The Efficacy of Drug-Coated Balloon for Acute Coronary Syndrome

Naganawa, Hirokazu; Ito, Akira; Saiki, Shinrou; Nishi, Daisuke; Takamatsu, Shinichi; Ito, Yoshihisa; Suzuki, Takeshi

doi:https://doi.org/10.1155/2023/4594818

Cardiology Research and Practice

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Abstract Introduction Materials and Methods Results Discussion Conclusions Data Availability Conflicts of Interest Authors’ Contributions Acknowledgments References Copyright Related Articles

Research Article | Open Access

Volume 2023 | Article ID 4594818 | https://doi.org/10.1155/2023/4594818

The Efficacy of Drug-Coated Balloon for Acute Coronary Syndrome

Hirokazu Naganawa,¹Akira Ito,¹Shinrou Saiki,¹Daisuke Nishi,¹Shinichi Takamatsu,¹Yoshihisa Ito,¹and Takeshi Suzuki¹

Academic Editor: Stefan Simovic

Received23 Jun 2022

Revised01 Jan 2023

Accepted15 Apr 2023

Published20 Apr 2023

Abstract

Background. Percutaneous coronary intervention using a drug-eluting stent (DES) is a common therapeutic option for acute coronary syndrome (ACS). However, stent-associated complications, such as bleeding associated with dual antiplatelet therapy, in-stent restenosis, stent thrombosis, and neoatherosclerosis, remain. Drug-coated balloons (DCBs) are expected to reduce stent-associated complications. This study aimed to assess the efficacy of DCB therapy and compare it with that of DES therapy in patients with ACS. Materials and Methods. In this single-center, retrospective, observational study, we examined all patients with ACS treated with DCB or DES between July 2014 and November 2020. Patients with left main trunk lesions were excluded. The primary outcome was a composite of major adverse cardiovascular events (MACE: cardiac death, myocardial infarction, and target lesion revascularization) at one year. Results. Three hundred and seventy-two patients were treated with DES, and 83 patients were treated with DCB. MACE occurred in 10 (12.0%) patients in the DCB group and in 50 (13.4%) patients in the DES group (). Conclusions. DCB is a valuable and effective therapy for patients with ACS. Moreover, DCB may become an alternative therapy for DES in patients with ACS.

1. Introduction

Acute coronary syndrome (ACS) is one of the leading causes of death worldwide [1–3]. Primary percutaneous coronary intervention (PCI) reportedly reduces cardiac events in patients with acute myocardial infarction (AMI) [4–7]. The use of second-generation drug-eluting stents (DES) is suggested and recommended in several clinical trials for safety and efficacy; therefore, PCI for ACS utilizing DES has recently become a common therapy [8–11]. However, stent-associated complications, such as bleeding event associated with dual antiplatelet therapy (DAPT), in-stent restenosis (ISR), stent thrombosis (ST), and neoatherosclerosis, remain. Drug-coated balloons (DCBs) are semicompliant angioplasty balloons covered with antirestenotic drugs, which are rapidly released locally into vessels during balloon inflation. Paclitaxel, which is coated on the balloon surface, is absorbed into the vessels and inhibits neointimal hyperplasia. Because the rationale behind DCB therapy is to combine balloon and drug therapy and does not involve leaving a permanent vascular implant, DCB is expected to reduce these stent-associated complications. DCB carries no risk of ISR or ST, and the native vessels maintain normal vascular function due to the absence of chronic inflammation caused by metallic struts and polymers. In addition, the duration of DAPT is reduced. Currently, DCB therapy is the standard treatment strategy for ISR [12–19] and small coronary vessel disease [20–22]. Although several studies have reported on the efficacy of DCB in ACS [23–25], there is still insufficient evidence. There is a paucity of current literature discussing the effects of DCB on the entire ACS population; therefore, this study aimed to assess the efficacy of DCB therapy and compare it with that of DES in patients with ACS.

2. Materials and Methods

This was a single-center, retrospective, observational study. We enrolled all patients with ACS who underwent PCI with DCB or DES at our hospital between July 2014 and November 2020. Patients with left main trunk lesions were excluded.

