCB (DCB-iRA; 54 patients, 68 lesions) or nDES (nDES-iRA; 69 patients, 98 lesions). Follow-up angiography was obtained at> 6 months. Results. eTh target vessels (right coronary and circumflex), bifurcation (67.6% versus 47.9%), reference diameter (2.28mm versus 2.49mm), and lesion length (11.89mm versus 18.78mm) were significantly different between the two groups. eTh median follow-up was 732 days. TLR and TVR in DCB-iRA and nDES-iRA at 3 years were similar: 15.6% versus 16.3% (P=0.99) and 15.6% versus 23.3% (P=0.38). In 41 well-matched lesion pairs aer ft propensity score analysis, the cumulative incidence of TLR and TVR in DCB-iRA and nDES-iRA at 3 years was 12.9% versus 16.3% (P=0.70) and 12.9% versus 26.1% (P=0.17), respectively. On QCA analysis, although the acute gain was smaller in DCB-iRA (0.85 mm versus 1.53 mm, P<0.001), the minimum lumen diameter at follow-up was similar (1.69 mm versus 1.87 mm, P=0.29). The late lumen loss was lower (0.09 mm versus 0.52 mm, P=0.009) in DCB-iRA. Conclusions. DCB-iRA is feasible for CAC. 1. Introduction lesions via single balloon inflation to prevent restenosis, with nothing implanted in the coronary artery tree [4]. A recent Despite the improved outcomes of new generation drug- study that compared outcomes of the treatment of de novo eluting stents (nDES) [1], a previous report shows that coronary artery lesions with DCB and nDES showed similar there are still more ischemic events and higher bleeding safety and long-term efficacy [5, 6]. In addition, we recently complications with the treatment of patients with severe reported that the clinical outcomes after DCB treatment of coronary artery calcicfi ation (CAC) [2]. moderate or severe calcified lesions and noncalcified lesions Innovative strategies are required for the treatment of were similar [7]. CAC [3]. Drug-coated balloons (DCB) are one of the leading- However, CAC is associated with larger dissections edge devices that transfer antiproliferative drugs into the aer ft high-pressure balloon dilatation, with more stents 2 Journal of Interventional Cardiology consequently required for bailout or due to unsatisfactory into the guiding catheter. An “oscillating ablation technique” results [8]. us, Th aggressive lesion debulking with rotational [14] was used that slowly and gently engaged the lesion atherectomy (RA) is occasionally performed to avoid large with the rotating burr, which was then slowly retracted (not dissections followed by subsequent high-pressure balloon pecking quickly) to limit the rotational speed from baseline dilatation [9], although the use of a large burr has not been (<5,000 rpm) during any run (<15 seconds). The operators recommended due to high complications [10]. were highly recommended to advance the burr as slowly On the other hand, the efficacy of intravascular imaging and smoothly as possible, by 1-2mm under u fl oroscopy, devices in PCI was recently reported [11] and these imaging while discerning lesion contours and borders by contrast devices are recently used to guide RA (intravascular image- injection. The operator monitored pitch changes, advancer guided RA: iRA) [3, 12]. knob resistance and drive shaft vibration. The operators also The aim of this study was to assess the safety of aggressive controlled the guidewire bias to avoid excessive load on the burr and rpm decreases, setting the optimal ablation vector debulking with iRA and the long-term efficacy of DCB angioplasty following iRA. Furthermore, we compared DCB of the burr by retracting the guidewire to a proximal position with nDES aer ft iRA in patients with CAC. or using a burr of smaller size, if needed. Although selection of DCB or nDES after an iRA was left to the discretion of the operator, the decision was made before iRA to investigate a 2. Methods crossover between the strategies. 2.1. Study Population. From April, 2014,toApril,2017, The only brand of DCB used was the SeQuentPlease 123 consecutive patients (166 lesions) were evaluated with (B. Braun, Berlin, Germany). In the nDES-RA group, the severely calciefi d de novo coronary artery lesions who under- stents implanted included 39 Xience (Abbott Laboratories, went an iRA followed by DCB angioplasty (DCB-iRA group: Abbott Park,IL),23 Ultimaster/ 3 Nobori(Terumo Corp.), 54 patients, 68 lesions) or nDES implantation (nDES-iRA 12 Premiere / 4 Synergy (Boston Scientific) and 17 Resolute group: 69 patients, 98 lesions) at Matsunami General Hospital (Medtronic Inc., Santa Rosa, California). (Gifu, Japan). 