Journal Article

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

Vlaar, Pieter Jan, Wijnbergen, Inge F., Tonino, Pim A.L., van Kuijk, Jan- Peter, Vink, Maarten A., Remkes, Wouter S., Somi, Samer, Dillen, Daimy M.M., Hofma, Sjoerd H., van Rees, Johannes B., Oemrawsingh, Rohit M., Teeuwen, Koen, Zimmermann, Frederik M., de Smet, Bart J.G.L., Halim, Jonathan, Paradies, Valeria, Vermeer, Amy J.E., Tijssen, Jan G.P., Magro, Michael

2023

Overview

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.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Angioplasty / Angioplasty, Balloon, Coronary - adverse effects / Balloon treatment / Bifurcations / Blood vessels / Catheters / Coronary Angiography - adverse effects / Coronary Artery Disease - complications / Coronary bifurcation lesion / Drug delivery / Drug- eltuing stent / Drug- eluting balloon / Drug-Eluting Stents - adverse effects / Equivalence Trials as Topic / Heart attacks / Humans / Implants / Lesions / Medical equipment / Multicenter Studies as Topic / Myocardial infarction / Myocardial Infarction - etiology / Optimization techniques / Patients / Percutaneous Coronary Intervention - adverse effects / Prospective Studies / Randomized Controlled Trials as Topic / Stenosis / Stents / Stents - adverse effects / Thrombolysis / Thrombolytic drugs / Treatment Outcome