ACS was defined as a range of conditions compatible with acute myocardial ischemia and/or AMI, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), and unstable angina pectoris (UAP) [26]. Diabetes mellitus was defined as hemoglobin A1c ≥6.5% or use of insulin or oral hypoglycemic drugs. Hypertension was defined as a systolic blood pressure (SBP) >140 mmHg, diastolic blood pressure >90 mmHg, or medical therapy for hypertension. Dyslipidemia was defined as total cholesterol ≥220 mg/dL, low-density lipoprotein cholesterol ≥140 mg/dL, high-density lipoprotein cholesterol ≤40 mg/dL, triglycerides ≥150 mg/dL, or the use of statins and/or lipid-lowering agents. A current smoker was defined as a smoker at the time of admission or one who had quit smoking within one year prior to admission. Left ventricular ejection fraction (LVEF) was measured using transthoracic echocardiography during the index hospitalization. LVEF was calculated using either the modified Simpson’s method, Teichholz method, or eyeball estimation. The Teichholz method was adopted only when the modified Simpson method was unavailable. An eyeball estimate was adopted only when Simpson’s and Teichholz’s methods were unavailable. Cardiac shock was defined as SBP <90 mmHg, administration of vasopressors to maintain blood pressure, or attempted cardiopulmonary resuscitation. Bifurcation lesions were defined as lesions with a side branch ≥2.0 mm on visual assessment.

PCI was performed according to the standard technique. All procedures were performed through the radial or femoral artery using a 6–8 Fr guiding catheter. A bolus injection of heparin (8000 units) was administered after sheath insertion, and the activated clotting time (ACT) was maintained at >250 s with an additional bolus of heparin during the procedure [27]. All patients were pretreated with a loading dose of aspirin 300 mg, clopidogrel 300 mg, or prasugrel 20 mg before PCI according to the Japanese Circulation Society (JCS) guidelines [28]. The choice of either clopidogrel or prasugrel was at the discretion of the operator. All patients underwent intravascular ultrasound (IVUS) using either OptiCross (Boston Scientific, CA, USA) or AltaView (Terumo Medical, Tokyo, Japan). ACT was measured when PCI was completed and the sheath pulled. If ACT was >300 s, heparin was neutralized using protamine [29]. The following procedures were performed at the operator’s discretion: lesion preparation and device selection for predilatation, thrombectomy and distal protection, final device selection, crossover therapy from DCB to DES, follow-up coronary angiography (CAG), duration of DAPT, and drugs administered for secondary prevention.

The operators used a paclitaxel-coated balloon (SeQuent Please, Nipro Corporation, Osaka, Japan) or a second-generation DES, considering the angiographical/IVUS findings and background of the patient. The inflation time of DCB had to be at least 30 s at optimal pressure. Whenever DCB was used, the operator carefully evaluated for further thrombus formation, acute recoil, and flow-limiting dissection in comparison with the results during the immediate phase and that after the 15-min phase. Bail-out stenting was carefully considered only in cases of residual stenosis of the lesion >50% (by visual estimation) after balloon dilatation with a sufficiently large balloon and/or dissection greater than or equal to type C, leading to acute vessel closure. Successful PCI was defined as a diameter stenosis <30% (by visual estimation) and thrombolysis in myocardial infarction (TIMI) flow grade ≥2 in the DCB group, and a diameter stenosis <20% and TIMI flow grade ≥2 in the DES group.

After the procedure, DAPT, a combination of aspirin (100 mg/day) and prasugrel (3.75 mg/day) or clopidogrel (75 mg/day) as a maintenance dose [28] was prescribed for 3–6 months for the DCB group or 6–12 months for the DES group, respectively. No routine follow-up CAG was performed. Follow-up CAG was performed if there were recurrent angina symptoms, silent ischemia detected by stress test and/or scintigraphy, or at the operator’s discretion and planned at 6–8 months after the procedure for the DCB group or at 10–12 months for the DES group.

Quantitative coronary angiography (QCA) parameters were measured using a cardiovascular angiography analysis system (QAngio XA 7.3; Medis Medical Imaging Systems, Leiden, Netherlands). The values were obtained at three points: preprocedural PCI (baseline), postprocedural PCI (final), and follow-up CAG (follow-up). Lesion length, reference diameter (RD), minimal lumen diameter (MLD), and degree of stenosis (%DS) were measured, and late lumen loss (final MLD minus follow-up MLD) (LLL) was calculated. If the lesion was occluded, the MLD was 0 and %DS was 100, and the lesion length was calculated after thrombus aspiration or small balloon dilatation. Binary restenosis was defined as %DS >50% in the follow-up phase.

The primary outcome of this study was the occurrence of major adverse cardiovascular events (MACE), defined as cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at one year. Cardiac death was defined as death resulting from cardiovascular causes such as AMI; sudden cardiac death, including unwitnessed death, heart failure, stroke, cardiovascular procedures, or cardiovascular hemorrhage; and death resulting from other cardiovascular causes [30]. MI was defined as an elevation of cardiac biomarker values above the upper limit in combination with at least one of the following: symptoms of myocardial ischemia, new ischemic electrocardiographic changes, development of new pathological Q waves, imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, or identification of a coronary thrombus via angiography or autopsy [31]. TLR was defined as repeated PCI of the target lesion (including 10 mm proximal and 10 mm distal to the index device) or coronary artery bypass surgery on the target vessel due to evidence of ischemia, such as typical symptoms and/or positive laboratory testing [30]. The secondary outcome was the occurrence of MACE, ST, stroke, or bleeding. ST was defined according to the Academic Research Consortium criteria [32]. Bleeding was defined as Bleeding Academic Research Consortium (BARC) types 2, 3, and 5 [33].