2.3. Burr Selection: Lesion Preparation with iRA before The patients included in this study had CAC that ap- peared on angiography as radio-opaque regions without car- DCB Angioplasty. A stepped-burr approach was used, with the maximum burr size determined by IVUS or OFDI diac motion before contrast injection and generally involved images (not by angiography), while considering guidewire both sides of the arterial wall. Only lesions were included in this study that met one of the following criteria: (1) the lesion bias. The target maximum burr size was set at 0.7 of the mean reference diameter (MRDI) obtained by intra- was not crossable by the smallest balloon or by intravascular coronary imaging. After every rotablation, intracoronary ultrasound (IVUS) or optical frequency domain imaging imaging was performed to decide whether to use a larger (OFDI) (70 lesions); (2) the lesion could not be dilated with a burr. high-pressure balloon or a scoring balloon (27 lesions); or (3) the lesions had extensive intimal deposition of calcium ( the Then, DCB was inflated at low pressure (1-4 atm) for 30 to 60 seconds to avoid major dissections, while confirming by arc of calcium> 270 ) assessed by an imaging catheter [13] angiographytoensurethattheballoonwasincontactwiththe (69 lesions). Patients with acute coronary syndrome, restenotic le- vessel luminal wall as well as estimated by changes in the ST segment of ECG. In order to ensure sufficient contact of the sions, thrombotic lesions, in-stent restenosis and bypass graft balloon surface with the vessel luminal wall at low pressure, lesions were excluded. All patients provided written informed the balloon diameter was the same or≥0.25 mm of the MRDI, consent. The study complied with the Declaration of Helsinki and the balloon length exceeded the target lesion at both sides for investigation in human beings and was approved by the by at least 2mm. institutional ethics committee of our institution. 2.4. Burr Selection: Lesion Preparation with iRA before nDES 2.2. Intravascular Image-Guided RA and the Choice of Adjunc- Implantation. A maximum burr size was also set at 0.7 of tive eTh rapy aeft r RA. Patients were pretreated with daily the MRDI. Before stenting after an iRA, the lesion was doses of 100mg of aspirin and 75mg of clopidogrel or 3.75mg dilated with a high-pressure balloon or a scoring balloon of prasugrel. A 300-mg loading dose of clopidogrel or a 20- until full expansion of the balloons was achieved at 12-22atm. mg loading dose of prasugrel was administered before the If necessary, high-pressure balloon dilatation was further procedure if patients had not been pretreated at least 4 days undertaken to treat stent underexpansion. earlier. Heparin was administered to maintain an activated clotting time of > 300 seconds during the procedure. All cases were treated with IVUS guidance (View IT, 35MHz and 2.5. Outcomes. The study end points were target lesion revas- AltaView, 40MHz; Terumo Corp. Tokyo, Japan or Opticross: cularization (TLR) and target vessel revascularization (TVR). Boston Scientific, Natick, MA, USA) or OFDI guidance Acute procedural success, defined as residual stenosis <50% (FastView and LUNAWAVE,Terumo Corp.). and stenosis reduction of at least 20% den fi ed by angiography, RA (Rotablator system, Boston Scientific) was performed procedural complications, death and major adverse cardiac by experienced operators. The baseline burr rotational speed events (MACE) were also investigated. All end points were defined according to the Academic Research Consortium was set at 195,000rpm for a 1.25mm burr and 175,000 rpm for larger burrs (1.5mm - 2.25mm burr) before passing the burr (ARC) definitions [15]. Journal of Interventional Cardiology 3 2.6. Quantitative Coronary Angiography. The latest coronary 3.3. Clinical Follow-Up. The median (IQR) follow-up was 732 angiograms, which were obtained at 6 months or later after (484-1,030) days. The cumulative incidence rates of TLR at PCI, were analyzed to obtain follow-up data. The angiograms 1, 2, and 3 years were not significantly different between the DCB-iRA and nDES-iRA group (9.3% versus 6.2% and 15.6% before and aeft r PCI and at follow-up were analyzed using the QAngio XA Version 7.3 (MEDIS Medical Imaging Systems versus 12.9%, and 15.6% versus 16.3%, respectively, P=0.99) BV, Leiden, the Netherlands). (HR 1.01, 95%CI 0.41-2.50, P=0.99). In addition, there was no significant difference between the DCB-iRA group and 2.7. Statistical Analysis. Continuous variables are presented nDES-iRA group in the cumulative incidence