Ischemic And Bleeding Risk Assessment After TAVR

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNiguarda Hospital

About this trial

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 criteria

Qualifiers

All patients with severe aortic stenosis undergoing TAVR.

Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT

Treatment groups

2,500 Participants
are divided into 3 treatment groups

Sponsors and collaborators