Ischemic And Bleeding Risk Assessment After TAVR

Condition(s) studied

Investigational drug(s) / intervention(s)

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)

Study 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

Primary outcome measure(s)

• Trend of average daily ischemic risk (ADIR) and average daily bleeding risk (ADBR) — At 30-days, 90-days and 1 year
  ADIR was calculated as the total number of ischemic events (CV deaths, MI, ischemic stroke and other thrombotic events-including repeat events) divided by the number of patients-day at risk. ADBR was calculated as the total number of bleeding events (including repeat events) divided by the number of the number of patients-day at risk.
• Average daily risks (ADRs) in different type of valve prosthesis — At 30-days, 90-days and 1 year
  Trend and prevalence of ADIR and ADBR in different type and number of prosthesis (long frame vs short frame, balloon versus self-expandable, porcine vs bovine, Single Valve vs Valve in Valve) and calculated as the total number of events divided by the number of patients-day at risk

Trial sites (12)

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