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Stentless Strategy by Drug-Coated Balloon Angioplasty following Directional Coronary Atherectomy for Left Main Bifurcation Lesion

Stentless Strategy by Drug-Coated Balloon Angioplasty following Directional Coronary Atherectomy... Hindawi Journal of Interventional Cardiology Volume 2021, Article ID 5529317, 7 pages https://doi.org/10.1155/2021/5529317 Research Article Stentless Strategy by Drug-Coated Balloon Angioplasty following Directional Coronary Atherectomy for Left Main Bifurcation Lesion Norihiro Kobayashi , Masahiro Yamawaki, Shinsuke Mori , Masakazu Tsutsumi, Yohsuke Honda , Kenji Makino, Shigemitsu Shirai, Masafumi Mizusawa, and Yoshiaki Ito Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan Correspondence should be addressed to Norihiro Kobayashi; ovation17@gmail.com Received 29 January 2021; Accepted 24 February 2021; Published 3 March 2021 Academic Editor: Leonardo De Luca 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. We aimed to evaluate the efficacy of stentless strategy by drug-coated balloon (DCB) angioplasty following directional coronary atherectomy (DCA) for left main (LM) bifurcation lesions. Methods. A total of 38 patients who underwent DCB angioplasty following DCA for LM bifurcation lesions were retrospectively enrolled. )e primary endpoint was target vessel failure (TVF) at 12 months. Secondary endpoints included procedure-related major events during the hospitalization, major adverse cardiac events at 12 months, ischemia-driven target lesion revascularization (TLR) at 12 months, and bleeding com- plications defined as the Bleeding Academic Research Consortium criteria ≥2 at 12 months. Results. Among these 38 lesions, 31 lesions were de novo LM bifurcation lesions and 7 lesions were stent edge restenosis at the left anterior descending (LAD) ostium. )e mean % plaque area (%PA) after DCA was 44.0 ± 7.4%. TVF at 12 months occurred in 1 lesion (3.2%) of de novo LM bifurcation lesion and in 3 lesions (42.9%) of stent edge restenosis at the LAD ostium. All events of TVF were ischemia-driven TLR by percutaneous coronary intervention. Among 4 TLR cases, %PA after DCA was high (55.9%) in the de novo LM bifurcation lesions; on the other hand, %PA after DCA was low (42.4%, 38.7%, and 25.7% in the 3 cases) in stent edge restenosis at the LAD ostium. No procedure-related major events were observed during hospitalization. )ere was no cardiac death, no myocardial infarction, no coronary artery bypass grafting, and no bleeding complications at 12 months. Conclusions. Stentless strategy by DCB angioplasty following DCA for de novo LM bifurcation lesions resulted in acceptable outcomes. On the other hand, its efficacy was limited for stent edge restenosis at the LAD ostium even after aggressive debulking by DCA. usually dependent on the anatomical complexity. Complex 1. Introduction stenting is often unavoidable especially for true bifurcation Clinical outcomes of percutaneous coronary intervention lesions with a large side branch and for true bifurcation (PCI) have improved with the development of drug-eluting lesions with a shallow bifurcation angle due to plaque and stents (DESs) and technical advancements. However, PCI carina shift [4]. In addition, although the risk of developing for left main (LM) bifurcation lesions remains challenging stent thrombosis has decreased with the development of due to concerns over future revascularization [1]. Previous DESs, stent thrombosis at LM bifurcation lesions becomes studies reported that a simple stent strategy had better critical due to large amount of myocardium at risk. On the clinical outcomes compared to a complex stent strategy even other hand, major bleeding events especially for patients using newer generation DESs for LM bifurcation lesions with a high bleeding risk, also becomes a critical issue; [2, 3]. However, the success of a single stent strategy is however, the ideal dual antiplatelet therapy (DAPT) 2 Journal of Interventional Cardiology duration after stenting for LM bifurcation lesions remains and also assessed the existence of lipid rich plaque, unclear. )is results in a clinical dilemma for physicians as thrombus, and superficial calcification. )e ATHEROCUT they need to balance the risk and benefits between DAPT (Nipro Corporation, Osaka, Japan) was used for all the continuation to prevent stent thrombosis or a short DAPT lesions and size selection was dependent on the reference duration to avoid major bleeding events after stenting for diameter identified by IVUS. DCA was started with low LM bifurcation lesions. With the advancement of the drug- balloon pressure (0 or 1 atm) and the IVUS evaluation was coated balloon (DCB), stentless strategy is one of the po- repeated after several sessions of DCA. Balloon pressure was tential options to overcome thrombotic and bleeding events. gradually increased according to the IVUS findings and A previous study reported the feasibility of the stentless multiple cuts were repeated to obtain residual % plaque area strategy by rotational atherectomy following DCB angio- (%PA) <60% if possible [7]. Experienced operators carefully plasty for severe calcified coronary lesions [5]. Similarly, for evaluated the IVUS and angiographical findings and de- LM bifurcation lesions, an improved novel directional termined whether stentless strategy was acceptable. When coronary atherectomy (DCA) catheter (ATHEROCUT , stentless strategy was acceptable, a balloon angioplasty using Nipro Corporation, Osaka, Japan) has been commercially the DCB (SeQuent Please , Nipro Corporation, Osaka, available in Japan since 2015 and the possibility of stentless Japan) was performed. )e size of the DCB was selected strategy using DCA followed by the DCB angioplasty has according to the reference lumen diameter by IVUS and the been investigated. A recent multicenter registry which was balloon inflation time was 30 sec with nominal pressure. conducted in Japan (DCA/DCB registry) reported the effi- Provisional stent implantation was considered at the dis- cacy of the DCB angioplasty following DCA for coronary cretion of an experienced operator when the IVUS showed bifurcation lesions [6]. We investigated the efficacy of large residual plaque burden, huge dissection, or hematoma stentless strategy by DCB angioplasty following DCA for LM formation. Dual antiplatelet therapy with 100 mg/day as- bifurcation lesions. pirin and either 75 mg/day clopidogrel or 3.75 mg/day prasugrel was started before the procedure and continued for 3 months after the procedure. All the patients were 2. Methods monitored until 30 days after discharge and following that every 2 to 3 months. Follow-up coronary angiography was 2.1. Study Design and Subjects. )is was a retrospective scheduled at 9 to 12 months after the procedure. observational study conducted at Saiseikai Yokohama-city Eastern Hospital. We retrospectively identified 78 patients with stable angina pectoris who underwent PCI using DCA 2.3. Quantitative Coronary Angiography and IVUS. from our database between April 2016 and October 2019. Quantitative coronary angiography (QCA) analysis was After the exclusion of 20 patients who underwent DCA for performed using computer-based software (HeartII lesions other than LM bifurcation lesions, a total of 58 ver2.0.2.3, GADELIUS) before the procedure, after the patients who underwent DCA