Clinical Outcomes of Bail-Out Stenting After Drug-Coated Balloon Angioplasty: The International Multicenter BAILOUT Registry.

IF 7.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Circulation: Cardiovascular Interventions Pub Date : 2026-04-30 DOI:10.1161/CIRCINTERVENTIONS.125.016461

Mauro Gitto, Pier Pasquale Leone, Tuomas T Rissanen, Natasha Corballis, Gianmaria Calamita, Francesco Tartaglia, Andrea Buono, Marco Ferrone, Alfonso Ielasi, Siamion Pismiankou, Marco Luciano Rossi, Ioannis Merinopoulos, Vassilios S Vassiliou, Luigi Salemme, Mauro Chiarito, Michele Galasso, Michele Morosato, Kasper Kyhl, Giovanni Occhipinti, Jonathan Hinton, Elodi Bacci, Guido Vellucci, Marcello Marchetta, Francesca De Micco, Damiano Regazzoli, Antonio Mangieri, Thomas Johnson, Fabrizio Ugo, Gabriele Gasparini, Bernhard Reimers, Peter O'Kane, Giuseppe Massimo Sangiorgi, Giulio G Stefanini, Stefano Galli, Fernando Alfonso, Diego Arroyo, Manel Sabaté, Carlo Briguori, Tullio Tesorio, Kambis Mashayekhi, Diego Maffeo, Azeem Latib, Simon Eccleshall, Antonio Colombo

{"title":"Clinical Outcomes of Bail-Out Stenting After Drug-Coated Balloon Angioplasty: The International Multicenter BAILOUT Registry.","authors":"Mauro Gitto, Pier Pasquale Leone, Tuomas T Rissanen, Natasha Corballis, Gianmaria Calamita, Francesco Tartaglia, Andrea Buono, Marco Ferrone, Alfonso Ielasi, Siamion Pismiankou, Marco Luciano Rossi, Ioannis Merinopoulos, Vassilios S Vassiliou, Luigi Salemme, Mauro Chiarito, Michele Galasso, Michele Morosato, Kasper Kyhl, Giovanni Occhipinti, Jonathan Hinton, Elodi Bacci, Guido Vellucci, Marcello Marchetta, Francesca De Micco, Damiano Regazzoli, Antonio Mangieri, Thomas Johnson, Fabrizio Ugo, Gabriele Gasparini, Bernhard Reimers, Peter O'Kane, Giuseppe Massimo Sangiorgi, Giulio G Stefanini, Stefano Galli, Fernando Alfonso, Diego Arroyo, Manel Sabaté, Carlo Briguori, Tullio Tesorio, Kambis Mashayekhi, Diego Maffeo, Azeem Latib, Simon Eccleshall, Antonio Colombo","doi":"10.1161/CIRCINTERVENTIONS.125.016461","DOIUrl":null,"url":null,"abstract":"Background: Drug-coated balloons (DCBs) are increasingly adopted in percutaneous coronary intervention. Bail-out drug-eluting stent (DES) implantation due to suboptimal immediate results after DCB angioplasty is not infrequent, and the clinical outcomes of percutaneous coronary intervention with DCB angioplasty followed by bail-out DES implantation remain unexplored. The aim of this study was to evaluate the safety of bail-out DES implantation following DCB angioplasty in percutaneous coronary intervention.Methods: The BAILOUT registry included consecutive patients undergoing bail-out DES implantation after DCB angioplasty at 17 European centers between 2011 and 2024. The primary end point was target lesion failure (TLF) at 1 year, defined as the composite of target lesion revascularization, target vessel myocardial infarction, and cardiac death. The TLF rate was compared with a performance goal of 7.0% for an upfront DES-only strategy, derived from a meta-analysis of contemporary randomized controlled trials.Results: A total of 733 patients were included, accounting for 5.5% of all DCB-based percutaneous coronary interventions. At 1 year, the cumulative TLF incidence in the overall population was 7.0% (95% CI, 5.2%-9.3%), which was comparable to the performance goal (P=0.916). This was mainly driven by target lesion revascularization (4.1%), while cardiac death and target vessel myocardial infarction occurred both in 1.9% of patients. The incidence of stent thrombosis was 0.6%. Independent predictors of 1-year TLF included lesion length (hazard ratio, 1.02 per mm increase [95% CI, 1.01-1.03]; P<0.001), moderate-to-severe calcification (hazard ratio, 2.82 [95% CI, 1.48-5.40]; P=0.002), and the use of paclitaxel- versus sirolimus-coated balloons (hazard ratio, 1.99 [95% CI, 1.01-4.05]; P=0.048).Conclusions: In cases of suboptimal angiographic results after DCB angioplasty, bail-out DES implantation is safe, with no increased risk of TLF at 1 year compared with the expected performance goal for an upfront DES-only strategy.","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016461"},"PeriodicalIF":7.4000,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation: Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/CIRCINTERVENTIONS.125.016461","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Drug-coated balloons (DCBs) are increasingly adopted in percutaneous coronary intervention. Bail-out drug-eluting stent (DES) implantation due to suboptimal immediate results after DCB angioplasty is not infrequent, and the clinical outcomes of percutaneous coronary intervention with DCB angioplasty followed by bail-out DES implantation remain unexplored. The aim of this study was to evaluate the safety of bail-out DES implantation following DCB angioplasty in percutaneous coronary intervention.

