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Vascular Response after Directional Coronary Atherectomy for Left Main Bifurcation Lesion

Vascular Response after Directional Coronary Atherectomy for Left Main Bifurcation Lesion Hindawi Journal of Interventional Cardiology Volume 2021, Article ID 5541843, 8 pages https://doi.org/10.1155/2021/5541843 Research Article Vascular Response after Directional Coronary Atherectomy for Left Main Bifurcation Lesion Norihiro Kobayashi , Masahiro Yamawaki, Mana Hiraishi, Shinsuke Mori , Masakazu Tsutsumi, Yohsuke Honda , Toshiki Chishiki, Kenji Makino, Shigemitsu Shirai, Masafumi Mizusawa, Kohei Yamaguchi, Takahide Nakano, Kaori Abe, Tomoya Fukagawa, Toshihiko Kishida, and Yoshiaki Ito Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa 230-8765, Japan Correspondence should be addressed to Norihiro Kobayashi; ovation17@gmail.com Received 30 August 2021; Accepted 3 December 2021; Published 14 December 2021 Academic Editor: Jochen Wo¨hrle Copyright © 2021 Norihiro Kobayashi 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. Aims. To evaluate the vascular response after directional coronary atherectomy (DCA) for left main (LM) bifurcation lesion. Methods. (is study was a retrospective, single-center study enrolling 31 patients who underwent stentless therapy using DCA followed by drug-coated balloon (DCB) angioplasty for LM bifurcation lesion. We compared intravascular ultrasound (IVUS) findings before and after DCA. Results. After DCA, the lumen and vessel areas significantly increased, whereas the plaque area (PA) and %PA were significantly reduced. When the lesions were divided into small vessel and large vessel groups using the median value of the vessel area, the maximum balloon pressure of the DCA catheter was greater in the large vessel group. Changes in the lumen and vessel areas were also significantly greater in the large vessel group. On the other hand, the changes in PA and % PA were similar between groups. Conclusions. (e main vascular responses associated with lumen enlargement after DCA were plaque reduction and vessel expansion. Contribution of vessel expansion to lumen enlargement was larger than the effect of plaque reduction in large vessel lesions. available in Japan in 2015. Recently, the efficacy of the 1. Introduction stentless strategy for LM bifurcation lesions using drug- Percutaneous coronary intervention (PCI) is an established coated balloon (DCB) angioplasty after DCA was reported option for the treatment of left main (LM) coronary artery [5]. Adequate lumen enlargement is important to achieve disease [1]. However, complex stenting is sometimes inev- maximum efficacy of the stentless strategy using DCA fol- itable in cases of LM bifurcation lesions and its efficacy has lowed by DCB angioplasty. (e percentage plaque area (% not been proven compared with that of the simple stent PA) is a popular indicator used to determine the optimal strategy [2]. Previous studies have reported the efficacy of endpoint of DCA. (e main mechanism of lumen en- directional coronary atherectomy (DCA) to avoid complex largement in DCA is plaque reduction [6–8], and increasing stenting in bifurcated lesions and to reduce restenosis of the the balloon pressure of the DCA catheter further enhances left circumflex artery (LCX) ostium after single stent im- plaque reduction [9]. On the other hand, balloon angioplasty plantation for LM bifurcation lesions [3, 4]. Once the DCA is known to induce vessel expansion which is also one of the catheter became commercially unavailable, a novel, im- mechanisms of lumen enlargement [10, 11]. During DCA in proved DCA catheter (ATHEROCUT, Nipro Corporation, LM bifurcation lesions, high balloon pressure of the DCA Osaka, Japan) was developed and became commercially catheter is frequently required for large vessel lesions 2 Journal of Interventional Cardiology several cuts of DCA and again repeated to obtain residual % because the large plaque burden must be debulked. (erefore, the efficacy of vessel expansion, as well as the PA< 60% when possible [3]. (e performance of the stentless strategy was decided after careful evaluation of the efficacy of plaque reduction, appears to increase for large vessel lesions. However, thus far, little is known regarding IVUS and angiographic findings by experienced operators. the vessel response after DCA in LM bifurcation lesions. We DCB angioplasty using SeQuent Please (Nipro Corporation, assessed intravascular ultrasound (IVUS) findings after Osaka, Japan) was performed after DCA when IVUS DCA for LM bifurcation lesions in order to evaluate the revealed that there were no large residual plaque burden, no vascular response. huge dissection, and no hematoma formation. (e size of DCB was selected according to the reference lumen diameter by IVUS, and the balloon inflation time was 30 s with 2. Materials and Methods nominal pressure. Dual antiplatelet therapy with 100 mg/day aspirin and either 75 mg/day clopidogrel or 3.75 mg/day 2.1. Patient Population. Between April 2016 and October prasugrel was administered before the procedure and 2019, 58 patients who underwent PCI with DCA for LM continued for 3 months following the procedure. Compli- bifurcation lesions were retrospectively identified. Of these, cations during the procedure and procedure-related major 27 patients were excluded; 18 underwent implantation of events during hospitalization including death, emergent drug-eluting stents (DESs) after DCA, two underwent DCA target lesion revascularization (TLR) and coronary artery alone, and seven underwent DCA for proximal stent edge graft bypass, myocardial infarction, and access site com- restenosis at the left anterior descending artery (LAD) os- plications were recorded. Myocardial infarction was defined tium. Finally, 31 patients who underwent stentless therapy as any postprocedural creatine kinase elevation of >2 times with DCA followed by DCB angioplasty for de novo LM the normal level. All patients were