for LM bifurcation lesion procedure, and at follow-up by an independent physician were identified. Our indications of DCA for LM bifurcation who was blinded to patient and procedural characteristics. lesion were as follows: (1) stable angina pectoris with LM Optimal views of the lesions were obtained at baseline, and bifurcation lesion involving the distal LM trunk, ostium of the same projection angle was used at follow-up. )e left anterior descending (LAD), or left circumflex artery minimal lumen diameter (MLD), reference diameter (RD), (LCX), (2) reference diameter in the main branch >2.5 mm lesion length, and percent diameter stenosis (%DS) were by visual estimation, and (3) intravascular ultrasound measured. )e acute gain was defined as the increase in (IVUS) findings were suitable for DCA (no lipid rich plaque, MLD after PCI; late lumen loss was defined as the difference no thrombus, no severe superficial calcification, and plaque between the postprocedural MLD and the MLD at follow- location to be debulked by DCA was accurately evaluated by up. Binary restenosis was defined as %DS>50% at follow-up. IVUS). )e exclusion criteria were as follows: (1) unstable All IVUS procedures were performed using commercially angina pectoris and myocardial infarction, (2) poor general available IVUS catheters (OptiCross ; Boston Scientific, or condition of the patient and renal insufficiency (Cr>1.5 mg/ ViewIT ; Terumo) with automatic pull-back at a rate of dl), (3) severe angled lesion, and (4) angiographical severe 0.5 mm/s. At the narrowest cross-section area, lumen di- calcified lesion. )is study was approved by the institutional ameter, lumen area, vessel area, and %PA were analyzed. )e review board of our hospital and complied with the Dec- %PA was defined as (vessel area-lumen area) × 100/vessel laration of Helsinki. area. )e incidence of hematoma, intimal dissection, and medial dissection was recorded. )e IVUS images were analyzed using computerized planimetry software (echo- 2.2. Procedure and Follow-Up. All the procedures were Plaque; INDEC Medical Systems, Los Altos, CA, USA). All performed through the femoral artery using 8Fr sheath and images were independently assessed by physicians who were 8Fr guiding catheter. A bolus injection of heparin (5000 U) blinded to patient and clinical data. was given after inserting the sheath and the activated co- agulation time was maintained at >300 sec with an addi- tional bolus of heparin. Lesion morphology was assessed by 2.4. Endpoints and Definitions. )e primary endpoint was IVUS after crossing the lesion by a conventional guidewire. target vessel failure (TVF) at 12 months. TVF was defined as We carefully evaluated plaque distribution to be debulked a composite of cardiac death, target vessel myocardial Journal of Interventional Cardiology 3 Table 1: Baseline characteristics. infarction (MI), and ischemia-driven target vessel revas- cularization (TVR) by PCI or coronary artery bypass Patient characteristics N � 38 grafting (CABG). Secondary endpoints included procedure- Age (years) 70± 9 related major events during hospitalization, major adverse Male (%) 34 (89) cardiac events (MACE) at 12 months, ischemia-driven target Hypertension (%) 28 (74) lesion revascularization (TLR) at 12 months, and bleeding Diabetes mellitus (%) 10 (26) Hyperlipidemia (%) 31 (82) complications which were defined as the Bleeding Academic Hemodialysis (%) 1 (3) Research Consortium criteria ≥2 at 12 months [8]. MACE Current smoking (%) 2 (5) were defined as a composite of cardiac death, MI, and is- Previous PCI (%) 17 (45) chemia-driven TVR. Ostial lesion of the LAD located≤5 mm Previous CABG (%) 0 (0) from the proximal stent edge of was defined as stent edge Medication restenosis at the LAD ostium. ACE/ARB (%) 24 (63) β-Blocker (%) 25 (66) Statin (%) 37 (97) 2.5. Statistical Analysis. Data were expressed as the mean- Aspirin (%) 38 (100) ± standard deviation for continuous variables and cate- Clopidogrel (%) 14 (37) gorical data were shown as numbers with percentages. Prasugrel (%) 16 (42) Continuous variables were examined using the unpaired t- Medina classification test or Mann–Whitney U test. Two-sided P< 0.05 was (0, 1, 0) (%) 26 (68) considered statistically significant. All analyses were per- (0, 0, 1) (%) 3 (8) formed using SPSS software (version 19; IBM-SPSS, Chi- (1, 0, 0) (%) 1 (3) cago, IL). (1, 1, 0) (%) 6 (15) (1, 0, 1) (%) 1 (3) 3. Results (1, 1, 1) (%) 1 (3) Main target of DCA 3.1. Study Participants. We performed DCA for LM bifur- LAD ostium (%) 27 (71) cation lesions for 58 patients during April 2016 to October LCX ostium (%) 3 (8) 2019. We enrolled 38 patients who underwent stentless Distal LM trunk (%) 2 (5) strategy by DCB angioplasty following DCA for LM bi- Distal LM trunk and LAD ostium (%) 5 (13) furcation lesions after excluding 20 patients (18 patients: Distal LM trunk, LAD ostium, and LCX ostium (%) 1 (3) DES implantation after DCA and 2 patients: DCA alone). Among 38 lesions, 31 lesions were de novo LM bifurcation Table 2: Procedural results. lesions and 7 lesions were stent edge restenosis at the LAD DCA N � 38 ostium. Size M (%) 5 (13) L (%) 33 (87) 3.2. Baseline Characteristics and Procedural Results. Total number of cuts (times) 27± 17 Table 1 describes the baseline characteristics. )e mean patient Maximum number of cuts (times) 78 age was 70± 9 years and 89% of the cohort was male. )e most Max balloon pressure (atm) 3.7± 1.3 frequent lesion classification was Medina (0, 1, 0) (68%) fol- DCB angioplasty lowed by Medina (1, 1, 0) (15%). )e main target of DCA was Diameter (mm) 3.3± 0.4 the LAD ostium (71%), followed by both distal LM trunk and Length (mm) 17.6± 3.2 LAD ostium (13%). Table 2 summarizes the procedural results. Balloon pressure (atm) 8.4± 2.8 Size L of the DCA catheter was the most frequently used (87%). Procedure time (min) 124± 39 )e mean number of cuts was 27 ± 17 times and the maximum Amount of contrast media (ml) 194± 71 balloon pressure of the DCA catheter was 3.7± 1.3 atm. )e Complications DCB angioplasty was performed after DCA for all lesions and Perforation (%) 0 (0) the diameter of the DCB was 3.3± 0.4 mm and balloon pressure Slow flow phenomenon (%) 0 (0) was 8.4± 2.8 atm. In the QCA analysis, MLD and % DS im- Stuck of the DCA catheter (%) 0 (0) proved significantly after the procedure (MLD: 1.3± 0.5 mm versus 3.4± 0.9 mm, P< 0.001; % DS: 63± 11% vs. 11± 8%, P< 0.001 (Table 3). Table 4 summarizes the IVUS findings catheter occurred. )ere were no procedure-related major during the procedure. Lumen area increased significantly (pre- events including cardiac death, MI, any emergent revascu- 2 2 DCA: 3.1± 1.0 mm versus post-DCA: 8.6± 2.0 mm , larization, and access site problems during hospitalization P< 0.001) and %PA decreased significantly after DCA (pre- (Table 5). DCA: 76.2± 7.1% versus post-DCA: 44.0± 7.4%, P< 0.001). Intimal dissection was observed in 5 lesions (13%); however, there was no medial dissection or hematoma formation. 3.3. Follow-Up Results. Angiographic follow-up was per- formed for 35 patients (angiographic follow-up rate: 92.1%). During the procedure, no complications including vessel At the follow-up coronary angiography, MLD and % DS perforation, slow flow phenomenon, and stuck of the DCA 4 Journal of Interventional Cardiology Table 3: Quantitative coronary analysis. stent edge restenosis at the LAD ostium. Preprocedure coronary angiography showed stent edge restenosis at the Preprocedure N � 38 LAD ostium (Figures 2(a) and 2(b)). A DCA with size L was Minimum lumen diameter (mm) 1.3± 0.5 performed and DCB angioplasty using 3.5 mm diameter by Reference lumen diameter (mm) 3.8± 1.1 15 mm was followed (Figures 2(c) and 2(d)). Postprocedure % diameter stenosis (%) 63± 11 Lesion length (mm) 17.3± 7.2 coronary angiography showed improved stenosis (Figure 2(e)). )e %PA identified by IVUS decreased to Post procedure Minimum lumen diameter (mm) 3.4± 0.9 25.9% from 61.4% (Figures 2(f) and 2(g)). However, the Acute gain (mm) 2.0± 1.0 follow-up angiography at 10 months revealed restenosis at Reference lumen diameter (mm) 3.8± 1.0 the LAD ostium (Figure 2(h)). % diameter stenosis (%) 11± 8 Follow-up 4. Discussion Minimum lumen diameter (mm) 3.2± 1.1 Late loss (mm) 0.2± 0.5 )e main findings of the current study were as follows. (1) % diameter stenosis (%) 17± 15 )e mean %PA after DCA for LM bifurcation lesions was 44.0% and the incidence of TVF at 12 months was low (3.1%) for de novo LM bifurcation lesions. On the other hand, the Table 4: Intravascular ultrasound findings. incidence of TVF was high (42.9%) for stent edge restenosis Pre-DCA N � 38 at the LAD ostium. All TVF resulted from ischemia-driven Minimum lumen diameter (mm) 1.7± 0.3 TLR. (2) )ere were no procedure-related major events Lumen area (mm ) 3.1± 1.0 during hospitalization, no cardiac death, no MI, and no Vessel area (mm ) 13.2± 3.5 bleeding events at 12 months. (3) )e %PA of de novo LM % plaque area (%) 76.2± 7.1 bifurcation with TLR was higher (55.9%) compared to the Post-DCA mean %PA. On the other hand, for stent edge restenosis at Minimum lumen diameter (mm) 2.8± 0.4 the LAD ostium, TLR was required even with low %PA after Lumen area (mm ) 8.6± 2.0 2 DCA (42.4%, 38.7%, and 25.7%). Vessel area (mm ) 15.5± 3.8 )e ABACAS study compared the incidence of TLR % plaque area (%) 44.0± 7.4 between balloon angioplasty after aggressive DCA and DCA Intimal dissection (%) 5 (13) alone, and there was no difference between the groups [9]. Medial dissection (%) 0 (0) Hematoma (%) 0 (0) )e %PA after DCA of the ABACAS study was 45.6% and this was almost similar to that of the current study (44.0%). However, our incidence of TLR at 12 months was extremely were similar to that after the procedure (MLD: 3.2± 1.1 mm low compared to the ABACAS study (3.2% versus 20.6%). versus 3.4± 0.9 mm, P � 0.48; % DS: 17± 15% versus We consider that DCB angioplasty played an important role 11± 8%, P � 0.30) (Table 3). Table 5 summarizes the clinical in inhibiting neointimal hyperplasia. On the other hand, a follow-up results. TVF at 12 months occurred in 4 patients recent multicenter registry (DCA/DCB registry) demon- (10.5%) and the cause of TVF across all 4 cases was ischemia- strated the low incidence of TLR at 12 months (3.6%) after driven TVR by PCI. In addition, TVR resulted from is- DCA following DCB angioplasty for coronary bifurcation chemia-driven TLR. For de novo LM bifurcation lesions, the lesions even though the mean %PA after DCA was higher incidence of binary restenosis and ischemia-driven TLR was than our study (56.3% versus 44.0%) [6]. Based on these 6.3% (2 lesions/32 lesions) and 3.2% (1 lesion/32 lesions), results, aggressive debulking of DCA to achieve a %PA less respectively. On the other hand, for stent edge restenosis at than 50% may not be necessary, if DCA was followed by the LAD ostium, the incidence of binary restenosis and DCB angioplasty. Although the definition of an optimal ischemia-driven TLR was 42.9% (3 lesions/7 lesions) and target %PA after DCA is difficult, we reckon that the optimal 42.9% (3 lesions/7 lesions), respectively. No MACE, except target %PA may be 50 to 55% for de novo LM bifurcation for ischemia-driven TVR, were observed at 12 months. In lesions as we experienced one TLR case in which the %PA addition, there were no bleeding complications at 12 after DCA was 55.9%. However, 55.9% of %PA is similar to months. the mean %PA of the DCA/DCB registry; therefore, not only %PA after DCA but also other factors such as severity of 3.4. IVUS Findings and Ischemia-Driven TLR at 12 Months. residual dissection, lumen area, and plaque morphology may Figure 1 shows the distribution of %PA for each case. Is- be associated with restenosis after stentless strategy for LM chemia-driven TLR was performed for 4 lesions; for 1 de bifurcation lesions. Further investigations are needed to novo LM bifurcation lesion (red dot) and for 3 stent edge clarify this issue. restenosis at the LAD ostium (blue dots). )e %PA of the de Stent thrombosis at LM bifurcation lesions is critical; novo LM bifurcation lesion with TLR (55.9%) was larger therefore, it is important to decrease the risk of stent compared to the mean %PA (44.0%). On the other hand, the thrombosis as low as possible. In general, the incidence of %PA of the stent edge restenosis at the LAD ostium with stent thrombosis has decreased with the development of TLR (42.4%, 38.7%, and 25.7%) was lower than mean %PA. DES technology. However, it is difficult to nullify its inci- Figure 2 shows a representative case of TLR after DCA for dence. Furthermore, optimal DAPT duration to avoid stent Journal of Interventional Cardiology 5 Table 5: Clinical outcomes. Overall De novo LM bifurcation lesion Stent edge restenosis at LAD ostium N � 38 N � 31 N � 7 Procedure-related major events during the hospitalization Cardiac death (%) 0 (0) 0 (0) 0 (0) MI (%) 0 (0) 0 (0) 0 (0) Any emergent revascularization (%) 0 (0) 0 (0) 0 (0) Access site problems (%) 0 (0) 0 (0) 0 (0) Clinical outcomes at 12 months TVF at 12 months (%) 4 (10.5) 1 (3.2) 3 (42.9) Cardiac death (%) 0 (0) 0 (0) 0 (0) Target vessel MI (%) 0 (0) 0 (0) 0 (0) Ischemia-driven TVR by PCI or CABG 4 (10.5) 1 (3.2) 3 (42.9) (%) MACE at 12 months (%) 4 (10.5) 1 (3.2) 3 (42.9) Cardiac death (%) 0 (0) 0 (0) 0 (0) MI (%) 0 (0) 0 (0) 0 (0) Ischemia-driven TVR (%) 4 (10.5) 1 (3.2) 3 (42.9) Ischemia-driven TLR at 12 months (%) 4 (10.5) 1 (3.2) 3 (42.9) Bleeding complications at 12 months (%) 0 (0) 0 (0) 0 (0) Mean % PA 44.0% 0 10 20 30 40 Cases Figure 1: Distribution of % PA after DCA for each case. Mean %PA in the overall population was 44.0%. )e red dot shows ischemia-driven TLR case at 12 months for the de novo LM bifurcation lesion after DCA. )e blue dots show ischemia-driven TLR cases at 12 months for stent edge restenosis at the LAD ostium after DCA. thrombosis and major bleeding events after stenting for LM edge restenosis at the LAD ostium were poor. Currently, bifurcation lesions remains unclear. We reckon that stentless data in relation to the efficacy of DCB angioplasty following strategy using DCB angioplasty following DCA is an ac- DCA for stent edge restenosis is lacking. A previous study ceptable option to resolve these issues. In particular, there reported that there was a tendency towards higher TLR were no procedure-related major events during hospitali- following DCB angioplasty compared to repeat implan- zation, no MACE except for ischemia-driven TLR at 12 tations of DESs for stent edge restenosis [10]. We reckon months, and no bleeding events at 12 months in the current that sufficient plaque debulking and DCB angioplasty are study. In addition, although we stopped DAPT at 3 months effective to obtain large lumen area and to inhibit neo- after the procedure, optimal