rates of TVR at as mean and standard deviation (SD) or median and 1, 2 and 3 years (9.3% versus 10.0%, 15.6% versus 18.0% and interquartile range (IQR) and categorical variables as counts 15.6% versus 23.3%, respectively, P=0.38) (HR 0.69, 95%CI and percentages. Student’s t-test and Chi-squared test were 0.30-1.60, P=0.39) (Figure 1). used for comparisons. A P value of< 0.05 was considered The propensity score was calculated from target vessel, significant. ostial lesion, bifurcation lesion, reference diameter, and lesion The cumulative incidence rates of TLR and TVR in the length as covariates with P< 0.05 in univariate analysis as well two groups were derived from Kaplan–Meier analyses, and as CTO and MLD before the procedure. In the propensity the log-rank test was used to compare the differences between score-matched group (41 lesions in each group, Table 4), the groups. Cox proportional hazard models were used to there was still no significant difference between the DCB-iRA compare the unadjusted outcomes between the groups, and group and nDES-iRA group in the cumulative incidence rates the results are presented as hazard ratios (HR) with 95% of TLR at 1, 2, and 3 years (7.5% versus 9.3% and 12.9% versus confidence intervals (CI). To adjust for differences in baseline 16.3% and 12.9% versus 16.3%, respectively, P=0.70) (HR 0.77, characteristics between the two procedures, propensity score 95%CI 0.21-2.88, P=0.70). The cumulative incidence rates of matching was performed with a greedy matching algorithm. TVR at 1, 2, and 3 years in the DCB-iRA group (7.5%, 12.9%, The matching algorithm used a multivariate logistic regres- and 12.9%, respectively) were also not different from those in sion model that included baseline covariates with P< 0.05 in the nDES-iRA group (19.2%, 26.1%, and 26.1%, respectively, univariate analysis as well as chronic total occlusion (CTO) P=0.17) (HR 0.44, 95% CI 0.13-1.47, P=0.18) (Figure 2). and the minimum lumen diameter (MLD) before procedure During the follow-up period, there were 10 cardiac deaths as established predictors [16]. All statistical analysis was (2/54, 3.7% in the DCB-iRA group and 8/69, 11.6% in the performed by R software version 3.4.1(2017-06-30). nDES-iRA group) and 9 noncardiac deaths (6/54, 11.1% in the DCB-iRA group and 3/69, 4.3% in the nDES-iRA group). At 1, 2, and 3 years, there were no significant differences 3. Results between the DCB-iRA group and the nDES-iRA group in 3.1. Characteristics of Patients and Lesions. The baseline the cumulative rates of all-cause mortality (7.6% versus 13.1%, characteristics of the patients and lesions are summarized in 10.5% versus 14.9% and 20.9% versus 14.9%, P=0.95), cardiac Table 1. The right coronary artery was the target vessel more death (1.9% versus 8.8%, 1.9% versus 10.7% and 9.4% versus oeft n in the nDES-iRA group, whereas the left circumefl x 10.7%, respectively, P=0.18), and MACE (15.1% versus 23.3%, coronary artery was more oeft n in the DCB-iRA group. Ostial 21.7% versus 28.2% and 31.6% versus 30.2%, respectively, lesions and bifurcation lesions were more frequent in the P=0.47). DCB-iRA group. The reference diameter was significantly There were no definite cases of vessel or stent thrombosis smaller in the DCB-iRA group (2.28± 0.58 mm versus 2.49 in either group, although one case of possible stent thrombo- ± 0.55 mm, respectively, P=0.019) and the lesion length was sis(1/69, 1.4%) and 2 casesofprobable stent thrombosis (2/69, significantly shorter in the DCB-iRA group (11.89 ± 6.41 mm 2.9%) were observed only in the nDES-iRA group. versus 18.78± 7.91 mm, respectively, P<0.001). 3.4. Quantitative Angiographic Analysis. Follow-up angiog- 3.2. Characteristics of the Procedural Devices and Acute Pro- raphy was performed for 38 patients (71.7%) with 51 lesions cedural Results. The DCB-iRA group had a significantly (76.1%) in the DCB-iRA group and 46 patients (66.7%) with higher mean maximum burr size (1.74± 0.28 mm versus 1.66 62 lesions (63.3%) in the nDES-iRA group. ± 0.22 mm, respectively, P=0.038) and a higher angiographic The results of quantitative coronary angiography are burr/artery ratio (B/A ratio) (0.79± 0.17 versus 0.69± 0.13, shown in Table 5. Aeft r propensity matching, the DCB-iRA respectively, P<0.001) (Table 2). group and the nDES-iRA group had a similar reference diam- eter (2.46± 0.64 mm versus 2.37± 0.39 mm, respectively, Theacutesuccess rates werehighand major complica- tions were rare in both groups. The incidence of coronary P=0.53), lesion length (15.01± 6.67 mm versus 15.77± 7.25 flow disturbance after rotablation was 14.8% in the DCB- mm, respectively, P=0.70), and B/A ratio (0.74± 0.11 versus iRA group and 11.6% in the nDES-iRA group (P=0.12). 