All statistical analyses were performed using EZR (Saitama Medical Center, Jichi Medical University, Saitama, Japan), which is a graphical user interface for R (The R Foundation for Statistical Computing, Vienna, Austria) [34]. Continuous variables are expressed as means and standard deviations. For continuous data, groups of normally distributed and homoscedastic variables were compared using Student’s t-test, while normally distributed and heteroscedastic variables were compared using the Welch test. Non-normally distributed variables were compared using the Mann–Whitney U test. Categorical variables are presented as numbers and percentages. For categorical data, groups were compared using the chi-squared test. Statistical significance was defined as a two-tailed value <0.05.

All procedures were in accordance with the ethical standards of the institutional and/or national research committee and the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study was approved by the Institutional Review Board of Toyokawa City Hospital. Informed consent was obtained from all the participants.

3. Results

During the study period, 83 and 372 patients were treated with DCB and DES, respectively. The baseline characteristics of the patients are shown in Table 1. The rates of prior PCI and MI were significantly higher in the DCB group than in the DES group. Clinical presentation differed between the DCB and DES groups (UAP was highest in the DCB group, while STEMI was highest in the DES group). Other baseline characteristics were not significantly different between the two groups. Medication after the procedure was similar in both groups, except for β-blockers.

The lesions and procedural characteristics are shown in Table 2. The target lesion and number of lesions were similar in both groups. De novo lesions were higher in the DES group, while bifurcation lesions were higher in the DCB group. Predilatation and the use of scoring/cutting balloons were higher in the DCB group. Inflation pressure was 9.4 and 11.9 atm () and duration of inflation was 58.2 and 54.8 s () in the DCB and DES groups, respectively.

QCA results are shown in Table 3. Lesion length and RD were significantly higher in the DES group. The %DS in the baseline phase was significantly lower in the DCB group; however, the %DS in the final phase was similar in both groups. Follow-up CAG was performed in 56 (67.5%) and 261 (70.2%) patients in the DCB and DES groups, respectively (). LLL tended to be lower and restenosis was significantly higher in the DCB group.

Clinical outcomes are shown in Table 4. The primary outcome (MACE) occurred in 10 (12.0%) patients in the DCB group and 50 (13.4%) patients in the DES group (). Cardiac death, MI, TLR, ST, and stroke were not significantly different between the groups. BARC 2, 3, 5 bleeding was significantly lower in the DCB group (0.0%) than in the DES group (4.6%) ().

4. Discussion

The main findings of the present study are as follows: (1) the occurrence of MACE was not significantly different between the DCB and DES groups; and (2) BARC 2, 3, 5 bleeding was significantly lower in the DCB group than in the DES group.

DES therapy has improved clinical outcomes and prognosis and is considered the standard revascularization therapy for de novo lesions. However, DES therapy is associated with complications such as ISR, ST, neoatherosclerosis, and bleeding. With advancements in DCB therapy, stentless PCI has become an alternative to DES. Owing to the absence of chronic inflammation caused by metallic struts and polymers, DCB might have the advantages of early healing and preservation of normal vessel functions. DCB carries no risk of ISR or ST, and the duration of DAPT might be shortened. If the patient has a metal allergy, DCB could be safer than DES. In addition, an important consequence of DCB therapy is an increase in the lumen area after several months, known as late lumen enlargement (LLE). It is considered to be caused by a reduction of plaque volume, positive remodeling, repair of dissection, and some vessel healing mechanisms. Approximately 50.5–74% of patients show LLE after DCB therapy [35–38]. Onishi et al. reported that the American Heart Association (AHA)/American College of Cardiology (ACC) lesion type and rate of LLE were related [36]. In this study, 39.3% (22/56) of patients demonstrated LLE, with rates lower than those reported in previous studies. This was because the rate of AHA/ACC type B2 + C lesions in this study was 78.3%, which is higher than those reported in previous studies.

Bonaventura et al. reported that lesion preparation using a scoring balloon was associated with high procedural success and low target-lesion failure [39]. In this study, predilatation and the use of a scoring/cutting balloon were higher in the DCB group. PCI using DES can result in immediate luminal gain; however, stentless PCI using DCB cannot obtain a stent-like result. Therefore, lesion preparation resulting in sufficient luminal gain and controlled dissection is necessary to achieve good clinical outcomes. In this study, predilatation was performed in 100% of cases, and the usage rate of scoring/cutting balloons was 65.1% in the DCB group.

