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初发非左主干冠状动脉分叉病变中裤裙式与双吻挤压式支架置入术的随机对照研究:比弗卡分岔不良克罗伊茨根试验-3(BBK-3)的原理与设计

Randomised Comparison of Culotte- versus Double Kissing Crush Stenting in de novo non-left Main Coronary Bifurcation Lesions: Rationale and Design of the Bifurcation Bad Krozingen trial-3 (BBK-3).

作者信息

Rahimi Faridun, Löffelhardt Nikolaus, Minners Jan, Breitbart Philipp, Franke Kilian, Hartikainen Tau Sarra, Valina Christian, Mühlen Constantin V Zur, Nührenberg Thomas, Kastrati Adnan, Woitek Felix, Elsaesser Albrecht, Abdel-Wahab Mohamed, Sossalla Samuel, Hochholzer Willibald, Westermann Dirk, Neumann Franz-Josef, Olivier Christoph, Ferenc Miroslaw

机构信息

Department of Cardiology and Angiology, Medical Center, Faculty of Medicine, University of Freiburg, University of Freiburg, Suedring 15, 79189, Bad Krozingen, Germany.

Department of Cardiology, Technische Universitaet Muenchen, Deutsches Herzzentrum Muenchen, Munich, Germany.

出版信息

J Cardiovasc Transl Res. 2025 May 27. doi: 10.1007/s12265-025-10626-x.

Abstract

Whether culotte or double kissing (DK)-crush stenting is the superior systematic 2-stent technique in non-left main bifurcation lesions is unclear. The BBK-3 (unique identifier NCT04192760) is a multicenter, prospective, randomized controlled trial to test the hypothesis that culotte stenting reduces maximal percent diameter restenosis at 9-month follow-up compared to DK-crush stenting in de-novo non-left main coronary bifurcation lesions using approved, third-generation drug-eluting stents (DES). A total of 400 patients will be randomized in a 1:1 ratio to receive a two-stent strategy. The primary study endpoint is the maximal percent diameter in-stent restenosis within the bifurcation at 9 months, assessed by quantitative coronary angiography. Secondary endpoints include target lesion revascularization (TLR), the composite of death and myocardial infarction, emergent cardiac bypass surgery and TLR (MACE) at 12 months. BBK-3 will assist in the identification of the preferable, contemporary 2-stent strategy in the treatment of de-novo non-left main coronary bifurcation lesions.

摘要

在非左主干分叉病变中,裤裙式支架置入术或双吻(DK)-挤压式支架置入术是否为更优的系统性双支架技术尚不清楚。BBK-3(唯一标识符NCT04192760)是一项多中心、前瞻性、随机对照试验,旨在检验以下假设:在使用已获批的第三代药物洗脱支架(DES)治疗初发非左主干冠状动脉分叉病变时,与DK-挤压式支架置入术相比,裤裙式支架置入术在9个月随访时可降低最大直径百分比再狭窄率。总共400例患者将按1:1比例随机分组,接受双支架策略。主要研究终点是9个月时通过定量冠状动脉造影评估的分叉部位支架内最大直径百分比再狭窄。次要终点包括12个月时的靶病变血运重建(TLR)、死亡和心肌梗死的复合终点、急诊心脏搭桥手术和TLR(MACE)。BBK-3将有助于确定治疗初发非左主干冠状动脉分叉病变时更优的当代双支架策略。

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