0.72± 0.11, respectively, P=0.45). However, most coronary flow disturbances were due to TIMI At intervention, the acute gain (AG) in lumen diameter 2 slow ow fl despite a high B/A ratio. Crossover and major was smaller in the propensity matched DCB-iRA group than dissections were rare; one patient (1.9%) in the DCB-iRA in the nDES-iRA group (0.85 ± 0.37 mm versus 1.53 ± group experienced major dissection (NHLBI type E) just 0.43mm, respectively, P<0.001), and the post-PCI percent aeft r rotablation (B/A ratio, 0.83) and crossover to DES diameter stenosis was larger in the propensity matched DCB- (Table 3). iRA group than in the nDES-iRA group (24.10 ± 10.0% 4 Journal of Interventional Cardiology Table 1: Baseline characteristics of patients and lesions. DCB-iRA lesions nDES-iRA lesions Variables P value (n=68) (n=98) Number of patients 54 69 Age (years) 71±971±90.75 Male (%) 38 (70.4) 45 (65.2) 0.57 Smoking (%) 10 (18.5) 20 (29.0) 0.21 Diabetes (%) 33 (61.1) 39 (56.5) 0.71 Hypertension (%) 38 (70.4) 53 (76.8) 0.54 Hyperlipidemia (%) 38 (70.4) 43 (62.3) 0.44 Chronic kidney disease (%) 19 (35.2) 28 (40.6) 0.58 Hemodialysis patients (%) 12 (22.2) 19 (27.5) 0.54 Previous MI (%) 17 (31.5) 20 (29.0) 0.84 Previous CABG (%) 7 (13.0) 6 (8.7) 0.56 PAD (%) 15 (27.8) 21 (30.4) 0.84 Target vessel, n (%) LMT 2 (2.9) 5 (5.1) 0.001 LAD 38 (55.9) 47 (48.0) RCA 9 (13.2) 35 (35.7) LCX 19 (27.9) 11 (11.2) Lesion anatomy Type B2/C (%) 67 (98.6) 95 (96.9) 0.62 Ostial (%) 19 (27.9) 14 (14.3) 0.047 Bifurcation (%) 46 (67.6) 46 (47.9) 0.016 CTO (%) 3 (4.4) 11 (11.2) 0.16 Quantitative angiography Reference diameter (mm) 2.28±0.58 2.49±0.55 0.019 Lesion length (mm) 11.89±6.41 18.78±7.91 <0.001 MLD Pre-intervention (mm) 0.87±0.35 0.90±0.41 0.65 Percent diameter stenosis Pre-intervention (%) 60.9±12.5 64.5±16.3 0.12 CABG, coronary artery bypass graft surgery; CTO, chronic total occlusion; DCB, drug-coated balloon; LAD, left anterior descending artery; LMT, left main trunk; LCX, left circumflex artery; MI, myocardial infarction; MLD, minimun lumen diameter; nDES, new generation drug-eluting stents; PAD, peripher al artery diseases; RCA, right coronary artery; SD, standard deviation. versus 9.80 ± 6.46%, respectively, P<0.001). However, at On this hypothesis, the prospective randomized trial follow-up, the minimum lumen diameter (1.69± 0.57 mm (STRATAS) was performed to investigate the outcome of versus 1.87± 0.60 mm, respectively, P=0.29) and the percent 500 patients randomized to either an aggressive rotablation diameter stenosis (29.52 ± 17.62% versus 23.81 ± 20.52%, strategy (maximum burr/artery ratio >0.7 followed by no respectively, P=0.29) were similar between the two propensity angioplasty, or angioplasty≤1 atm) versus routine rotablation matched groups, and the late lumen loss (LLL) and loss index (maximum burr/artery ratio≤0.7, followed by routine bal- (LLL/AG) in the DCB-iRA group was significantly lower than loon angioplasty≥4 atm) [9]. MACE and emergent CABG that in the nDES-iRA group (0.09± 0.48 mm versus 0.52± were less in aggressive RA than in routine RA (2.0% versus 0.63 mm, respectively, P=0.009, and 0.03± 0.52 versus 0.32± 4.0%), coronary perforation occurred only in the routine 0.39, respectively, P=0.026). group, and severe ow fl disturbance occurred in only 1.2% in the aggressive RA. Nonetheless the aggressive rotational atherectomy strategy offered no advantage over more routine 4. Discussion burr sizing plus routine angioplasty in MLD at follow-up, The method in the present study is based on the hypothesis loss index (0.62 for the aggressive strategy versus 0.54 for the routine strategy) and restenosis rate. Therefore, since the that sufficient plaque debulking without barotrauma is a better approach for complex lesions [9, 17]. advent of the rfi st-generation DES, a B/A ratio has been Journal of Interventional Cardiology 5 Table 2: Device characteristics. DCB-iRA lesions (n=68) nDES-iRA lesions (n=98) P value Number of patients n=54 n=69 Sheath size, French(F) 6F (%) 32 (59.3) 53 (76.8) 0.11 7F (%) 10 (18.5) 9 (13.0) 8F (%) 12 (22.2) 7 (10.1) Approach via radial artery (%) 36 (66.7) 44 (63.8) 0.67 via brachial artery (%) 0 (0.0) 2 (2.9) via femoral artery (%) 18 (33.3) 23 (33.3) Maximum burr size (%) 1.25mm 5 (7.4) 8 (8.2) 0.18 1.5mm 19 (27.9) 34 (34.7) 1.75mm 27 (39.7) 45 (45.9) 2.0mm 7 (10.3) 7 (7.1) 2.15mm 1 (1.5) 1 (1.0) 2.25mm 9 (13.2) 3 (3.1) Mean burr size, mm 1.74±0.28 1.66±0.22 0.038 B/A ratio 0.79±0.17 0.69±0.13 <0.001 B/A ratio, burr-to-artery ratio. 