Methods: The BAILOUT registry included consecutive patients undergoing bail-out DES implantation after DCB angioplasty at 17 European centers between 2011 and 2024. The primary end point was target lesion failure (TLF) at 1 year, defined as the composite of target lesion revascularization, target vessel myocardial infarction, and cardiac death. The TLF rate was compared with a performance goal of 7.0% for an upfront DES-only strategy, derived from a meta-analysis of contemporary randomized controlled trials.

Results: A total of 733 patients were included, accounting for 5.5% of all DCB-based percutaneous coronary interventions. At 1 year, the cumulative TLF incidence in the overall population was 7.0% (95% CI, 5.2%-9.3%), which was comparable to the performance goal (P=0.916). This was mainly driven by target lesion revascularization (4.1%), while cardiac death and target vessel myocardial infarction occurred both in 1.9% of patients. The incidence of stent thrombosis was 0.6%. Independent predictors of 1-year TLF included lesion length (hazard ratio, 1.02 per mm increase [95% CI, 1.01-1.03]; P<0.001), moderate-to-severe calcification (hazard ratio, 2.82 [95% CI, 1.48-5.40]; P=0.002), and the use of paclitaxel- versus sirolimus-coated balloons (hazard ratio, 1.99 [95% CI, 1.01-4.05]; P=0.048).

Conclusions: In cases of suboptimal angiographic results after DCB angioplasty, bail-out DES implantation is safe, with no increased risk of TLF at 1 year compared with the expected performance goal for an upfront DES-only strategy.

查看原文本刊更多论文

药物包被球囊血管成形术后置入术的临床结果：国际多中心救助登记。

背景：药物包被球囊（DCBs）在经皮冠状动脉介入治疗中的应用越来越广泛。由于DCB血管成形术后立即效果不理想而植入搭救药物洗脱支架（DES）的情况并不少见，经皮冠状动脉介入治疗后搭救药物洗脱支架（DES）植入的临床效果尚不清楚。本研究的目的是评估经皮冠状动脉介入治疗中DCB血管成形术后纾困DES植入的安全性。方法：纾困登记包括2011年至2024年在17个欧洲中心连续接受DCB血管成形术后纾困DES植入的患者。主要终点为1年时靶病变失败（TLF），定义为靶病变血运重建、靶血管心肌梗死和心源性死亡的复合。TLF率与仅采用des的前期策略的7.0%的性能目标进行比较，该目标来自当代随机对照试验的荟萃分析。结果：共纳入733例患者，占所有基于dbc的经皮冠状动脉介入治疗的5.5%。1年后，总体人群中TLF的累计发病率为7.0% (95% CI, 5.2%-9.3%)，与疗效目标相当（P=0.916）。这主要是由靶病变血运重建（4.1%）引起的，而心源性死亡和靶血管心肌梗死均发生在1.9%的患者中。支架内血栓的发生率为0.6%。1年TLF的独立预测因子包括病灶长度（风险比，1.02 / mm增加[95% CI， 1.01-1.03]； PP=0.002），以及紫杉醇与西罗莫司包被球囊的使用（风险比，1.99 [95% CI, 1.01-4.05]； P=0.048）。结论：在DCB血管成形术后血管造影结果不理想的情况下，救援DES植入是安全的，与预先仅使用DES策略的预期性能目标相比，1年后TLF的风险没有增加。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

1.80%

发文量

221

审稿时长

6-12 weeks

期刊介绍： Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.