Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 15
- 主要终点
- Trend of average daily ischemic risk (ADIR) and average daily bleeding risk (ADBR)
研究概览
简要总结
Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2).
Giving an established uniform approach towards anticoagulation and antithrombotic therapy after TAVR in the post POPULAR-TAVI era, recent data coming from the analysis of different trials, highlight the relevance of the patient's background on the occurrence of ischemic and bleeding events.
Despite this a targeted antithrombotic strategy remains unexplored and all patients undergoing TAVR without other indication to DAPT or OAC, were currently treated according with the concept of "less is more" (only SAPT or only OAC) regardless the risk level (5-6).
The keys points of the project will be 1) the assessment of ischemic and bleeding risk after TAVR stratified according with antithrombotic therapy and surgical risk; 2) the evaluation of the impact of prostheses type and the complete blood count variables (hemoglobine and platelets) on the daily average ischemic and bleeding risk and 3) the evaluation of the dynamic therapeutic changes after TAVR during the follow up.
详细描述
Nowadays in the post POPULAR-TAVI era, after transcatheter aortic valve replacement (TAVR), an establish uniform approach towards anticoagulation and antithrombotic therapy were established.
All patients undergoing TAVR without other indication to dual antiplatelet therapy (DAPT) or oral anticoagulation (OAC), were currently treated according with the general concept of "less is more" (only single antiplatelet therapy - SAPT or only oral anticoagulation - OAC) [1-3].
By comparing the frequency of ischemic and bleeding events, data from trial revealed that the bleeding events were more frequent than the ischemic one despite the level of surgical risk, however a gradient of reduction in terms of difference was seen from the highest to the lowest risk profile [4].
Furthermore, recent literature showed how the timeframe analysis approach, giving the possibility for a complete time variability evaluation, is able to visualize the fluctuation of the risk over the time. Unfortunately, no stratified data according with the surgical risk level, are available using this approach [5].
Moreover, despite these results that highlight the relevance of the patient's background on the occurrence of ischemic and bleeding events, a tailored antithrombotic strategy remains unexplored and all patients undergoing TAVR without other indication to DAPT or OAC, were currently treated with a uniform approach in terms of intensity during the time (1-3).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •All patients with severe aortic stenosis undergoing TAVR.
- •Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.
排除标准
- •Patients who died during the index procedure
- •Patients in triple antithrombotic therapy at discharge
- •Patients with a known prognosis less than 1 year at the time of TAVR
研究组 & 干预措施
Lower Surgical Risk
Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)
干预措施: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT (Other)
Intermediate Surgical Risk
Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)
干预措施: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT (Other)
High Surgical Risk
Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)
干预措施: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT (Other)
结局指标
主要结局
Trend of average daily ischemic risk (ADIR) and average daily bleeding risk (ADBR)
时间窗: At 30-days, 90-days and 1 year
ADIR was calculated as the total number of ischemic events (CV deaths, MI, ischemic stroke and other thrombotic events-including repeat events) divided by the number of patients-day at risk. ADBR was calculated as the total number of bleeding events (including repeat events) divided by the number of the number of patients-day at risk.
Average daily risks (ADRs) in different type of valve prosthesis
时间窗: At 30-days, 90-days and 1 year
Trend and prevalence of ADIR and ADBR in different type and number of prosthesis (long frame vs short frame, balloon versus self-expandable, porcine vs bovine, Single Valve vs Valve in Valve) and calculated as the total number of events divided by the number of patients-day at risk
次要结局
- Type of antithrombotic regimen changes after TAVR(At 30-days, 90-days and 1 year)
- Average daily risks (ADRs) in different type of valve prosthesis(At 30-days, 90-days and 1 year)
- Average daily risks (ADRs) in anaemic and thrombocytopenic patients(In hospital up to 1 year)
- Rate of antithrombotic regimen changes after TAVR(At 30-days, 90-days and 1 year)
- Timing of antithrombotic regimen changes after TAVR(At 30-days, 90-days and 1 year)
