A Multicenter Observational Registry on Coronary Revascularization After Implantation of Transcatheter Aortic Valve Bioprosthesis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Evaluate the technical feasibility of PCI in patients with prior TAVI
研究概览
简要总结
Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.
详细描述
The increasing operator experience combined with an improved performance of devices have led to extend current transcatheter aortic valve implantation (TAVI) indications to patients at low or intermediate risk. The safety of TAVI in this population was initially tested in small observational studies and recently reported in the randomized PARTNER 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Trial (SURTAVI) trials, which demonstrated non- inferiority of TAVI in low or intermediate risk patients as compared to surgery with respect to the primary endpoint of death or disabling stroke. In view of the changes in the TAVI population, including younger patients with longer survival, the number of patients that may require coronary revascularization after TAVI is expected to increase over the time. Of note, challenges in performing percutaneous coronary interventions (PCI) in patients previously treated with TAVI have been reported in small series.
Against this background, the purpose of this retrospective multicenter study is to evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.
Objectives
- Evaluate the incidence of PCI after TAVI
- Evaluate the clinical indications for PCI after TAVI
- Evaluate the technical feasibility of PCI in patients with prior TAVI
- Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
排除标准
- 未提供
结局指标
主要结局
Evaluate the technical feasibility of PCI in patients with prior TAVI
时间窗: intraoperative
Successful target coronary vessel revascularization
Evaluate the incidence of PCI after TAVI
时间窗: up to 5 year after TAVI implantation
Evaluate the incidence of PCI after TAVI
Evaluate the clinical indications for PCI after TAVI
时间窗: intraoperative
Clinical indication for PCI: stable angina; documented silent ischemia; acute coronary syndrome/non-ST elevation myocardial infarction; acute coronary syndrome/ST elevation myocardial infarction
Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI
时间窗: up to 5 year after TAVI implantation
outcome defined as MACE (Major Adverse Coronary Event) a composite of Death, Myocardial Infarction, Target Lesion Failure
次要结局
未报告次要终点
研究者
Enrico Cerrato
Principal Investigator
San Luigi Gonzaga Hospital
