Key result
Vitamin K antagonists did not significantly reduce thromboembolic events compared to antiplatelet therapy (5% vs 6.8%, OR 0.73) after bioprosthetic valve implantation, but increased major bleeding.
Why the study?
The optimum medical therapy in the first three months after surgical bioprosthetic valve implantation remains controversial, with current ACC guideline recommendations based on non-randomized studies.
Does anticoagulation with vitamin K antagonists compared to antiplatelet therapy reduce thromboembolism or mortality in adult patients after surgical bioprosthetic valve implantation?
Meta-Analysis (n=590)
Open-label
Randomized
Does anticoagulation with vitamin K antagonists compared to antiplatelet therapy reduce thromboembolism or mortality in adult patients after surgical bioprosthetic valve implantation?
Odds Ratio: 0.73 (95% CI 0.36–1.46)
Absolute Event Rate: 5% vs 6.8%
p-value: p=0.37
In the first three months after surgical bioprosthetic valve implantation, vitamin K antagonists and antiplatelet therapy have similar rates of thromboembolism and mortality, but VKAs significantly increase major bleeding, suggesting antiplatelet therapy may be preferable.
Aspirin may be preferable to VKA early after bioprosthetic valve implantation; challenges guideline equipoise by showing excess bleeding without thromboembolic or mortality benefit.
BACKGROUND: The optimum medical therapy in the first three months after surgical bioprosthetic valve implantation (BVI) remains controversial. Current guidelines of the American College of Cardiology recommend either anticoagulation with vitamin K antagonists (VKA) (level IIa) or antiplatelet (AP) using aspirin (level IIa) after surgery, which is based on non-randomized studies. Hence, we performed a meta-analysis of randomized controlled trials (RCT) comparing the efficacy and safety of VKA vs AP therapy early after surgical BVI. METHODS: An extensive search of PubMed, Medline, Cochrane and Ovid was performed for RCTs comparing VKA vs AP therapy among adult patients who underwent surgical BVI. Outcome measures for thromboembolism, all-cause mortality and major bleeding were extracted and analyzed using a random effect model via Review Manager V5.3. RESULTS: Three RCTs with 590 patients were included. There were no differences in the rates of thromboembolic events (5% vs 6.8%; p=0.37) or all-cause mortality (4.7% vs 5.8% p=0.64) between the VKA vs AP groups There was a higher incidence of major bleeding in the VKA group (6% vs 2.4%), which was statistically significant (OR 2.63 (95% CI 1.08–6.43; p=0.03)). CONCLUSION: Vitamin K antagonist and AP therapies have similar rates of thromboembolic events and all-cause mortality in the first three months among patients post-surgical BVI. However, VKAs have a significantly higher incidence of major bleeding, which suggests that AP therapy may be the preferable strategy for anticoagulation in BVI post-surgery.
No takes yet. Share an insight, caveat, or question.
Gerodias et al. (2019) conducted a meta-analysis in Surgical bioprosthetic valve implantation (n=590). Vitamin K antagonists vs. Antiplatelet therapy was evaluated on Thromboembolic events (OR 0.73, 95% CI 0.36-1.46, p=0.37). Vitamin K antagonists did not significantly reduce thromboembolic events compared to antiplatelet therapy (5% vs 6.8%, OR 0.73) after bioprosthetic valve implantation, but increased major bleeding.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: