冠状动脉非左主干分叉病变的随机比较:分叉Bad Krozingen试验-3 (BBK-3)的原理和设计。

IF 2.4 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
Faridun Rahimi, Nikolaus Löffelhardt, Jan Minners, Philipp Breitbart, Kilian Franke, Tau Sarra Hartikainen, Christian Valina, Constantin V Zur Mühlen, Thomas Nührenberg, Adnan Kastrati, Felix Woitek, Albrecht Elsaesser, Mohamed Abdel-Wahab, Samuel Sossalla, Willibald Hochholzer, Dirk Westermann, Franz-Josef Neumann, Christoph Olivier, Miroslaw Ferenc
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引用次数: 0

摘要

在非左主干分叉病变中,导管支架置入或双吻合器(DK)挤压支架置入是否是更好的系统双支架技术尚不清楚。BBK-3(唯一标识号NCT04192760)是一项多中心、前瞻性、随机对照试验,旨在验证在9个月的随访中,与使用经批准的第三代药物洗脱支架(DES)治疗新生非左主干冠状动脉分叉病变的DK-crush支架相比,冠脉支架置入可减少最大直径再狭窄百分比的假设。共有400名患者将按1:1的比例随机接受双支架治疗。主要研究终点是9个月时支架内再狭窄的最大直径百分比,通过定量冠状动脉造影评估。次要终点包括靶病变血运重建术(TLR)、死亡和心肌梗死的复合、紧急心脏搭桥手术和12个月时的TLR (MACE)。BBK-3将有助于确定治疗非左主干冠状动脉分叉病变的首选、现代双支架策略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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).

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.

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来源期刊
Journal of Cardiovascular Translational Research
Journal of Cardiovascular Translational Research CARDIAC & CARDIOVASCULAR SYSTEMS-MEDICINE, RESEARCH & EXPERIMENTAL
CiteScore
6.10
自引率
2.90%
发文量
148
审稿时长
6-12 weeks
期刊介绍: Journal of Cardiovascular Translational Research (JCTR) is a premier journal in cardiovascular translational research. JCTR is the journal of choice for authors seeking the broadest audience for emerging technologies, therapies and diagnostics, pre-clinical research, and first-in-man clinical trials. JCTR''s intent is to provide a forum for critical evaluation of the novel cardiovascular science, to showcase important and clinically relevant aspects of the new research, as well as to discuss the impediments that may need to be overcome during the translation to patient care.
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