Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial With Stent Evaluation in All-comers IV (TWENTE IV)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,470
- 试验地点
- 8
- 主要终点
- Target vessel failure (TVF)
研究概览
简要总结
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.
详细描述
rationale: The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.
Aim:
The aim of the study is to compare the outcome of the bioresorbable polymer coated stent (ORSIRO) and a new generation permanent polymer coated stent (RESOLUTE ONYX) in an all-comers patient population and non-inferiority setting.
Study design:
The study is a prospective, randomized, single-blinded, multicentre trial with 1:1 randomization for drug-eluting stent type, stratified for gender and the presence of diabetes mellitus.
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 (Participant, Outcomes Assessor)
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
- •Patients of 18 years and older, requiring PCI for the treatment of significant coronary artery or bypass graft lesions, being eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement, and capable of providing informed consent.
- •Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location or length of lesions to be treated.
排除标准
- •Known intolerance to components of one of the study DES, or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to any dual anti-platelet therapy (DAPT).
- •Planned elective surgical procedure necessitating interruption of DAPT during the first 3 months after randomization.
- •Participation in another randomized cardiovascular device trial or randomized pharmacological study related to antithrombotic and/or anticoagulant therapy before reaching the primary endpoint.
- •Known pregnancy, adherence to scheduled follow-up is unlikely, or life expectancy is assumed to be less than 1 year
结局指标
主要结局
Target vessel failure (TVF)
时间窗: 1 year
Composite endpoint consisting of: Cardiac death (All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established); Target vessel related MI (Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel); Clinically driven repeated target vessel revascularization by means of CABG or PCI.
次要结局
- Target lesion failure (TLF) at 1 and 2 year follow-up(1 and 2 year)
- Major adverse cardiac events (MACE) at 1 and 2 year follow-up(1 and 2 year follow-up)
- Revascularization at 1 and 2 year follow-up(1 and 2 year)
- Stent thrombosis at 1 and 2 year follow-up(1 and 2 year)
- Patient oriented composite endpoint (POCE) at 1 and 2 year follow-up(1 and 2 year follow-up)
- Death at 1 and 2 year follow-up(1 and 2 year)
- Major Bleeding at 1 and 2 year follow-up(1 and 2 year follow-up)
- Myocardial infarction at 1 and 2 year follow-up(1 and 2 year)
研究者
Clemens von Birgelen
MD, PhD
Thorax Centrum Twente