Effect of Crack Patterns in Calcified Plaque on Lumen Area after Stenting for a Severe Calcified Coronary Artery (from the Optical Frequency Domain Imaging-Guided Percutaneous Coronary Artery Intervention for Calcified Lesion Registry)

Hirooki Higami; Hiroaki Matsuda; Hikaru Tateyama; Yoriyasu Suzuki; Kazuaki Kaitani

doi:10.1155/2022/7821956

Effect of Crack Patterns in Calcified Plaque on Lumen Area after Stenting for a Severe Calcified Coronary Artery (from the Optical Frequency Domain Imaging-Guided Percutaneous Coronary Artery Intervention for Calcified Lesion Registry)

Higami, Hirooki;Matsuda, Hiroaki;Tateyama, Hikaru;Suzuki, Yoriyasu;Kaitani, Kazuaki 2022-02-27 00:00:00 Hindawi Journal of Interventional Cardiology Volume 2022, Article ID 7821956, 9 pages https://doi.org/10.1155/2022/7821956 Research Article Effect of Crack Patterns in Calcified Plaque on Lumen Area after Stenting for a Severe Calcified Coronary Artery (from the Optical Frequency Domain Imaging-Guided Percutaneous Coronary Artery Intervention for Calcified Lesion Registry) 1 2 3 2 Hirooki Higami , Hiroaki Matsuda , Hikaru Tateyama, Yoriyasu Suzuki, and Kazuaki Kaitani Department of Cardiovascular Medicine, Japanese Red Cross Otsu Hospital, Otsu, Shiga, Japan Department of Cardiology, Nagoya Heart Centre, Nagoya, Aichi, Japan Department of Clinical Engineering, Japanese Red Cross Otsu Hospital, Otsu, Shiga, Japan Correspondence should be addressed to Hirooki Higami; hhigami@kuhp.kyoto-u.ac.jp Received 19 October 2021; Revised 31 January 2022; Accepted 5 February 2022; Published 27 February 2022 Academic Editor: Faisal Latif Copyright © 2022 Hirooki Higami 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. Background. Severely calciﬁed coronary artery stenting remains a challenge due to stent thrombosis, target vessel failure, and higher mortality. Moreover, optimal vessel preparation for calciﬁed plaque with a crack formation pattern has not been established yet. We aimed to identify the eﬀect of crack formation in calciﬁed plaque in the coronary artery on the lumen area after stenting. Materials and Methods. We evaluated 50 consecutive patients undergoing drug-eluting stent implantation for severely calciﬁed lesions by using optical frequency domain imaging (OFDI) (54 lesions); we analyzed OFDI image slices every 3 mm and evaluated the segments of 242 images in those who had the arc of calcium more than 180 . Crack formation in calciﬁed plaque was classiﬁed into three types: type 0, no cracks; type 1, no dissection between calciﬁed plaque and vessel wall; and type 2, any dissection between calciﬁed plaque and vessel wall. Results. Type 2 had a signiﬁcantly higher area expansion ratio between preballooning and poststenting (type 0, 196% (interquartile range (IQR), 163–244); type 1, 210% (IQR, 174–244); type 2, 237% (IQR, 203–294)). Conclusions. ,e dissection between calciﬁed plaque and vessel wall was a signiﬁcant factor aﬀecting lumen area expansion after stenting. clearly detect calcium distribution and crack formation 1. Introduction of calciﬁed plaque. ,e disadvantage of OFDI is that the Percutaneous coronary intervention (PCI) outcomes entire vessel measurement is diﬃcult due to signal at- have improved with the development of drug-eluting tenuation. On the other hand, intravascular ultrasound stent (DES) [1–4]. However, stenting for a severely (IVUS) was demonstrated to achieve better clinical calciﬁed coronary artery has several clinical risks, such as outcomes of PCI [11] and is superior in evaluating the stent thrombosis, target vessel failure, and higher entire vessel measurement. However, in the treatment of mortality [5–10]. Despite the improvement in devices calciﬁed plaque, ultrasound waves are reﬂected by the and techniques, optimal vessel preparation for calciﬁed surface of calcium; therefore, IVUS cannot provide plaque with a crack formation pattern has not been quantitative evaluation of calciﬁed plaque. ,us, this clearly established. Optical frequency domain imaging study aimed to evaluate the eﬀect of crack formation (OFDI) is an intracoronary imaging device used to pattern in calciﬁed plaque after balloon angioplasty on evaluate the formation of calciﬁed plaque. OFDI can ﬁnal lumen area using OFDI. 2 Journal of Interventional Cardiology 242 image slices were analyzed in this study. ,e same 2. Methods anatomic image slices were examined before and after 2.1. Study Design and Patient Population. ,e Optical Fre- balloon dilatation and after stenting. ,e timing of pre- quency Domain Imaging-Guided Percutaneous Coronary balloon OFDI assessment in lesions treated with rotablator Artery Intervention for Calciﬁed Lesion registry is a phy- was just after rotational atherectomy with maximum burr sician-directed, noncompany sponsored, and retrospectively size. ,e correspondence between OFDI imaging before, two-centered registry that enrolled consecutive patients who after balloon angioplasty, and after stenting (if post- were undergoing PCI by using OFDI and DES for severely ballooning was performed after stenting, then post- calciﬁed coronary stenotic lesion. A severely calciﬁed cor- ballooning phase was analyzed) was identiﬁed by a onary stenotic lesion was deﬁned angiographically according synchronizing application that was a standard installation to the SYNTAX score. ,is score deﬁnes heavy calciﬁcation in LUNAWAVE. Regarding errors that might occur as multiple persisting opaciﬁcations, of the coronary wall, depending on the longitudinal movement of the OFDI that are visible in more than one projection, surrounding the catheter during the cardiac cycle, identiﬁcation of corre- complete lumen of the coronary artery at the site of the sponding frames in each phase was adjusted manually by lesion [12]. Fifty-eight patients who underwent PCI using the shape of calciﬁed plaque or/and side branch location. In OFDI for severely calciﬁed coronary disease for the ﬁrst time addition, crack of calciﬁed plaque is easily aﬀected longi- at two tertiary hospitals in Japan from January 2017 to June tudinally; therefore, we analyzed images approximately at 2019 were enrolled. Eight patients who had no stents, no 3 mm intervals. In case the correspondence of the frame OFDI data before/after ballooning, or stenting, <180 of was inaccurate, that frame was excluded from analysis. calciﬁed plaque over the entire lesion length, or calciﬁed All OFDI analyses were performed by two independent nodule were excluded. Calciﬁed nodule lesions were ex- investigators, including a clinical engineering technologist cluded according to their pathological diﬀerence from and physician. ,e angle and thickness of calciﬁed plaque normal calciﬁed plaque [13]. Calciﬁed nodule was deﬁned and vessel morphology (lumen area and minor and major based on previous reports as “when ﬁbrous cap disruption axis diameters of the lumen before balloon dilatation and was detected over a calciﬁed plaque characterized by pro- after stenting) were quantitatively measured. Measuring the truding calciﬁcation, superﬁcial calcium, and the presence of vessel area and diameter using OFDI is often challenging substantive calcium proximal and/or distal to the lesion” because of the thick calciﬁed plaque; thus, vessel area was [14]. ,us, the study population consisted of 50 patients (54 estimated from the immediate proximal and/or distal site at lesions). ,e stent choice, use of debulking devices, type of the image. ,e following quantitative measurements were balloons, poststenting dilatation, OFDI pullback speed, and obtained in preballooning phase: estimated vessel diameter dual antiplatelet therapy duration were decided upon the and area, lumen major and minor axis diameter, lumen area, discretion of individual centers. and calcium arc. In the postballooning phase, lumen major ,e research protocol was approved by the local ethics and minor axis diameter, lumen area, cracked calcium committee of all participating medical centers, which waived thickness, and crack patterns of calciﬁed plaque were the requirement for obtaining informed consent from pa- measured. In the poststenting phase, ﬁnal lumen area and tients because of the retrospective nature of this study. We stent symmetry index (symmetry index � minimal stent further excluded the patients who declined to participate in diameter/maximal stent diameter) were also determined. this study during the follow-up. All patient records were anonymized and deidentiﬁed before the analysis. 2.2. Deﬁnitions and Clinical Outcomes. We collected de- In this study, we analyzed all OFDI data of patients who mographic, angiographic, and procedural data from hospital had PCI and compared the baseline characteristics and charts based on prespeciﬁed deﬁnitions. ,e primary out- clinical outcomes among three types of crack formation in come measure in this study was the area expansion ratio calciﬁed plaque after balloon angioplasty: type 0, no crack between preballooning and poststenting. ,e secondary in the plaque; type 1, no dissection between calciﬁed plaque outcome measures included symmetry index of implanted and vessel wall; and type 2, with any dissection between stents, thickness of cracked calciﬁed plaque, and percentage calciﬁed plaque and vessel wall (Figure 1). OFDI can de- of the ﬁnal lumen area in the estimated vessel area. In the lineate media as a low-signal band. However, an assessment subanalysis, we compared the primary outcome measure of media behind heavy calcium is diﬃcult in some seg- ° ° according to calcium arc degrees (i.e., 180–224 , 225–269 , ments. ,us, it is hard to discriminate whether the dis- ° ° 270–314 , and 315–360 ). Moreover, we analyzed the pri- section between calcium sheet and vessel wall is medial or mary outcome measure only in the frame with the minimal adventitial. Hence, a type-2 crack was deﬁned as any ex- lumen area (MLA) after procedure. foliation of a calcium sheet from the vessel wall. OFDI measurements were performed using commercially avail- able oﬄine analysis software (LUNAWAVE, Terumo 2.3. Statistical Analysis. Continuous variables are expressed Corporation, Tokyo, Japan). ,e calcium component was as mean and standard deviation (SD), unless otherwise detected according to previously validated