Aspirin alone reduces bleeding after TAVI in patients without indication for OAC
POPular-TAVI Aspirin With our Without Clopidogrel after Transcatheter Aortic Valve Implantation
Presented at the ESC congress 2020 by: Jorn Brouwer (Nieuwegein, The Netherlands)
Introduction and methods
Patients with severe symptomatic aortic valve stenosis may undergo transcatheter aortic valve implantation (TAVI). While this an established treatment, patients have a relatively high risk of bleeding or thromboembolic complications. Antithrombotic treatment after TAVI is not completely determined yet. For patients not on oral anticoagulation (OAC), the 2012 ESC guidelines on valvular heart disease recommend a combination of low-dose aspirin and clopidogrel early after TAVI followed by aspirin or clopidogrel alone. However, small studies have suggested aspirin alone is sufficient to decrease the risk of thromboembolic events with a reduced rate of bleeding.
POPular TAVI, is a multicenter, randomized, open-label clinical trial. Patients without an indication for long-term OAC, who were scheduled to undergo TAVI surgery were randomly allocated to either aspirin alone (n=331) or aspirin plus 3 months of clopidogrel (n=347). Follow-up was 1 year.
The study tested the hypothesis that aspirin alone would be superior to aspirin with 3 months clopidogrel with regard to primary outcome of all bleeding (procedural and non-procedural). The second hypothesis was that aspirin alone is non-inferior to aspirin with clopidogrel with regard to bleeding and thromboembolic events (a composite of CV mortality, non-procedural bleeding, stroke, or MI). Furthermore, it was evaluated whether aspirin alone was non-inferior to aspirin plus clopidogrel for thromboembolic events (a composite of CV mortality, stroke, or MI).
- Aspirin alone was superior to aspirin with clopidogrel treatment for the primary outcome all bleeding. All bleeding occurred in 15.1% of patients receiving aspirin alone and 26.6% of patients receiving aspirin with clopidogrel (RR 0.57, 95%CI: 0.42–0.77, P=0.001).
- CV mortality, non-procedural bleeding, stroke, or MI occurred in 23% of patients receiving aspirin and in 31.1% of patients receiving aspirin and clopidogrel (RR 0.74, 95% CI: 0.57-0.95, Pnon-inferiority<0.001, Psuperiority=0.04). CV mortality, stroke, or MI occurred in 9.7% of patients on aspirin and in 9.9 % of patients on aspirin and clopidogrel (RR 0.98, 95% CI: 0.62-1.55, Pnon-inferiority=0.004, Psuperiority=0.93).
These results indicate that treatment with aspirin alone as compared to aspirin and 3 months of clopidogrel reduces the risk of bleeding event with no increased risk of thromboembolism in patients without an indication of OAC treatment after TAVI. The authors conclude that aspirin alone should be used in patients undergoing TAVI who are not on OAC and have not recently undergone coronary stenting.
The discussant, Anna Sonia Petronio (Italy), said that this trial confirmed what smaller trials, such as the ARTIC trial, have suggested, but they were not powered to demonstrate significant effects. Although the results were positive, a few things need attention, she said. Younger patients need to be included and they will likely undergo more PCIs in life and have increased risk of AF, for which they will need anticoagulation. Furthermore, Petronio said that a substudy of GALILEO showed no benefit with anticoagulation with regard to thrombosis in the leaflets after TAVI and this requires further clarification as more patients will undergo TAVI in the future.
During the discussion session at the pressconference , the question was asked how large the subgroup of TAVI patients that do not have an indication of OAC is. Professor Jurrien ten Berg (Nieuwegein, The Netherlands), the principle investigator, answered, when looking at the entire POPular-TAVI cohort, this is around 60% to 65%.
- Our reporting is based on the information provided at the ESC congress