Furthermore, in this study, the rate of bifurcation lesions was higher in the DCB group than in the DES group. Generally, PCI for bifurcation lesions is associated with high procedural complications and worse outcomes [40]. Provisional stenting has been the gold standard for bifurcation lesions, and the two-stent strategy can be considered for narrowed large-side branches. However, the two-stent strategy has a higher risk of complications than the single-stent strategy. Therefore, an optimal strategy for the treatment of bifurcation lesions has not yet been established. However, Corballis et al. reported on the efficacy of the DCB strategy for bifurcation lesions [41]. DCB therapy could reduce the loss of side branches (owing to the absence of stent strut jailing) and shorten the procedure time. Many operators consider completing the procedure in a short time, particularly in cases of ACS; therefore, DCB therapy may be suitable for bifurcation lesions.

Wiviott et al. reported that the treatment for patients with ACS who were undergoing PCI and were administered prasugrel at a loading and maintenance doses of 60 mg and 10 mg, respectively, was associated with reduced ischemic events; however, it was associated with increased bleeding events compared with clopidogrel [42]. The European Society of Cardiology (ESC) and ACC/AHA/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines recommend a loading and maintenance dose of prasugrel 60 mg and 10 mg or 5 mg, respectively [43, 44]. However, East Asians, including the Japanese, have a higher risk of bleeding than Western populations [45, 46] and have a different risk-benefit profile for antithrombotic therapy compared with Western populations [47]. Therefore, Saito et al. reported that a reduced dose of prasugrel (loading and maintenance doses of 20 mg and 3.75 mg, respectively) has confirmed the safety and efficacy in Japanese patients with ACS [48]. Accordingly, a reduced dose of prasugrel and a standard dose of prasugrel were recommended by the JCS guideline. In this study, we determined a loading and maintenance dose of prasugrel and clopidogrel according to the JCS guideline. In general, patients with ACS have a high risk of bleeding and ischemia [49]. Many previous studies have recommended that the optimal duration of DAPT be determined based on the risk of bleeding and ischemia [50–52]. In this study, the academic research consortium high bleeding risk (ARC-HBR) was 48.2% (40/83) and 41.9% (156/372) in the DCB and DES groups, respectively (). The Japanese version of the HBR (J-HBR) [28] was 62.7% (52/83) and 66.9% (249/372) in the DCB and DES groups, respectively (). Natsuaki et al. reported that the ARC-HBR and J-HBR rates were 48% and 64%, respectively [53], which are similar to our results. All bleeding events in this study occurred during DAPT therapy. In this study, we set the duration of DAPT at 3–6 months and 6–12 months for the DCB and DES groups, respectively. Because the duration of DAPT was longer in the DES group than in the DCB group, the rate of bleeding was higher in the DES group. Many clinical trials have been performed to shorten the duration of DAPT after DES implantation, including ACS [54–58], but the optimal duration of DAPT remains uncertain. Similarly, the optimal duration of DAPT for DCB therapy remains unclear; two trials reported a duration of 1–3 months [59, 60]. Theoretically, DCB could shorten DAPT due to the mechanism described above, and it has an advantage in HBR patients. A shorter DAPT duration with both DCB and DES may be possible in the future, and the superiority of DCB for bleeding risk may decrease.

Previous studies have evaluated the efficacy and feasibility of DCB therapy for STEMI [23], NSTEMI [24], and ACS [25]. Recently, Li et al. reported the efficacy and safety of DCB therapy in patients with AMI in a meta-analysis [61]. However, to the best of our knowledge, this is the first report involving only patients with ACS, including those with de novo and ISR lesions.

This study has several limitations. First, it was a nonrandomized, retrospective study; therefore, selection bias could not be excluded. Second, this study was performed at a single center with a small sample size. Third, the duration of DAPT in both groups was determined at the operator’s discretion; therefore, it was not uniform. Fourth, owing to the small number of patients, we did not distinguish between in-hospital and postdischarge events. Finally, our follow-up data were limited to one year; longer follow-up data are necessary to evaluate the influence of rare clinical outcomes such as ST and neoatherosclerosis. Further prospective and randomized trials involving a large number of patients are necessary to confirm the results of this study.

5. Conclusions

DCB is an effective and valuable therapy for patients with ACS. Moreover, DCB therapy may become an alternative to DES in patients with ACS, especially in cases where bleeding complications are not desirable.

Data Availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Conflicts of Interest

The authors declare that there are no conflicts of interest regarding the publication of this article.

