Evaluation of Late Clinical Events After Drug-eluting Versus Bare-metal Stents in Patients at Risk: BAsel Stent Kosten Effektivitäts Trial - PROspective Validation Examination Part II (BASKET-PROVE II)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,291
- 试验地点
- 14
- 主要终点
- MACE (composite endpoint including cardiac death, myocardial infarction (MI) and target-vessel revascularization (TVR)
研究概览
简要总结
Background:
Retrospective analyses of long-term BASKET findings identified patients with large drug-eluting stents (DES) (>2.5mm Stents) as patients at risk for late cardiac death/nonfatal myocardial infarction. In view of new DES with absorbable polymers and new bare metal stents BMS) with thin struts and biocompatible polymers, BP-II will be launched to test their comparative clinical safety up to 12 years if treated with an aspirin/prasugrel combination, since prasugrel halved stent thrombosis rates compared to clopidogrel in a large ACS trial.
The primary objective is to demonstrate non-inferiority of the Nobori DES stent compared to the Xience Prime DES stent on safety and e cacy in patients requiring stents >=3.0mm in diameter on the background of contemporary dual antiplatelet therapy (DAPT) with prasugrel and aspirin
Set-up:
Multicenter open-label randomized trial.
Patient inclusion:
Unselected series of patients in need of large (>3mm) stents only in native vessels irrespective of clinical indication.
Patient exclusion:
In-stent restenosis, Left-main disease, cardiogenic shock, planned surgery <12months, increased bleeding risk, no compliance expected, History of stroke or transient ischemic attack (TIA).
Randomization:
By centre using sealed envelopes 1:1:1: Nobori:Xience Prime:Prokinetik-stent.
详细描述
Background and Study Design
The study is a multicentre, prospective, randomized, open-label trial comparing safety and efficacy of the Nobori® drug-eluting stent (DES), the Xience Prime® DES, and the ProKinetic® bare-metal stent (BMS) in patients at low risk of restenosis, i.e. receiving stents >=3.0mm diameter only, on the background of contemporary antiplatelet therapy.
2289 patients were recruited at 8 centres in 5 countries and randomized 2:1 to DES or BMS, and 1:1 to either DES subgroup. Randomization was stratified according to centre.
Analysis Datasets
The full analysis set (FAS) will include all randomized patients of whom written informed consent was obtained. Patients needing an urgent PCI were asked for oral consent prior to the percutaneous coronary intervention (PCI) and for written informed consent afterwards. This means that some randomized patients gave oral but not written informed consent. Patients who gave oral informed consent and died before written informed consent could be obtained will be included in the FAS. All other patients without signed informed consent will be excluded regardless of oral informed consent. In accordance with the intention-to-treat principle all patients will be analysed according to the allocated treatment group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed concent
- •need for large (≥3.0 mm stents only) native vessel stenting
排除标准
- •in-Stent Restenosis or in-Stent Thrombosis
- •bypass graft disease to be stented
- •main stem disease to be stented
- •cardiogenic shock by clinical assessment (signs of organ hypoperfusion)
- •planned surgery within the next 12 months
- •oral anticoagulation needed (artificial heart valves,atrial fibrillation) or chronic haemorrhagic diathesis
- •active bleeding disorders
- •index-PCI = planned PCI of additional lesion
- •no follow-up (FU) expected/possible
- •History of stroke or TIA (contraindication for prasugrel)
- •known severe hypersensitivity reaction to ASS and/or Prasugrel
- •no compliance expected / no informed consent given
- •enrolled in another study
结局指标
主要结局
MACE (composite endpoint including cardiac death, myocardial infarction (MI) and target-vessel revascularization (TVR)
时间窗: 2 years
次要结局
- Cardiac death(2 years)
- Myocardial infarction (MI)(2 years)
- Target vessel revascularization (TVR)(2 years)
- Composite safety endpoint of cardiac death and non-fatal MI(2 years)
- Stent thrombosis according to ARC definitions(2 years)
- Major bleeding including fatal bleeding, i.e., BARC >=3(2 years)
- All cause death(2 years)
- Net clinical benefit = Primary endpoint plus major bleeding(2 years)