criteria [15]. noted, and were compared using one-way analysis of var- Each plaque was measured at approximately 3 mm intervals iance or the Kruskal–Wallis test, depending on their dis- along a calciﬁed lesion as long as the arc of the calcium was tributions. Categorical variables are presented as numbers ≥180 . ,e lesion length was measured by OFDI. A total of and percentages and were compared using the χ test. We Journal of Interventional Cardiology 3 a) b) c) d) Type 0 Type 1 Type 2 Figure 1: Crack formation pattern of calciﬁed plaque. (a) Type 0, no cracks or injury in the vessel. (b, c) Type 1, with crack in calciﬁed plaque (yellow arrowhead) or intima injury (red arrowhead) without medial dissection between calciﬁed plaque and vessel wall. (d) Type 2, with crack in calciﬁed plaque with medial dissection between calciﬁed plaque and vessel wall (blue arrowhead). evaluated the diﬀerence among the three types of crack Table 1: Baseline clinical characteristics. formation in calciﬁed plaque using the t-test. We investi- Variable n � 50 gated the aﬀecting factors for area expansion ratio between Age (years) 74.9± 7.9 preballooning and poststenting including multiple cracks, Male 34 (68%) rotablator use, calcium arc, cutting balloon (CB) inﬂation BMI (kg/m ) 23.4± 3.8 pressure, balloon diameter/vessel diameter ratio, dissection Hypertension 46 (92%) beside calcium or crack inside it, and type of crack in cal- Dyslipidemia 36 (72%) ciﬁed plaque based on prespeciﬁed deﬁnitions, using mul- Current smoker 9 (18%) tivariate analysis of variance. To determine the optimal Diabetes mellitus 27 (54%) balloon size that could predict type-2 lesion modiﬁcation, we Atrial ﬁbrillation 4 (8%) evaluated the percentage of balloon diameter/mean vessel LVEF (%) 63.8± 12.2 diameter among the lesions that could predict type-2 cracks ESRD on HD 3 (6%) eGFR≤60 without HD (mL/min/1.73 m ) 25 (50%) among the full length of the lesion based on ROC curve PAD 6 (12%) analysis. COPD 1 (2%) A receiver operating characteristic (ROC) curve analysis Aortic disease 1 (2%) was performed. ,e cutoﬀ point was deﬁned as the greatest Prior PCI 21 (42%) sum of sensitivity and speciﬁcity estimates. Prior CABG 2 (4%) Statistical analysis was conducted by a physician (HH) Prior stroke 6 (12%) using the JMP 10.0 software (SAS Institute Inc., Cary, NC). CHF 7 (14%) All statistical analyses were two-tailed, and P< 0.05 was Prior MI 18 (36%) considered statistically signiﬁcant. ,e authors had full SYNTAX score 21.5± 22.9 access to and take full responsibility for the integrity of the SYNTAX2 score (PCI) 34.3± 15.9 data. Acute coronary syndrome 5 (10%) Multivessel disease 27 (54%) Medications 3. Results Aspirin 49 (98%) ,ienopyridine 50 (100%) 3.1.BaselineCharacteristicsandProcedureDetails. ,e study OAC 5 (10%) population reﬂected the real-world clinical practice, in- Statins 43 (86%) cluding large proportions of patients with advanced age, β-blockers 25 (50%) diabetes mellitus, multivessel disease, and high SYNTAX ACE-I/ARB 30 (60%) score (Table 1). Data are presented as number (%) or mean± standard deviation, unless Regarding the lesion characteristics, majority of the le- otherwise noted. ACE-I, angiotensin-converting-enzyme inhibitor; ARB, sions in this study were in the left anterior descending artery angiotensinI receptor blocker; BMI, body mass index; CABG, coronary artery bypass grafting; CHF, congestive heart failure; COPD, chronic ob- (LAD). ,e lesion length was 35.0 ± 15.9 mm. Initial passage TM structive pulmonary disease; eGFR, estimated glomerular ﬁltration rate; of the OFDI imaging catheter (FastView , Terumo Cor- ESRD, end-stage renal disease; HD, hemodialysis; LVEF, left ventricular poration, Tokyo, Japan) through the lesion without rota- ejection fraction; MI, myocardial infarction; OAC, oral anticoagulants; tional atherectomy or/and balloon angioplasty was PAD, peripheral artery disease; PCI, percutaneous coronary intervention. 4 Journal of Interventional Cardiology Table 2: Baseline lesion characteristics and procedure details. successful in 56% of the cases, and rotational atherectomy was performed in 81% of the procedures. An orbital athe- Variable n � 54 rectomy system (OAS) was not used at all. All lesions were Target vessel treated with a CB before stenting. ,e CB diameter was Isolated LMCA 0 2.74± 0.31 mm, and maximum pressure of CB dilatation was LMCA + LAD 2 (3.7%) 10.4± 2.98 atm. All procedures were successful; no severe LAD 39 (72%) complications were observed (Table 2). LCx 2 (3.7%) RCA 11 (20%) Lesion length (mm) 35.0± 15.9 3.2. OFDI Analysis. Among 242 frame analysis, the dis- Tortuous vessel 12 (22%) CTO 0 crepancy of crack type between 2 independent investigators Rotational atherectomy 44 (81%) was in 7 frames (κ � 0.95, 95% CI: 0.92–0.99). In these CB diameter (mm) 2.74± 0.31 frames, inter- and intraobserver revalidated together and Maximum pressure of CB dilatation (atm) 10.4± 2.98 ﬁxed data. In other analyzed parameters, inter- and intra- Rotablator burr size (mm) 1.78± 0.20 observer reproducibility was acceptable. Out of the 242 Slow ﬂow/no reﬂow during procedure 5 (9.3%) OFDI slices, 58 segments were type 0, 72 were type 1, and Data are presented as number (%) or mean± standard deviation, unless 112 were type 2. Estimated vessel area and diameter were otherwise noted. CTO, chronic total occlusion; LAD, left anterior signiﬁcantly lower in type 2 (p � 0.01). Lumen area before descending artery; LCx, left circumﬂex artery; LMCA, left main coronary balloon dilatation was also signiﬁcantly lower in type 2 artery; RCA, right coronary artery; CB, cutting balloon. Calculated in 44 lesions. (p � 0.0003). ,e overall degrees of calcium arc were sig- niﬁcantly higher in type 1 (p � 0.0001). ,ickness of cracked calcium was 465± 162µm in type 1 and ballooning (Supplementary Table 1). Moreover, the CB size 387± 312µm in type 2, and the maximum thickness was that could predict type-2 cracks among the full length of the 820µm. No signiﬁcant diﬀerences in the symmetry index of lesion based on ROC curve analysis was 77.1% (CB diam- the implanted stent (p � 0.45) and the ﬁnal lumen area (p � eter/mean vessel diameter among the lesion (sensitivity, 0.38) among the three groups were found (Table 3). 50.0%; speciﬁcity, 88.1%; area under the curve, 0.727; 95% ,e lumen area expansion ratio between preballooning conﬁdence interval, −0.19–0.04; p � 0.0009)) (Figure 3). and poststenting was signiﬁcantly higher in type 2 than in other types (type 0, 196% (IQR, 163–244); type 1, 210% 4. Discussion (IQR, 174–244); and type 2, 237% (IQR, 203–294) (Figure 2(a)). Regarding secondary outcome measure, ,e primary ﬁndings of this study are as follows: dissection percentage of the ﬁnal lumen area in the estimated vessel between calciﬁed plaque and the vessel wall is the most area was signiﬁcantly higher in type 2 than in other types signiﬁcant factor for lesion preparation of calciﬁed coronary (type 0, 51.2% (IQR, 43.1–58.4); type 1, 50.0% (IQR, artery disease. 41.9–51.9); type 2, 56.9% (IQR, 47.0–64.3)) (Table 3, Sup- When performing PCI for severely calciﬁed coronary plementary Figure 1). In the subanalysis according to the disease, vessel preparation is essential for favorable short- degrees of calcium arc, the area expansion ratio between and long-term clinical outcomes [16–18], and optical co- preballooning and poststenting was signiﬁcantly higher in herence tomography (OCT)/OFDI could be used to assess type 2 segments in 315–360 calcium sections (type 0, 135% the mechanistic eﬀects of atherectomy devices [19, 20]. A (IQR, 110–231); type 1, 197% (IQR, 167–241); and type 2, previous report suggested that lumen dilatation following 242% (IQR, 220–368)); 270–314 calcium sections (type 0, balloon angioplasty was due not only to vessel wall dis- 207% (IQR, 175–247); type 1, 214% (IQR, 177–255); and section but also to the longitudinal displacement of the type 2, 227% (IQR, 200–280)); and 225–269 calcium sec- plaque [21]. However, calciﬁed plaque is too hard to modify tions (type 0, 200% (IQR, 182–236); type 1, 199% (IQR, or compress by balloon dilatation. ,erefore, to expand the 175–220); and type 2, 232% (IQR, 212–334)). However, no area of the coronary artery with calciﬁed plaque, the volume signiﬁcant diﬀerence among the three types was found in of calciﬁed plaque should be reduced by using an atherec- 180–224 calcium sections. (type 0, 198% (IQR, 157–247); tomy device or/and stretching the vessel arc without calciﬁed type 1, 228% (IQR, 189–265); and type 2, 231% (IQR, plaque. In the present study, rotablator use was 81% (44 of 54 201–269) (Figure 2(b)). In the frame with MLA analysis, the cases). ,e high usage rate was made by indication of OFDI lumen area expansion ratio between preballooning and for calciﬁed lesion. In the participating 2 hospitals, operators poststenting was signiﬁcantly higher in type 2 than in other tend to use OFDI for severely calciﬁed lesion which seems to types (type 0, 196% (IQR, 141–255); type 1, 210% (IQR, be needed debulking strategy from pre-PCI angiography. 