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.

Autor: Dillen DMM; Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands. Electronic address: daimy.dillen@catharinaziekenhuis.nl., Vlaar PJ; Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands., Vermeer AJE; Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands; Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands., Paradies V; Department of Cardiology, Maasstad Hospital, Rotterdam, The Netherlands., van Kuijk JP; Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands., Vink MA; Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands., Oemrawsingh RM; Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, The Netherlands., Hofma SH; Department of Cardiology, Medical Center Leeuwarden, The Netherlands., Magro M; Department of Cardiology, Elisabeth- TweeSteden Hospital, Tilburg, The Netherlands., Remkes WS; Department of Cardiology, VieCuri, Venlo, The Netherlands., de Smet BJGL; Department of Cardiology, Meander Medical Center, Amersfoort, The Netherlands., van Rees JB; Department of Cardiology, Rijnstate, Arnhem, The Netherlands., Somi S; Department of Cardiology, Haga Hospital, The Hague, The Netherlands., Halim J; Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands., Zimmermann FM; Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands., Wijnbergen IF; Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands., Tijssen JGP; Department of Clinical Epidemiology and Biostatistics, Amsterdam University Medical Center, Amsterdam, The Netherlands., Tonino PAL; Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands., Teeuwen K; Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.
Jazyk: angličtina
Zdroj: American heart journal [Am Heart J] 2023 Dec; Vol. 266, pp. 168-175. Date of Electronic Publication: 2023 Oct 06.
DOI: 10.1016/j.ahj.2023.09.010
Abstrakt: 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.
Trial Design: 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.
Conclusion: 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.
Trial Registration: ClinicalTrials.gov no. NCT05731687.
Competing Interests: Disclosure Koen Teeuwen reports research grant from DaVinci Medical B.V. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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