Authors’ Contributions

H. N. and T. S. conceived the idea of the study. H. N., S. T., and Y. I. contributed to the interpretation of the result. H. N. wrote the main manuscript. S. T., Y. I., and T. S. supervised the manuscript. All authors discussed and approved the final version of the manuscript.

Acknowledgments

The authors recognized the contribution of all the patients who were involved in this clinical study for their participation. The authors thank the members of the Cardiac Catheterization Laboratory at their hospital.

References

R. Vedanthan, B. Seligman, and V. Fuster, “Global perspective on acute coronary syndrome: a burden on the young and poor,” Circulation Research, vol. 114, no. 12, pp. 1959–1975, 2014.
View at: Publisher Site | Google Scholar
G. R. Shroff, B. M. Heubner, and C. A. Herzog, “Incidence of acute coronary syndrome in the general Medicare population, 1992 to 2009: a real-world perspective,” JAMA Internal Medicine, vol. 174, no. 10, pp. 1689-1690, 2014.
View at: Publisher Site | Google Scholar
F. Sanchis-Gomar, C. Perez-Quilis, R. Leischik, and A. Lucia, “Epidemiology of coronary heart disease and acute coronary syndrome,” Annals of Translational Medicine, vol. 4, no. 13, p. 256, 2016.
View at: Publisher Site | Google Scholar
E. C. Keeley, J. A. Boura, and C. L. Grines, “Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials,” The Lancet, vol. 361, no. 9351, pp. 13–20, 2003.
View at: Publisher Site | Google Scholar
H. R. Andersen, T. T. Nielsen, K. Rasmussen et al., “A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction,” ACC Current Journal Review, vol. 12, no. 6, pp. 47–742, 2003.
View at: Publisher Site | Google Scholar
P. Widimský, T. Budesínský, D. Vorác et al., “Long distance transport for primary angioplasty vs. immediate thrombolysis in acute myocardial infarction. Final results of the randomized national multicentre trial--PRAGUE-2,” European Heart Journal, vol. 24, no. 1, pp. 94–104, 2003.
View at: Publisher Site | Google Scholar
P. G. Steg, E. Bonnefoy, S. Chabaud et al., “Impact of time to treatment on mortality after prehospital fibrinolysis or primary angioplasty: data from the CAPTIM randomized clinical trial,” Circulation, vol. 108, no. 23, pp. 2851–2856, 2003.
View at: Publisher Site | Google Scholar
T. Palmerini, G. Biondi-Zoccai, D. Della Riva et al., “Clinical outcomes with drug-eluting and bare-metal stents in patients with ST-segment elevation myocardial infarction: evidence from a comprehensive network meta-analysis,” Journal of the American College of Cardiology, vol. 62, no. 6, pp. 496–504, 2013.
View at: Publisher Site | Google Scholar
F. Philip, S. Stewart, and J. A. Southard, “Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: network meta-analysis of randomized primary percutaneous coronary intervention trials,” Catheterization and Cardiovascular Interventions, vol. 88, no. 1, pp. 38–48, 2016.
View at: Publisher Site | Google Scholar
P. Chichareon, R. Modolo, C. Collet et al., “Efficacy and safety of stents in ST-segment elevation myocardial infarction,” Journal of the American College of Cardiology, vol. 74, no. 21, pp. 2572–2584, 2019.
View at: Publisher Site | Google Scholar
S. Brugaletta, J. Gomez-Lara, L. Ortega-Paz et al., “10-year follow-up of patients with everolimus-eluting versus bare-metal stents after ST-segment elevation myocardial infarction,” Journal of the American College of Cardiology, vol. 77, no. 9, pp. 1165–1178, 2021.
View at: Publisher Site | Google Scholar
R. A. Byrne, F. J. Neumann, J. Mehilli et al., “Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial,” The Lancet, vol. 381, no. 9865, pp. 461–467, 2013.
View at: Publisher Site | Google Scholar
B. Xu, R. Gao, J. Wang et al., “A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial,” JACC: Cardiovascular Interventions, vol. 7, no. 2, pp. 204–211, 2014.
View at: Publisher Site | Google Scholar
F. Alfonso, M. J. Pérez-Vizcayno, A. Cárdenas et al., “A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V clinical trial (Restenosis intra-stent of bare metal stents: paclitaxel-eluting balloon vs. everolimus-eluting stent),” Journal of the American College of Cardiology, vol. 63, no. 14, pp. 1378–1386, 2014.
View at: Publisher Site | Google Scholar