186–245); and type 2, 243% (IQR, 207–295), that was the ,at made high frequency of rotational atherectomy strategy same trend with main analysis (Supplementary Figure 2). in the present study. Multivariate analysis, which was performed to determine However elastic vessel arc without calciﬁcation could the factors that could signiﬁcantly aﬀect lesion modiﬁcation, make elongation, excessive elongation may result in coro- suggested degree of calcium arc, CB/vessel diameter ratio nary perforation. A previous report demonstrated that ro- and type-2 crack had signiﬁcantly inﬂuenced lumen area tational atherectomy before stenting is eﬀective for calciﬁed expansion after stenting compared with that before Journal of Interventional Cardiology 5 Table 3: OFDI analysis. Variable Type 0 (n � 58) Type 1 (n � 72) Type 2 (n � 112) p value Estimated vessel diameter (mm) 4.05± 0.49 4.09± 0.51 3.89± 0.46 0.01 Estimated vessel area (mm ) 13.04± 3.26 13.27± 3.17 12.03± 2.74 0.01 Major axis diameter before using CB (mm) 2.36± 0.37 2.29± 0.37 2.11± 0.46 0.0004 Minor axis diameter before using CB (mm) 1.79± 0.31 1.72± 0.31 1.57± 0.31 0.0001 Lumen area before using CB (mm ) 3.37± 1.02 3.10± 0.91 2.73± 1.01 0.0003 Calcium arc ( ) 251± 56 294± 62 277± 53 0.0001 Calcium arc 315–360 8 (14%) 32 (44%) 28 (25%) 0.0009 Calcium arc 270–314 16 (28%) 18 (25%) 40 (36%) 0.25 Calcium arc 225–269 10 (17%) 12 (17%) 24 (21%) 0.67 Calcium arc 180–224 24 (41%) 10 (15%) 20 (18%) 0.0005 Major axis diameter after using CB (mm) 2.56± 0.32 2.63± 0.42 2.67± 0.41 0.22 Minor axis diameter after using CB (mm) 1.99± 0.28 1.99± 0.28 1.95± 0.29 0.52 Lumen area after using CB (mm ) 4.08± 0.87 4.21± 1.08 4.17± 1.15 0.80 Cracked calcium thickness (µm) N/A 465± 162 (n � 42) 387± 312 (n � 26) 0.08 Final lumen area (mm ) 6.43± 1.31 6.38± 1.36 6.66± 1.51 0.38 Symmetry index 0.86± 0.09 0.84± 0.08 0.86± 0.08 0.45 Final lumen area/estimated vessel area (%) 51.2± 12.4 50.0± 12.2 56.9± 13.0 0.0005 Data are presented as number (%) or mean± standard deviation, unless otherwise noted. CB, cutting balloon; OFDI, optical frequency domain imaging. lesions [17, 18]; on the other hand, the eﬀectiveness of arc stenting; therefore, the crack pattern may not be important elongation was not reported. We hypothesized that dis- in lower degree of calcium arc lesions. section between the calciﬁed plaque and vessel wall is as- Multivariate analysis showed CB/vessel diameter that sociated with a safe arc elongation and enlarged lumen area might be eﬀective in causing dissection was also a signiﬁ- after stenting. Previous evidence for the eﬀectiveness of CB cantly important factor for lesion preparation. We showed for severely calciﬁed lesions has been reported [22], and that under 77.1% (cutting balloon diameter/mean vessel operators in the participating hospitals employed CB in all diameter) balloon size might not be favorable for vessel procedures. Type-2 group includes higher ratio of higher preparation in calciﬁed lesion. Whereas, regarding there was calcium arc degree. Operators in the participating hospitals no vessel perforation in this study population, we could not might consider that using bigger size balloon may be safe suggest the size limit of cutting balloon that could crack without perforation in case of higher calcium arc degrees. calcium signiﬁcantly without vessel perforation (Figure 3). However, few reports have evaluated the crack formation of ,e low sensitivity for making type 2 crack might depend on calciﬁed plaque using OCT/OFDI. A previous report, which the operators’ discretion of not using too large size balloon to included only calciﬁed lesions treated with rotational avoid vessel perforation. In this study, ﬁnal lumen area was atherectomy, suggested the best cutoﬀ for the calcium arc similar among the 3 groups. However, percentage of ﬁnal and calcium thickness for the prediction of calcium crack lumen area in the estimated vessel area was signiﬁcantly were >227 and <670μm [16]. Although this study included higher in type 2. ,us, type-2 crack may be a predictor for both lesions treated with (81%) and without (19%) rotational great lumen enlargement, whereas, in the whole length of atherectomy, as the calcium arc decreases, the ratio of no stenosis lesion, type 2 crack might occur easier in smaller cracks increases. Furthermore, mean cracked calcium vessel segments than larger segments because balloon size/ thickness was 465µm in type 1 crack segments and 387μm vessel diameter was relatively larger in smaller vessel seg- in type-2 segments. ,ese results have corresponded with a ments. ,is might be a reason for the signiﬁcant diﬀerence in previous report. estimated vessel area among 3 groups. Hence, in nearly all rounded calciﬁed lesions, type-2 crack could result from ,e type-2 crack pattern of calciﬁed plaque, i.e., dis- section between calciﬁed plaque and the vessel wall, was a balloon angioplasty with an optimal size balloon after re- signiﬁcantly important factor for lesion preparation in both ducing calcium volume using rotational atherectomy analysis of including all image frames and only in MLA (Figures 4(a)–4(d)). Type-1 crack was not eﬀective for lumen frames, as hypothesized, particularly in segments with a high area expansion. Based on OFDI, calcium gaps resulting from degree of calciﬁed arc. Regarding the crack type may be in balloon dilatation did not grow wider after stenting part depending on the morphology of calciﬁed plaque, it was (Figures 4(e)–4(g)). diﬃcult to make deﬁnition of concentric/eccentric calciﬁed ,e ﬁnal symmetry index of implanted stents was not plaque; however, PCI operators may feel the plaque as diﬀerent among three groups. Logically, high volume concentric that occupies larger degree of arc. ,erefore, we eccentric calciﬁed lesion, that seems to have lower degree performed subanalysis depending on calcium arc that was of calciﬁed arc, has potential of low ﬁnal stent symmetry index. On the other hand, lower degree of calciﬁed arc able to be evaluated quantitively. In the 315–360 group, type 2 crack was particularly signiﬁcant for stent expansion, location has rich elastic vessel wall which could elongate whereas 180–224 group was not. In the lower degree of well after stenting. Hence, it is limited to discuss the calcium arc lesion, elastic vessel wall could extend well after result of symmetry index because of diﬃculty to 6 Journal of Interventional Cardiology Comparison between 3 groups: p<.0001 p<.0001 p=0.63 p<.0001 n=58 n=72 n=112 Type 0 Type 1 Type 2 (a) p=0.005 p=0.50 p=0.0009 p=0.008 p=0.04 p=0.48 p=0.08 p=0.06 p=0.79 p=0.07 p=0.53 p=0.34 n=8 n=32 n=28 n=16 n=18 n=40 n=10 n=12 n=24 n=24 n=10 n=20 Crack type 0 1 20 1 2 0 1 2 012 Calcified arc 315-360° 270-314° 225-269° 180-224° (b) Figure 2: Lumen area expansion ratio between before ballooning and after stenting. (a) Lumen area expansion ratio between before ballooning and after stenting (all analyzed frames (n � 242)). Type 0, 196% (interquartile range (IQR), 163–244), type 1, 210% (IQR, 174–244), and type 2, 237% (IQR, 203–294). (b) Lumen area expansion ratio between before ballooning and after stenting according to the degrees of calcium arc. 315–360 calcium sections: type 0, 135% (IQR, 110–231); type 1, 197% (IQR, 167–241); and type 2, 242% (IQR, 220–368)). 270–314 calcium sections (type 0, 207% (IQR, 175–247); type 1, 214% (IQR, 177–255); and type 2, 227% (IQR, 200–280)). ° ° 225–269 calcium sections (type 0, 200% (IQR, 182–236); type 1, 199% (IQR, 175–220); and type 2, 232% (IQR, 212–334)). 180–224 calcium sections (type 0, 198% (IQR, 157–247); type 1, 228% (IQR, 189–265); and type 2, 231% (IQR, 201–269)). quantitate calciﬁed plaque volume and distribution in must be explored. OFDI or OCT enables visualization of the the vessel. crack pattern and has an important role in PCI for severely Whereas, ﬁnal lumen area was not signiﬁcantly diﬀerent calciﬁed coronary disease [23]. Furthermore, several previous among the three groups; however, the ratio of ﬁnal lumen reports discussed rotational atherectomy for the treatment of area to estimated vessel area was signiﬁcantly higher in type- severe calciﬁed coronary lesions. Routine lesion preparation by 2 crack group that was according to lower estimated vessel using rotational atherectomy did not reduce late lumen loss. area in type-2 group. ,erefore, these secondary outcome However, rotational atherectomy was eﬀective for initial measures also suggest that type-2 crack was a feasible lesion procedural success particularly in complex lesion including preparation of calciﬁed plaque. tortuous artery, left main disease, and previous coronary artery bypass grafting [17]. Hence, the role of lithoplasty and OAS for While the ideal lesion preparation for severely calciﬁed lesion was suggested in this study, in clinical practice, operators calciﬁed coronary lesion remains unclear [19, 24, 25]. have diﬃculty in controlling the crack type of calciﬁed plaque. ,is study has several limitations. First, this was a small ,us, optimal lesion preparation using atherectomy devices number retrospective study. ,e procedure strategy had including rotational atherectomy, OAS, or/and special balloons depended on operators, and thus, the ﬁnal stent diameter or Final lumen area / Lumen area before balloon angioplasty (%) Final lumen area / Lumen area before balloon angioplasty (%) Journal of Interventional Cardiology 7 Type 2 crack Speciﬁcity 0.88 Sensitivity 0.50 Cutting balloon diameter/ Mean vessel diameter 77.1% 1.00 0.90 0.80 0.70 0.60 0.50 0.40 0.30 0.20 AUC=0.727 0.10 0.00 0.00 0.20 0.40 0.60 0.80 1.00 1 - specificity Figure 3: Receiver operating characteristic analysis for the prediction of type-2 cracks after balloon angioplasty. AUC, areas under the curve. a) b) c) d) e) f) g) Figure 4: Representative cases of those who underwent optical frequency domain imaging (OFDI)-guided percutaneous coronary in- tervention (PCI) for severely calciﬁed coronary disease. (a–d) A 69-year-old male with LAD lesion. Serial OFDI images obtained the same cross-section. (a) Initial OFDI image showed all rounded calciﬁed plaque. (b) Postrotational atherectomy using a 1.5 mm and 2.0 mm burr; the calcium almost disappeared within the circumference (yellow arrowhead). ,e lumen area was 3.5 mm and the lumen perimeter 6.6 mm. (c) Postballooning using a cutting balloon (diameter, 3.0 mm; dilatation atmosphere, 10 atm; perimeter, 10.2 mm). Blue arrowheads show the medial dissection between calciﬁed plaque and vessel wall. (d) Final OFDI image after stenting (DES diameter was 3.5 mm). ,e lumen area was 8.1 mm , and the expansion ratio (ﬁnal lumen area/lumen area before ballooning) was 231%. (e–g) A 74-year-old female with LAD lesion. Serial OFDI images obtained the same cross-section. Fast view catheter (TERUMO) did not pass the lesion. ,us, there was no initial OFDI image before rotational atherectomy. (e) Postrotational atherectomy using a 1.5 mm and 2.0 mm burr; the lumen was totally surrounded by thick calcium. ,e lumen area was 3.3 mm2 and the lumen perimeter 6.4 mm. (f) Postballooning using a cutting balloon (diameter, 2.25 mm; dilatation atmosphere, 8 atm; perimeter, 7.3 mm). ,e sheet calcium was cracked without medial dissection (blue arrowhead). (g) Final OFDI image after stenting (DES diameter was 2.5 mm). ,e lumen area was 4.6 mm and the expansion ratio (ﬁnal lumen area/lumen area before ballooning) was 139%. DES, drug-eluting