DUrable Polymer-based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity (DUTCH PEERS): Randomized Multicenter Trial in All-Comers Population Treated Within Eastern NeThErlands-2 (TWENTE-2).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,811
- 试验地点
- 4
- 主要终点
- Target-vessel failure (TVF)
研究概览
简要总结
Rationale:
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.
Objective:
To investigate whether the clinical outcome is similar after implantation of the Promus Element versus the Resolute Integrity stent (non-inferiority hypothesis).
Study design:
Multicenter, prospective, randomized single-blinded study.
Study population:
Patients who require percutaneous coronary interventions (PCI) for the treatment of coronary stenoses with an indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included.
Intervention:
In patients who are eligible for DES implantation, the type of DES implanted will be randomized (Resolute Integrity stent versus Promus Element stent). At the start of the study, both DES will also be used in routine clinical practice.
Main study endpoints:
The primary endpoint is the incidence of target vessel failure at one year follow-up. Target vessel failure (TVF) is a composite endpoint consisting of cardiac death, target vessel MI, or clinically driven target vessel revascularization. Further secondary clinical and angiographic endpoints will be investigated, defined in accordance with suggestions of the Academic Research Consortium (ARC). Of note, the angiographic assessment is based on clinically indicated projections only and results in no additional x-ray exposure. There is no routine angiographic follow-up. If angiographic data are available in patients who undergo symptom-driven re-catheterization, we will analyze these data to get insight into the mechanisms of potential DES restenosis.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive the routine clinical treatment. As a consequence, the risks of this trial do not exceed the risks of any routine PCI procedure.
详细描述
- OBJECTIVES
Primary research questions To investigate whether the outcome after the randomized implantation of the Resolute Integrity versus Promus Element drug-eluting stent are similar, as assessed in a non-inferiority setting by comparing target-vessel failure (TVF) of both stents at one year follow-up post stent implantation. In brief, we want to compare for both drug-eluting stents the combined endpoint of (1) cardiac death, (2) myocardial infarction that can be related to the target vessel or cannot be related to another vessel, and (3) clinically indicated revascularization related to the target-vessel. Based on the results of the RESOLUTE all-comers trial (the study stents in the RESOLUTE all comers trial used the same coatings and drugs used in the current trial but on different bare metal stent platforms), non-inferiority of Resolute Integrity and Promus Element is expected. This is not tested in a controlled randomized trial yet.
Secondary research questions Effectivity, safety, clinical short- and long-term outcome, and the acute angiographic results of the implantation of two third-generation drug-eluting stents will be compared in a "real world", all-comers scenario. Angiographic comparison will be based on the routine coronary angiography runs recorded during diagnostic coronary angiography and PCI procedures. No additional mandatory angiographic studies after the index PCI are required. 2. STUDY DESIGN
The DUTCH PEERS Study is a multi-center prospective single-blinded randomized study. Randomization will involve the type of DES used in study population. Patients will be blinded to the type DES they will receive. The general practitioner of the patient will be requested not to disclose this information to the patient. Analysts who perform the data analyses will be blinded to the type DES used as well. 3. STUDY POPULATION 3.1 Population (base) All patients who fulfil the inclusion criteria and undergo PCI with potential DES implantation will be asked to participate in the DUTCH PEERS, unless they meet one or more of the exclusion criteria.
Patients will receive a drug-eluting stent according to the guidelines (Guidelines NVVC/ESC) and/or the clinical decision of the interventional cardiologist.
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
- Single (Participant)
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
- •Minimum age of 18 years;
- •Coronary artery disease and lesion(s) eligable for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement;
- •Patient is willing and able to cooperate with study procedures and required follow-up visits; and patient has been informed and agrees on the participation by signing an EC approved written informed consent.
排除标准
- •Participation in another randomized drug or device study before reaching primary endpoint;
- •Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
- •Intolerance to aspirin, clopidogrel or ticlopidin, heparin, or components of the two DES examined;
- •Known pregnancy;
- •Life expectancy of less than 1 year.
结局指标
主要结局
Target-vessel failure (TVF)
时间窗: 1 year
Components of the primary endpoint in hierarchical order: 1. Cardiac death. All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established; 2. Target vessel related MI that is Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel; 3. Clinically driven repeated target vessel revascularization by means of CABG or PCI.
次要结局
- Death at 1 and 2 year follow-up(1 and 2 year)
- Myocardial infarction at 1 and 2 year follow-up(1 and 2 year)
- 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)
研究者
Clemens von Birgelen
Professor
Thorax Centrum Twente