• Silvia Galliazzo, Valentina Pelitti, Leonardo Campiotti, Daniela Poli, and Alessandro Squizzato.
• Internal Medicine, Ospedale San Valentino-AULSS 2 Marca Trevigiana, Via Palmiro Togliatti, 1, 31044, Montebelluna, Treviso, Italy. galliazzosil@gmail.com.
• Intern Emerg Med. 2023 Mar 1; 18 (2): 535547535-547.

AbstractTo 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 I2 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; I2 = 0%) and a RR of major bleeding of 0.50 (95% CI 0.39-0.63; I2 = 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, I2 = 0%) and of 0.68 (95% CI 0.32-1.44; I2 = 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; I2 = 0%) and of 0.76 (95% CI 0.05-10.72; I2 = 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.© 2023. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).

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