DAPT duration after DCB intimal hyperplasia which is the main cause of restenosis in angioplasty may shorten according to the future clinical nonstented vessels. On the other hand, several mechanisms of stent edge restenosis have been reported including studies. )e DCA procedure requires a skilled operator. However, if stentless strategy for LM bifurcation lesions negative remodeling, mechanical injury at stent edge due to succeeds, it may be beneficial compared to stent implan- hinge motion, and local changes in shear stress [11–13]. In tation for LM bifurcation lesion. particular, all the TLR cases in the current study of stent )e current study demonstrated acceptable results of edge restenosis at the LAD ostium had a low %PA following DCB angioplasty following DCA for de novo LM bifur- DCA. )erefore, these factors may contribute to restenosis. cation lesions. However, the results of this strategy for stent To overcome these factors, repeat stent implantation may Post % plaque area 6 Journal of Interventional Cardiology (a) (f ) (b) (c) % PA 61.4% (d) (g) (e) (h) % PA 25.9% Figure 2: Representative case of ischemia-driven TLR after DCA for stent edge restenosis at the LAD ostium: (a) preprocedure coronary angiography, (b) yellow dotted line indicates previously implanted stent, (c) DCA was performed for stent proximal edge restenosis at the LAD ostium, (d) DCB angioplasty was performed, (e) postprocedure coronary angiography, (f) IVUS findings at preprocedure shows %PA was 61.4%, (g) IVUS findings after DCA shows %PA decreased to 25.9%, and (h) follow-up coronary angiography at 10 months. be a favorable strategy for stent edge restenosis at the LAD 4.1. Study Limitations. )is study has several limitations. ostium. However, stentless strategy without LM stenting is First, this was a retrospective analysis of a single center and advantageous in terms of shortening DAPT duration and sample volume, especially the number of patients with stent lowering the risk of stent thrombosis. )e current study edge restenosis at the LAD ostium was small. Selection bias failed to demonstrate the efficacy of DCB angioplasty should be considered and other large-scale studies are following DCA for stent edge restenosis at the LAD ostium. needed to clarify the clinical impact of stentless strategy for However, only a small number of patients were analyzed. LM bifurcation lesions. Second, we performed only IVUS Further research with a large sample number is required to after DCA to evaluate the lumen area and dissection for- confirm the results of the present study. mation. As such, we were unable to categorize the dissection Journal of Interventional Cardiology 7 [7] E. Tsuchikane, T. Aizawa, H. Tamai et al., “Pre-drug-eluting severity. It is well known that optical coherence tomography stent debulking of bifurcated coronary lesions,” Journal of the (OCT) is superior to IVUS to evaluate detailed dissection American College of Cardiology, vol. 50, no. 20, pp. 1941–1945, morphology [14]. )erefore, further evaluations using OCT to investigate the characteristics of dissection are required. [8] R. Mehran, S. V. Rao, D. L. Bhatt et al., “Standardized bleeding However, we reckon that DCA should be performed under definitions for cardiovascular clinical trials,” Circulation, the guidance of IVUS and not OCT because OCT is unable vol. 123, no. 23, pp. 2736–2747, 2011. to provide information about vessel size and plaque volume, [9] T. Suzuki, H. Hosokawa, O. Katoh et al., “Effects of adjunctive thereby limiting its safety. )ird, the DCA procedure re- balloon angioplasty after intravascular ultrasound-guided quires a specific technique in IVUS interpretation and optimal directional coronary atherectomy,” Journal of the manipulation of the DCA catheter, thereby limiting the American College of Cardiology, vol. 34, no. 4, pp. 1028–1035, applicability and generalizability of the results from the 1999. [10] S. Habara, K. Kadota, T. Kanazawa et al., “Paclitaxel-coated current study. Finally, our follow-up data was limited to 12 balloon catheter compared with drug-eluting stent for drug- months. To evaluate the efficacy of stentless strategy of DCB eluting stent restenosis in routine clinical practice,” Euro- angioplasty following DCA for LM bifurcation lesions, fu- Intervention, vol. 11, no. 10, pp. 1098–1105, 2016. ture trials with a longer follow-up are necessary. [11] R. Sakurai, J. Ako, Y. Morino et al., “Predictors of edge ste- nosis following sirolimus-eluting stent deployment (a quan- 5. Conclusions titative intravascular ultrasound analysis from the SIRIUS trial),” 8e American Journal of Cardiology, vol. 96, no. 9, )e early results of stentless strategy by DCB angioplasty pp. 1251–1253, 2005. following DCA for de novo LM bifurcation lesions are [12] Y. G. Kim, I.-Y. Oh, Y.-W. Kwon et al., “Mechanism of edge acceptable. On the other hand, this stentless strategy may not restenosis after drug-eluting stent implantation,” Circulation Journal, vol. 77, no. 12, pp. 2928–2935, 2013. be effective for stent edge restenosis at the LAD ostium. [13] J. J. Wentzel, D. M. Whelan, W. J. van der Giessen et al., “Coronary stent implantation changes 3-D vessel geometry Data Availability and 3-D shear stress distribution,” Journal of Biomechanics, vol. 33, no. 10, pp. 1287–1295, 2000. )e data used to support the findings of this study are re- [14] D. Chamie, ´ H. G. Bezerra, G. F. Attizzani et al., “Incidence, stricted by the Ethics Committee of Saiseikai Yokohama City predictors, morphological characteristics, and clinical out- Eastern Hospital in order to protect patient privacy and are comes of stent edge dissections detected by optical coherence available from the corresponding author upon request. tomography,” JACC: Cardiovascular Interventions, vol. 6, no. 8, pp. 800–813, 2013. Conflicts of Interest )e authors declare that they have no conflicts of interest. References [1] A. H. Gershlick, D. E. Kandzari, A. Banning et al., “Outcomes after left main percutaneous coronary intervention versus coronary artery bypass grafting according to lesion site,” JACC: Cardiovascular Interventions, vol. 11, no. 13, pp. 1224–1233, 2018. [2] D. E. Kandzari, A. H. Gershlick, P. W. Serruys et al., “Out- comes among patients undergoing distal left main percuta- neous coronary intervention,” Circulation: Cardiovascular Interventions, vol. 11, no. 10, Article ID e007007, 2018. [3] S. Cho, T. S. Kang, J.-S. Kim et al., “Long-term clinical outcomes and optimal stent strategy in left main coronary bifurcation stenting,” JACC: Cardiovascular Interventions, vol. 11, no. 13, pp. 1247–1258, 2018. [4] S.-J. Kang, G. S. Mintz, W.-J. Kim et al., “Changes in left main bifurcation geometry after a single-stent crossover technique,” Circulation: Cardiovascular Interventions, vol. 4, no. 4, pp. 355–361, 2011. [5] T. T. Rissanen, S. Uskela, A. Siljander et al., “Percutaneous coronary intervention of complex calcified lesions with drug- coated balloon after rotational atherectomy,” Journal of Interventional Cardiology, vol. 30, no. 2, pp. 139–146, 2017. [6] S. Kitani, Y. Igarashi, E. Tsuchikane et al., “Efficacy of drug- coated balloon angioplasty after directional coronary athe- rectomy for coronary bifurcation lesions (DCA/DCB regis- try),” Catheterization and Cardiovascular Interventions, 2020. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Interventional Cardiology Hindawi Publishing Corporation