followed up at 30 days bifurcation lesions were enrolled. Among these, one patient after discharge and every 2 to 3 months subsequently. underwent DCA followed by DCB angioplasty for both the Follow-up coronary angiography was scheduled at 9 to 12 LAD ostium and the left circumflex artery (LCX) ostium; months after the procedure. TLR at 12 months and a major therefore, we analyzed IVUS findings after DCA for 32 adverse cardiac event (MACE), defined as a composite of lesions in 31 patients. cardiac death, myocardial infarction, and any repeat re- Indications for DCA for LM bifurcation lesions were as vascularization at 12 months were investigated. follows: (1) stable angina pectoris with LM bifurcation lesion involving the distal LM trunk, the LAD ostium, or the LCX ostium; (2) a reference diameter of >2.5 mm in the main 2.3. Quantitative Coronary Angiography Analysis. branch using visual estimation; and (3) IVUS findings Quantitative coronary angiography (QCA) analysis was suitable for DCA (no lipid-rich plaque, no thrombus, no performed using the computer-based software (Heart II ver severe superficial calcification, and plaque location to be 2.0.2.3, GADELIUS) before the procedure, after the pro- debulked by DCA was accurately evaluated using IVUS). (e cedure, and at follow-up examinations using a guiding exclusion criteria were as follows: (1) unstable angina pec- catheter to calibrate the magnification. Optimal views of the toris and myocardial infarction, (2) poor patient’s general lesions were obtained at baseline, and the same projection condition and renal insufficiency (Cr> 1.5 mg/dL), (3) se- angle was used at follow-up. Independent physicians who vere angle lesion, and (4) angiographic severe calcified le- were blinded to all clinical information analyzed the min- sion. (is study was approved by the institutional review imal lumen diameter (MLD), reference diameter (RD), le- board of our hospital and complied with the Declaration of sion length, and percent diameter stenosis (%DS). (e acute Helsinki. Written informed consent was obtained from all gain was defined as the increase in MLD after PCI; late patients for both the procedure and subsequent data lumen loss was defined as the difference between the collection. postprocedural MLD and MLD at follow-up. 2.4. Intravascular Ultrasound Analysis. All IVUS procedures 2.2. Procedure and Follow-Up. All PCIs were performed via the femoral artery using an 8Fr sheath introducer and 8Fr were performed using commercially available IVUS cathe- ters (OptiCross guiding catheter. During the procedure, the activated co- ; Boston Scientific, or ViewIT; Terumo) agulation time was maintained at>300 s with administration with automatic pull-back at a rate of 0.5 mm/s. At the lumen of heparin. We carefully evaluated plaque distribution and site where the lumen area was the smallest, the lumen di- plaque characteristics using IVUS after crossing the lesion ameter, lumen area, vessel area, and %PA were analyzed. PA with a conventional guidewire. We decided to perform DCA was defined as the vessel area minus the lumen area. %PA after plaque distribution to be debulked was adequately was defined as (vessel area minus lumen area) × 100/vessel evaluated using IVUS and when there were no lipid-rich area. (e changes in the vessel area, the lumen area, PA, and plaque, thrombus, and severe superficial calcification. (e %PA after DCA were defined as postprocedure minus ATHEROCUT (Nipro Corporation, Osaka, Japan) was used preprocedure values for the vessel area (Δ vessel area), lumen for all lesions, and size selection was dependent on the area (Δ lumen area), PA (Δ PA), and %PA (Δ %PA), re- reference diameter of IVUS. DCA was initiated with low spectively. (ese measurements were compared between balloon pressure (0 or 1 atm) and gradually increased based small vessel and large vessel lesions, which were determined on the IVUS findings. We repeated IVUS evaluation after based on the median value of the vessel area. (e incidence Journal of Interventional Cardiology 3 Table 1: Baseline characteristics of participants. of hematoma, intimal dissection, and medial dissection was recorded. All images were analyzed using computerized Patient characteristics planimetry software (echoPlaque; INDEC Medical Systems, patients Los Altos, CA, USA) by independent physicians who were Age (years) 70± 10 blinded to all clinical data. Male (%) 29 (94) Hypertension (%) 24 (77) Diabetes mellitus (%) 8 (26) 2.5. Statistical Analysis. Data are shown as numbers with Hyperlipidemia (%) 24 (77) percentages or means± standard deviations. Comparisons of Hemodialysis (%) 1 (3) categorical variables were performed using Fisher’s exact Current smoker (%) 2 (6) test. Comparisons of continuous variables were performed Previous percutaneous coronary intervention (%) 10 (32) using Student’s t-test or the Mann–Whitney U test. (e Previous coronary artery bypass graft (%) 0 (0) Spearman rank correlation method was applied to estimate Medication correlations between continuous variables. All P values were ACE/ARB (%) 21 (68) two-sided, and P values of<0.05 were considered statistically β-Blocker (%) 22 (71) Statin (%) 30 (97) significant. All analyses were performed using SPSS software Aspirin (%) 31 (100) (version 19; IBM-SPSS, Chicago, IL). Clopidogrel (%) 10 (32) Prasugrel (%) 21 (68) 3. Results Medina classification (0, 1, 0) (%) 18 (58) 3.1. Patient and Lesion Characteristics. Patient and lesion (0, 0, 1) (%) 4 (13) characteristics are summarized in Table 1. A total of 31 (1, 0, 0) (%) 1 (3) patients with LM bifurcation lesions (mean age: 70± 10 (1, 1, 0) (%) 7 (23) years; male: 94%; diabetes mellitus: 26%; hemodialysis: 3%) (1, 1, 1) (%) 1 (3) were enrolled. DCA was performed more frequently for the Main target of DCA LAD ostium (68%), followed by both distal left main trunk LAD ostium (%) 21 (68) and the LAD ostium (17%). One patient (3%) with a true LCX ostium (%) 2 (6) bifurcation lesion (Medina 1, 1, 1) underwent DCA for the