DUAL VERSUS MONO-ANTIPLATELET THERAPY POST-TRANSCATHETER AORTIC VALVE IMPLANTATION: A META-ANALYSIS OF 30-DAY OUTCOMES

Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement in patients considered at very high surgical risk. Despite high success rates, ischemic complications such as myocardial infarction (MI) and stroke are not uncommon. Post-procedure dual antiplatelet therapy (DAPT) with ASA and clopidogrel is commonly used to reduce these complications despite the lack of clinical trial evidence demonstrating superiority over mono-antiplatelet therapy alone. We conducted a systematic review and performed a meta-analysis of studies comparing DAPT vs. mono-antiplatelet therapy in patients who underwent TAVI. Meta-analysis was conducted by combining odds ratios of individual studies into a pooled odds ratio (OR) using a random-effects model. 95% confidence intervals for both individual and composite outcomes were calculated. Hypotheses of a difference in DAPT vs. mono-antiplatelet therapy were evaluated at an alpha level of 0.05. Our search strategy yielded 91 studies of which 3 studies met inclusion: 1 randomized controlled trial and 2 prospective cohort studies. In total, 520 patients were included (466 trans-femoral approach, 54 trans-apical approach), with 226 in the DAPT group (combined ASA and clopidogrel) and 294 patients in the mono-antiplatelet therapy group (2 studies ASA alone, 1 study ASA or clopidogrel alone). In comparison of DAPT versus mono-antiplatelet therapy, there was no difference in 30-day spontaneous MI (OR 0.59, [95% CI 0.09 - 4.07], p=0.59, I2= 0%), 30-day major stroke (OR 1.61, [95% CI 0.36 - 7.15], p=0.53, I2= 14%), 30-day cardiovascular death (OR 1.28, [95% CI 0.67 - 2.45], p=0.45, I2= 0%), and combined 30-day MI and/or stroke (OR 1.31, [95% CI 0.43 - 3.97], p=0.64, I2= 0%). Patients in the DAPT group experienced increased major bleeding (OR 3.46, [95% CI 1.71 - 6.99], p=0.0006, I2= 0%), and increased combined 30-day MI/stroke/cardiovascular death/major bleeding (OR 2.13, [95% CI 1.30 - 3.48], p=0.003, I2= 12%). The results of this meta-analysis show that DAPT post-TAVI compared to mono-antiplatelet therapy alone increases the risk of major bleeding, with no clear benefit in reduction of 30-day MI, stroke, and/or cardiovascular death. Given the limitations of the pooled analysis (such as small sample size and observational studies), the optimal antiplatelet regimen post-TAVI should be explored in a large randomized controlled trial.