Stentless Strategy by Drug-Coated Balloon Angioplasty following Directional Coronary Atherectomy for Left Main Bifurcation Lesion

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Abstract

Hindawi Journal of Interventional Cardiology Volume 2021, Article ID 5529317, 7 pages https://doi.org/10.1155/2021/5529317 Research Article Stentless Strategy by Drug-Coated Balloon Angioplasty following Directional Coronary Atherectomy for Left Main Bifurcation Lesion Norihiro Kobayashi , Masahiro Yamawaki, Shinsuke Mori , Masakazu Tsutsumi, Yohsuke Honda , Kenji Makino, Shigemitsu Shirai, Masafumi Mizusawa, and Yoshiaki Ito Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan Correspondence should be addressed to Norihiro Kobayashi; ovation17@gmail.com Received 29 January 2021; Accepted 24 February 2021; Published 3 March 2021 Academic Editor: Leonardo De Luca 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. We aimed to evaluate the efficacy of stentless strategy by drug-coated balloon (DCB) angioplasty following directional coronary atherectomy (DCA) for left main (LM) bifurcation lesions. Methods. A total of 38 patients who underwent DCB angioplasty following DCA for LM bifurcation lesions were retrospectively enrolled. )e primary endpoint was target vessel failure (TVF) at 12 months. Secondary endpoints included procedure-related major events during the hospitalization, major adverse cardiac events at 12 months, ischemia-driven target lesion revascularization (TLR) at 12 months, and bleeding com- plications defined as the Bleeding Academic Research Consortium criteria ≥2 at 12 months. Results. Among these 38 lesions, 31 lesions were de novo LM bifurcation lesions and 7 lesions were stent edge restenosis at the left anterior descending (LAD) ostium. )e mean % plaque area (%PA) after DCA was 44.0 ± 7.4%. TVF at 12 months occurred in 1 lesion (3.2%) of de novo LM bifurcation lesion and in 3 lesions (42.9%) of stent edge restenosis at the LAD ostium. All events of TVF were ischemia-driven TLR by percutaneous coronary intervention. Among 4 TLR cases, %PA after DCA was high (55.9%) in the de novo LM bifurcation lesions; on the other hand, %PA after DCA was low (42.4%, 38.7%, and 25.7% in the 3 cases) in stent edge restenosis at the LAD ostium. No procedure-related major events were observed during hospitalization. )ere was no cardiac death, no myocardial infarction, no coronary artery bypass grafting, and no bleeding complications at 12 months. Conclusions. Stentless strategy by DCB angioplasty following DCA for de novo LM bifurcation lesions resulted in acceptable outcomes. On the other hand, its efficacy was limited for stent edge restenosis at the LAD ostium even after aggressive debulking by DCA. usually dependent on the anatomical complexity. Complex 1. Introduction stenting is often unavoidable especially for true bifurcation Clinical outcomes of percutaneous coronary intervention lesions with a large side branch and for true bifurcation (PCI) have improved with the development of drug-eluting lesions with a shallow bifurcation angle due to plaque and stents (DESs) and technical advancements. However, PCI carina shift [4]. In addition, although the risk of developing for left main (LM) bifurcation lesions remains challenging stent thrombosis has decreased with the development of due to concerns over future revascularization [1]. Previous DESs, stent thrombosis at LM bifurcation lesions becomes studies reported that a simple stent strategy had better critical due to large amount of myocardium at risk. On the clinical outcomes compared to a complex stent strategy even other hand, major bleeding events especially for patients using newer generation DESs for LM bifurcation lesions with a high bleeding risk, also becomes a critical issue; [2, 3]. However, the success of a single stent strategy is however, the ideal dual antiplatelet therapy (DAPT) 2 Journal of Interventional Cardiology duration after stenting for LM bifurcation lesions remains and also assessed the existence of lipid rich plaque, unclear. )is results in a clinical dilemma for physicians as thrombus, and superficial calcification. )e ATHEROCUT they need to balance the risk and benefits between DAPT (Nipro Corporation, Osaka, Japan) was used for all the continuation to prevent stent thrombosis or a short DAPT lesions and size selection was dependent on the reference duration to avoid major bleeding events after stenting for diameter identified by IVUS. DCA was started with low LM bifurcation lesions. With the advancement of the drug- balloon pressure (0 or 1 atm) and the IVUS evaluation was coated balloon (DCB), stentless strategy is one of the po- repeated after several sessions of DCA. Balloon pressure was tential options to overcome thrombotic and bleeding events. gradually increased according to the IVUS findings and A previous study reported the feasibility of the stentless multiple cuts were repeated to obtain residual % plaque area strategy by rotational atherectomy following DCB angio- (%PA) <60% if possible [7]. Experienced operators carefully plasty for severe calcified coronary lesions [5]. Similarly, for evaluated the IVUS and angiographical findings and de- LM bifurcation lesions, an improved novel directional termined whether stentless strategy was acceptable. When coronary atherectomy (DCA) catheter (ATHEROCUT , stentless strategy was acceptable, a balloon angioplasty using Nipro Corporation, Osaka, Japan) has been commercially the DCB (SeQuent Please , Nipro Corporation, Osaka, available in Japan since 2015 and the possibility of stentless Japan) was performed. )e size of the DCB was selected strategy using DCA followed by the DCB angioplasty has according to the reference lumen diameter by IVUS and the been investigated. A recent multicenter registry which was balloon inflation time was 30 sec with nominal pressure. conducted in Japan (DCA/DCB registry) reported the effi- Provisional stent implantation was considered at the dis- cacy of the DCB angioplasty following DCA for coronary cretion of an experienced operator when the IVUS showed bifurcation lesions [6]. We investigated the efficacy of large residual plaque burden, huge dissection, or hematoma stentless strategy by DCB angioplasty following DCA for LM formation. Dual antiplatelet therapy with 100 mg/day as- bifurcation lesions. pirin and either 75 mg/day clopidogrel or 3.75 mg/day prasugrel was started before the procedure and continued for 3 months after the procedure. All the patients were 2. Methods monitored until 30 days after discharge and following that every 2 to 3 months. Follow-up coronary angiography was 2.1. Study Design and Subjects. )is was a retrospective scheduled at 9 to 12 months after the procedure. observational study conducted at Saiseikai Yokohama-city Eastern Hospital. We retrospectively identified 78 patients with stable angina pectoris who underwent PCI using DCA 2.3. Quantitative Coronary Angiography and IVUS. from our database between April 2016 and October 2019. Quantitative coronary angiography (QCA) analysis was After the exclusion of 20 patients who underwent DCA for performed using computer-based software (HeartII lesions other than LM bifurcation lesions, a total of 58 ver2.0.2.3, GADELIUS) before the procedure, after the patients who underwent DCA for LM bifurcation lesion procedure, and at follow-up