stent; LAD, left anterior descending artery; OFDI, optical frequency domain imaging; PCI, percutaneous coronary intervention. Sensitivity 8 Journal of Interventional Cardiology balloon diameter after stenting was not standardized with expansion ratio between before ballooning and after stenting clear criteria, which in turn makes the actual maximum area (MLA frames only). Type 0, 196% (interquartile range expansion ratio between ﬁnal lumen area and the lumen area (IQR), 141–255), type 1, 210% (IQR, 187–245), and type 2, before ballooning diﬃcult to establish. Moreover, in this 243% (IQR, 207–295). Supplementary Table 1: multivariate study, the stents used were not uniﬁed. ,e diﬀerence in analysis of lesion modiﬁcation factors. ,e aﬀecting factors radial force in each drug-eluting stent possibly aﬀected the for area expansion ratio between preballooning and post- ﬁnal lumen area in the calciﬁed coronary artery. Second, stenting. (Supplementary Materials) majority of the lesions were in the LAD. Particularly, left circumﬂex artery lesion was only 3.7% of all the lesions. ,e References left circumﬂex artery is often a tortuous vessel, and the indications for OFDI/OCT and atherectomy devices are [1] T. Kimura, T. Morimoto, M. Natsuaki et al., “Comparison of limited. Hence, lesion preparation in other locations needs everolimus-eluting and sirolimus-eluting coronary stents: 1- further investigation. ,ird, this study includes two lesion year outcomes from the randomized evaluation of sirolimus- eluting versus everolimus-eluting stent trial (RESET),” Cir- preparation groups, using both rotational atherectomy and culation, vol. 126, no. 10, pp. 1225–1236, 2012. balloon angioplasty group and angioplasty alone group. [2] H. Shiomi, K. Kozuma, T. Morimoto et al., “7-year outcomes However, the aim of this study was to investigate the ef- of a randomized trial comparing the ﬁrst-generation siroli- fectiveness of crack formation pattern of calciﬁed plaque on mus-eluting stent versus the new-generation everolimus- stent expansion. ,erefore, we included these two groups in eluting stent: the RESET trial,” JACC: Cardiovascular Inter- the same analysis. Forth, there are no follow-up data of ventions, vol. 12, no. 7, pp. 637–647, 2019. enrolled patients in this study. Fifth, this study did not [3] H. Shiomi, K. Kozuma, T. Morimoto et al., “Long-term include quantitative coronary angiography (QCA) data clinical outcomes after everolimus- and sirolimus-eluting analysis. ,erefore, further investigation including whether coronary stent implantation: ﬁnal 3-year follow-up of the successful lesion preparation corresponds to target lesion randomized evaluation of sirolimus-eluting versus ever- revascularization or/and adverse cardiac events is required. olimus-eluting stent trial,” Circulation: Cardiovascular In- terventions, vol. 7, no. 3, pp. 343–354, 2014. Fifth, we suggested cutting balloon size to make optimal [4] C. von Birgelen, M. M. Kok, L. C. van der Heijden et al., “Very crack for calciﬁed lesion. However, it was diﬃcult to thin strut biodegradable polymer everolimus-eluting and compare 4-blade and 3-blade cutting balloon because only sirolimus-eluting stents versus durable polymer zotarolimus- one lesion which was used 4-blade cutting balloon. eluting stents in allcomers with coronary artery disease (BIO- Despite these limitations and limited availability of RESORT): a three-arm, randomised, non-inferiority trial,” OFDI in the world, from a clinical perspective, evaluation of 0e Lancet, vol. 388, no. 10060, pp. 2607–2617, 2016. lesion modiﬁcation for calciﬁed plaque using optical [5] M. P. Savage, S. Goldberg, J. W. Hirshfeld et al., “Clinical and intracoronary imaging has possibility to improve clinical angiographic determinants of primary coronary angioplasty outcome of severely calciﬁed coronary lesion. success. M-HEART investigators,” Journal of the American College of Cardiology, vol. 17, no. 1, pp. 22–28, 1991. 5. Conclusion [6] R. Hoﬀmann, G. S. Mintz, J. J. Popma et al., “Treatment of calciﬁed coronary lesions with Palmaz-Schatz stents an in- In conclusion, dissection between calciﬁed plaque and the travascular ultrasound study,” European Heart Journal, vessel wall is a signiﬁcant factor for a satisfactory ﬁnal lumen vol. 19, no. 8, pp. 1224–1231, 1998. [7] J. W. Van Werkum, A. A. C. M. Heestermans, F. I. De Korte area after stenting. et al., “Long-term clinical outcome after a ﬁrst angio- graphically conﬁrmed coronary stent thrombosis: an analysis Data Availability of 431 cases,” Circulation, vol. 119, no. 6, pp. 828–834, 2009. [8] K. Nishida, K. Nakatsuma, H. Shiomi et al., “Second-gener- ,e data used to support the ﬁndings of this study are ation vs. First-generation drug-eluting stents in patients with available from the corresponding author upon request. calciﬁed coronary lesions―pooled analysis from the RESET and NEXT trials―,” Circulation Journal, vol. 82, no. 2, Conflicts of Interest pp. 376–387, 2018. [9] J. Huisman, L. C. Van Der Heijden, M. M. Kok et al., “Impact ,e authors declare that they have no conﬂicts of interest. of severe lesion calciﬁcation on clinical outcome of patients with stable angina, treated with newer generation permanent Acknowledgments polymer-coated drug-eluting stents: a patient-level pooled analysis from TWENTE and DUTCH PEERS (TWENTE II),” ,e authors thank the members of the catheterization American Heart Journal, vol. 175, pp. 121–129, 2016. laboratories and physicians of the participating centers. [10] J. Huisman, L. C. van der Heijden, M. M. Kok et al., “Two-year outcome after treatment of severely calciﬁed lesions with Supplementary Materials newer-generation drug-eluting stents in acute coronary syndromes: a patient-level pooled analysis from TWENTE Supplementary Figure 1: ﬁnal lumen area/estimated vessel and DUTCH PEERS,” Journal of Cardiology, vol. 69, no. 4, area (%). Type 0, 50.0% (interquartile range (IQR), pp. 660–665, 2017. 43.4–58.7), type 1, 48.6% (IQR, 41.8–54.4), and type 2, 53.9% [11] B. Witzenbichler, A. Maehara, G. Weisz et al., “Relationship (IQR, 47.0–64.3). Supplementary Figure 2: lumen area between intravascular ultrasound guidance and clinical Journal of Interventional Cardiology 9 outcomes after drug-eluting stents: ,e assessment of dual of Cardiology: Cardiovascular Imaging, vol. 10, no. 8, antiplatelet therapy with drug-eluting stents (ADAPT-DES) pp. 897–906, 2017. [25] F. Alfonso, T. Bastante, P. Antuña et al., “Coronary lithoplasty study,” Circulation, vol. 129, no. 4, pp. 463–470, 2014. for the treatment of undilatable calciﬁed de novo and in-stent [12] G. Sianos, M.-A. Morel, A. P. Kappetein et al., “,e SYNTAX restenosis lesions,” JACC: Cardiovascular Interventions, Score: an angiographic tool grading the complexity of cor- vol. 12, no. 5, pp. 497–499, 2019. onary artery disease,” EuroIntervention, vol. 1, no. 2, pp. 219–227, 2005. [13] R. Virmani, A. P. Burke, A. Farb, and F. D. Kolodgie, “Pa- thology of the vulnerable plaque,” Journal of the American College of Cardiology, vol. 47, no. 8, pp. C13–C18, 2006. [14] H. Jia, F. Abtahian, A. D. Aguirre et al., “In vivo diagnosis of plaque erosion and calciﬁed nodule in patients with acute coronary syndrome by intravascular optical coherence to- mography,” Journal of the American College of Cardiology, vol. 62, no. 19, pp. 1748–1758, 2013. [15] H. Yabushita, B. E. Bouma, S. L. Houser et al., “Character- ization of human atherosclerosis by optical coherence to- mography,” Circulation, vol. 106, no. 13, pp. 1640–1645, 2002. [16] N. Maejima, K. Hibi, K. Saka et al., “Relationship between thickness of calcium on optical coherence tomography and crack formation after balloon dilatation in calciﬁed plaque requiring rotational atherectomy,” Circulation Journal, vol. 80, no. 6, pp. 1413–1419, 2016. [17] M. Abdel-Wahab, R. Toelg, R. A. Byrne et al., “High-speed rtational atherectomy versus modiﬁed balloons prior to drug- eluting stent implantation in severely calciﬁed coronary le- sions: the randomized PREPARE-CALC Trial,” Circ Cardiovasc Interv, vol. 11, pp. 1–12, 2018. [18] M. Abdel-Wahab, G. Richardt, H. Joachim Buttner ¨ et al., “High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calciﬁed coronary lesions: the randomized ROTAXUS (rotational atherectomy prior to Taxus stent treatment for complex native coronary artery disease) trial,” JACC: Cardiovascular Interventions, vol. 6, no. 1, pp. 10–19, 2013. [19] A. S. Kini, Y. Vengrenyuk, J. Pena et al., “Optical coherence tomography assessment of the mechanistic eﬀects of rota- tional and orbital atherectomy in severely calciﬁed coronary lesions,” Catheterization and Cardiovascular Interventions, vol. 86, no. 6, pp. 1024–1032, 2015. [20] M. H. Yamamoto, A. Maehara, K. Karimi Galougahi et al., “Mechanisms of orbital versus rotational atherectomy plaque modiﬁcation in severely calciﬁed lesions assessed by optical coherence tomography,” JACC: Cardiovascular Interventions, vol. 10, no. 24, pp. 2584–2586, 2017. [21] G. S. Mintz, A. D. Pichard, K. M. Kent, L. F. Satler, J. J. Popma, and M. B. Leon, “Axial plaque redistribution as a mechanism of percutaneous transluminal coronary angioplasty,” 0e American Journal of Cardiology, vol. 77, no. 5, pp. 427–430, [22] B. Redfors, A. Maehara, B. Witzenbichler et al., “Outcomes after successful percutaneous coronary intervention of cal- ciﬁed lesions using rotational atherectomy, cutting-balloon angioplasty, or balloon-only angioplasty before drug-eluting stent implantation,” Journal of Invasive Cardiology, vol. 29, no. 11, pp. 378–386, 2017. [23] N. Kobayashi, Y. Ito, M. Yamawaki et al., “Optical coherence tomography-guided versus intravascular ultrasound-guided rotational atherectomy in patients with calciﬁed coronary lesions,” EuroIntervention, vol. 16, no. 4, pp. e313–e321, 2019. [24] Z. A. Ali, T. J. Brinton, J. M. Hill et al., “Optical coherence tomography characterization of coronary lithoplasty for treatment of calciﬁed lesions,” Journal of the American College http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Interventional Cardiology Hindawi Publishing Corporation http://www.deepdyve.com/lp/hindawi-publishing-corporation/effect-of-crack-patterns-in-calcified-plaque-on-lumen-area-after-sAVDgMpToK

