Direct oral anticoagulants in patients with a left-sided bioprosthetic heart valve: a systematic review and meta-analysis

To compare the efficacy/effectiveness and safety of DOACs versus VKAs in patients with a previously and newly surgically implanted BHV with or without AF. A systematic search on MEDLINE and EMBASE was performed till November 2022. Treatment effects were estimated with relative risk (RR) and 95% confidence intervals (CIs) . Statistical heterogeneity was assessed with the I 2 statistic. Four randomized controlled trials (RCTs), 2 subgroup analysis from ARISTOTLE and ENGAGE-AF-TIMI 48 and 4 observational studies were included for a total of 5808 patients, 1893 on DOACs and 3915 on VKAs. AF prevalence was 98.28%. In the overall analysis, DOACs vs VKAs were associated with a RR for stroke/transient ischemic attack (TIA)/systemic embolism (SE) of 0.63 (95% CI 0.51–0.79; I 2 = 0%) and a RR of major bleeding of 0.50 (95% CI 0.39–0.63; I 2 = 0%) in a median follow-up of 19 months (IQR 4.5–33.4). In the 3 RCTs (DAWA, RIVER, ENAVLE), DOACs vs VKAs were associated with a RR of stroke/TIA/SE and major bleeding of 0.38 (95% CI 0.13–1.58, I 2 = 0%) and of 0.68 (95% CI 0.32–1.44; I 2 = 5%) respectively. In patients randomized during the first three months from valve surgery, DOACs vs VKAs were associated with a RR of stroke/TIA/SE and major bleeding of 0.54 (95% CI 0.14–2.08; I 2 = 0%) and of 0.76 (95% CI 0.05–10.72; I 2 = 66%). In previously implanted BHV patients with AF, DOACs showed a risk–benefit profile at least comparable to VKAs. DOACs showed a similar, even if underpowered, risk–benefit profile during the first three months after BHV implantation prevalently in patients with AF.