by an independent physician were identified. Our indications of DCA for LM bifurcation who was blinded to patient and procedural characteristics. lesion were as follows: (1) stable angina pectoris with LM Optimal views of the lesions were obtained at baseline, and bifurcation lesion involving the distal LM trunk, ostium of the same projection angle was used at follow-up. )e left anterior descending (LAD), or left circumflex artery minimal lumen diameter (MLD), reference diameter (RD), (LCX), (2) reference diameter in the main branch >2.5 mm lesion length, and percent diameter stenosis (%DS) were by visual estimation, and (3) intravascular ultrasound measured. )e acute gain was defined as the increase in (IVUS) findings were suitable for DCA (no lipid rich plaque, MLD after PCI; late lumen loss was defined as the difference no thrombus, no severe superficial calcification, and plaque between the postprocedural MLD and the MLD at follow- location to be debulked by DCA was accurately evaluated by up. Binary restenosis was defined as %DS>50% at follow-up. IVUS). )e exclusion criteria were as follows: (1) unstable All IVUS procedures were performed using commercially angina pectoris and myocardial infarction, (2) poor general available IVUS catheters (OptiCross ; Boston Scientific, or condition of the patient and renal insufficiency (Cr>1.5 mg/ ViewIT ; Terumo) with automatic pull-back at a rate of dl), (3) severe angled lesion, and (4) angiographical severe 0.5 mm/s. At the narrowest cross-section area, lumen di- calcified lesion. )is study was approved by the institutional ameter, lumen area, vessel area, and %PA were analyzed. )e review board of our hospital and complied with the Dec- %PA was defined as (vessel area-lumen area) × 100/vessel laration of Helsinki. area. )e incidence of hematoma, intimal dissection, and medial dissection was recorded. )e IVUS images were analyzed using computerized planimetry software (echo- 2.2. Procedure and Follow-Up. All the procedures were Plaque; INDEC Medical Systems, Los Altos, CA, USA). All performed through the femoral artery using 8Fr sheath and images were independently assessed by physicians who were 8Fr guiding catheter. A bolus injection of heparin (5000 U) blinded to patient and clinical data. was given after inserting the sheath and the activated co- agulation time was maintained at >300 sec with an addi- tional bolus of heparin. Lesion morphology was assessed by 2.4. Endpoints and Definitions. )e primary endpoint was IVUS after crossing the lesion by a conventional guidewire. target vessel failure (TVF) at 12 months. TVF was defined as We carefully evaluated plaque distribution to be debulked a composite of cardiac death, target vessel myocardial Journal of Interventional Cardiology 3 Table 1: Baseline characteristics. infarction (MI), and ischemia-driven target vessel revas- cularization (TVR) by PCI or coronary artery bypass Patient characteristics N � 38 grafting (CABG). Secondary endpoints included procedure- Age (years) 70± 9 related major events during hospitalization, major adverse Male (%) 34 (89) cardiac events (MACE) at 12 months, ischemia-driven target Hypertension (%) 28 (74) lesion revascularization (TLR) at 12 months, and bleeding Diabetes mellitus (%) 10 (26) Hyperlipidemia (%) 31 (82) complications which were defined as the Bleeding Academic Hemodialysis (%) 1 (3) Research Consortium criteria ≥2 at 12 months [8]. MACE Current smoking (%) 2 (5) were defined as a composite of cardiac death, MI, and is- Previous PCI (%) 17 (45) chemia-driven TVR. Ostial lesion of the LAD located≤5 mm Previous CABG (%) 0 (0) from the proximal stent edge of was defined as stent edge Medication restenosis at the LAD ostium. ACE/ARB (%) 24 (63) β-Blocker (%) 25 (66) Statin (%) 37 (97) 2.5. Statistical Analysis. Data were expressed as the mean- Aspirin (%) 38 (100) ± standard deviation for continuous variables and cate- Clopidogrel (%) 14 (37) gorical data were shown as numbers with percentages. Prasugrel (%) 16 (42) Continuous variables were examined using the unpaired t- Medina classification test or Mann–Whitney U test. Two-sided P< 0.05 was (0, 1, 0) (%) 26 (68) considered statistically significant. All analyses were per- (0, 0, 1) (%) 3 (8) formed using SPSS software (version 19; IBM-SPSS, Chi- (1, 0, 0) (%) 1 (3) cago, IL). (1, 1, 0) (%) 6 (15) (1, 0, 1) (%) 1 (3) 3. Results (1, 1, 1) (%) 1 (3) Main target of DCA 3.1. Study Participants. We performed DCA for LM bifur- LAD ostium (%) 27 (71) cation lesions for 58 patients during April 2016 to October LCX ostium (%) 3 (8) 2019. We enrolled 38 patients who underwent stentless Distal LM trunk (%) 2 (5) strategy by DCB angioplasty following DCA for LM bi- Distal LM trunk and LAD ostium (%) 5 (13) furcation lesions after excluding 20 patients (18 patients: Distal LM trunk, LAD ostium, and LCX ostium (%) 1 (3) DES implantation after DCA and 2 patients: DCA alone). Among 38 lesions, 31 lesions were de novo LM bifurcation Table 2: Procedural results. lesions and 7 lesions were stent edge restenosis at the LAD DCA N � 38 ostium. Size M (%) 5 (13) L (%) 33 (87) 3.2. Baseline Characteristics and Procedural Results. Total number of cuts (times) 27± 17 Table 1 describes the baseline characteristics. )e mean patient Maximum number of cuts (times) 78 age was 70± 9 years and 89% of the cohort was male. )e most Max balloon pressure (atm) 3.7± 1.3 frequent lesion classification was Medina (0, 1, 0) (68%) fol- DCB angioplasty lowed by Medina (1, 1, 0) (15%). )e main target of DCA was Diameter (mm) 3.3± 0.4 the LAD ostium (71%), followed by both distal LM trunk and Length (mm) 17.6± 3.2 LAD ostium (13%). Table 2 summarizes the procedural results. Balloon pressure (atm) 8.4± 2.8 Size L of the DCA catheter was the most frequently used (87%). Procedure time (min) 124± 39 )e mean number of cuts was 27 ± 17 times and the maximum Amount of contrast media (ml) 194± 71 balloon pressure of the DCA catheter was 3.7± 1.3 atm. )e Complications DCB angioplasty was performed after DCA for all lesions and Perforation (%) 0 (0) the diameter of the DCB was 3.3± 0.4 mm and balloon pressure Slow flow phenomenon (%) 0 (0) was 8.4± 2.8 atm. In the QCA analysis, MLD and % DS im- Stuck of the DCA catheter (%) 0 (0) proved significantly after the procedure (MLD: 1.3± 0.5 mm versus 3.4± 0.9 mm, P< 0.001; % DS: 63± 11% vs. 11± 8%, P< 0.001 (Table 3). Table 4 summarizes the IVUS findings catheter occurred. )ere were no procedure-related major during the procedure. Lumen area increased significantly (pre- events including cardiac death, MI, any emergent revascu- 2 2 DCA: 3.1± 1.0 mm versus post-DCA: 8.6± 2.0 mm , larization, and access site problems during hospitalization P< 0.001) and %PA decreased significantly after DCA (pre- (Table 5). DCA: 76.2± 7.1% versus post-DCA: 44.0± 7.4%, P< 0.001). Intimal dissection was observed in 5 lesions (13%); however, there was no medial dissection or hematoma formation. 