What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Bioprosthetic valve replacement with another indication for anticoagulation (n=4088). Intervention: Direct oral anticoagulants (DOACs) vs. Vitamin K antagonists (VKAs). Primary outcome: Bleeding (OR 0.94, 95% CI 0.56-1.57, p=0.81).

February 27, 2023Frontiers in Cardiovascular Medicine4 citationsOpen Access

Safety and efficacy of direct oral anticoagulants in bioprosthetic valves: A systematic review and meta-analysis

LBLubna Bakr AEAhmed Elsayed OSOmar Saleh

Key Result

Direct oral anticoagulants showed no significant difference in bleeding (OR 0.94), stroke (OR 0.75), or all-cause mortality (OR 0.85) compared to vitamin K antagonists in patients with bioprosthetic valves.

Study Design

Type

Meta-Analysis (n=4,088)

Structured PICO

Do direct oral anticoagulants improve safety and efficacy outcomes compared to vitamin K antagonists in patients with bioprosthetic valves and another indication for anticoagulation?

Population

4,088 patients with bioprosthetic valves and an indication for anticoagulation (mostly atrial fibrillation) included in a meta-analysis of 10 studies comparing direct oral anticoagulants to vitamin K antagonists.

Intervention

Direct oral anticoagulants (DOACs)

Comparator

Vitamin K antagonists (VKAs) / warfarin

Outcome

Bleeding, stroke, and all-cause mortalityhard clinical

DOACs appear to be a safe and effective alternative to VKAs in patients with bioprosthetic valves who require anticoagulation for other indications.

Main Result

Odds Ratio: 0.94 (95% CI 0.56–1.57)

Absolute Event Rate: 16% vs 17%

p-value: p=0.81

Limitations

Most of the included studies are either retrospective or prospective lacking in randomisation.
Many of the included studies did not include a large number of patients.
Wide variation between the studies in terms of the follow-up period.
Studies were not consistent in terms of the position of the bioprosthetic valve.
The overall number of events was relatively small.

Abstract

Background Direct oral anticoagulants are efficient alternatives to vitamin K antagonists. There is little evidence regarding their use in patients who underwent bioprosthetic valve replacement whether surgically or through a transcatheter approach and have another indication of anticoagulation. Trials have compared different members of the DOACs family to VKAs and showed that they were at least non-inferior to VKAs with regard to safety and efficacy. However, this is still controversial. Our meta-analysis aims at providing a clearer view of their future use in this subgroup of patients. Methods PubMed and Cochrane were searched for randomised clinical trials and observational studies. Bleeding, stroke, and all-cause mortality were the outcomes of interest. Results Ten papers with a total of 4, 088 patients were included. Our meta-analysis revealed no significant differences between the incidence of bleeding between DOACs and warfarin (16% vs. 17%, OR = 0. 94, 95% CI 0. 56–1. 57, p = 0. 81, I 2 = 81%). No statistical difference was found in stroke between both groups (2. 5% vs. 3. 3%, OR = 0. 75, 95% CI 0. 41–1. 38, p = 0. 36, I 2 = 35%). All-cause mortality was not statistically significant between both groups (9. 2% vs. 13. 7%, OR = 0. 85, 95% CI 0. 68–1. 07, p = 0. 16, I 2 = 56%). Interestingly, subgroup analysis of randomised controlled trials and prospective studies favoured DOACs with lower risks of both bleeding and stroke. Conclusion Direct oral anticoagulants appear to be at least as safe and effective as VKAs in patients with bioprosthetic valves and another indication of anticoagulation. There could be potential benefit from the use of DOACs; however, further evidence is required. Systematic Review Registration https: //www. crd. york. ac. uk/prospero/displayᵣecord. php? ID=CRD42021222146, identifier CRD42021222146.

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