TY - JOUR
T1 - Bifurcation PCI with a hybrid strategy with drug- eluting balloons versus a stepwise provisional two- stent strategy
T2 - Rationale and design of the hybrid DEB study
AU - Dillen, Daimy M. M.
AU - Vlaar, Pieter Jan
AU - Vermeer, Amy J. E.
AU - Paradies, Valeria
AU - van Kuijk, Jan- Peter
AU - Vink, Maarten A.
AU - Oemrawsingh, Rohit M.
AU - Hofma, Sjoerd H.
AU - Magro, Michael
AU - Remkes, Wouter S.
AU - de Smet, Bart J. G. L.
AU - van Rees, Johannes B.
AU - Somi, Samer
AU - Halim, Jonathan
AU - Zimmermann, Frederik M.
AU - Wijnbergen, Inge F.
AU - Tijssen, Jan G. P.
AU - Tonino, Pim A. L.
AU - Teeuwen, Koen
N1 - Funding Information: The Hybrid DEB study is an investigator initiated trial supported by an research grant from DaVinci Medical B.V. Funding Information: The study is supported by a research grant provided by Davinci Medical B.V. Publisher Copyright: © 2023 Elsevier Inc.
PY - 2023/12/1
Y1 - 2023/12/1
N2 - 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.
AB - 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.
KW - Coronary bifurcation lesion
KW - Drug- eltuing stent
KW - Drug- eluting balloon
UR - http://www.scopus.com/inward/record.url?scp=85175533327&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ahj.2023.09.010
DO - https://doi.org/10.1016/j.ahj.2023.09.010
M3 - Article
C2 - 37806333
SN - 0002-8703
VL - 266
SP - 168
EP - 175
JO - American Heart Journal
JF - American Heart Journal
ER -