Distal left main trunk (%) 2 (6) distal LM trunk, LAD ostium, and LCX ostium. Distal left main trunk and LAD ostium (%) 5 (17) Distal left main trunk, LAD ostium, and LCX ostium 1 (3) (%) 3.2. Procedure Results. (e procedure results are presented in Table 2. ATHEROCUT type L was the most frequently used (91%). (e total number of cuts was 28 ± 17, and the Table 2: Procedural results. maximum balloon pressure of the DCA catheter was Directional coronary atherectomy 32 lesions (31 patients) 3.5± 1.3 atm. When lesions were divided into small vessel Size of the catheter and large vessel groups according to the median value of the ATHEROCUT type M (%) 3 (9) vessel area (14.9 mm ), the maximum balloon pressure was ATHEROCUT type L (%) 29 (91) significantly higher in the large vessel group than in the small Total number of cuts (times) 28± 17 vessel group (2.8± 0.9 atm vs. 4.1± 1.3 atm, P � 0.014). All Maximum balloon pressure (atm) 3.5± 1.3 lesions underwent DCB angioplasty after DCA with di- Drug-coated balloon ameter 3.3± 0.4 mm and balloon pressure 8.3± 2.9 atm. In Diameter (mm) 3.3± 0.4 the QCA analysis, MLD and %DS were significantly im- Length (mm) 17.5± 3.4 proved after the procedure (MLD: 1.3± 0.4 mm vs. Balloon pressure (atm) 8.3± 2.9 3.4± 0.9 mm, P< 0.001; %DS: 63.3%± 10.6% vs. Procedure time (min) 126± 41 Amount of contrast media (mL) 196± 72 12.2%± 7.9%, P< 0.001) (Table 3). (ere were no compli- cations during the procedure and no procedure-related Complication during the procedure Vessel perforation (%) 0 (0) major events during hospitalization (Table 2). Slow flow phenomenon (%) 0 (0) Stuck of the DCA catheter (%) 0 (0) 3.3. IVUS Findings during DCA. IVUS findings during DCA Procedure-related major events during the hospitalization are summarized in Table 4. Both lumen and vessel areas Death (%) 0 (0) became significantly larger after DCA (lumen area: Emergent TLR or CABG (%) 0 (0) 2 2 Myocardial infarction (Q or non-Q) (%) 0 (0) 3.0± 0.9 mm vs. 8.9± 2.1 mm , P< 0.001; vessel area: 2 2 Access site complications (%) 0 (0) 13.5± 3.6 mm vs. 16.1± 3.8 mm , P � 0.004). Both plaque area and %PA significantly decreased after DCA (plaque 2 2 area: 10.5± 3.3 mm vs. 7.2± 2.3 mm , P< 0.001; %PA: 77.5%± 6.1% vs. 44.3%± 6.7%, P< 0.001). (ere was a there was no correlation between %PA after DCA and the positive correlation between the lumen area after DCA and vessel area after DCA (r � 0.21, P � 0.26) (Figures 1(a) and the vessel area after DCA (r � 0.90, P< 0.001). However, 1(b)). Δ lumen area and Δ vessel area were significantly 4 Journal of Interventional Cardiology Table 3: Quantitative coronary analysis results. was observed at 12 months. (e only TLR case was LM bifurcation lesion with Medina classification (0, 1, 0). DCA Before the procedure 32 lesions was performed for the LAD ostium; however, post-%PA was Minimum lumen diameter (mm) 1.3± 0.4 55.9% which was the largest in the enrolled population. Reference lumen diameter (mm) 3.9± 1.1 % diameter stenosis 63.3± 10.6 Lesion length (mm) 18.5± 6.7 4. Discussion After the procedure Minimum lumen diameter (mm) 3.4± 0.9 (e main findings of the current study were as follows: First, Acute gain (mm) 2.0± 1.0 the mean %PA after DCA was 44.3%, and the incidence of Reference lumen diameter (mm) 3.8± 1.1 TLR at 12 months was 3.2% for de novo LM bifurcation lesions % diameter stenosis 12.2± 7.9 after the stentless strategy by DCA followed by DCB angio- Follow-up plasty. Second, IVUS revealed that the lumen and vessel areas Minimum lumen diameter (mm) 3.3± 1.1 increased, while PA and %PA decreased after DCA. (ird, the Late lumen loss (mm) 0.1± 0.5 lumen area after DCA was well correlated with the vessel area % diameter stenosis 15.4± 15.3 after DCA; however, %PA after DCA was not correlated with the vessel area after DCA. Fourth, the Δ lumen area and Δ Table 4: Intravascular ultrasound findings. vessel area after DCA were larger in large vessel lesions than in small vessel lesions. However, Δ PA and Δ%PA after DCA Before directional coronary atherectomy 32 lesions were similar between small vessel and large vessel lesions. Minimum lumen diameter (mm) 1.6± 0.3 2 A previous study reported that lumen enlargement is Lumen area (mm ) 3.0± 0.9 the result of a combination of vessel expansion, plaque Vessel area (mm ) 13.5± 3.6 dissection, and plaque redistribution after balloon angio- Plaque area (mm ) 10.5± 3.3 % plaque area 77.5± 6.1 plasty [11]. On the other hand, plaque removal was the specific mechanism in DCA that is associated with lumen After directional coronary atherectomy Minimum lumen diameter (mm) 2.8± 0.3 enlargement [6–8], and the effect of plaque removal is Lumen area (mm ) 8.9± 2.1 controlled by increasing the balloon pressure of the DCA Vessel area (mm ) 16.1± 3.8 catheter [9]. Generally, large vessel lesions have a large Plaque area (mm ) 7.2± 2.3 amount of plaque to be debulked; therefore, high balloon % plaque area 44.3± 6.7 pressure of the DCA catheter is required to achieve a lower Intimal dissection (%) 5 (15.6) %PA. Actually, the maximum balloon pressure was greater Medial dissection (%) 0 (0) in large vessel lesions than in small vessel lesions in the Hematoma (%) 0 (0) current study. Our results revealed that increasing the maximum balloon pressure of the DCA catheter in large larger in the large vessel group than in the small vessel group vessel lesions was associated with greater vessel expansion 2 2 but did not increase the effect on plaque reduction com- (Δ lumen area: 4.6± 1.4 mm vs. 7.3± 1.8 mm , P< 0.001; Δ 2 2 pared with that in small vessel lesions. Previous studies vessel area: 1.6± 2.5 mm vs. 3.7± 3.0 mm , P � 0.04) have also reported that vessel expansion is a significant (Figures 2(a) and 2(b)). On the other hand,Δ PA andΔ %PA contributor to lumen enlargement after DCA [12, 13]. were similar between the small vessel and large vessel groups 2 2 (Δ PA: −3.0± 1.6 mm vs. −3.6± 3.8 mm , P � 0.54; Δ %PA: Nakamura et al. demonstrated that the lumen cross-sec- 2 2 