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
This trial does not accept healthy volunteersQualifiers
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 population
Consecutive patients with severe aortic stenosis diagnosed according to ESC guidelines, undergoing TAVR
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT
Other interventionAll 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)
Treatment groups
2,500 Participants
are divided into 3 treatment groupsGroup A: Lower Surgical Risk1 intervention
Group B: Intermediate Surgical Risk1 intervention
Group C: High Surgical Risk1 intervention
Trial outcomes
Primary outcomes
1
Trend of average daily ischemic risk (ADIR) and average daily bleeding risk (ADBR)
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.
Time frame
At 30-days, 90-days and 1 year2
Average daily risks (ADRs) in different type of valve prosthesis
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
Time frame
At 30-days, 90-days and 1 yearSecondary outcomes
1
Average daily risks (ADRs) in different type of valve prosthesis
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
Time frame
At 30-days, 90-days and 1 year2
Average daily risks (ADRs) in anaemic and thrombocytopenic patients
Trend and prevalence of ADIR and ADBR in patients who developed anaemia and thrombocytopenia after the procedure and during the hospitalization. Anaemia and thrombocytopenia were defined according to the WHO and EHA guidelines. ADRs were calculated as the total number of events divided by the number of patients-day at risk
Time frame
In hospital up to 1 year3
Rate of antithrombotic regimen changes after TAVR
Percentage of antithrombotic strategy changes
Time frame
At 30-days, 90-days and 1 year4
Timing of antithrombotic regimen changes after TAVR
Number of days after the procedure in which the antithrombotic strategy was changed
Time frame
At 30-days, 90-days and 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov