RecruitingNCT06000943

Ischemic And Bleeding Risk Assessment After TAVR

Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)


Sponsor

Niguarda Hospital

Enrollment

2,500 participants

Start Date

Aug 1, 2023

Study Type

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

Min Age: 18 Years

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

OTHERLow 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

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NCT06000943


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