Bifurcation PCI with a hybrid strategy with drug- eluting balloons versus a stepwise provisional two- stent strategy: Rationale and design of the hybrid DEB study

医学 传统PCI 支架 经皮冠状动脉介入治疗 临床终点 心肌梗塞 药物洗脱支架 外科 血运重建 随机对照试验 心脏病学 放射科 内科学
作者
Daimy M. M. Dillen,Pieter J. Vlaar,Amy J.E. Vermeer,Valeria Paradies,J.P. van Kuijk,M Vink,Rohit M. Oemrawsingh,Sjoerd H. Hofma,Michael Magro,Wouter Remkes,Bart J.G.L. de Smet,Johannes B. van Rees,Samer Somi,Jonathan Halim,Frederik M. Zimmermann,Inge Wijnbergen,Jan G.P. Tijssen,Pim A.L. Tonino,Koen Teeuwen
出处
期刊:American Heart Journal [Elsevier]
卷期号:266: 168-175
标识
DOI:10.1016/j.ahj.2023.09.010
摘要

The optimal treatment strategy for coronary bifurcation lesions by percutaneous coronary intervention (PCI) is complex and remains a subject of debate. Current guidelines advise a stepwise provisional approach with optional two-stent strategy. However, a two-stent strategy, both upfront and stepwise provisional, is technically demanding. Therefore, there is increasing interest in the use of drug-eluting balloons (DEB) in bifurcation lesions, mainly after a provisional approach with unsatisfactory result of the side branch. Some small pilot studies already showed that the use of DEB in bifurcation lesions is safe and feasible. However, a randomized comparison of this hybrid DEB strategy with a two-stent strategy is currently lacking. The Hybrid DEB study is a prospective, multicenter, randomized controlled trial investigating noninferiority of a hybrid DEB approach, using a combination of a drug-eluting stent (DES) in the main vessel and DEB in the side branch, compared to stepwise provisional two-stent strategy in patients with true bifurcation lesions. A total of 500 patients with de novo true coronary bifurcation lesions, treated with a stepwise provisional approach and an unsatisfactory result of the side branch after main vessel stenting (≥ 70% stenosis and/or < thrombolysis in myocardial infarction III flow), will be randomized in a 1:1 ratio to receive either treatment with a DEB or with a DES in the side branch. The primary endpoint is a composite endpoint of the occurrence of all-cause death, periprocedural or spontaneous myocardial infarction and/or target vessel revascularization at the anticipated median 2-year follow-up. The Hybrid DEB study will compare in a multicenter, randomized fashion a hybrid DEB approach with a stepwise provisional two-stent strategy in patients with true bifurcation lesions. ClinicalTrials.gov no. NCT05731687.
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