tional area improved from 2.9± 1.5 mm to 7.0± 1.5 mm −32.2%± 7.9% vs. −34.1%± 10.9%, P � 0.58) (Figures 2(c) and 2(d)). Intimal dissection was observed in five lesions (P< 0.0001), while the vessel cross-sectional area increased 2 2 from 17.1± 5.9 mm to 18.7± 5.5 mm (P< 0.001) on IVUS (15.6%); however, there was no medial dissection and he- matoma formation. Figure 3 shows representative IVUS after DCA [12]. (e largest size (L) of the DCA catheter was frequently used (91%) in the current study; therefore, a findings before and after DCA in small and large vessel lesions. For small vessel lesions, Δ lumen area, Δ vessel area, larger DCA catheter will be necessary for further plaque 2 2 2 reduction in large vessel lesions. However, %PA obtained Δ PA, and Δ %PA were 5.6 mm , 2.3 mm , −3.3 mm , and −34.0%, respectively (Figure 3(a)). For large vessel lesions,Δ was sufficiently low even in large vessel lesions, and the incidence of TLR at 12 months was acceptable. Accord- lumen area, Δ vessel area, Δ PA, and Δ %PA were 8.3 mm , 2 2 5.0 mm , −3.4 mm , and −38.3%, respectively (Figure 3(b)). ingly, we consider that the current size (L) of the DCA catheter will be adequate for DCA for large vessel LM bifurcation lesions. High balloon pressure of the DCA 3.4. Follow-Up Results. Angiographic follow-up was per- catheter will strengthen the contribution of vessel expan- formed for 28 patients (angiographic follow-up rate: 90.3%). sion in large vessel lesions. However, the DCA catheter is a At follow-up coronary angiography, MLD and %DS were bulky device and can cause vessel injury. Operators should similar to those after the procedure (MLD: 3.3± 1.1 mm vs. pay careful attention to the occurrence of dissection, he- 3.4± 0.9 mm, P � 0.78; %DS: 15.4%± 15.3% vs. matoma, and vessel perforation, particularly for large vessel 12.2%± 7.9%, P � 0.32) (Table 3). TLR at 12 months oc- lesions with eccentric plaque or mild calcified plaque when curred in one patient (3.2%), and no MACE other than TLR the balloon pressure of the DCA catheter is increased. Journal of Interventional Cardiology 5 (%) (mm ) 16 60 8 30 r = 0.21 r = 0.90 P = 0.26 P < 0.001 0 0 5 10 15 20 25 30 5 10 15 20 25 (mm ) (mm ) Vessel area aer DCA Vessel area aer DCA (a) (b) Figure 1: (a) Correlation between the lumen area after DCA and the vessel area after DCA. (b) Correlation between %PA after DCA and the vessel area after DCA. P < 0.001 2 P = 0.04 (mm ) (mm ) 14 25 P= 0.003 P < 0.001 P< 0.001 P= 0.013 Small vessel Large vessel Small vessel Large vessel Pre lumen area Pre vessel area Vessel area aer DCA Vessel area aer DCA ∆ lumen area ∆ vessel area (a) (b) Figure 2: Continued. Lumen area aer DCA % plaque area aer DCA 6 Journal of Interventional Cardiology P= 0.57 P= 0.58 (mm ) (%) P< 0.001 P < 0.001 P< 0.001 P< 0.001 -1 -20 -3 -5 -40 Small vessel Large vessel Small vessel Large vessel Pre % plaque area Pre plaque area % plaque area aer DCA plaque area aer DCA ∆% plaque area ∆ plaque area (c) (d) Figure 2: (a) Comparison of the lumen area before DCA, lumen area after DCA, and change in the lumen area between the small vessel and large vessel groups. (b) Comparison of the vessel area before DCA, vessel area after DCA, and change in the vessel area between the small vessel and large vessel groups. (c) Comparison of PA before DCA, PA after DCA, and change in PA between the small vessel and large vessel groups. (d) Comparison of %PA before DCA, %PA after DCA, and change in %PA between the small vessel and large vessel groups. Pre DCA Aer DCA Pre DCA Aer DCA LCX LCX LCX LCX LCX LCX LCX LCX (a) (b) Figure 3: (a) IVUS findings before and after DCA in small vessel lesions. (e red line represents the vessel area, and the yellow line 2 2 2 represents the lumen area. (e lumen area, vessel area, PA, and %PA before DCA were 2.7 mm , 12.6 mm , 9.9 mm , and 78.5%, re- 2 2 2 spectively. (e lumen area, vessel area, PA, and %PA after DCA were 8.3 mm , 14.9 mm , 6.6 mm , and 44.5%, respectively. (e Δ lumen 2 2 2 area,Δ vessel area,Δ PA, andΔ %PA were 5.6 mm , 2.3 mm , −3.3 mm , and −34.0%, respectively. (b) IVUS findings before and after DCA in large vessel lesions. (e red line represents the vessel area, and the yellow line represents the lumen area. (e lumen area, vessel area, PA, 2 2 2 and %PA before DCA were 2.3 mm , 14.8 mm , 12.6 mm , and 84.8%, respectively. (e lumen area, vessel area, PA, and %PA after DCA 2 2 2 2 2 were 10.6 mm , 19.8 mm , 9.2 mm , and 46.5%, respectively. (e Δ lumen area, Δ vessel area, Δ PA, and Δ %PA were 8.3 mm , 5.0 mm , −3.4 mm , and −38.3%, respectively. Journal of Interventional Cardiology 7 4.1. Study Limitations. (is study has several limitations. References First, the sample size was small, and data were analyzed [1] G. W. Stone, A. P. Kappetein, J. F. Sabik et al., “Five-year retrospectively. (us, this should be considered a prelimi- outcomes after PCI or CABG for left main coronary disease,” nary study for generating a hypothesis. Second, DCA for the New England Journal of Medicine, vol. 381, no. 19, LCX ostium was associated with higher technical challenges pp. 1820–1830, 2019. during the procedure and higher rates of restenosis than [2] D. E. Kandzari, A. H. Gershlick, P. W. Serruys et al., “Out- DCA for the LAD ostium. 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Leung et al., “Intracoronary ultrasound imaging before and after directional coronary Disclosure atherectomy: in vitro and clinical observations,” American Heart Journal, vol. 129, no. 5, pp. 841–851, 1995. A preprint has previously been submitted at Research Square [13] Y. Takeda, E. Tsuchikane, T. Kobayashi et al., “Effect of plaque [16]. debulking before stent implantation on in-stent neointimal proliferation: a serial 3-dimensional intravascular ultrasound study,” American Heart Journal, vol. 146, no. 1, pp. 175–182, Conflicts of Interest (e authors declare that there are no conflicts of interest [14] J. M. Ahmed, G. S. Mintz, N. J. Weissman et al., “Mechanism regarding the publication of this article. of lumen enlargement during intracoronary stent 8 Journal of Interventional Cardiology implantation: an intravascular ultrasound study,” Circulation, vol. 102, no. 1, pp. 7–10, 2000. [15] X. Wu, A. Maehara, Y. He et al., “Plaque shift and distal embolism in patients with acute myocardial infarction: a volumetric intravascular ultrasound analysis from the HO- RIZONS-AMI trial,” Catheterization and Cardiovascular In- terventions, vol. 82, no. 2, pp. 203–209, 2013. [16] N. Kobayashi, M. Yamawaki, M. Hiraishi et al., Vascular Response after Directional Coronary Atherectomy for Left Main Bifurcation LesionResearch Square, Durham, North Carolina, http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Interventional Cardiology Hindawi Publishing Corporation