1.0 1.0 TVR TLR 0.8 0.8 0.6 0.6 0.4 0.4 0.2 0.2 0.0 0.0 0 200 400 600 800 1000 0 200 400 600 800 1000 Time aer t ft he procedure (days) Time aer t ft he procedure (days) Number at risk Number at risk DCB-iRA 67 61 49 32 21 11 DCB-iRA 67 61 49 32 21 11 nDES-iRA 98 81 72 59 48 23 nDES-iRA 98 81 69 55 43 20 DCB-iRA DCB-iRA nDES-iRA nDES-iRA Figure 1: Cumulative Kaplan–Meier estimates of the incidence of target lesion revascularization (TLR) (left panel) and target vessel revascularization (TVR) (right panel), using the crude cohorts of 68 lesions treated with drug-coated balloons (DCB) aer ft intravascular image-guided rotational atherectomy (iRA) (DCB-iRA) and 98 lesions treated with new generation drug-eluting stents (nDES) aeft r iRA (nDES-iRA). recommended to be set at 0.5 to 0.6 before implantation of To the best of our knowledge, this is the rfi st report to DES [3]. assess the effect of DCB angioplasty at low pressure avoiding However, even in new generation DES era, CAC has barotrauma aer ft an aggressive rotablation of severely calci- been reported to be associated with higher procedural fied lesions. complications and an increased risk of MACE in patients The acute results of aggressive iRA in the present study undergoing not only PCI but also CABG [2, 18]. More showed that this procedure was safe, with less complication and less bailout stenting. Although the targeted maximum innovative strategies are required for the treatment of CAC. bur size was set at 0.7 of MRDI and a high B/A ratio Cumulative incidence of target lesion revascularization (TLR) Cumulative incidence of target vessel revascularization (TVR) 6 Journal of Interventional Cardiology Table 3: Acute procedural outcomes. DCB-iRA patients nDES-iRA patients P value (n=54) (n=69) Procedure success (%) 53 (98.1) 68 (98.6) 1.0 Patient success (%) 54 (100) 68 (98.6) Crossover (%) 1 (1.9) 0 1.0 Major complications 1.0 Death (%) 0 1 (1.4) MI (%) 0 1 (1.4) CABG (%) 0 0 Congestive heart failure (%) 0 2 (2.9) Minor complications 1.0 Ventricular fibrillation (%) 0 1 (1.4) Side branch occlusions (%) 0 1 (1.4) RA complications Perforation (%) 0 0 1.0 TIMI 0 slow flow (%) 0 2 (2.9) 0.12 TIMI 1 slow flow (%) 0 2 (2.9) TIMI 2 slow flow (%) 8 (14.8) 4 (5.8) Dissection; NHLBI classification A(%) 1 (1.9) 0 0.08 C(%) 1 (1.9) 0 E(%) 1 (1.9) 0 CABG, coronary artery bypass graft surgery; MI, myocardial infarction; RA rotational atherectomy. 1.0 1.0 TVR TLR 0.8 0.8 0.6 0.6 0.4 0.4 0.2 0.2 0.0 0.0 0 200 400 600 800 1000 0 200 400 600 800 1000 Time aer t ft he procedure (days) Time aer t ft he procedure (days) Number at risk Number at risk DCB-iRA DCB-iRA 41 37 30 18 11 6 41 37 30 18 11 6 nDES-iRA 41 33 27 24 21 11 nDES-iRA 41 33 24 21 18 9 DCB-iRA DCB-iRA nDES-iRA nDES-iRA Figure 2: Cumulative Kaplan–Meier estimates of the incidence of target lesion revascularization (TLR) (left panel) and target vessel revascularization (TVR) (right panel), using the propensity matched cohorts of 41 lesions treated with drug-coated balloons (DCB) after intravascular image-guided rotational atherectomy (iRA) (DCB-iRA) and 41 lesions treated with new generation drug-eluting stents (nDES) after iRA (nDES-iRA). Cumulative incidence of target lesion revascularization (TLR) Cumulative incidence of target vessel revascularization (TVR) Journal of Interventional Cardiology 7 Table 4: Baseline characteristics of patients and lesions in the propensity-matched cohorts. DCB-iRA lesions nDES-iRA lesions Variables P value (n=41) (n=41) Number of patients 34 35 Age (years) 70±872±90.63 Male (%) 24 (70.6) 20(57.1) 0.32 Smoking (%) 6 (17.6) 10 (28.6) 0.39 Diabetes (%) 22 (64.7) 17 (48.6) 0.23 Hypertension (%) 24(70.6) 28 (80.0) 0.41 Hyperlipidemia (%) 22 (64.7) 22(62.9) 1.00 Chronic kidney disease (%) 13 (38.2) 14 (40.0) 1.00 Hemodialysis patients (%) 10 (29.4) 12 (34.3) 0.80 Previous MI (%) 11 (32.4) 7 (20.0) 0.28 Previous CABG (%) 3 (8.8) 1(2.9) 0.36 PAD (%) 10 (29.4) 12 (34.3) 0.80 Target vessel LMT (%) 2(4.9) 2(4.9) 0.79 LAD (%) 23 (56.1) 21 (51.2) RCA (%) 9(22.0) 13(31.7 LCX (%) 7 (17.1) 5 (12.2) Lesion anatomy Type B2/C (%) 41(100) 39 (95.1) 0.60 Ostial (%) 10 (24.4) 10(24.4) 1.0 Bifurcation (%) 24 (58.5) 23 (56.1) 1.0 CTO (%) 3 (7.3) 5 (12.2) 0.71 Quantitative angiography Reference diameter (mm) 2.44±0.63 2.39±0.42 0.66 Lesion length (mm) 14.29±6.84 14.67±6.00 0.79 MLD Pre-intervention (mm) 0.93±0.39 0.87±0.35 0.43 