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Publisher: Hindawi Publishing Corporation
Copyright: Copyright © 2022 Hirooki Higami 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.
ISSN: 1540-8183
eISSN: 0896-4327
DOI: 10.1155/2022/7821956
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Abstract

Hindawi Journal of Interventional Cardiology Volume 2022, Article ID 7821956, 9 pages https://doi.org/10.1155/2022/7821956 Research Article Effect of Crack Patterns in Calcified Plaque on Lumen Area after Stenting for a Severe Calcified Coronary Artery (from the Optical Frequency Domain Imaging-Guided Percutaneous Coronary Artery Intervention for Calcified Lesion Registry) 1 2 3 2 Hirooki Higami , Hiroaki Matsuda , Hikaru Tateyama, Yoriyasu Suzuki, and Kazuaki Kaitani Department of Cardiovascular Medicine, Japanese Red Cross Otsu Hospital, Otsu, Shiga, Japan Department of Cardiology, Nagoya Heart Centre, Nagoya, Aichi, Japan Department of Clinical Engineering, Japanese Red Cross Otsu Hospital, Otsu, Shiga, Japan Correspondence should be addressed to Hirooki Higami; hhigami@kuhp.kyoto-u.ac.jp Received 19 October 2021; Revised 31 January 2022; Accepted 5 February 2022; Published 27 February 2022 Academic Editor: Faisal Latif Copyright © 2022 Hirooki Higami 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. Background. Severely calciﬁed coronary artery stenting remains a challenge due to stent thrombosis, target vessel failure, and higher mortality. Moreover, optimal vessel preparation for calciﬁed plaque with a crack formation pattern has not been established yet. We aimed to identify the eﬀect of crack formation in calciﬁed plaque in the coronary artery on the lumen area after stenting. Materials and Methods. We evaluated 50 consecutive patients undergoing drug-eluting stent implantation for severely calciﬁed lesions by using optical frequency domain imaging (OFDI) (54 lesions); we analyzed OFDI image slices every 3 mm and evaluated the segments of 242 images in those who had the arc of calcium more than 180 . Crack formation in calciﬁed plaque was classiﬁed into three types: type 0, no cracks; type 1, no dissection between calciﬁed plaque and vessel wall; and type 2, any dissection between calciﬁed plaque and vessel wall. Results. Type 2 had a signiﬁcantly higher area expansion ratio between preballooning and poststenting (type 0, 196% (interquartile range (IQR), 163–244); type 1, 210% (IQR, 174–244); type 2, 237% (IQR, 203–294)). Conclusions. ,e dissection between calciﬁed plaque and vessel wall was a signiﬁcant factor aﬀecting lumen area expansion after stenting. clearly detect calcium distribution and crack formation 1. Introduction of calciﬁed plaque. ,e disadvantage of OFDI is that the Percutaneous coronary intervention (PCI) outcomes entire vessel measurement is diﬃcult due to signal at- have improved with the development of drug-eluting tenuation. On the other hand, intravascular ultrasound stent (DES) [1–4]. However, stenting for a severely (IVUS) was demonstrated to achieve better clinical calciﬁed coronary artery has several clinical risks, such as outcomes of PCI [11] and is superior in evaluating the stent thrombosis, target vessel failure, and higher entire vessel measurement. However, in the treatment of mortality [5–10]. Despite the improvement in devices calciﬁed plaque, ultrasound waves are reﬂected by the and techniques, optimal vessel preparation for calciﬁed surface of calcium; therefore, IVUS cannot provide plaque with a crack formation pattern has not been quantitative evaluation of calciﬁed plaque. ,us, this clearly established. Optical frequency domain imaging study aimed to evaluate the eﬀect of crack formation (OFDI) is an intracoronary imaging device used to pattern in calciﬁed plaque after balloon angioplasty on evaluate the formation of calciﬁed plaque. OFDI can ﬁnal lumen area using OFDI. 2 Journal of Interventional Cardiology 242 image slices were analyzed in this study. ,e same 2. Methods anatomic image slices were examined before and after 2.1. Study Design and Patient Population. ,e Optical Fre- balloon dilatation and after stenting. ,e timing of pre- quency Domain Imaging-Guided Percutaneous Coronary balloon OFDI assessment in lesions treated with rotablator Artery Intervention for Calciﬁed Lesion registry is a phy- was just after rotational atherectomy with maximum burr sician-directed, noncompany sponsored, and retrospectively size. ,e correspondence between OFDI imaging before, two-centered registry that enrolled consecutive patients who after balloon angioplasty, and after stenting (if post- were undergoing PCI by using OFDI and DES for severely ballooning was performed after stenting, then post- calciﬁed coronary stenotic lesion. A severely calciﬁed cor- ballooning phase was analyzed) was identiﬁed by a onary stenotic lesion was deﬁned angiographically according synchronizing application that was a standard installation to the SYNTAX score. ,is score deﬁnes heavy calciﬁcation in LUNAWAVE. Regarding errors that might occur as multiple persisting opaciﬁcations, of the coronary wall, depending on the longitudinal movement of the OFDI that are visible in more than one projection, surrounding the catheter during the cardiac cycle, identiﬁcation of corre- complete lumen of the coronary artery at the site of the sponding frames in each phase was adjusted manually by lesion [12]. Fifty-eight patients who underwent PCI using the shape of calciﬁed plaque or/and side branch location. In OFDI for severely calciﬁed coronary disease for the ﬁrst time addition, crack of calciﬁed plaque is easily aﬀected longi- at two tertiary hospitals in Japan from January 2017 to June tudinally; therefore, we analyzed images approximately at 2019 were enrolled. Eight patients who had no stents, no 3 mm intervals. In case the correspondence of the frame OFDI data before/after ballooning, or stenting, <180 of was inaccurate, that frame was excluded from analysis. calciﬁed plaque over the entire lesion length, or calciﬁed All OFDI analyses were performed by two independent nodule were excluded. Calciﬁed nodule lesions were ex- investigators, including a clinical engineering technologist cluded according to their pathological diﬀerence from and physician. ,e angle and thickness of calciﬁed plaque normal calciﬁed plaque [13]. Calciﬁed nodule was deﬁned and vessel morphology (lumen area and minor and major based on previous reports as “when ﬁbrous cap disruption axis diameters of the lumen before balloon dilatation and was detected over a calciﬁed plaque characterized by pro- after stenting) were quantitatively measured. Measuring the truding calciﬁcation, superﬁcial calcium, and the presence of vessel area and diameter using OFDI is often challenging substantive calcium proximal and/or distal to the lesion” because of the thick calciﬁed plaque; thus, vessel area was [14]. ,us, the study population consisted of 50 patients (54 estimated from the immediate proximal and/or distal site at lesions). ,e stent choice, use of debulking devices, type of the image. ,e following quantitative measurements were balloons, poststenting dilatation, OFDI pullback speed, and obtained in preballooning phase: estimated vessel diameter dual antiplatelet therapy duration were decided upon the and area, lumen major and minor axis diameter, lumen area, discretion of individual centers. and calcium arc. In the postballooning phase, lumen major ,e research protocol was approved by the local ethics and minor axis diameter, lumen area, cracked calcium committee of all participating medical centers, which waived thickness, and crack patterns of calciﬁed plaque were the requirement for obtaining informed consent from pa- measured. In the poststenting phase, ﬁnal lumen area and tients because of the retrospective nature of this study. We stent symmetry index (symmetry index � minimal stent further excluded the patients who declined to participate in diameter/maximal stent diameter) were also determined. this study during the follow-up. All patient records were anonymized and deidentiﬁed before the analysis. 2.2. Deﬁnitions and Clinical Outcomes. We collected de- In this study, we analyzed all OFDI data of patients who mographic, angiographic, and procedural data from hospital had PCI and compared the baseline characteristics and charts based on prespeciﬁed deﬁnitions. ,e primary out- clinical outcomes among three types of crack formation in come measure in this study was the area expansion ratio calciﬁed plaque after balloon angioplasty: type 0, no crack between preballooning and poststenting. ,e secondary in the plaque; type 1, no dissection between calciﬁed plaque outcome measures included symmetry index of implanted and vessel wall; and type 2, with any dissection between stents, thickness of cracked calciﬁed plaque, and percentage calciﬁed plaque and vessel wall (Figure 1). OFDI can de- of the ﬁnal lumen area in the estimated vessel area. In the lineate media as a low-signal band. However, an assessment subanalysis, we compared the primary outcome measure of media behind heavy calcium is diﬃcult in some seg- ° ° according to calcium arc degrees (i.e., 180–224 , 225–269 , ments. ,us, it is hard to discriminate whether the dis- ° ° 270–314 , and 315–360 ). Moreover, we analyzed the pri- section between calcium sheet and vessel wall is medial or mary outcome measure only in the frame with the minimal adventitial. Hence, a type-2 crack was deﬁned as any ex- lumen area (MLA) after procedure. foliation of a calcium sheet from the vessel wall. OFDI measurements were performed using commercially avail- able oﬄine analysis software (LUNAWAVE, Terumo 2.3. Statistical Analysis. Continuous variables are expressed Corporation, Tokyo, Japan). ,e calcium component was as mean and standard deviation (SD), unless otherwise detected according to previously validated criteria [15]. noted, and were compared using one-way analysis of var- Each plaque was measured at approximately 3 mm intervals iance or the Kruskal–Wallis test, depending on their dis- along a calciﬁed lesion as long as the arc of the calcium was tributions. Categorical variables are presented as numbers ≥180 . ,e lesion length was measured by OFDI. A total of and percentages and were compared using the χ test. We Journal of Interventional Cardiology 3 a) b) c) d) Type 0 Type 1 Type 2 Figure 1: Crack formation pattern of calciﬁed plaque. (a) Type 0, no cracks or injury in the vessel. (b, c) Type 1, with crack in calciﬁed plaque (yellow arrowhead) or intima injury (red arrowhead) without medial dissection between calciﬁed plaque and vessel wall. (d) Type 2, with crack in calciﬁed plaque with medial dissection between calciﬁed plaque and vessel wall (blue arrowhead). evaluated the diﬀerence among the three types of crack Table 1: Baseline clinical characteristics. formation in calciﬁed plaque using the t-test. We investi- Variable n � 50 gated the aﬀecting factors for area expansion ratio between Age (years) 74.9± 7.9 preballooning and poststenting including multiple cracks, Male 34 (68%) rotablator use, calcium arc, cutting balloon (CB) inﬂation BMI (kg/m ) 23.4± 3.8 pressure, balloon diameter/vessel diameter ratio, dissection Hypertension 46 (92%) beside calcium or crack inside it, and type of crack in cal- Dyslipidemia 36 (72%) ciﬁed plaque based on prespeciﬁed deﬁnitions, using mul- Current smoker 9 (18%) tivariate analysis of variance. To determine the optimal Diabetes mellitus 27 (54%) balloon size that could predict type-2 lesion modiﬁcation, we Atrial ﬁbrillation 4 (8%) evaluated the percentage of balloon diameter/mean vessel LVEF (%) 63.8± 12.2 diameter among the lesions that could predict type-2 cracks ESRD on HD 3 (6%) eGFR≤60 without HD (mL/min/1.73 m ) 25 (50%) among the full length of the lesion based on ROC curve PAD 6 (12%) analysis. COPD 1 (2%) A receiver operating characteristic (ROC) curve analysis Aortic disease 1 (2%) was performed. ,e cutoﬀ point was deﬁned as the greatest Prior PCI 21 (42%) sum of sensitivity and speciﬁcity estimates. Prior CABG 2 (4%) Statistical analysis was conducted by a physician (HH) Prior stroke 6 (12%) using the JMP 10.0 software (SAS Institute Inc., Cary, NC). CHF 7 (14%) All statistical analyses were two-tailed, and P< 0.05 was Prior MI 18 (36%) considered statistically signiﬁcant. ,e authors had full SYNTAX score 21.5± 22.9 access to and take full responsibility for the integrity of the SYNTAX2 score (PCI) 34.3± 15.9 data. Acute coronary syndrome 5 (10%) Multivessel disease 27 (54%) Medications 3. Results Aspirin 49 (98%) ,ienopyridine 50 (100%) 3.1.BaselineCharacteristicsandProcedureDetails. ,e study OAC 5 (10%) population reﬂected the real-world clinical practice, in- Statins 43 (86%) cluding large proportions of patients with advanced age, β-blockers 25 (50%) diabetes mellitus, multivessel disease, and high SYNTAX ACE-I/ARB 30 (60%) score (Table 1). Data are presented as number (%) or mean± standard deviation, unless Regarding the lesion characteristics, majority of the le- otherwise noted. ACE-I, angiotensin-converting-enzyme inhibitor; ARB, sions in this study were in the left anterior descending artery angiotensinI receptor blocker; BMI, body mass index; CABG, coronary artery bypass grafting; CHF, congestive heart failure; COPD, chronic ob- (LAD). ,e lesion length was 35.0 ± 15.9 mm. Initial passage TM structive pulmonary disease; eGFR, estimated glomerular ﬁltration rate; of the OFDI imaging catheter (FastView , Terumo Cor- ESRD, end-stage renal disease; HD, hemodialysis; LVEF, left ventricular poration, Tokyo, Japan) through the lesion without rota- ejection fraction; MI, myocardial infarction; OAC, oral anticoagulants; tional atherectomy or/and balloon angioplasty was PAD, peripheral artery disease; PCI, percutaneous coronary intervention. 