Vascular Response after Directional Coronary Atherectomy for Left Main Bifurcation Lesion

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Abstract

Hindawi Journal of Interventional Cardiology Volume 2021, Article ID 5541843, 8 pages https://doi.org/10.1155/2021/5541843 Research Article Vascular Response after Directional Coronary Atherectomy for Left Main Bifurcation Lesion Norihiro Kobayashi , Masahiro Yamawaki, Mana Hiraishi, Shinsuke Mori , Masakazu Tsutsumi, Yohsuke Honda , Toshiki Chishiki, Kenji Makino, Shigemitsu Shirai, Masafumi Mizusawa, Kohei Yamaguchi, Takahide Nakano, Kaori Abe, Tomoya Fukagawa, Toshihiko Kishida, and Yoshiaki Ito Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa 230-8765, Japan Correspondence should be addressed to Norihiro Kobayashi; ovation17@gmail.com Received 30 August 2021; Accepted 3 December 2021; Published 14 December 2021 Academic Editor: Jochen Wo¨hrle Copyright © 2021 Norihiro Kobayashi 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. Aims. To evaluate the vascular response after directional coronary atherectomy (DCA) for left main (LM) bifurcation lesion. Methods. (is study was a retrospective, single-center study enrolling 31 patients who underwent stentless therapy using DCA followed by drug-coated balloon (DCB) angioplasty for LM bifurcation lesion. We compared intravascular ultrasound (IVUS) findings before and after DCA. Results. After DCA, the lumen and vessel areas significantly increased, whereas the plaque area (PA) and %PA were significantly reduced. When the lesions were divided into small vessel and large vessel groups using the median value of the vessel area, the maximum balloon pressure of the DCA catheter was greater in the large vessel group. Changes in the lumen and vessel areas were also significantly greater in the large vessel group. On the other hand, the changes in PA and % PA were similar between groups. Conclusions. (e main vascular responses associated with lumen enlargement after DCA were plaque reduction and vessel expansion. Contribution of vessel expansion to lumen enlargement was larger than the effect of plaque reduction in large vessel lesions. available in Japan in 2015. Recently, the efficacy of the 1. Introduction stentless strategy for LM bifurcation lesions using drug- Percutaneous coronary intervention (PCI) is an established coated balloon (DCB) angioplasty after DCA was reported option for the treatment of left main (LM) coronary artery [5]. Adequate lumen enlargement is important to achieve disease [1]. However, complex stenting is sometimes inev- maximum efficacy of the stentless strategy using DCA fol- itable in cases of LM bifurcation lesions and its efficacy has lowed by DCB angioplasty. (e percentage plaque area (% not been proven compared with that of the simple stent PA) is a popular indicator used to determine the optimal strategy [2]. Previous studies have reported the efficacy of endpoint of DCA. (e main mechanism of lumen en- directional coronary atherectomy (DCA) to avoid complex largement in DCA is plaque reduction [6–8], and increasing stenting in bifurcated lesions and to reduce restenosis of the the balloon pressure of the DCA catheter further enhances left circumflex artery (LCX) ostium after single stent im- plaque reduction [9]. On the other hand, balloon angioplasty plantation for LM bifurcation lesions [3, 4]. Once the DCA is known to induce vessel expansion which is also one of the catheter became commercially unavailable, a novel, im- mechanisms of lumen enlargement [10, 11]. During DCA in proved DCA catheter (ATHEROCUT, Nipro Corporation, LM bifurcation lesions, high balloon pressure of the DCA Osaka, Japan) was developed and became commercially catheter is frequently required for large vessel lesions 2 Journal of Interventional Cardiology several cuts of DCA and again repeated to obtain residual % because the large plaque burden must be debulked. (erefore, the efficacy of vessel expansion, as well as the PA< 60% when possible [3]. (e performance of the stentless strategy was decided after careful evaluation of the efficacy of plaque reduction, appears to increase for large vessel lesions. However, thus far, little is known regarding IVUS and angiographic findings by experienced operators. the vessel response after DCA in LM bifurcation lesions. We DCB angioplasty using SeQuent Please (Nipro Corporation, assessed intravascular ultrasound (IVUS) findings after Osaka, Japan) was performed after DCA when IVUS DCA for LM bifurcation lesions in order to evaluate the revealed that there were no large residual plaque burden, no vascular response. huge dissection, and no hematoma formation. (e size of DCB was selected according to the reference lumen diameter by IVUS, and the balloon inflation time was 30 s with 2. Materials and Methods nominal pressure. Dual antiplatelet therapy with 100 mg/day aspirin and either 75 mg/day clopidogrel or 3.75 mg/day 2.1. Patient Population. Between April 2016 and October prasugrel was administered before the procedure and 2019, 58 patients who underwent PCI with DCA for LM continued for 3 months following the procedure. Compli- bifurcation lesions were retrospectively identified. Of these, cations during the