Percent diameter stenosis Pre-intervention (%) 61.43±14.47 64.67±15.34 0.33 Mean burr size (mm) 1.78±0.32 1.66±0.18 0.028 B/A ratio 0.76±0.14 0.71±0.12 0.10 Abbreviations are the same for Table 1. In the SeQuentPlease World Wide Registry, the TLR was obtained, procedural complications were rare and only one crossover from DCB to DES was observed (1.9%). A rate aer ft DCB only for de novo lesions was similar to that severe flow disturbance (TIMI 0) was observed in only 2 aer ft DCB plus bare metal stents (BMS) (1.0% versus 2.4%, cases (1.6%). Since the incidence of flow disturbance was respectively), whereas the TVR rate after DCB only tended reported to be 0-3.8% with a contemporary approach [3, 12], to be smaller than that of DCB plus BMS (1.0% versus it is reasonable to suppose that aggressive iRA (oscillating 3.6%, respectively, P=0.09) [19]. However, this tendency for ablation technique by the burr of 0.7MRDI) is as safe as a difference in the TVR rate was not found in the present rotablation when the B/A ratio is set at 0.5 to 0.6 by study (12.9% in the DCB-iRA versus 26.1% in the nDES-iRA, angiography. P=0.17). In addition, with respect to long-term efficacy, the loss Of note, Rissanen et al. recently reported that a stentless index in the DCB-iRA group in the present study was smaller strategy with DCB following balloon dilatation or cutting than that in the aggressive RA-low pressure POBA group balloon dilatation aeft r RA for CAC was safe and eeff ctive in the STRATAS trial (0.08 versus 0.62, respectively) [9]. (TLR / MACE at 1 and 2 years were 1.5% / 14% and 3.1% Furthermore, it was found that the DCB-iRA group has an / 20%, respectively) [20]. Compared with their results, the equivalent TLR and TVR rate to the nDES-iRA group, as well TLR rates in our study were higher although MACE was as after propensity matching. similar (9.3% / 15.1% and 15.6% / 21.7%, respectively). This 8 Journal of Interventional Cardiology Table 5: Pre- and postprocedural quantitative angiographic characteristics in the crude and matched cohorts. DCB-iRA lesions nDES-iRA lesions P value Crude cohorts n=51 n=62 At PCI Reference diameter (mm) 2.33±0.63 2.50±0.57 0.14 Lesion length (mm) 11.56±6.19 18.57±7.98 <0.001 MLD (mm) Pre-intervention (mm) 0.86±0.38 0.91±0.40 0.49 Post-intervention (mm) 1.75±0.50 2.57±0.51 <0.001 Percent diameter stenosis Pre-intervention (%) 62.27±13.31 64.70±15.39 0.38 Post-intervention (%) 22.86±10.11 9.59±6.10 <0.001 Acute Gain (mm) 0.90±0.39 1.66±0.53 <0.001 Rotablator burr size Mean burr size (mm) 1.74±0.28 1.68±0.21 0.21 B/A ratio 0.78±0.17 0.70±0.14 0.006 At follow-up MLD (mm) 1.68±0.63 2.03±0.84 0.015 % diameter stenosis (%) 29.01±20.25 25.12±23.56 0.36 Late lumen loss (mm) 0.08±0.43 0.54±0.80 <0.001 Loss index 0.05±0.48 0.33±0.45 0.002 Matched cohorts n=26 n=26 At PCI Reference diameter (mm) 2.46±0.64 2.37±0.39 0.53 Lesion length (mm) 15.01±6.67 15.77±7.25 0.70 MLD (mm) Pre-intervention 0.94±0.36 0.86±0.34 0.42 Post-intervention 1.78±0.42 2.38±0.34 <0.001 Acute Gain (mm) 0.85±0.37 1.53±0.43 <0.001 Percent diameter stenosis Pre-intervention (%) 60.78±13.27 65.48±15.44 0.24 Post-intervention (%) 24.10±10.00 9.80±6.46 <0.001 Rotablator burr size Mean burr size (mm) 1.78±0.32 1.67±0.20 0.16 B/A ratio 0.74±0.11 0.72±0.11 0.45 At follow-up MLD (mm) 1.69±0.57 1.87±0.60 0.29 % diameter stenosis (%) 29.52±17.62 23.81±20.52 0.29 Late lumen loss (mm) 0.09±0.48 0.52±0.63 0.009 Loss index 0.03±0.52 0.32±0.39 0.026 B/A ratio, burr-to-artery ratio; MLD, minimum lumen diameter; SD, standard deviation; PCI, percutaneous coronary intervention. Loss index; Late lumen loss / Acute gain. is attributed to the fact that the target lesions were in larger bailout stent (1.9% of the patients) was needed in the present vessels in their study, and routine noninvasive testing and study. follow-up angiographies were not performed. In contrast, Although there was no difference between the two groups the reference diameter in our study was smaller (2.28±0.58 in the reference diameter or B/A ratio after propensity match- mm). Moreover, 61.1% were diabetic mellitus patients and ing, the results of acute angiography showed that the DCB- 27.9% of the lesions were ostial lesions in our study. Since the iRA group had significantly less acute gain, lower post-PCI predictors of restenosis are a history of diabetes mellitus, a MLD, and higher residual stenosis. The differences in acute small reference diameter, and ostial lesions [21], the outcome gain and residual stenosis between the groups are attributed obtained