P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI With Biologically Active Stents (P2BiTO) Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,500
- 主要终点
- Death, Myocardial infarction, Stent Thrombosis
研究概览
简要总结
Prasugrel and ticagrelor were both associated with a significant reduction in the risk of MACE in patients undergoing PCI for an ACS, mostly through a reduced stent thrombosis. The 1-year relative risk reduction (RRR) of definite of probable stent thrombosis in patients receiving a DES were fairly different in TRITON-TIMI 38 and PLATO trials. The incidence of "biologically active" stent (DES or BVS) thrombosis is largely variable according to different lesion settings. We aim to verify the translation of the postulated different reduction in thrombosis rate among various P2Y12 inhibitors (clopidogrel, prasugrel and ticagrelor) in a high-risk setting such as the PCI with DES or BVS in CTO and bifurcating lesions.
详细描述
All patients aged 18-80 who underwent PCI of a CTO or bifurcating lesion (all Medina types, side branch ≥2 mm) with "biologically active stents" (DES or BVS) between January 2012 and december 2014 at participating centers will be deemed eligible to enter the registry.
In-hospital outcomes will be recorded; all patients discharged alive will be followed up with a telephone interview (minimum follow-up 6 months).
The primary end-point will be the occurrence of a cluster of major adverse cardiovascular events at 1 year:
- Death from any cause.
- Myocardial infarction.
- Stent thrombosis, defined as definite, probable or possible following the Academic Research Consortium.
Sample size 3150 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-80 years old
- •PCI of a CTO or bifurcating lesion (all Medina types, side branch ≥2 mm) with "biologically active stents"
排除标准
- 未提供
结局指标
主要结局
Death, Myocardial infarction, Stent Thrombosis
时间窗: 30 months
1. Death from any cause. 2. Myocardial infarction, defined as an elevation of the creatine kinase MB fraction or cardiac troponins by a factor of 3 or more, or the development of new Q waves in 2 or more contiguous leads at surface ECG7. Levels of total creatine kinase and the creatine kinase MB fraction will be measured in all patients between 12 and 24 hours after PCI. 3. Stent thrombosis, defined as definite, probable or possible3 following the Academic Research Consortium
次要结局
未报告次要终点
研究者
Raffaele De Caterina
MD/PhD
G. d'Annunzio University