3.3. Follow-Up Results. Angiographic follow-up was per- formed for 35 patients (angiographic follow-up rate: 92.1%). During the procedure, no complications including vessel At the follow-up coronary angiography, MLD and % DS perforation, slow flow phenomenon, and stuck of the DCA 4 Journal of Interventional Cardiology Table 3: Quantitative coronary analysis. stent edge restenosis at the LAD ostium. Preprocedure coronary angiography showed stent edge restenosis at the Preprocedure N � 38 LAD ostium (Figures 2(a) and 2(b)). A DCA with size L was Minimum lumen diameter (mm) 1.3± 0.5 performed and DCB angioplasty using 3.5 mm diameter by Reference lumen diameter (mm) 3.8± 1.1 15 mm was followed (Figures 2(c) and 2(d)). Postprocedure % diameter stenosis (%) 63± 11 Lesion length (mm) 17.3± 7.2 coronary angiography showed improved stenosis (Figure 2(e)). )e %PA identified by IVUS decreased to Post procedure Minimum lumen diameter (mm) 3.4± 0.9 25.9% from 61.4% (Figures 2(f) and 2(g)). However, the Acute gain (mm) 2.0± 1.0 follow-up angiography at 10 months revealed restenosis at Reference lumen diameter (mm) 3.8± 1.0 the LAD ostium (Figure 2(h)). % diameter stenosis (%) 11± 8 Follow-up 4. Discussion Minimum lumen diameter (mm) 3.2± 1.1 Late loss (mm) 0.2± 0.5 )e main findings of the current study were as follows. (1) % diameter stenosis (%) 17± 15 )e mean %PA after DCA for LM bifurcation lesions was 44.0% and the incidence of TVF at 12 months was low (3.1%) for de novo LM bifurcation lesions. On the other hand, the Table 4: Intravascular ultrasound findings. incidence of TVF was high (42.9%) for stent edge restenosis Pre-DCA N � 38 at the LAD ostium. All TVF resulted from ischemia-driven Minimum lumen diameter (mm) 1.7± 0.3 TLR. (2) )ere were no procedure-related major events Lumen area (mm ) 3.1± 1.0 during hospitalization, no cardiac death, no MI, and no Vessel area (mm ) 13.2± 3.5 bleeding events at 12 months. (3) )e %PA of de novo LM % plaque area (%) 76.2± 7.1 bifurcation with TLR was higher (55.9%) compared to the Post-DCA mean %PA. On the other hand, for stent edge restenosis at Minimum lumen diameter (mm) 2.8± 0.4 the LAD ostium, TLR was required even with low %PA after Lumen area (mm ) 8.6± 2.0 2 DCA (42.4%, 38.7%, and 25.7%). Vessel area (mm ) 15.5± 3.8 )e ABACAS study compared the incidence of TLR % plaque area (%) 44.0± 7.4 between balloon angioplasty after aggressive DCA and DCA Intimal dissection (%) 5 (13) alone, and there was no difference between the groups [9]. Medial dissection (%) 0 (0) Hematoma (%) 0 (0) )e %PA after DCA of the ABACAS study was 45.6% and this was almost similar to that of the current study (44.0%). However, our incidence of TLR at 12 months was extremely were similar to that after the procedure (MLD: 3.2± 1.1 mm low compared to the ABACAS study (3.2% versus 20.6%). versus 3.4± 0.9 mm, P � 0.48; % DS: 17± 15% versus We consider that DCB angioplasty played an important role 11± 8%, P � 0.30) (Table 3). Table 5 summarizes the clinical in inhibiting neointimal hyperplasia. On the other hand, a follow-up results. TVF at 12 months occurred in 4 patients recent multicenter registry (DCA/DCB registry) demon- (10.5%) and the cause of TVF across all 4 cases was ischemia- strated the low incidence of TLR at 12 months (3.6%) after driven TVR by PCI. In addition, TVR resulted from is- DCA following DCB angioplasty for coronary bifurcation chemia-driven TLR. For de novo LM bifurcation lesions, the lesions even though the mean %PA after DCA was higher incidence of binary restenosis and ischemia-driven TLR was than our study (56.3% versus 44.0%) [6]. Based on these 6.3% (2 lesions/32 lesions) and 3.2% (1 lesion/32 lesions), results, aggressive debulking of DCA to achieve a %PA less respectively. On the other hand, for stent edge restenosis at than 50% may not be necessary, if DCA was followed by the LAD ostium, the incidence of binary restenosis and DCB angioplasty. Although the definition of an optimal ischemia-driven TLR was 42.9% (3 lesions/7 lesions) and target %PA after DCA is difficult, we reckon that the optimal 42.9% (3 lesions/7 lesions), respectively. No MACE, except target %PA may be 50 to 55% for de novo LM bifurcation for ischemia-driven TVR, were observed at 12 months. In lesions as we experienced one TLR case in which the %PA addition, there were no bleeding complications at 12 after DCA was 55.9%. However, 55.9% of %PA is similar to months. the mean %PA of the DCA/DCB registry; therefore, not only %PA after DCA but also other factors such as severity of 3.4. IVUS Findings and Ischemia-Driven TLR at 12 Months. residual dissection, lumen area, and plaque morphology may Figure 1 shows the distribution of %PA for each case. Is- be associated with restenosis after stentless strategy for LM chemia-driven TLR was performed for 4 lesions; for 1 de bifurcation lesions. Further investigations are needed to novo LM bifurcation lesion (red dot) and for 3 stent edge clarify this issue. restenosis at the LAD ostium (blue dots). )e %PA of the de Stent thrombosis at LM bifurcation lesions is critical; novo LM bifurcation lesion with TLR (55.9%) was larger therefore, it is important to decrease the risk of stent compared to the mean %PA (44.0%). On the other hand, the thrombosis as low as possible. In general, the incidence of %PA of the stent edge restenosis at the LAD ostium with stent thrombosis has decreased with the development of TLR (42.4%, 38.7%, and 25.7%) was lower than mean %PA. DES technology. However, it is difficult to nullify its inci- Figure 2 shows a representative case of TLR after DCA for dence. Furthermore, optimal DAPT duration to avoid stent Journal of Interventional Cardiology 5 Table 5: Clinical outcomes. Overall De novo LM bifurcation lesion Stent edge restenosis at LAD ostium N � 38 N � 31 N � 7 Procedure-related major events during the hospitalization Cardiac death (%) 0 (0) 0 (0) 0 (0) MI (%) 0 (0) 0 (0) 0 (0) Any emergent revascularization (%) 0 (0) 0 (0) 0 (0) Access site problems (%) 0 (0) 0 (0) 0 (0) Clinical outcomes at 12 months TVF at 12 months (%) 4 (10.5) 1 (3.2) 3 (42.9) Cardiac death (%) 0 (0) 0 (0) 0 (0) Target vessel MI (%) 0 (0) 0 (0) 0 (0) Ischemia-driven TVR by PCI or CABG 4 (10.5) 1 (3.2) 3 (42.9) (%) MACE at 12 months (%) 4 (10.5) 1 (3.2) 3 (42.9) Cardiac death (%) 0 (0) 0 (0) 0 (0) MI (%) 0 (0) 0 (0) 0 (0) Ischemia-driven TVR (%) 4 (10.5) 1 (3.2) 3 (42.9) Ischemia-driven TLR at 12 months (%) 4 (10.5) 1 (3.2) 3 (42.9) Bleeding complications at 12 months (%) 0 (0) 0 (0) 0 (0) Mean % PA 44.0% 0 10 20 30 40 Cases Figure 1: Distribution of % PA after DCA for each case. Mean %PA in the overall population was 44.0%. )e red dot shows ischemia-driven TLR case at 12 months for the de novo LM bifurcation lesion after DCA. )e blue dots show ischemia-driven TLR cases at 12 months for stent edge restenosis at the LAD ostium after DCA. thrombosis and major bleeding events after stenting for LM edge restenosis at the LAD ostium were poor. Currently, bifurcation lesions remains unclear. We reckon that stentless data in relation to the efficacy of DCB angioplasty following strategy using DCB angioplasty following DCA is an ac- DCA for stent edge restenosis is lacking. A previous study ceptable option to resolve these issues. In particular, there reported that there was a tendency towards higher TLR were no procedure-related major events during hospitali- following DCB angioplasty compared to repeat implan- zation, no MACE except for ischemia-driven TLR at 12 tations of DESs for stent edge restenosis [10]. We reckon months, and no bleeding events at 12 months in the current that sufficient plaque debulking and DCB angioplasty are study. In addition, although we stopped DAPT at 3 months effective to obtain large lumen area and to inhibit neo- after the procedure, optimal DAPT duration after DCB intimal hyperplasia