Ischemic And Bleeding Risk Assessment After TAVR

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.

NCT Number	NCT06000943
Lead Sponsor	Niguarda Hospital
Conditions	Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Enrollment	2,500 participants
Start Date	2023-08-01
Primary Completion	2024-11-01 (estimated)
Study Completion	2026-12-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-16