Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE Study): Long-Term Follow-up Study
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)
研究概览
简要总结
We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large vessels compared with bare metal stent.
详细描述
Drug-eluting stent (DES) has been proved to reduced restenosis rate dramatically compared to bare metal stent (BMS). However, the long-term safety of DES is still uncertain. Recent meta-analysis showed that very late stent thrombosis rate was higher in DES group although overall mortality was similar between 2 groups.
The safety issue of DES was first suggested in the BASKET-LATE study, which compared cobalt chromium alloy BMS (VISION®, Guidant, USA) with sirolimus- or paclitaxel-coated DES. The study showed a significantly higher rate of death or myocardial infarction in the DES group between 7 and 18 month after the procedure (BMS 1.3%, DES 4.9%, p=0.01). Moreover, benefit to reduce target vessel revascularization was not found and there was even the possibility of late harm in patients treated with DES in large native vessels.
We perform a multicenter prospective randomized study comparing paclitaxel-eluting stent with cobalt chromium stent several years, originally to see whether major adverse cardiac event is significantly lower in DES compared to thin-strut BMS in the non-complex lesion subset. In this article, we would like to investigate the 2-year clinical events in DES and BMS groups.
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
- •Angiographically proved significant stenosis in native coronary artery (> 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study)
- •planned target lesion number =< 2
- •reference diameter 2.75 - 4.0 mm
- •lesions can be fully covered by one 28 mm or shorter stent
排除标准
- •unprotected left main coronary disease with more than 50% stenosis or planned left main angioplasty
- •ostial target lesion (within 5 mm of ostium)
- •angiographic evidence of thrombus within target lesion
- •calcified lesions which cannot be successfully predilated
- •instent restenosis
- •multi-vessel intervention more than 2 lesions
- •atherectomy is planned before stenting
- •bifurcation lesion that needs side branch ballooning or stenting
- •Severe left ventricular dysfunction with echocardiographic ejection fraction less than 30%
- •ST-elevation myocardial infarction within the preceding 72 hours
结局指标
主要结局
Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)
时间窗: 1 year
次要结局
- MACE and stent thrombosis by the criteria of Academic Research Consortium(2 years)