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Ischemic And Bleeding Risk Assessment After TAVR
Sponsor: Niguarda Hospital
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.
Official title: Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2500
Start Date
2023-08-01
Completion Date
2026-12-15
Last Updated
2026-04-16
Healthy Volunteers
No
Interventions
Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT
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)
OLV Hospital
Aalst, Belgium
Complejo Asistencial Dr. Sótero del Río
Santiago, Chile
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, Czechia
ASST GOM Niguarda
Milan, Italia, Italy
Humanitas Research Hospital
Rozzano, Milano, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Milano, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Ospedale Galeazzi Sant'Ambrogio
Milan, Italy
San Carlo Hospital
Potenza, Italy
Azienda Ospedaliera Sant'Andrea
Roma, Italy
A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy
Puerto Real University Hospital, Puerto Real
Cadiz, Spain