4 Journal of Interventional Cardiology Table 2: Baseline lesion characteristics and procedure details. successful in 56% of the cases, and rotational atherectomy was performed in 81% of the procedures. An orbital athe- Variable n � 54 rectomy system (OAS) was not used at all. All lesions were Target vessel treated with a CB before stenting. ,e CB diameter was Isolated LMCA 0 2.74± 0.31 mm, and maximum pressure of CB dilatation was LMCA + LAD 2 (3.7%) 10.4± 2.98 atm. All procedures were successful; no severe LAD 39 (72%) complications were observed (Table 2). LCx 2 (3.7%) RCA 11 (20%) Lesion length (mm) 35.0± 15.9 3.2. OFDI Analysis. Among 242 frame analysis, the dis- Tortuous vessel 12 (22%) CTO 0 crepancy of crack type between 2 independent investigators Rotational atherectomy 44 (81%) was in 7 frames (κ � 0.95, 95% CI: 0.92–0.99). In these CB diameter (mm) 2.74± 0.31 frames, inter- and intraobserver revalidated together and Maximum pressure of CB dilatation (atm) 10.4± 2.98 ﬁxed data. In other analyzed parameters, inter- and intra- Rotablator burr size (mm) 1.78± 0.20 observer reproducibility was acceptable. Out of the 242 Slow ﬂow/no reﬂow during procedure 5 (9.3%) OFDI slices, 58 segments were type 0, 72 were type 1, and Data are presented as number (%) or mean± standard deviation, unless 112 were type 2. Estimated vessel area and diameter were otherwise noted. CTO, chronic total occlusion; LAD, left anterior signiﬁcantly lower in type 2 (p � 0.01). Lumen area before descending artery; LCx, left circumﬂex artery; LMCA, left main coronary balloon dilatation was also signiﬁcantly lower in type 2 artery; RCA, right coronary artery; CB, cutting balloon. Calculated in 44 lesions. (p � 0.0003). ,e overall degrees of calcium arc were sig- niﬁcantly higher in type 1 (p � 0.0001). ,ickness of cracked calcium was 465± 162µm in type 1 and ballooning (Supplementary Table 1). Moreover, the CB size 387± 312µm in type 2, and the maximum thickness was that could predict type-2 cracks among the full length of the 820µm. No signiﬁcant diﬀerences in the symmetry index of lesion based on ROC curve analysis was 77.1% (CB diam- the implanted stent (p � 0.45) and the ﬁnal lumen area (p � eter/mean vessel diameter among the lesion (sensitivity, 0.38) among the three groups were found (Table 3). 50.0%; speciﬁcity, 88.1%; area under the curve, 0.727; 95% ,e lumen area expansion ratio between preballooning conﬁdence interval, −0.19–0.04; p � 0.0009)) (Figure 3). and poststenting was signiﬁcantly higher in type 2 than in other types (type 0, 196% (IQR, 163–244); type 1, 210% 4. Discussion (IQR, 174–244); and type 2, 237% (IQR, 203–294) (Figure 2(a)). Regarding secondary outcome measure, ,e primary ﬁndings of this study are as follows: dissection percentage of the ﬁnal lumen area in the estimated vessel between calciﬁed plaque and the vessel wall is the most area was signiﬁcantly higher in type 2 than in other types signiﬁcant factor for lesion preparation of calciﬁed coronary (type 0, 51.2% (IQR, 43.1–58.4); type 1, 50.0% (IQR, artery disease. 41.9–51.9); type 2, 56.9% (IQR, 47.0–64.3)) (Table 3, Sup- When performing PCI for severely calciﬁed coronary plementary Figure 1). In the subanalysis according to the disease, vessel preparation is essential for favorable short- degrees of calcium arc, the area expansion ratio between and long-term clinical outcomes [16–18], and optical co- preballooning and poststenting was signiﬁcantly higher in herence tomography (OCT)/OFDI could be used to assess type 2 segments in 315–360 calcium sections (type 0, 135% the mechanistic eﬀects of atherectomy devices [19, 20]. A (IQR, 110–231); type 1, 197% (IQR, 167–241); and type 2, previous report suggested that lumen dilatation following 242% (IQR, 220–368)); 270–314 calcium sections (type 0, balloon angioplasty was due not only to vessel wall dis- 207% (IQR, 175–247); type 1, 214% (IQR, 177–255); and section but also to the longitudinal displacement of the type 2, 227% (IQR, 200–280)); and 225–269 calcium sec- plaque [21]. However, calciﬁed plaque is too hard to modify tions (type 0, 200% (IQR, 182–236); type 1, 199% (IQR, or compress by balloon dilatation. ,erefore, to expand the 175–220); and type 2, 232% (IQR, 212–334)). However, no area of the coronary artery with calciﬁed plaque, the volume signiﬁcant diﬀerence among the three types was found in of calciﬁed plaque should be reduced by using an atherec- 180–224 calcium sections. (type 0, 198% (IQR, 157–247); tomy device or/and stretching the vessel arc without calciﬁed type 1, 228% (IQR, 189–265); and type 2, 231% (IQR, plaque. In the present study, rotablator use was 81% (44 of 54 201–269) (Figure 2(b)). In the frame with MLA analysis, the cases). ,e high usage rate was made by indication of OFDI lumen area expansion ratio between preballooning and for calciﬁed lesion. In the participating 2 hospitals, operators poststenting was signiﬁcantly higher in type 2 than in other tend to use OFDI for severely calciﬁed lesion which seems to types (type 0, 196% (IQR, 141–255); type 1, 210% (IQR, be needed debulking strategy from pre-PCI angiography. 186–245); and type 2, 243% (IQR, 207–295), that was the ,at made high frequency of rotational atherectomy strategy same trend with main analysis (Supplementary Figure 2). in the present study. Multivariate analysis, which was performed to determine However elastic vessel arc without calciﬁcation could the factors that could signiﬁcantly aﬀect lesion modiﬁcation, make elongation, excessive elongation may result in coro- suggested degree of calcium arc, CB/vessel diameter ratio nary perforation. A previous report demonstrated that ro- and type-2 crack had signiﬁcantly inﬂuenced lumen area tational atherectomy before stenting is eﬀective for calciﬁed expansion after stenting compared with that before Journal of Interventional Cardiology 5 Table 3: OFDI analysis. Variable Type 0 (n � 58) Type 1 (n � 72) Type 2 (n � 112) p value Estimated vessel diameter (mm) 4.05± 0.49 4.09± 0.51 3.89± 0.46 0.01 Estimated vessel area (mm ) 13.04± 3.26 13.27± 3.17 12.03± 2.74 0.01 Major axis diameter before using CB (mm) 2.36± 0.37 2.29± 0.37 2.11± 0.46 0.0004 Minor axis diameter before using CB (mm) 1.79± 0.31 1.72± 0.31 1.57± 0.31 0.0001 Lumen area before using CB (mm ) 3.37± 1.02 3.10± 0.91 2.73± 1.01 0.0003 Calcium arc ( ) 251± 56 294± 62 277± 53 0.0001 Calcium arc 315–360 8 (14%) 32 (44%) 28 (25%) 0.0009 Calcium arc 270–314 16 (28%) 18 (25%) 40 (36%) 0.25 Calcium arc 225–269 10 (17%) 12 (17%) 24 (21%) 0.67 Calcium arc 180–224 24 (41%) 10 (15%) 20 (18%) 0.0005 Major axis diameter after using CB (mm) 2.56± 0.32 2.63± 0.42 2.67± 0.41 0.22 Minor axis diameter after using CB (mm) 1.99± 0.28 1.99± 0.28 1.95± 0.29 0.52 Lumen area after using CB (mm ) 4.08± 0.87 4.21± 1.08 4.17± 1.15 0.80 Cracked calcium thickness (µm) N/A 465± 162 (n � 42) 387± 312 (n � 26) 0.08 Final lumen area (mm ) 6.43± 1.31 6.38± 1.36 6.66± 1.51 0.38 Symmetry index 0.86± 0.09 0.84± 0.08 0.86± 0.08 0.45 Final lumen area/estimated vessel area (%) 51.2± 12.4 50.0± 12.2 56.9± 13.0 0.0005 Data are presented as number (%) or mean± standard deviation, unless otherwise noted. CB, cutting balloon; OFDI, optical frequency domain imaging. lesions [17, 18]; on the other hand, the eﬀectiveness of arc stenting; therefore, the crack pattern may not be important elongation was not reported. We hypothesized that dis- in lower degree of calcium arc lesions. section between the calciﬁed plaque and vessel wall is as- Multivariate analysis showed CB/vessel diameter that sociated with a safe arc elongation and enlarged lumen area might be eﬀective in causing dissection was also a signiﬁ- after stenting. Previous evidence for the eﬀectiveness of CB cantly important factor for lesion preparation. We showed for severely calciﬁed lesions has been reported [22], and that under 77.1% (cutting balloon diameter/mean vessel operators in the participating hospitals employed CB in all diameter) balloon size might not be favorable for vessel procedures. Type-2 group includes higher ratio of higher preparation in calciﬁed lesion. Whereas, regarding there was calcium arc degree. Operators in the participating hospitals no vessel perforation in this study population, we could not might consider that using bigger size balloon may be safe suggest the size limit of cutting balloon that could crack without perforation in case of higher calcium arc degrees. calcium signiﬁcantly without vessel perforation (Figure 3). However, few reports have evaluated the crack formation of ,e low sensitivity for making type 2 crack might depend on calciﬁed plaque using OCT/OFDI. A previous report, which the operators’ discretion of not using too large size balloon to included only calciﬁed lesions treated with rotational avoid vessel perforation. In this study, ﬁnal lumen area was atherectomy, suggested the best cutoﬀ for the calcium arc similar among the 3 groups. However, percentage of ﬁnal and calcium thickness for the prediction of calcium crack lumen area in the estimated vessel area was signiﬁcantly were >227 and <670μm [16]. Although this study included higher in type 2. ,us, type-2 crack may be a predictor for both lesions treated with (81%) and without (19%) rotational great lumen enlargement, whereas, in the whole length of atherectomy, as the calcium arc decreases, the ratio of no stenosis lesion, type 2 crack might occur easier in smaller cracks increases. Furthermore, mean cracked calcium vessel segments than larger segments because balloon size/ thickness was 465µm in type 1 crack segments and 387μm vessel diameter was relatively larger in smaller vessel seg- in type-2 segments. ,ese results have corresponded with a ments. ,is might be a reason for the signiﬁcant diﬀerence in previous report. estimated vessel area among 3 groups. Hence, in nearly all rounded calciﬁed lesions, type-2 crack could result from ,e type-2 crack pattern of calciﬁed plaque, i.e., dis- section between calciﬁed plaque and the vessel wall, was a balloon angioplasty with an optimal size balloon after re- signiﬁcantly important factor for lesion preparation in both ducing calcium volume using rotational atherectomy analysis of including all image frames and only in MLA (Figures 4(a)–4(d)). Type-1 crack was not eﬀective for lumen frames, as hypothesized, particularly in segments with a high area expansion. Based on OFDI, calcium gaps resulting from degree of calciﬁed arc. Regarding the crack type may be in balloon dilatation did not grow wider after stenting part depending on the morphology of calciﬁed plaque, it was (Figures 4(e)–4(g)). diﬃcult to make deﬁnition of concentric/eccentric calciﬁed ,e ﬁnal symmetry index of implanted stents was not plaque; however, PCI operators may feel the plaque as diﬀerent among three groups. Logically, high volume concentric that occupies larger degree of arc. ,erefore, we eccentric calciﬁed lesion, that seems to have lower degree performed subanalysis depending on calcium arc that was of calciﬁed arc, has potential of low ﬁnal stent symmetry index. On the other hand, lower degree of calciﬁed arc able to be evaluated quantitively. In the 315–360 group, type 2 crack was particularly signiﬁcant for stent expansion, location has rich elastic vessel wall which could elongate whereas 180–224 group was not. In the lower degree of well after stenting. Hence, it is limited to discuss the calcium arc lesion, elastic vessel wall could extend well after result of symmetry index because of diﬃculty to 6 Journal of Interventional Cardiology Comparison between 3 groups: p<.0001 p<.0001 p=0.63 p<.0001 n=58 n=72 n=112 Type 0 Type 1 Type 2 (a) p=0.005 p=0.50 p=0.0009 p=0.008 p=0.04 p=0.48 p=0.08 p=0.06 p=0.79 p=0.07 p=0.53 p=0.34 n=8 n=32 n=28 n=16 n=18 n=40 n=10 n=12 n=24 n=24 n=10 n=20 Crack type 0 1 20 1 2 0 1 2 012 Calcified arc 315-360° 270-314° 225-269° 180-224° (b) Figure 2: Lumen area expansion ratio between before ballooning and after stenting. (a) Lumen area expansion ratio between before ballooning and after stenting (all analyzed frames (n � 242)). Type 0, 196% (interquartile range (IQR), 163–244), type 1, 210% (IQR, 174–244), and type 2, 237% (IQR, 203–294). (b) Lumen area expansion ratio between before ballooning and after stenting according to the degrees of calcium arc. 315–360 calcium sections: type 0, 135% (IQR, 110–231); type 1, 197% (IQR, 167–241); and type 2, 242% (IQR, 220–368)). 270–314 calcium sections (type 0, 207% (IQR, 175–247); type 1, 214% (IQR, 177–255); and type 2, 227% (IQR, 200–280)). ° ° 225–269 calcium sections (type 0, 200% (IQR, 182–236); type 1, 199% (IQR, 175–220); and type 2, 232% (IQR, 212–334)). 