F. Alfonso, M. J. Pérez-Vizcayno, A. Cárdenas et al., “A prospective randomized trial of drug-eluting balloons versus everolimus-eluting stents in patients with in-stent restenosis of drug-eluting Stents: the RIBS IV Randomized Clinical Trial,” Journal of the American College of Cardiology, vol. 66, no. 1, pp. 23–33, 2015.
View at: Publisher Site | Google Scholar
J. Baan Jr, B. E. Claessen, K. B. Dijk et al., “A randomized comparison of paclitaxel-eluting balloon versus everolimus-eluting stent for the treatment of any in-stent restenosis: the DARE Trial,” JACC: Cardiovascular Interventions, vol. 11, no. 3, pp. 275–283, 2018.
View at: Publisher Site | Google Scholar
Y. T. A. Wong, D. Y. Kang, J. B. Lee et al., “Comparison of drug-eluting stents and drug-coated balloon for the treatment of drug-eluting coronary stent restenosis: a randomized RESTORE trial,” American Heart Journal, vol. 197, pp. 35–42, 2018.
View at: Publisher Site | Google Scholar
C. J. Jensen, G. Richardt, R. Tölg et al., “Angiographic and clinical performance of a paclitaxel-coated balloon compared to a second-generation sirolimus-eluting stent in patients with in-stent restenosis: the BIOLUX randomised controlled trial,” EuroIntervention, vol. 14, no. 10, pp. 1096–1103, 2018.
View at: Publisher Site | Google Scholar
D. Giacoppo, F. Alfonso, B. Xu et al., “Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study),” European Heart Journal, vol. 41, no. 38, pp. 3715–3728, 2020.
View at: Publisher Site | Google Scholar
A. Latib, N. Ruparelia, A. Menozzi et al., “3-year follow-up of the balloon elution and late loss optimization study (BELLO),” JACC: Cardiovascular Interventions, vol. 8, no. 8, pp. 1132–1134, 2015.
View at: Publisher Site | Google Scholar
Y. Tang, S. Qiao, X. Su et al., “Drug-coated balloon versus drug-eluting stent for small-vessel disease: the RESTORE SVD China randomized trial,” JACC: Cardiovascular Interventions, vol. 11, no. 23, pp. 2381–2392, 2018.
View at: Publisher Site | Google Scholar
R. V. Jeger, A. Farah, M. A. Ohlow et al., “Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial,” Lancet, vol. 392, pp. 849–856, 2018.
View at: Publisher Site | Google Scholar
N. S. Vos, N. D. Fagel, G. Amoroso et al., “Paclitaxel-coated balloon angioplasty versus drug-eluting stent in acute myocardial infarction: the REVELATION randomized trial,” JACC: Cardiovascular Interventions, vol. 12, no. 17, pp. 1691–1699, 2019.
View at: Publisher Site | Google Scholar
B. Scheller, M. A. Ohlow, S. Ewen et al., “Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial,” EuroIntervention, vol. 15, no. 17, pp. 1527–1533, 2020.
View at: Publisher Site | Google Scholar
Y. Mizutani, T. Ishikawa, H. Nakamura et al., “A propensity score-matched comparison of midterm outcomes between drug-coated balloons and drug-eluting stents for patients with acute coronary syndrome,” International Heart Journal, vol. 63, no. 2, pp. 217–225, 2022.
View at: Publisher Site | Google Scholar
E. A. Amsterdam, N. K. Wenger, R. G. Brindis et al., “2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American heart association task force on Practice guidelines,” Journal of the American College of Cardiology, vol. 64, no. 24, pp. e139–e228, 2014.
View at: Publisher Site | Google Scholar
P. T. O'Gara, F. G. Kushner, D. D. Ascheim et al., “2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology foundation/American heart association task force on Practice guidelines,” Journal of the American College of Cardiology, vol. 61, no. 4, pp. e78–e140, 2013.
View at: Google Scholar
M. Nakamura, K. Kimura, T. Kimura et al., “JCS 2020 guideline focused update on antithrombotic therapy in patients with coronary artery disease,” Circulation Journal, vol. 84, no. 5, pp. 831–865, 2020.
View at: Publisher Site | Google Scholar
H. Naganawa, A. Ito, S. Saiki et al., “Efficacy of the hemostatic device VasoSTAT and the study of hemostatic factor,” Scientific Reports, vol. 11, no. 1, Article ID 21343, 2021.
View at: Publisher Site | Google Scholar
K. A. Hicks, K. W. Mahaffey, R. Mehran et al., “2017 cardiovascular and stroke endpoint definitions for clinical trials,” Journal of the American College of Cardiology, vol. 71, no. 9, pp. 1021–1034, 2018.
View at: Publisher Site | Google Scholar
