Drug-Coated Balloon Versus Drug-eluting Stent for Treatment of Clinically Relevant Side Branch in Complex Coronary Bifurcation Lesion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 3
- 主要终点
- Major Adverse Cardiac Event (MACE)
研究概览
简要总结
A prospective, multi-center, open-label, randomized controlled, superiority trial. The aim of the study is to compare clinical outcomes between upfront 2-stenting strategy versus upfront drug-coated balloon (DCB)-based hybrid strategy in patients with complex coronary bifurcation with clinically relevant side branch lesions.
详细描述
Among complex coronary artery lesions, percutaneous coronary intervention (PCI) for true bifurcation lesions has been challenging to perform and associated with a higher risk of mortality, unplanned repeat revascularization or stent thrombosis.15-17 Although current guidelines recommend 1-stenting with provisional side branch approach as an initial treatment strategy for the bifurcation lesions based on previous trials,11,12,18-22 there are studies that demonstrate better or similar outcomes with the upfront 2-stenting strategy.3,4,21,23 Of note, these trials that have favored upfront 2-stenting strategy have shown a tendency for better efficacy of 2-stenting as the severity of bifurcation lesions increases.3,4,21,23 Considering that the discrepancy among study results could be attributable to the complexity of true bifurcation lesions, it can be argued that 1-stenting with provisional SB approach by conventional balloon dilatation shows limitations in dealing with severely complex true bifurcation lesions.
During provisional stenting, unplanned side branch stenting is associated with worse clinical outcomes.24 In addition, SB failure occurred more frequently than main vessel failure in both 1-stenting and 2-stenting group.25 Considering these results, there have been some studies trying to demonstrate the effect of drug-coated balloon (DCB) angioplasty at side branch during the PCI for bifurcation lesions.5,26 In the most recent trial, DCB angioplasty yielded better results compared to conventional simple balloon dilatation.5 Thus, for true bifurcation lesions, upfront DCB-based hybrid strategy could serve as a good alternative treatment strategy that improves clinical outcomes for patients with complex coronary bifurcation lesion with clinically relevant side branch.
On this background, this trial sought to compare the clinical outcomes between upfront DCB-based hybrid strategy and upfront 2-stenting strategy in patients with complex coronary bifurcation with clinically relevant side branch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 19 years of age
- •Patients with acute or chronic coronary syndrome intended for percutaneous coronary intervention (PCI)
- •Patients with de novo complex coronary bifurcation with clinically relevant side branch. Definition of complex coronary bifurcation with clinically relevant side branch is true bifurcation lesion (Medina 1,1,1 / 1,0,1 / 0,1,1) with side branch lesion length ≥10mm and should meet at least one of the below criteria.
- •i. Left main bifurcation with side branch stenosis severity ≥70% by visual estimation ii. Non-left main bifurcation with side branch reference vessel diameter ≥2.75mm and stenosis severity ≥90% by visual estimation
- •Subject who can verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
排除标准
- •Hemodynamically unstable condition (SBP <90 mmHg even after administration of vasopressor, ventricular arrhythmias, or cardiogenic shock)
- •Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- •Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms.
- •Severe left ventricular systolic dysfunction (ejection fraction <30%)
- •Intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, or heparin.
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- •Unwillingness or inability to comply with the procedures described in this protocol.
研究组 & 干预措施
Upfront DCB-based hybrid strategy
In upfront DCB-based hybrid strategy group, stepwise provisional strategy with side branch DCB angioplasty will be performed according to the follow standardized procedural steps. In this group, provisional stenting strategy will be performed in accordance with the European Bifurcation Club (EBC) consensus. Bail-out stenting will be performed using operator's preferred technique (e.g. T, TAP, culotte) when there will be one of the following after hybrid strategy: <TIMI 3 flow in the side branch, severe (>90%) ostial pinching, or flow-limiting dissection.
干预措施: Upfront DCB-based hybrid strategy (Other)
Upfront 2-stenting strategy
In upfront 2-stenting strategy group, systematic planned 2-stenting will be performed according to EBC recommendations. The stent technique will be at the discretion of the operator but could be one of culotte, DK-culotte, mini-crush, DK-crush, T or TAP.
干预措施: Upfront 2-stenting strategy (Other)
结局指标
主要结局
Major Adverse Cardiac Event (MACE)
时间窗: 1 year after last patient enrollment
MACE (a composite of death, MI, clinically-driven target-vessel revascularization), according to the Academic Research Consortium (ARC) II-consensus.
次要结局
- All-cause death(1 year after last patient enrollment)
- Cardiac death(1 year after last patient enrollment)
- Any MI (myocardial infarction)(1 year after last patient enrollment)
- Spontaneous MI (myocardial infarction)(1 year after last patient enrollment)
- Procedure-related MI (myocardial infarction)(1 year after last patient enrollment)
- Stent thrombosis(1 year after last patient enrollment)
- Unplanned revascularization (clinically-driven)(1 year after last patient enrollment)
- Target-vessel revascularization (clinically-driven)(1 year after last patient enrollment)
- Cerebrovascular accidents (ischemic or hemorrhagic)(1 year after last patient enrollment)
- Bleeding (BARC 2, 3, or 5)(1 year after last patient enrollment)
- Seattle Angina Questionnaire (SAQ) (angina severity)(1 year after last patient enrollment)
- Procedure-related complications during index procedure(1 year after last patient enrollment)
研究者
Young Bin Song
Professor
Samsung Medical Center