procedure and procedure-related major 27 patients were excluded; 18 underwent implantation of events during hospitalization including death, emergent drug-eluting stents (DESs) after DCA, two underwent DCA target lesion revascularization (TLR) and coronary artery alone, and seven underwent DCA for proximal stent edge graft bypass, myocardial infarction, and access site com- restenosis at the left anterior descending artery (LAD) os- plications were recorded. Myocardial infarction was defined tium. Finally, 31 patients who underwent stentless therapy as any postprocedural creatine kinase elevation of >2 times with DCA followed by DCB angioplasty for de novo LM the normal level. All patients were followed up at 30 days bifurcation lesions were enrolled. Among these, one patient after discharge and every 2 to 3 months subsequently. underwent DCA followed by DCB angioplasty for both the Follow-up coronary angiography was scheduled at 9 to 12 LAD ostium and the left circumflex artery (LCX) ostium; months after the procedure. TLR at 12 months and a major therefore, we analyzed IVUS findings after DCA for 32 adverse cardiac event (MACE), defined as a composite of lesions in 31 patients. cardiac death, myocardial infarction, and any repeat re- Indications for DCA for LM bifurcation lesions were as vascularization at 12 months were investigated. follows: (1) stable angina pectoris with LM bifurcation lesion involving the distal LM trunk, the LAD ostium, or the LCX ostium; (2) a reference diameter of >2.5 mm in the main 2.3. Quantitative Coronary Angiography Analysis. branch using visual estimation; and (3) IVUS findings Quantitative coronary angiography (QCA) analysis was suitable for DCA (no lipid-rich plaque, no thrombus, no performed using the computer-based software (Heart II ver severe superficial calcification, and plaque location to be 2.0.2.3, GADELIUS) before the procedure, after the pro- debulked by DCA was accurately evaluated using IVUS). (e cedure, and at follow-up examinations using a guiding exclusion criteria were as follows: (1) unstable angina pec- catheter to calibrate the magnification. Optimal views of the toris and myocardial infarction, (2) poor patient’s general lesions were obtained at baseline, and the same projection condition and renal insufficiency (Cr> 1.5 mg/dL), (3) se- angle was used at follow-up. Independent physicians who vere angle lesion, and (4) angiographic severe calcified le- were blinded to all clinical information analyzed the min- sion. (is study was approved by the institutional review imal lumen diameter (MLD), reference diameter (RD), le- board of our hospital and complied with the Declaration of sion length, and percent diameter stenosis (%DS). (e acute Helsinki. Written informed consent was obtained from all gain was defined as the increase in MLD after PCI; late patients for both the procedure and subsequent data lumen loss was defined as the difference between the collection. postprocedural MLD and MLD at follow-up. 2.4. Intravascular Ultrasound Analysis. All IVUS procedures 2.2. Procedure and Follow-Up. All PCIs were performed via the femoral artery using an 8Fr sheath introducer and 8Fr were performed using commercially available IVUS cathe- ters (OptiCross guiding catheter. During the procedure, the activated co- ; Boston Scientific, or ViewIT; Terumo) agulation time was maintained at>300 s with administration with automatic pull-back at a rate of 0.5 mm/s. At the lumen of heparin. We carefully evaluated plaque distribution and site where the lumen area was the smallest, the lumen di- plaque characteristics using IVUS after crossing the lesion ameter, lumen area, vessel area, and %PA were analyzed. PA with a conventional guidewire. We decided to perform DCA was defined as the vessel area minus the lumen area. %PA after plaque distribution to be debulked was adequately was defined as (vessel area minus lumen area) × 100/vessel evaluated using IVUS and when there were no lipid-rich area. (e changes in the vessel area, the lumen area, PA, and plaque, thrombus, and severe superficial calcification. (e %PA after DCA were defined as postprocedure minus ATHEROCUT (Nipro Corporation, Osaka, Japan) was used preprocedure values for the vessel area (Δ vessel area), lumen for all lesions, and size selection was dependent on the area (Δ lumen area), PA (Δ PA), and %PA (Δ %PA), re- reference diameter of IVUS. DCA was initiated with low spectively. (ese measurements were compared between balloon pressure (0 or 1 atm) and gradually increased based small vessel and large vessel lesions, which were determined on the IVUS findings. We repeated IVUS evaluation after based on the median value of the vessel area. (e incidence Journal of Interventional Cardiology 3 Table 1: Baseline characteristics of participants. of hematoma, intimal dissection, and medial dissection was recorded. All images were analyzed using computerized Patient characteristics planimetry software (echoPlaque; INDEC Medical Systems, patients Los Altos, CA, USA) by independent physicians who were Age (years) 70± 10 blinded to all clinical data. Male (%) 29 (94) Hypertension (%) 24 (77) Diabetes mellitus (%) 8 (26) 2.5. Statistical Analysis. Data are shown as numbers with Hyperlipidemia (%) 24 (77) percentages or means± standard deviations. Comparisons of Hemodialysis (%) 1 (3) categorical variables were performed using Fisher’s exact Current smoker (%) 2 (6) test. Comparisons of continuous variables were performed Previous percutaneous coronary intervention (%) 10 (32) using Student’s t-test or the Mann–Whitney U test. (e Previous coronary artery bypass graft (%) 0 (0) Spearman rank correlation method was applied to estimate Medication correlations between continuous variables. All P values were ACE/ARB (%) 21 (68) two-sided, and P values of<0.05 were considered statistically β-Blocker (%) 22 (71) Statin (%) 30 (97) significant. All analyses were performed using SPSS software Aspirin (%) 31 (100) (version 19; IBM-SPSS, Chicago, IL). Clopidogrel (%) 10 (32) Prasugrel (%) 21 (68) 3. Results Medina classification (0, 1, 0) (%) 18 (58) 3.1. Patient and Lesion Characteristics. Patient and lesion (0, 0, 1) (%) 4 (13) characteristics are summarized in Table 1. A total of 31 (1, 0, 0) (%) 1 (3) patients with LM bifurcation lesions (mean age: 70± 10 (1, 1, 0) (%) 7 (23) years; male: 94%; diabetes mellitus: 26%; hemodialysis: 3%) (1, 1, 1) (%) 1 (3) were enrolled. DCA was performed more frequently for the Main target of DCA LAD ostium (68%), followed by both distal left main trunk LAD ostium (%) 21 (68) and the LAD ostium (17%). One patient (3%) with a true LCX ostium (%) 2 (6) bifurcation lesion (Medina 1, 1, 1) underwent DCA for the Distal left main trunk (%) 2 (6) distal LM trunk, LAD ostium, and LCX ostium. Distal left main trunk and LAD ostium (%) 5 (17) Distal left main trunk, LAD ostium, and LCX ostium 1 (3) (%) 3.2. Procedure Results. (e procedure results are presented in Table 2. ATHEROCUT type L was the most frequently used (91%). (e total number of cuts was 28 ± 17, and the Table 2: Procedural results. maximum balloon pressure of the DCA catheter was Directional coronary atherectomy 32 lesions (31 patients) 3.5± 1.3 atm. When lesions were divided into small vessel Size of the catheter and large vessel groups according to the median value of the ATHEROCUT type M (%) 3 (9) vessel area (14.9 mm ), the maximum balloon pressure was ATHEROCUT type L (%) 29 (91) significantly higher in the large vessel group than in the small Total number of cuts (times) 28± 17 vessel group (2.8± 0.9 atm vs. 4.1± 1.3 atm, P � 0.014). All Maximum balloon pressure (atm) 3.5± 1.3 lesions underwent DCB angioplasty after DCA with di- Drug-coated balloon ameter 3.3± 0.4 mm and balloon pressure 8.3± 2.9 atm. In Diameter (mm) 3.3± 0.4 the QCA analysis, MLD and %DS were significantly im- Length (mm) 17.5± 3.4 proved after the procedure (MLD: 1.3± 0.4 mm vs. Balloon pressure (atm) 8.3± 2.9 3.4± 0.9 mm, P< 0.001; %DS: 63.3%± 10.6% vs. Procedure time (min) 126± 41 Amount of contrast media (mL) 196± 72 12.2%± 7.9%, P< 0.001) (Table 3). (ere were no compli- cations during the procedure and no procedure-related Complication during the procedure Vessel perforation (%) 0 (0) major events during hospitalization (Table 2). Slow flow phenomenon (%) 0 (0) Stuck of the DCA catheter (%) 0 (0) 3.3. IVUS Findings during DCA. IVUS findings during DCA Procedure-related major events during the hospitalization are summarized in Table 4. Both lumen and vessel areas Death (%) 0 (0) became significantly larger after DCA (lumen area: Emergent TLR or CABG (%) 0 (0) 2 2 Myocardial infarction (Q or non-Q) (%) 0 (0) 3.0± 0.9 mm vs. 8.9± 2.1 mm , P< 0.001; vessel area: 2 2 Access site complications (%) 0 (0) 13.5± 3.6 mm vs. 16.1± 3.8 mm , P � 0.004). Both plaque area and %PA significantly decreased after DCA (plaque 2 2 area: 10.5± 3.3 mm vs. 7.2± 2.3 mm , P< 0.001; %PA: 77.5%± 6.1% vs. 44.3%± 6.7%, P< 0.001). (ere was a there was no correlation between %PA after DCA and the positive correlation between the lumen area after DCA and vessel area after DCA (r � 0.21, P � 0.26) (Figures 1(a) and the vessel area after DCA (r � 0.90, P< 0.001). However, 1(b)). Δ lumen area and Δ vessel area were significantly 4 Journal of Interventional Cardiology Table 3: Quantitative coronary analysis results. was observed at 12 months. (e only TLR case was LM bifurcation lesion with Medina classification (0, 1, 0). DCA Before the procedure 32 lesions was performed for the LAD ostium; however, post-%PA was Minimum lumen diameter (mm) 1.3± 0.4 55.9% which was the largest in the enrolled population. Reference lumen diameter (mm) 3.9± 1.1 % diameter stenosis 63.3± 10.6 Lesion length (mm) 18.5± 6.7 4. Discussion After the procedure Minimum lumen diameter (mm) 3.4± 0.9 (e main findings of the current study were as follows: First, Acute gain (mm) 2.0± 1.0 the mean %PA after DCA was 44.3%, and the incidence of Reference lumen diameter (mm) 3.8± 1.1 TLR at 12 months was 3.2% for de novo LM bifurcation lesions % diameter stenosis 12.2± 7.9 after the stentless strategy by DCA followed by DCB angio- Follow-up plasty. Second, IVUS revealed that the lumen and vessel areas Minimum lumen diameter (mm) 3.3± 1.1 increased, while PA and %PA decreased after DCA. (ird, the Late lumen loss (mm) 0.1± 0.5 lumen area after DCA was well correlated with the vessel area % diameter stenosis 15.4± 15.3 after DCA; however, %PA after DCA was not correlated with the vessel area after DCA. Fourth, the Δ lumen area and Δ Table 4: Intravascular ultrasound findings. vessel area after DCA were larger in large vessel lesions than in small vessel lesions. However, Δ PA and Δ%PA after DCA Before directional coronary atherectomy 32 lesions were similar between small vessel and large vessel lesions. Minimum lumen diameter (mm) 1.6± 0.3 2 A previous study reported that lumen enlargement is Lumen area (mm ) 3.0± 0.9 the result of a combination of vessel expansion, plaque Vessel area (mm ) 13.5± 3.6 dissection, and plaque redistribution after balloon angio- Plaque area (mm ) 10.5± 3.3 % plaque area 77.5± 6.1 plasty [11]. On the other hand, plaque removal was the specific mechanism in DCA that is associated with lumen After directional coronary atherectomy Minimum lumen diameter (mm) 2.8± 0.3 enlargement [6–8], and the effect of plaque removal is Lumen area (mm ) 8.9± 2.1 controlled by increasing the balloon pressure of the DCA Vessel area (mm ) 16.1± 3.8 catheter [9]. Generally, large vessel lesions have a large Plaque area (mm ) 7.2± 2.3 amount of plaque to be debulked; therefore, high balloon % plaque area 44.3± 6.7 pressure of the DCA catheter is required to achieve a lower Intimal dissection (%) 5 (15.6) %PA. Actually, the maximum balloon pressure was greater Medial dissection (%) 0 (0) in large vessel lesions than in small vessel lesions in the Hematoma (%) 0 (0) current study. Our results revealed that increasing the maximum balloon pressure of the DCA catheter in large larger