K. Thygesen, J. S. Alpert, A. S. Jaffe et al., “Fourth universal definition of myocardial infarction (2018),” European Heart Journal, vol. 40, no. 3, pp. 237–269, 2018.
View at: Publisher Site | Google Scholar
D. E. Cutlip, S. Windecker, R. Mehran et al., “Clinical end points in coronary stent trials: a case for standardized definitions,” Circulation, vol. 115, no. 17, pp. 2344–2351, 2007.
View at: Publisher Site | Google Scholar
R. Mehran, S. V. Rao, D. L. Bhatt et al., “Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium,” Circulation, vol. 123, no. 23, pp. 2736–2747, 2011.
View at: Publisher Site | Google Scholar
Y. Kanda, “Investigation of the freely available easy-to-use software 'EZR' for medical statistics,” Bone Marrow Transplantation, vol. 48, no. 3, pp. 452–458, 2013.
View at: Publisher Site | Google Scholar
K. Sogabe, M. Koide, K. Fukui et al., “Optical coherence tomography analysis of late lumen enlargement after paclitaxel-coated balloon angioplasty for de-novo coronary artery disease,” Catheterization and Cardiovascular Interventions: Official Journal of the Society for Cardiac Angiography & Interventions, vol. 98, no. 1, pp. E35–E42, 2021.
View at: Publisher Site | Google Scholar
T. Onishi, Y. Onishi, I. Kobayashi, and Y. Sato, “Late lumen enlargement after drug-coated balloon angioplasty for de novo coronary artery disease,” Cardiovascular Intervention and Therapeutics, vol. 36, no. 3, pp. 311–318, 2021.
View at: Publisher Site | Google Scholar
F. X. Kleber, A. Schulz, M. Waliszewski et al., “Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty,” Clinical Research in Cardiology, vol. 104, no. 3, pp. 217–225, 2015.
View at: Publisher Site | Google Scholar
T. Yamamoto, T. Sawada, K. Uzu, T. Takaya, H. Kawai, and Y. Yasaka, “Possible mechanism of late lumen enlargement after treatment for de novo coronary lesions with drug-coated balloon,” International Journal of Cardiology, vol. 321, pp. 30–37, 2020.
View at: Publisher Site | Google Scholar
K. Bonaventura, M. Schwefer, A. K. M. Yusof et al., “Systematic scoring balloon lesion preparation for drug-coated balloon angioplasty in clinical routine: results of the PASSWORD observational study,” Advances in Therapy, vol. 37, no. 5, pp. 2210–2223, 2020.
View at: Publisher Site | Google Scholar
J. F. Lassen, N. R. Holm, A. Banning et al., “Percutaneous coronary intervention for coronary bifurcation disease: 11th consensus document from the European Bifurcation Club,” EuroIntervention, vol. 12, no. 1, pp. 38–46, 2016.
View at: Publisher Site | Google Scholar
N. H. Corballis, S. Paddock, T. Gunawardena, I. Merinopoulos, V. S. Vassiliou, and S. C. Eccleshall, “Drug coated balloons for coronary artery bifurcation lesions: a systematic review and focused meta-analysis,” PLoS One, vol. 16, no. 7, 2021.
View at: Publisher Site | Google Scholar
S. D. Wiviott, E. Braunwald, C. H. McCabe et al., “Prasugrel versus clopidogrel in patients with acute coronary syndromes,” New England Journal of Medicine, vol. 357, no. 20, pp. 2001–2015, 2007.
View at: Publisher Site | Google Scholar
F. J. Neumann, M. Sousa-Uva, A. Ahlsson et al., “2018 ESC/EACTS Guidelines on myocardial revascularization,” European Heart Journal, vol. 40, no. 2, pp. 87–165, 2019.
View at: Publisher Site | Google Scholar
J. S. Lawton, J. E. Tamis-Holland, S. Bangalore et al., “2021 ACC/AHA/SCAI guideline for coronary artery revascularization: a report of the American College of Cardiology/American heart association joint committee on clinical Practice guidelines,” Circulation, vol. 145, no. 3, pp. e18–e114, 2022.
View at: Google Scholar
K. H. Mak, D. L. Bhatt, M. Shao et al., “Ethnic variation in adverse cardiovascular outcomes and bleeding complications in the clopidogrel for high atherothrombotic risk and ischemic stabilization, management, and avoidance (CHARISMA) study,” American Heart Journal, vol. 157, no. 4, pp. 658–665, 2009.
View at: Publisher Site | Google Scholar
R. H. Mehta, M. Cox, E. E. Smith et al., “Race/ethnic differences in the risk of hemorrhagic complications among patients with ischemic stroke receiving thrombolytic therapy,” Stroke, vol. 45, no. 8, pp. 2263–2269, 2014.
View at: Publisher Site | Google Scholar
H. K. Kim, U. S. Tantry, S. C. Smith Jr et al., “The East Asian paradox: an updated position statement on the challenges to the current antithrombotic strategy in patients with cardiovascular disease,” Thrombosis & Haemostasis, vol. 121, no. 04, pp. 422–432, 2021.
