PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in Primary Angioplasty (PASEO) Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- The primary end point was target lesion revascularization (TLR) at 1-year follow-up
研究概览
简要总结
Stent implantation is the best treatment in patients with acute myocardial infarction (STEMI) referred for primary angioplasty (pPCI). However the occurrence of in stent restenosis is responsible for the need of repeat intervention. Both Sirolimus-eluting stents (SES) and Paclitaxel-eluting stents (PES) have been proven to virtually abolish in-stent restenosis in elective patients in simple e more complex lesions. Both SES and PES have raised concerns regarding occurrence of late stent thrombosis, especially in complex lesion subsets or in high risk patients. The PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in primary angioplasty (PASEO) trial was a prospective, single-center, randomized trial evaluating the benefits of SES or PES as compared to BMS implantation in patients undergoing primary angioplasty for acute STEMI. From 1 October 2003 we randomized with 1:1:1 ratio, 270 patients with STEMI and treated with pPCI, to implantation of a bare metal stent (BMS n=90), PES (n=90) or SES (n=90).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptoms of STEMI, with initial onset of chest pain within the past 12 hours, an ECG demonstrating > 0.1 mV ST-segment elevation in 2 or more contiguous leads or documented new left bundle-branch block and were suitable candidates for percutaneous revascularization.
排除标准
- •Active internal bleeding or a history of bleeding diathesis within the previous 30 days
- •An history of intracranial hemorrhage
- •Intracranial neoplasm
- •Arteriovenous malformation or aneurysm
- •Known allergy to sirolimus
- •Paclitaxel
- •Heparin, aspirin, or clopidogrel
- •An history of stroke within 30 days or any history of hemorrhagic stroke
- •History, symptoms, or findings suggestive of aortic dissection, fibrinolytic therapy within 24 hours
- •History of thrombocytopenia, pregnancy, patients on warfarin or acenocoumarol within the last seven days
- •Inability to obtain the informed consent
结局指标
主要结局
The primary end point was target lesion revascularization (TLR) at 1-year follow-up
时间窗: 1 year
次要结局
- Cumulative combined incidence of death and/or reinfarction at 2 year; Cumulative incidence of in-stent thrombosis at 2 year; 3) Major Adverse Cardiac Events (MACE) (combined death and/or reinfarction and/or TLR) at 2 years(2 year)