in the large vessel group than in the small vessel group vessel lesions was associated with greater vessel expansion 2 2 but did not increase the effect on plaque reduction com- (Δ lumen area: 4.6± 1.4 mm vs. 7.3± 1.8 mm , P< 0.001; Δ 2 2 pared with that in small vessel lesions. Previous studies vessel area: 1.6± 2.5 mm vs. 3.7± 3.0 mm , P � 0.04) have also reported that vessel expansion is a significant (Figures 2(a) and 2(b)). On the other hand,Δ PA andΔ %PA contributor to lumen enlargement after DCA [12, 13]. were similar between the small vessel and large vessel groups 2 2 (Δ PA: −3.0± 1.6 mm vs. −3.6± 3.8 mm , P � 0.54; Δ %PA: Nakamura et al. demonstrated that the lumen cross-sec- 2 2 tional area improved from 2.9± 1.5 mm to 7.0± 1.5 mm −32.2%± 7.9% vs. −34.1%± 10.9%, P � 0.58) (Figures 2(c) and 2(d)). Intimal dissection was observed in five lesions (P< 0.0001), while the vessel cross-sectional area increased 2 2 from 17.1± 5.9 mm to 18.7± 5.5 mm (P< 0.001) on IVUS (15.6%); however, there was no medial dissection and he- matoma formation. Figure 3 shows representative IVUS after DCA [12]. (e largest size (L) of the DCA catheter was frequently used (91%) in the current study; therefore, a findings before and after DCA in small and large vessel lesions. For small vessel lesions, Δ lumen area, Δ vessel area, larger DCA catheter will be necessary for further plaque 2 2 2 reduction in large vessel lesions. However, %PA obtained Δ PA, and Δ %PA were 5.6 mm , 2.3 mm , −3.3 mm , and −34.0%, respectively (Figure 3(a)). For large vessel lesions,Δ was sufficiently low even in large vessel lesions, and the incidence of TLR at 12 months was acceptable. Accord- lumen area, Δ vessel area, Δ PA, and Δ %PA were 8.3 mm , 2 2 5.0 mm , −3.4 mm , and −38.3%, respectively (Figure 3(b)). ingly, we consider that the current size (L) of the DCA catheter will be adequate for DCA for large vessel LM bifurcation lesions. High balloon pressure of the DCA 3.4. Follow-Up Results. Angiographic follow-up was per- catheter will strengthen the contribution of vessel expan- formed for 28 patients (angiographic follow-up rate: 90.3%). sion in large vessel lesions. However, the DCA catheter is a At follow-up coronary angiography, MLD and %DS were bulky device and can cause vessel injury. Operators should similar to those after the procedure (MLD: 3.3± 1.1 mm vs. pay careful attention to the occurrence of dissection, he- 3.4± 0.9 mm, P � 0.78; %DS: 15.4%± 15.3% vs. matoma, and vessel perforation, particularly for large vessel 12.2%± 7.9%, P � 0.32) (Table 3). TLR at 12 months oc- lesions with eccentric plaque or mild calcified plaque when curred in one patient (3.2%), and no MACE other than TLR the balloon pressure of the DCA catheter is increased. Journal of Interventional Cardiology 5 (%) (mm ) 16 60 8 30 r = 0.21 r = 0.90 P = 0.26 P < 0.001 0 0 5 10 15 20 25 30 5 10 15 20 25 (mm ) (mm ) Vessel area aer DCA Vessel area aer DCA (a) (b) Figure 1: (a) Correlation between the lumen area after DCA and the vessel area after DCA. (b) Correlation between %PA after DCA and the vessel area after DCA. P < 0.001 2 P = 0.04 (mm ) (mm ) 14 25 P= 0.003 P < 0.001 P< 0.001 P= 0.013 Small vessel Large vessel Small vessel Large vessel Pre lumen area Pre vessel area Vessel area aer DCA Vessel area aer DCA ∆ lumen area ∆ vessel area (a) (b) Figure 2: Continued. Lumen area aer DCA % plaque area aer DCA 6 Journal of Interventional Cardiology P= 0.57 P= 0.58 (mm ) (%) P< 0.001 P < 0.001 P< 0.001 P< 0.001 -1 -20 -3 -5 -40 Small vessel Large vessel Small vessel Large vessel Pre % plaque area Pre plaque area % plaque area aer DCA plaque area aer DCA ∆% plaque area ∆ plaque area (c) (d) Figure 2: (a) Comparison of the lumen area before DCA, lumen area after DCA, and change in the lumen area between the small vessel and large vessel groups. (b) Comparison of the vessel area before DCA, vessel area after DCA, and change in the vessel area between the small vessel and large vessel groups. (c) Comparison of PA before DCA, PA after DCA, and change in PA between the small vessel and large vessel groups. (d) Comparison of %PA before DCA, %PA after DCA, and change in %PA between the small vessel and large vessel groups. Pre DCA Aer DCA Pre DCA Aer DCA LCX LCX LCX LCX LCX LCX LCX LCX (a) (b) Figure 3: (a) IVUS findings before and after DCA in small vessel lesions. (e red line represents the vessel area, and the yellow line 2 2 2 represents the lumen area. (e lumen area, vessel area, PA, and %PA before DCA were 2.7 mm , 12.6 mm , 9.9 mm , and 78.5%, re- 2 2 2 spectively. (e lumen area, vessel area, PA, and %PA after DCA were 8.3 mm , 14.9 mm , 6.6 mm , and 44.5%, respectively. (e Δ lumen 2 2 2 area,Δ vessel area,Δ PA, andΔ %PA were 5.6 mm , 2.3 mm , −3.3 mm , and −34.0%, respectively. (b) IVUS findings before and after DCA in large vessel lesions. (e red line represents the vessel area, and the yellow line represents the lumen area. (e lumen area, vessel area, PA, 2 2 2 and %PA before DCA were 2.3 mm , 14.8 mm , 12.6 mm , and 84.8%, respectively. (e lumen area, vessel area, PA, and %PA after DCA 2 2 2 2 2 were 10.6 mm , 19.8 mm , 9.2 mm , and 46.5%, respectively. (e Δ lumen area, Δ vessel area, Δ PA, and Δ %PA were 8.3 mm , 5.0 mm , −3.4 mm , and −38.3%, respectively. Journal of Interventional Cardiology 7 4.1. Study Limitations. (is study has several limitations. References First, the sample size was small, and data were analyzed [1] G. W. Stone, A. P. Kappetein, J. F. Sabik et al., “Five-year retrospectively. (us, this should be considered a prelimi- outcomes after PCI or CABG for left main coronary disease,” nary study for generating a hypothesis. Second, DCA for the New England Journal of Medicine, vol. 381, no. 19, LCX ostium was associated with higher technical challenges pp. 1820–1830, 2019. during the procedure and higher rates of restenosis than [2] D. E. Kandzari, A. H. Gershlick, P. W. Serruys et al., “Out- DCA for the LAD ostium. 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