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• W4387409619 abstract "The optimal treatment strategy for coronary bifurcation lesions by percutaneous coronary intervention 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 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 to a conventional two-stent strategy is currently lacking. The Hybrid DEB study is a prospective, multicentre, randomized controlled trial investigating non-inferiority of a hybrid DEB approach, using a combination of a drug-eluting stent in the main vessel and drug-eluting balloon 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 drug-eluting balloon or with a second stent 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." @default.
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• W4387409619 date "2023-10-01" @default.
• W4387409619 modified "2023-10-14" @default.
• W4387409619 title "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" @default.
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• W4387409619 doi "https://doi.org/10.1016/j.ahj.2023.09.010" @default.
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