180–224 calcium sections (type 0, 198% (IQR, 157–247); type 1, 228% (IQR, 189–265); and type 2, 231% (IQR, 201–269)). quantitate calciﬁed plaque volume and distribution in must be explored. OFDI or OCT enables visualization of the the vessel. crack pattern and has an important role in PCI for severely Whereas, ﬁnal lumen area was not signiﬁcantly diﬀerent calciﬁed coronary disease [23]. Furthermore, several previous among the three groups; however, the ratio of ﬁnal lumen reports discussed rotational atherectomy for the treatment of area to estimated vessel area was signiﬁcantly higher in type- severe calciﬁed coronary lesions. Routine lesion preparation by 2 crack group that was according to lower estimated vessel using rotational atherectomy did not reduce late lumen loss. area in type-2 group. ,erefore, these secondary outcome However, rotational atherectomy was eﬀective for initial measures also suggest that type-2 crack was a feasible lesion procedural success particularly in complex lesion including preparation of calciﬁed plaque. tortuous artery, left main disease, and previous coronary artery bypass grafting [17]. Hence, the role of lithoplasty and OAS for While the ideal lesion preparation for severely calciﬁed lesion was suggested in this study, in clinical practice, operators calciﬁed coronary lesion remains unclear [19, 24, 25]. have diﬃculty in controlling the crack type of calciﬁed plaque. ,is study has several limitations. First, this was a small ,us, optimal lesion preparation using atherectomy devices number retrospective study. ,e procedure strategy had including rotational atherectomy, OAS, or/and special balloons depended on operators, and thus, the ﬁnal stent diameter or Final lumen area / Lumen area before balloon angioplasty (%) Final lumen area / Lumen area before balloon angioplasty (%) Journal of Interventional Cardiology 7 Type 2 crack Speciﬁcity 0.88 Sensitivity 0.50 Cutting balloon diameter/ Mean vessel diameter 77.1% 1.00 0.90 0.80 0.70 0.60 0.50 0.40 0.30 0.20 AUC=0.727 0.10 0.00 0.00 0.20 0.40 0.60 0.80 1.00 1 - specificity Figure 3: Receiver operating characteristic analysis for the prediction of type-2 cracks after balloon angioplasty. AUC, areas under the curve. a) b) c) d) e) f) g) Figure 4: Representative cases of those who underwent optical frequency domain imaging (OFDI)-guided percutaneous coronary in- tervention (PCI) for severely calciﬁed coronary disease. (a–d) A 69-year-old male with LAD lesion. Serial OFDI images obtained the same cross-section. (a) Initial OFDI image showed all rounded calciﬁed plaque. (b) Postrotational atherectomy using a 1.5 mm and 2.0 mm burr; the calcium almost disappeared within the circumference (yellow arrowhead). ,e lumen area was 3.5 mm and the lumen perimeter 6.6 mm. (c) Postballooning using a cutting balloon (diameter, 3.0 mm; dilatation atmosphere, 10 atm; perimeter, 10.2 mm). Blue arrowheads show the medial dissection between calciﬁed plaque and vessel wall. (d) Final OFDI image after stenting (DES diameter was 3.5 mm). ,e lumen area was 8.1 mm , and the expansion ratio (ﬁnal lumen area/lumen area before ballooning) was 231%. (e–g) A 74-year-old female with LAD lesion. Serial OFDI images obtained the same cross-section. Fast view catheter (TERUMO) did not pass the lesion. ,us, there was no initial OFDI image before rotational atherectomy. (e) Postrotational atherectomy using a 1.5 mm and 2.0 mm burr; the lumen was totally surrounded by thick calcium. ,e lumen area was 3.3 mm2 and the lumen perimeter 6.4 mm. (f) Postballooning using a cutting balloon (diameter, 2.25 mm; dilatation atmosphere, 8 atm; perimeter, 7.3 mm). ,e sheet calcium was cracked without medial dissection (blue arrowhead). (g) Final OFDI image after stenting (DES diameter was 2.5 mm). ,e lumen area was 4.6 mm and the expansion ratio (ﬁnal lumen area/lumen area before ballooning) was 139%. DES, drug-eluting stent; LAD, left anterior descending artery; OFDI, optical frequency domain imaging; PCI, percutaneous coronary intervention. Sensitivity 8 Journal of Interventional Cardiology balloon diameter after stenting was not standardized with expansion ratio between before ballooning and after stenting clear criteria, which in turn makes the actual maximum area (MLA frames only). Type 0, 196% (interquartile range expansion ratio between ﬁnal lumen area and the lumen area (IQR), 141–255), type 1, 210% (IQR, 187–245), and type 2, before ballooning diﬃcult to establish. Moreover, in this 243% (IQR, 207–295). Supplementary Table 1: multivariate study, the stents used were not uniﬁed. ,e diﬀerence in analysis of lesion modiﬁcation factors. ,e aﬀecting factors radial force in each drug-eluting stent possibly aﬀected the for area expansion ratio between preballooning and post- ﬁnal lumen area in the calciﬁed coronary artery. Second, stenting. (Supplementary Materials) majority of the lesions were in the LAD. Particularly, left circumﬂex artery lesion was only 3.7% of all the lesions. ,e References left circumﬂex artery is often a tortuous vessel, and the indications for OFDI/OCT and atherectomy devices are [1] T. Kimura, T. Morimoto, M. Natsuaki et al., “Comparison of limited. Hence, lesion preparation in other locations needs everolimus-eluting and sirolimus-eluting coronary stents: 1- further investigation. ,ird, this study includes two lesion year outcomes from the randomized evaluation of sirolimus- eluting versus everolimus-eluting stent trial (RESET),” Cir- preparation groups, using both rotational atherectomy and culation, vol. 126, no. 10, pp. 1225–1236, 2012. balloon angioplasty group and angioplasty alone group. [2] H. Shiomi, K. Kozuma, T. Morimoto et al., “7-year outcomes However, the aim of this study was to investigate the ef- of a randomized trial comparing the ﬁrst-generation siroli- fectiveness of crack formation pattern of calciﬁed plaque on mus-eluting stent versus the new-generation everolimus- stent expansion. ,erefore, we included these two groups in eluting stent: the RESET trial,” JACC: Cardiovascular Inter- the same analysis. Forth, there are no follow-up data of ventions, vol. 12, no. 7, pp. 637–647, 2019. enrolled patients in this study. Fifth, this study did not [3] H. Shiomi, K. Kozuma, T. Morimoto et al., “Long-term include quantitative coronary angiography (QCA) data clinical outcomes after everolimus- and sirolimus-eluting analysis. ,erefore, further investigation including whether coronary stent implantation: ﬁnal 3-year follow-up of the successful lesion preparation corresponds to target lesion randomized evaluation of sirolimus-eluting versus ever- revascularization or/and adverse cardiac events is required. olimus-eluting stent trial,” Circulation: Cardiovascular In- terventions, vol. 7, no. 3, pp. 343–354, 2014. Fifth, we suggested cutting balloon size to make optimal [4] C. von Birgelen, M. M. Kok, L. C. van der Heijden et al., “Very crack for calciﬁed lesion. However, it was diﬃcult to thin strut biodegradable polymer everolimus-eluting and compare 4-blade and 3-blade cutting balloon because only sirolimus-eluting stents versus durable polymer zotarolimus- one lesion which was used 4-blade cutting balloon. eluting stents in allcomers with coronary artery disease (BIO- Despite these limitations and limited availability of RESORT): a three-arm, randomised, non-inferiority trial,” OFDI in the world, from a clinical perspective, evaluation of 0e Lancet, vol. 388, no. 10060, pp. 2607–2617, 2016. lesion modiﬁcation for calciﬁed plaque using optical [5] M. P. Savage, S. Goldberg, J. W. Hirshfeld et al., “Clinical and intracoronary imaging has possibility to improve clinical angiographic determinants of primary coronary angioplasty outcome of severely calciﬁed coronary lesion. success. M-HEART investigators,” Journal of the American College of Cardiology, vol. 17, no. 1, pp. 22–28, 1991. 5. Conclusion [6] R. Hoﬀmann, G. S. Mintz, J. J. Popma et al., “Treatment of calciﬁed coronary lesions with Palmaz-Schatz stents an in- In conclusion, dissection between calciﬁed plaque and the travascular ultrasound study,” European Heart Journal, vessel wall is a signiﬁcant factor for a satisfactory ﬁnal lumen vol. 19, no. 8, pp. 1224–1231, 1998. [7] J. W. Van Werkum, A. A. C. M. Heestermans, F. I. De Korte area after stenting. et al., “Long-term clinical outcome after a ﬁrst angio- graphically conﬁrmed coronary stent thrombosis: an analysis Data Availability of 431 cases,” Circulation, vol. 119, no. 6, pp. 828–834, 2009. [8] K. Nishida, K. Nakatsuma, H. Shiomi et al., “Second-gener- ,e data used to support the ﬁndings of this study are ation vs. First-generation drug-eluting stents in patients with available from the corresponding author upon request. calciﬁed coronary lesions―pooled analysis from the RESET and NEXT trials―,” Circulation Journal, vol. 82, no. 2, Conflicts of Interest pp. 376–387, 2018. [9] J. Huisman, L. C. Van Der Heijden, M. M. Kok et al., “Impact ,e authors declare that they have no conﬂicts of interest. of severe lesion calciﬁcation on clinical outcome of patients with stable angina, treated with newer generation permanent Acknowledgments polymer-coated drug-eluting stents: a patient-level pooled analysis from TWENTE and DUTCH PEERS (TWENTE II),” ,e authors thank the members of the catheterization American Heart Journal, vol. 175, pp. 121–129, 2016. laboratories and physicians of the participating centers. [10] J. Huisman, L. C. van der Heijden, M. M. Kok et al., “Two-year outcome after treatment of severely calciﬁed lesions with Supplementary Materials newer-generation drug-eluting stents in acute coronary syndromes: a patient-level pooled analysis from TWENTE Supplementary Figure 1: ﬁnal lumen area/estimated vessel and DUTCH PEERS,” Journal of Cardiology, vol. 69, no. 4, area (%). Type 0, 50.0% (interquartile range (IQR), pp. 660–665, 2017. 43.4–58.7), type 1, 48.6% (IQR, 41.8–54.4), and type 2, 53.9% [11] B. Witzenbichler, A. Maehara, G. Weisz et al., “Relationship (IQR, 47.0–64.3). Supplementary Figure 2: lumen area between intravascular ultrasound guidance and clinical Journal of Interventional Cardiology 9 outcomes after drug-eluting stents: ,e assessment of dual of Cardiology: Cardiovascular Imaging, vol. 10, no. 8, antiplatelet therapy with drug-eluting stents (ADAPT-DES) pp. 897–906, 2017. [25] F. Alfonso, T. Bastante, P. Antuña et al., “Coronary lithoplasty study,” Circulation, vol. 129, no. 4, pp. 463–470, 2014. for the treatment of undilatable calciﬁed de novo and in-stent [12] G. Sianos, M.-A. Morel, A. P. Kappetein et al., “,e SYNTAX restenosis lesions,” JACC: Cardiovascular Interventions, Score: an angiographic tool grading the complexity of cor- vol. 12, no. 5, pp. 497–499, 2019. onary artery disease,” EuroIntervention, vol. 1, no. 2, pp. 219–227, 2005. [13] R. Virmani, A. P. Burke, A. Farb, and F. D. Kolodgie, “Pa- thology of the vulnerable plaque,” Journal of the American College of Cardiology, vol. 47, no. 8, pp. C13–C18, 2006. [14] H. Jia, F. Abtahian, A. D. Aguirre et al., “In vivo diagnosis of plaque erosion and calciﬁed nodule in patients with acute coronary syndrome by intravascular optical coherence to- mography,” Journal of the American College of Cardiology, vol. 62, no. 19, pp. 1748–1758, 2013. [15] H. Yabushita, B. E. Bouma, S. L. Houser et al., “Character- ization of human atherosclerosis by optical coherence to- mography,” Circulation, vol. 106, no. 13, pp. 1640–1645, 2002. [16] N. Maejima, K. Hibi, K. Saka et al., “Relationship between thickness of calcium on optical coherence tomography and crack formation after balloon dilatation in calciﬁed plaque requiring rotational atherectomy,” Circulation Journal, vol. 80, no. 6, pp. 1413–1419, 2016. [17] M. Abdel-Wahab, R. Toelg, R. A. Byrne et al., “High-speed rtational atherectomy versus modiﬁed balloons prior to drug- eluting stent implantation in severely calciﬁed coronary le- sions: the randomized PREPARE-CALC Trial,” Circ Cardiovasc Interv, vol. 11, pp. 1–12, 2018. [18] M. Abdel-Wahab, G. Richardt, H. Joachim Buttner ¨ et al., “High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calciﬁed coronary lesions: the randomized ROTAXUS (rotational atherectomy prior to Taxus stent treatment for complex native coronary artery disease) trial,” JACC: Cardiovascular Interventions, vol. 6, no. 1, pp. 10–19, 2013. [19] A. S. Kini, Y. Vengrenyuk, J. Pena et al., “Optical coherence tomography assessment of the mechanistic eﬀects of rota- tional and orbital atherectomy in severely calciﬁed coronary lesions,” Catheterization and Cardiovascular Interventions, vol. 86, no. 6, pp. 1024–1032, 2015. [20] M. H. Yamamoto, A. Maehara, K. Karimi Galougahi et al., “Mechanisms of orbital versus rotational atherectomy plaque modiﬁcation in severely calciﬁed lesions assessed by optical coherence tomography,” JACC: Cardiovascular Interventions, vol. 10, no. 24, pp. 2584–2586, 2017. [21] G. S. Mintz, A. D. Pichard, K. M. Kent, L. F. Satler, J. J. Popma, and M. B. Leon, “Axial plaque redistribution as a mechanism of percutaneous transluminal coronary angioplasty,” 0e American Journal of Cardiology, vol. 77, no. 5, pp. 427–430, [22] B. Redfors, A. Maehara, B. Witzenbichler et al., “Outcomes after successful percutaneous coronary intervention of cal- ciﬁed lesions using rotational atherectomy, cutting-balloon angioplasty, or balloon-only angioplasty before drug-eluting stent implantation,” Journal of Invasive Cardiology, vol. 29, no. 11, pp. 378–386, 2017. [23] N. Kobayashi, Y. Ito, M. Yamawaki et al., “Optical coherence tomography-guided versus intravascular ultrasound-guided rotational atherectomy in patients with calciﬁed coronary lesions,” EuroIntervention, vol. 16, no. 4, pp. e313–e321, 2019. [24] Z. A. Ali, T. J. Brinton, J. M. Hill et al., “Optical coherence tomography characterization of coronary lithoplasty for treatment of calciﬁed lesions,” Journal of the American College