which is the main cause of restenosis in angioplasty may shorten according to the future clinical nonstented vessels. On the other hand, several mechanisms of stent edge restenosis have been reported including studies. )e DCA procedure requires a skilled operator. However, if stentless strategy for LM bifurcation lesions negative remodeling, mechanical injury at stent edge due to succeeds, it may be beneficial compared to stent implan- hinge motion, and local changes in shear stress [11–13]. In tation for LM bifurcation lesion. particular, all the TLR cases in the current study of stent )e current study demonstrated acceptable results of edge restenosis at the LAD ostium had a low %PA following DCB angioplasty following DCA for de novo LM bifur- DCA. )erefore, these factors may contribute to restenosis. cation lesions. However, the results of this strategy for stent To overcome these factors, repeat stent implantation may Post % plaque area 6 Journal of Interventional Cardiology (a) (f ) (b) (c) % PA 61.4% (d) (g) (e) (h) % PA 25.9% Figure 2: Representative case of ischemia-driven TLR after DCA for stent edge restenosis at the LAD ostium: (a) preprocedure coronary angiography, (b) yellow dotted line indicates previously implanted stent, (c) DCA was performed for stent proximal edge restenosis at the LAD ostium, (d) DCB angioplasty was performed, (e) postprocedure coronary angiography, (f) IVUS findings at preprocedure shows %PA was 61.4%, (g) IVUS findings after DCA shows %PA decreased to 25.9%, and (h) follow-up coronary angiography at 10 months. be a favorable strategy for stent edge restenosis at the LAD 4.1. Study Limitations. )is study has several limitations. ostium. However, stentless strategy without LM stenting is First, this was a retrospective analysis of a single center and advantageous in terms of shortening DAPT duration and sample volume, especially the number of patients with stent lowering the risk of stent thrombosis. )e current study edge restenosis at the LAD ostium was small. Selection bias failed to demonstrate the efficacy of DCB angioplasty should be considered and other large-scale studies are following DCA for stent edge restenosis at the LAD ostium. needed to clarify the clinical impact of stentless strategy for However, only a small number of patients were analyzed. LM bifurcation lesions. Second, we performed only IVUS Further research with a large sample number is required to after DCA to evaluate the lumen area and dissection for- confirm the results of the present study. mation. As such, we were unable to categorize the dissection Journal of Interventional Cardiology 7 [7] E. Tsuchikane, T. Aizawa, H. Tamai et al., “Pre-drug-eluting severity. It is well known that optical coherence tomography stent debulking of bifurcated coronary lesions,” Journal of the (OCT) is superior to IVUS to evaluate detailed dissection American College of Cardiology, vol. 50, no. 20, pp. 1941–1945, morphology [14]. )erefore, further evaluations using OCT to investigate the characteristics of dissection are required. [8] R. Mehran, S. V. Rao, D. L. Bhatt et al., “Standardized bleeding However, we reckon that DCA should be performed under definitions for cardiovascular clinical trials,” Circulation, the guidance of IVUS and not OCT because OCT is unable vol. 123, no. 23, pp. 2736–2747, 2011. to provide information about vessel size and plaque volume, [9] T. Suzuki, H. Hosokawa, O. Katoh et al., “Effects of adjunctive thereby limiting its safety. )ird, the DCA procedure re- balloon angioplasty after intravascular ultrasound-guided quires a specific technique in IVUS interpretation and optimal directional coronary atherectomy,” Journal of the manipulation of the DCA catheter, thereby limiting the American College of Cardiology, vol. 34, no. 4, pp. 1028–1035, applicability and generalizability of the results from the 1999. [10] S. Habara, K. Kadota, T. Kanazawa et al., “Paclitaxel-coated current study. Finally, our follow-up data was limited to 12 balloon catheter compared with drug-eluting stent for drug- months. To evaluate the efficacy of stentless strategy of DCB eluting stent restenosis in routine clinical practice,” Euro- angioplasty following DCA for LM bifurcation lesions, fu- Intervention, vol. 11, no. 10, pp. 1098–1105, 2016. ture trials with a longer follow-up are necessary. [11] R. Sakurai, J. Ako, Y. Morino et al., “Predictors of edge ste- nosis following sirolimus-eluting stent deployment (a quan- 5. Conclusions titative intravascular ultrasound analysis from the SIRIUS trial),” 8e American Journal of Cardiology, vol. 96, no. 9, )e early results of stentless strategy by DCB angioplasty pp. 1251–1253, 2005. following DCA for de novo LM bifurcation lesions are [12] Y. G. Kim, I.-Y. Oh, Y.-W. Kwon et al., “Mechanism of edge acceptable. On the other hand, this stentless strategy may not restenosis after drug-eluting stent implantation,” Circulation Journal, vol. 77, no. 12, pp. 2928–2935, 2013. be effective for stent edge restenosis at the LAD ostium. [13] J. J. Wentzel, D. M. Whelan, W. J. van der Giessen et al., “Coronary stent implantation changes 3-D vessel geometry Data Availability and 3-D shear stress distribution,” Journal of Biomechanics, vol. 33, no. 10, pp. 1287–1295, 2000. )e data used to support the findings of this study are re- [14] D. Chamie, ´ H. G. Bezerra, G. F. Attizzani et al., “Incidence, stricted by the Ethics Committee of Saiseikai Yokohama City predictors, morphological characteristics, and clinical out- Eastern Hospital in order to protect patient privacy and are comes of stent edge dissections detected by optical coherence available from the corresponding author upon request. tomography,” JACC: Cardiovascular Interventions, vol. 6, no. 8, pp. 800–813, 2013. Conflicts of Interest )e authors declare that they have no conflicts of interest. References [1] A. H. Gershlick, D. E. Kandzari, A. Banning et al., “Outcomes after left main percutaneous coronary intervention versus coronary artery bypass grafting according to lesion site,” JACC: Cardiovascular Interventions, vol. 11, no. 13, pp. 1224–1233, 2018. [2] D. E. Kandzari, A. H. Gershlick, P. W. Serruys et al., “Out- comes among patients undergoing distal left main percuta- neous coronary intervention,” Circulation: Cardiovascular Interventions, vol. 11, no. 10, Article ID e007007, 2018. [3] S. Cho, T. S. Kang, J.-S. Kim et al., “Long-term clinical outcomes and optimal stent strategy in left main coronary bifurcation stenting,” JACC: Cardiovascular Interventions, vol. 11, no. 13, pp. 1247–1258, 2018. [4] S.-J. Kang, G. S. Mintz, W.-J. Kim et al., “Changes in left main bifurcation geometry after a single-stent crossover technique,” Circulation: Cardiovascular Interventions, vol. 4, no. 4, pp. 355–361, 2011. [5] T. T. Rissanen, S. Uskela, A. Siljander et al., “Percutaneous coronary intervention of complex calcified lesions with drug- coated balloon after rotational atherectomy,” Journal of Interventional Cardiology, vol. 30, no. 2, pp. 139–146, 2017. [6] S. Kitani, Y. Igarashi, E. Tsuchikane et al., “Efficacy of drug- coated balloon angioplasty after directional coronary athe- rectomy for coronary bifurcation lesions (DCA/DCB regis- try),” Catheterization and Cardiovascular Interventions, 2020.

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Published: Mar 3, 2021

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