Objective Use of vitamin K antagonist (VKA) versus antiplatelet (AP)/no therapy following bioprosthetic valve implantation remains controversial. The aims of the current study were to (a) systematically review the published literature comparing the use of VKA versus AP/no treatment in such patients and (b) perform a meta-analysis of the risks and benefits of using a VKA compared with AP/no therapy.
Methods Five databases were searched including PubMed, Medline, Embase, Ovid and Cochrane for randomised clinical trials and observational studies comparing VKA (group I) versus AP/no therapy (group II). Outcome was after surgical intervention. Mantel-Haenszel odds ratio (OR) was calculated using random-effects meta-analysis for the outcome. Heterogeneity was assessed by I2 statistics. A total of 14 studies were included (two randomised trials, 12 observational studies and one conference abstract, 31 740 patients).
Results Between groups I (VKA) and II (AP/no therapy), there were no differences in thromboembolic events (145 (1%) vs 262 (1.5%), OR 0.96 (95% CI 0.60 to 1.52)), all-cause mortality (351 (3.5%) vs 415 (2.9%), OR 1.48 (95% CI 0.87 to 2.50)) or need for redo surgery (47 (3.3%) vs 55 (3.2%); OR 0.81 (95% CI 0.42 to 1.58)). However, there were more bleeding events in group I versus group II (292 (2.6%) vs 189 (1.1%); OR 2.26 (95% CI 1.67 to 3.05)).
Conclusions In a meta-analysis of randomised and observational studies of VKA versus AP/no treatment in patients undergoing bioprosthetic valve implantation, there was no benefit of adding a VKA regarding thromboembolism or mortality. However, use of a VKA was associated with increased risk of major bleeding.
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Contributors AM: Designed the study, wrote paper, revised paper, performed analysis. AMG, DMJ, JFS, LGS, LLR, SRK, WJS, RAG, BPG: Designed study, edited manuscript, edited revised manuscript. MYD: Designed the study, wrote paper, revised paper, performed analysis, overall supervision of the study.
Funding AMG is on the speakers' bureau for Atricure, Edwards, Medtronic and St. Jude's Medical. He also reports equity stake in Pleuraflow. DMJ is a consultant for Edwards, St. Judes, iVHR and KEF. JFS is a consultant for Medtronic and Sorin.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.