View at: Publisher Site | Google Scholar
S. Saito, T. Isshiki, T. Kimura et al., “Efficacy and safety of adjusted-dose prasugrel compared with clopidogrel in Japanese patients with acute coronary syndrome: the PRASFIT-ACS study,” Circulation Journal, vol. 78, no. 7, pp. 1684–1692, 2014.
View at: Publisher Site | Google Scholar
P. G. Steg, K. Huber, F. Andreotti et al., “Bleeding in acute coronary syndromes and percutaneous coronary interventions: position paper by the Working Group on Thrombosis of the European Society of Cardiology,” European Heart Journal, vol. 32, no. 15, pp. 1854–1864, 2011.
View at: Publisher Site | Google Scholar
F. Costa, D. van Klaveren, S. James et al., “Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials,” The Lancet, vol. 389, no. 10073, pp. 1025–1034, 2017.
View at: Publisher Site | Google Scholar
R. W. Yeh, E. A. Secemsky, D. J. Kereiakes et al., “Development and validation of a prediction rule for benefit and harm of dual antiplatelet therapy beyond 1 Year after percutaneous coronary intervention,” JAMA, vol. 315, no. 16, pp. 1735–1749, 2016.
View at: Publisher Site | Google Scholar
M. Natsuaki, T. Morimoto, K. Yamaji et al., “Prediction of thrombotic and bleeding events after percutaneous coronary intervention: CREDO-Kyoto thrombotic and bleeding risk scores,” Journal of the American Heart Association, vol. 7, no. 11, 2018.
View at: Publisher Site | Google Scholar
M. Natsuaki, T. Morimoto, H. Shiomi et al., “Application of the modified high bleeding risk criteria for Japanese patients in an all-comers registry of percutaneous coronary intervention - from the CREDO-kyoto registry cohort-3,” Circulation Journal, vol. 85, no. 6, pp. 769–781, 2021.
View at: Publisher Site | Google Scholar
H. Watanabe, T. Domei, T. Morimoto et al., “Effect of 1-month dual antiplatelet therapy followed by clopidogrel vs. 12-month dual antiplatelet therapy on cardiovascular and bleeding events in patients receiving PCI: the STOPDAPT-2 randomized clinical trial,” JAMA, vol. 321, no. 24, pp. 2414–2427, 2019.
View at: Publisher Site | Google Scholar
P. Vranckx, M. Valgimigli, P. Jüni et al., “Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs. aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial,” The Lancet, vol. 392, no. 10151, pp. 940–949, 2018.
View at: Publisher Site | Google Scholar
J. Y. Hahn, Y. B. Song, J. H. Oh et al., “Effect of P2Y12 inhibitor monotherapy vs. dual antiplatelet therapy on cardiovascular events in patients undergoing percutaneous coronary intervention: the SMART-CHOICE randomized clinical trial,” JAMA, vol. 321, no. 24, pp. 2428–2437, 2019.
View at: Publisher Site | Google Scholar
R. Mehran, U. Baber, S. K. Sharma et al., “Ticagrelor with or without aspirin in high-risk patients after PCI,” New England Journal of Medicine, vol. 381, no. 21, pp. 2032–2042, 2019.
View at: Publisher Site | Google Scholar
B. K. Kim, S. J. Hong, Y. H. Cho et al., “Effect of ticagrelor monotherapy vs. ticagrelor with aspirin on major bleeding and cardiovascular events in patients with acute coronary syndrome: the TICO randomized clinical trial,” JAMA, vol. 323, no. 23, pp. 2407–2416, 2020.
View at: Publisher Site | Google Scholar
S. Uskela, J. M. Kärkkäinen, J. Eränen et al., “Percutaneous coronary intervention with drug-coated balloon-only strategy in stable coronary artery disease and in acute coronary syndromes: an all-comers registry study,” Catheterization and Cardiovascular Interventions, vol. 93, no. 5, pp. 893–900, 2019.
View at: Publisher Site | Google Scholar
T. T. Rissanen, S. Uskela, J. Eränen et al., “Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial,” The Lancet, vol. 394, pp. 230–239, 2019.
View at: Publisher Site | Google Scholar
Q. Y. Li, M. Y. Chang, X. Y. Wang et al., “Efficacy and safety of drug-coated balloon in the treatment of acute myocardial infarction: a meta-analysis of randomized controlled trials,” Scientific Reports, vol. 12, no. 1, p. 6552, 2022.
View at: Publisher Site | Google Scholar

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Copyright © 2023 Hirokazu Naganawa et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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