is considered to be clinically acceptable. In addition, to the expansion of the lumen during stenting. In contrast, it should be noted that bailout stent was needed in 10% of at follow-up angiography, there was no difference between the groups in residual stenosis or MLD. The reason for this the procedures in their study, while alternatively only one Journal of Interventional Cardiology 9 was a signicfi antly larger late lumen loss (LLL) in the nDES- Acknowledgments iRA group than in the DCB-iRA group (0.52 mm versus 0.09 We would like to express our deepest gratitude to Gregory mm, respectively, P=0.009). The LLL in the stented group was A. Braden M.D. who taught us his masterful rotablator larger than what has been reported previously for the stenting technique and the fundamentals that this study was based of noncalcified lesions [22]. We speculate that this is due upon. We would also like to thank Takeshi Fukuda R.T. and to residual calcium causing damage to the stent polymer or Leigh Childs who gave us invaluable comments and warm chronic stent recoil, even after preparation of the lesions with encouragements. Finally, we would like to thank radiology rotablation. Additionally, further barotrauma was incurred nurses, radiology technicians, medical technologists, and by the high-pressure balloons. clinical engineering technologists in our cath lab for their On the other hand, given that the SeQuentPlease balloon continuous contribution and their warm support. is folded, a majority of the drug is protected by the folds during delivery to the calcified lesions. The reported washout of a delivered and retracted noninflated balloon is 6% [23]. References With appropriate drug delivery during balloon inflation, drug [1] A. E. Rodriguez, O. Santaera, M. Larribau et al., “ERACI IV uptake into the lesion is sufficient to inhibit LLL and reduce Investigators. Second vs. first-generation drug-eluting stents in the TLR rate. complex lesions subsets: 3 years’ follow-up of ERACI IV study,” Several potential advantages of stentless strategy using Minerva Cardioangiol,vol.65, no. 1,pp. 81–90,2017. DCB over stenting have been suggested [5, 19]: (1) a short [2] P. Gen ´ er ´ eux, B. Redfors, B. Witzenbichler et al., “Two-year duration of dual antiplatelet therapy (DAPT) of 1 month outcomes aer ft percutaneous coronary intervention of calcified is feasible, and DAPT can be discontinued at any time lesions with drug-eluting stents,” International Journal of Cardi- if there are bleeding events; (2) the absence of a metal ology, vol.231,pp.61–67, 2017. scaffold to deliver antiproliferative drug maintains vaso- [3] M. I. Tomey, A. S. Kini, and S. K. Sharma, “Current status motion and may prevent neoatherosclerosis in the treated of rotational atherectomy,” JACC: Cardiovascular Interventions, artery; (3) finally and most important, stentless PCI with vol. 7, no. 4, pp. 345–353, 2014. low pressure DCB dilation is often simpler and less time [4] C. Herdeg, M. Oberhoff, A. Baumbach et al., “Local paclitaxel consuming, especially for complex anatomy such as cal- delivery for the prevention of restenosis: Biological eeff cts and cified ostial lesions, bifurcation lesions and diffuse long efficacy in vivo,” Journal of the American College of Cardiology, lesions. vol. 35, no. 7, pp. 1969–1976, 2000. [5] D. Venetsanos, S. S. Lawesson, G. Panayi et al., “Long-term 4.1. Study Limitations. There are several limitations in this efficacy of drug coated balloons compared with new generation study. First, the two procedures were assigned in a nonran- drug-eluting stents for the treatment of de novo coronary artery domized manner. We conducted propensity score match- lesions,” Catheterization and Cardiovascular Interventions,vol. ing to minimize the difference in patient characteristics. 92, no. 5, pp. E317–E326, 2018. However, there may still be residual selection bias and [6] R.V.Jeger, A.Farah, M. A.Ohlow, N. Mangner etal., “Drug- confounding, and the number of propensity matched QCA coated balloons for small coronary artery disease (BASKET- pairs was small. Second, this study was a retrospective, small SMALL 2): an open-label randomised non-inferiority trial,” Lancet,vol.392,pp.849–856, 2018. study performed at a single center. Since a relatively small number of the patients were enrolled and only a small [7] R. Ito, K. Ueno, T. Yoshida et al., “Outcomes aer ft drug-coated number of events occurred due to small sample size, the balloon treatment for patients with calcified coronary lesions,” Journal of Interventional Cardiology, vol.31, no.4, pp. 436–441, present study may have been underpowered to determine the relationship between the incidence of TLR/TVR and DCB treatment aer ft iRA. A study in a larger popula- [8] T. Dill, U. Dietz, C. W. Hamm et al., “A randomized comparison of balloon angioplasty versus rotational atherectomy in complex tion is needed to definitively define the effects of DCB coronary lesions (COBRA study),” European Heart Journal,vol. angioplasty. 