Aspirin alone lowers net clinical outcome compared to DAPT after TAVI
Aspirin Alone Versus Dual Antiplatelet Therapy After Transcatheter Aortic Valve Implantation: A Systematic Review and Patient-Level Meta-Analysis
Literature - Brouwer J, Nijenhuis VJ, Rodés-Cabau J, et al. - J Am Heart Assoc. 2021;10:e019604. doi: 10.1161/JAHA.120.019604.Introduction and methods
Patient undergoing transcatheter aortic valve implantation (TAVI) have a high risk for bleeding and thrombotic events. The current guidelines recommend dual antiplatelet therapy (DAPT) with aspirin and clopidogrel for the first 3-6 months followed by lifelong aspirin [1,2]. Yet, the optimal antithrombotic treatment to minimize the bleeding and thromboembolic risk in patient without a long-term indication for oral anticoagulation after TAVI is not completely determined.
The POPular TAVI cohort A trial in patients without a long-term indication for anticoagulation after TAVI demonstrated a lower incidence of bleeding without increased thromboembolic events with aspirin alone compared to DAPT [3]. This trial was powered for bleeding events and a composite endpoint of bleeding and thromboembolic events. However, it was not powered for thromboembolic events alone.
This study conducted a patient-level meta-analysis in order to increase the statistical power for thromboembolic events by pooling data of 4 RCTs that investigated the efficacy of aspirin vs. DAPT for the prevention of thromboembolic and bleeding events after TAVI in patients without an indication for oral anticoagulation.
4 Prospective RCTs that investigated aspirin alone vs aspirin with clopidogrel were included in the meta-analysis: 1) the POPular TAVI trial (n=665), 2) the ARTE trial (n=222), 3) the SAT-TAVI trial (n=120), and 4) the Dual Antiplatelet Therapy Versus Aspirin Alone in Patients Undergoing Transcatheter Aortic Valve Implantation trial (n=79) [3-6]. All trials randomly assigned patients in a 1:1 ratio to aspirin (80-160 mg daily for the entire trial duration) or DAPT (aspirin 80-160 mg daily with 75 mg clopidogrel daily or ticlopidine 500 mg twice daily for 3 to 6 months followed by 80-160 mg aspirin daily). The primary outcome was the composite of all-cause mortality, major or life-threatening bleeding, and stroke or myocardial infarction. The co-primary outcome was the composite of all-cause mortality, stroke or myocardial infarction. Follow-up was 30 days and 3 months. Outcome data at 30 days were available for all 4 RCTs. The three months follow-up outcomes were available for the POPular TAVI, ARTE, and Dual Antiplatelet Therapy Versus Aspirin Alone in Patients Undergoing Transcatheter Aortic Valve Implantation trials.
Main results
- The primary composite outcome of all-cause mortality, major of life-threatening bleeding, stroke and MI at 30 days occurred in 10.3% of patients treated with aspirin alone compared to 14.7% of patients on DAPT (OR 0.67, 95% CI: 0.46-0.97, P=0.0034).
- The co-primary outcome of the composite all-cause mortality, stroke or myocardial infarction at 30 days was similar in aspirin treated patients compared to patients on DAPT.
- The incidence of major bleeding at 30 days was less in the aspirin treated group compared to the DAPT treated group (2.4% vs. 5.9%, respectively, OR 0.40, 95% CI: 0.21-0.78, P=0.007). Also the combination of major or life-threatening bleeding occurred less in patients with aspirin alone than in those treated with DAPT (5.4% vs. 10.1%, respectively, OR 0.51, 95% CI: 0.32-0.82, P=0.005).
- The primary composite outcome of all-cause mortality, major and life-threatening bleeding, stroke or MI after 3 months occurred in 11.0% of patients on aspirin alone compared to 16.5% of patients receiving DAPT (HR 0.66, 95% CI: 0.47-0.94, P=0.02). There was no difference in the co-primary composite outcome of all-cause mortality, stroke or MI between aspirin and DAPT groups.
- There were less major bleedings after 3 months in patients receiving aspirin than in those on DAPT (2.3% vs. 6.4%, respectively, OR 0.35, 95% CI: 0.17-0.71, P=0.004). Also, the incidence of major and life-threatening bleedings combined was lower in the aspirin group compared with the DAPT group (4.8% vs. 10.5%, respectively, OR 0.43, 95% CI: 0.26-0.72, P=0.001).
Conclusion
This meta-analysis showed a lower incidence of the composite of bleedings and thrombotic events after TAVI in patients without a chronic indication for oral anticoagulation treated with aspirin compared to those receiving DAPT at 30 days or 3 months. Furthermore, a reduction in major or life-threatening bleeding and no increase in thromboembolic events were observed in the group treated with aspirin compared to DAPT.
References
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3. Brouwer J, Nijenhuis VJ, Delewi R, et al. Aspirin with or without clopidogrel after transcatheter aorticvalve implantation. N Engl J Med. 2020;383:1447–1457. DOI: 10.1056/ NEJMoa2017815.
4. Rodés-Cabau J, Masson J-B, Welsh RC, Garcia del Blanco B, Pelletier M, Webb JG, Al-Qoofi F, Généreux P, Maluenda G, Thoenes M, et al. Aspirin versus aspirin plus clopidogrel as antithrombotic treatment following transcatheter aortic valve replacement with a balloon expandable valve. JACC Cardiovasc Interv. 2017;10:1357–1365. DOI: 10.1016/j.jcin.2017.04.014.
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6. Ussia GP, Scarabelli M, Mulè M, Barbanti M, Sarkar K, Cammalleri V, Immè S, Aruta P, Pistritto AM, Gulino S, et al. Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol. 2011;108:1772–1776. DOI: 10.1016/j.amjca rd.2011.07.049.
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