Ischemic And Bleeding Risk Assessment After TAVR
Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)
Niguarda Hospital
2,500 participants
Aug 1, 2023
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- All patients with severe aortic stenosis undergoing TAVR.
- Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.
Exclusion Criteria3
- 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
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Interventions
All patients undergoing TAVR will be stratified according with surgical risk level and all combination of antithrombotic therapy at discharge Low risk (SAPT vs DAPT and OAC vs OAC+SAPT) Intermediate risk (SAPT vs DAPT and OAC vs OAC+SAPT) High risk (SAPT vs DAPT and OAC vs OAC+SAPT)
Locations(12)
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NCT06000943