Journal

Journal of Interventional Cardiology – Hindawi Publishing Corporation

Published: Feb 27, 2022

References

Comparison of everolimus-eluting and sirolimus-eluting coronary stents: 1-year outcomes from the randomized evaluation of sirolimus-eluting versus everolimus-eluting stent trial (RESET),

T. Kimura, T. Morimoto, M. Natsuaki et al.
7-year outcomes of a randomized trial comparing the first-generation sirolimus-eluting stent versus the new-generation everolimus-eluting stent: the RESET trial,

H. Shiomi, K. Kozuma, T. Morimoto et al.
Long-term clinical outcomes after everolimus- and sirolimus-eluting coronary stent implantation: final 3-year follow-up of the randomized evaluation of sirolimus-eluting versus everolimus-eluting stent trial,

H. Shiomi, K. Kozuma, T. Morimoto et al.
Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial,

C. von Birgelen, M. M. Kok, L. C. van der Heijden et al.
Clinical and angiographic determinants of primary coronary angioplasty success. M-HEART investigators,

M. P. Savage, S. Goldberg, J. W. Hirshfeld et al.
Treatment of calcified coronary lesions with Palmaz-Schatz stents an intravascular ultrasound study,

R. Hoffmann, G. S. Mintz, J. J. Popma et al.
Long-term clinical outcome after a first angiographically confirmed coronary stent thrombosis: an analysis of 431 cases,

J. W. Van Werkum, A. A. C. M. Heestermans, F. I. De Korte et al.
Second-generation vs. First-generation drug-eluting stents in patients with calcified coronary lesions―pooled analysis from the RESET and NEXT trials―,

K. Nishida, K. Nakatsuma, H. Shiomi et al.
Impact of severe lesion calcification on clinical outcome of patients with stable angina, treated with newer generation permanent polymer-coated drug-eluting stents: a patient-level pooled analysis from TWENTE and DUTCH PEERS (TWENTE II),

J. Huisman, L. C. Van Der Heijden, M. M. Kok et al.
Two-year outcome after treatment of severely calcified lesions with newer-generation drug-eluting stents in acute coronary syndromes: a patient-level pooled analysis from TWENTE and DUTCH PEERS,

J. Huisman, L. C. van der Heijden, M. M. Kok et al.
Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: The assessment of dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study,

B. Witzenbichler, A. Maehara, G. Weisz et al.
The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease,

G. Sianos, M.-A. Morel, A. P. Kappetein et al.
Pathology of the vulnerable plaque,

R. Virmani, A. P. Burke, A. Farb, and F. D. Kolodgie
In vivo diagnosis of plaque erosion and calcified nodule in patients with acute coronary syndrome by intravascular optical coherence tomography,

H. Jia, F. Abtahian, A. D. Aguirre et al.
Characterization of human atherosclerosis by optical coherence tomography,

H. Yabushita, B. E. Bouma, S. L. Houser et al.
Relationship between thickness of calcium on optical coherence tomography and crack formation after balloon dilatation in calcified plaque requiring rotational atherectomy,

N. Maejima, K. Hibi, K. Saka et al.
High-speed rtational atherectomy versus modified balloons prior to drug-eluting stent implantation in severely calcified coronary lesions: the randomized PREPARE-CALC Trial,

M. Abdel-Wahab, R. Toelg, R. A. Byrne et al.
High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (rotational atherectomy prior to Taxus stent treatment for complex native coronary artery disease) trial,

M. Abdel-Wahab, G. Richardt, H. Joachim Büttner et al.
Optical coherence tomography assessment of the mechanistic effects of rotational and orbital atherectomy in severely calcified coronary lesions,

A. S. Kini, Y. Vengrenyuk, J. Pena et al.
Mechanisms of orbital versus rotational atherectomy plaque modification in severely calcified lesions assessed by optical coherence tomography,

M. H. Yamamoto, A. Maehara, K. Karimi Galougahi et al.
Axial plaque redistribution as a mechanism of percutaneous transluminal coronary angioplasty,

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Effect of Crack Patterns in Calcified Plaque on Lumen Area after Stenting for a Severe Calcified Coronary Artery (from the Optical Frequency Domain Imaging-Guided Percutaneous Coronary Artery Intervention for Calcified Lesion Registry)

Effect of Crack Patterns in Calcified Plaque on Lumen Area after Stenting for a Severe Calcified Coronary Artery (from the Optical Frequency Domain Imaging-Guided Percutaneous Coronary Artery Intervention for Calcified Lesion Registry)

Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

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Effect of Crack Patterns in Calcified Plaque on Lumen Area after Stenting for a Severe Calcified Coronary Artery (from the Optical Frequency Domain Imaging-Guided Percutaneous Coronary Artery Intervention for Calcified Lesion Registry)

Effect of Crack Patterns in Calcified Plaque on Lumen Area after Stenting for a Severe Calcified Coronary Artery (from the Optical Frequency Domain Imaging-Guided Percutaneous Coronary Artery Intervention for Calcified Lesion Registry)

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