21, no. 21, pp. 1759–1766, 2000. [9] P.L. Whitlow,T. A.Bass, R. M. Kipperman et al.,“Results of 4.2. Conclusion. For severely calcified coronary lesions, a the study to determine rotablator and transluminal angioplasty stentless strategy utilizing DCB angioplasty at low pressure strategy (STRATAS),” American Journal of Cardiology,vol.87, following iRA is feasible and effective. no. 6, pp. 699–705, 2001. [10] R. D. Safian, T. Feldman, D. W. M. Muller et al., “Coro- nary Angioplasty and Rotablator Atherectomy Trial (CARAT): Data Availability Immediateand late results ofaprospectivemulticenter ran- domized trial,” Catheterization and Cardiovascular Interven- The data used to support the findings of this study are tions,vol.53,no.2, pp. 213–220,2001. available from the corresponding author upon request. [11] B. E. Claessen, R. Mehran, G. S. Mintz et al., “Impact of intravascular ultrasound imaging on early and late clinical outcomes following percutaneous coronary intervention with Conflicts of Interest drug-eluting stents,” JACC: Cardiovascular Interventions,vol. 4, The authors have no conflicts of interest to declare. no. 9, pp. 974–981, 2011. 10 Journal of Interventional Cardiology [12] W. Tian, M. Mahmoudi, T. Lhermusier et al., “Clinical outcomes of first- and second-generation drug-eluting stents in patients undergoing rotational atherectomy for heavily calcified coro- nary lesions,” Cardiovascular Revascularization Medicine,vol. 16, no. 3, pp. 147–150, 2015. [13] M.Mosseri,L.F.Satler,A.D.Pichard,andR.Waksman,“Impact of vessel calcification on outcomes after coronary stenting,” Cardiovascular Revascularization Medicine, vol.6,no. 4,pp. 147–153, 2005. [14] M. Reisman, Guide to Rotational Atherectomy, Physicians’ Press, Birmingham, Mich, USA, 1997. [15] D. E. Cutlip, S. Windecker, R. Mehran et al., “Clinical end points in coronary stent trials: a case for standardized definitions,” Circulation,vol.115,no.17,pp.2344–2351, 2007. [16] P. Rubartelli, E. Verna, L. Niccoli et al., “Coronary stent implantation is superior to balloon angioplasty for chronic coronary occlusions: Six-year clinical follow-up of the GISSOC trial,” Journal of the American College of Cardiology,vol. 41, no. 9, pp. 1488–1492, 2003. [17] F. Otsuka, M. Nakano, K. Sakakura, E. Ladich, F. D. Kolodgie, and R. Virmani, “Unique demands of the femoral anatomy and pathology and the need for unique interventions,” Journal of Cardiovascular Surgery, vol.54,no. 2,pp.191–210, 2013. [18] M. V. Madhavan, M. Tarigopula, G. S. Mintz, A. Maehara, G. W. Stone, and P. Gen ´ er ´ eux, “Coronary artery calcification: patho- genesis and prognostic implications,” Journal of the American College of Cardiology,vol.63,no.17, pp. 1703–1714, 2014. [19] J. Wo¨hrle, M. Zadura, S. Mob ¨ ius-Winkler et al., “SeQuent- Please World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospec- tive registry study,” Journal of the American College of Cardiol- ogy,vol.60,no. 18, pp.1733–1738, 2012. [20] T. T. Rissanen, S. Uskela, A. Siljander et al., “Percutaneous coro- nary intervention of complex calcified lesions with drug-coated balloon after rotational atherectomy,” Journal of Interventional Cardiology,vol.30,no. 2,pp.139–146, 2017. [21] P. A. Lemos, A. Hoye, D. Goedhart et al., “Clinical, angio- graphic, and procedural predictors of angiographic restenosis aer ft sirolimus-eluting stent implantation in complex patients: an evaluation from the rapamycin-eluting stent evaluated at rotterdam cardiology hospital (research) study,” Circulation, vol. 109, no. 11, pp. 1366–1370, 2004. [22] S. J. Brener, A. J. Prasad, Z. Khan, and T. J. Sacchi, “eTh rela- tionship between late lumen loss and restenosis among various drug-eluting stents: A systematic review and meta-regression analysis of randomized clinical trials,” Atherosclerosis,vol.214, no. 1, pp. 158–162, 2011. [23] B. Scheller, U. Speck, C. Abramjuk, U. Bernhardt, M. Bohm, ¨ and G. Nickenig, “Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis,” Circulation, vol. 110, no.7,pp.810–814,2004. 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