Abstract
Objective: We aimed to compare non-vitamin K oral anticoagulants (NOACs) with a traditional antithrombotic such as vitamin K antagonist (VKA) and antiplatelet agents in patients after transcatheter aortic valve replacement (TAVR). Methods: We conducted a search in PubMed, EMBASE, and the Cochrane Library until November 2021 for studies involving comparisons of any type of NOACs, including dabigatran, apixaban, rivaroxaban, and edoxaban, with VKA or antiplatelet agents after TAVR. A comparison of NOACs versus VKA was performed in patients with an indication for oral anticoagulation. In addition, we compared NOACs versus antiplatelet in patients without such indication. We calculated the hazard ratios with 95% confidence intervals (CIs) to determine long-term outcomes. The primary outcome was a combined endpoint consisting of all-cause mortality, stroke, major bleeding, or any related clinical adverse events. Secondary outcomes were all-cause mortality, major bleeding, and stroke, respectively. Results: A total of 10 studies including 10,563 patients after TAVR were included in this meta-analysis. There were no significant differences in any of the long-term outcomes between the NOAC and VKA groups. Although there were no significant differences in the combined endpoint, major bleeding, or stroke, a significant difference was observed in the all-cause mortality (HR 1.74, 95% CI 1.25–2.43, p = 0.001) between the NOAC and antiplatelet groups. Conclusion: For patients with an indication for oral anticoagulation after TAVR, NOACs seem to be associated with noninferior outcomes compared with VKA therapy. However, for patients without an indication for oral anticoagulation, NOACs appear to be associated with a higher risk of all-cause death as compared with antiplatelet treatment. Systematic Review Registration: https://clinicaltrials.gov/, identifier CRD42020155122.
Highlights
Since the introduction of transcatheter aortic valve replacement (TAVR) in 2002, it has been widely used in high-risk patients with aortic stenosis (Cribier et al, 2002; Hamm et al, 2016)
There were no significant differences in the combined endpoint, major bleeding, or stroke, a significant difference was observed in the all-cause mortality (HR 1.74, 95% confidence intervals (CIs) 1.25–2.43, p = 0.001) between the non-vitamin K oral anticoagulants (NOACs) and antiplatelet groups
For patients with an indication for oral anticoagulation after TAVR, NOACs seem to be associated with noninferior outcomes compared with vitamin K antagonist (VKA) therapy
Summary
Since the introduction of transcatheter aortic valve replacement (TAVR) in 2002, it has been widely used in high-risk patients with aortic stenosis (Cribier et al, 2002; Hamm et al, 2016). Recent guidelines from the American College of Cardiology (ACC) and European Society of Cardiology (ESC) have divided patients who have undergone TAVR into those who have an indication for oral anticoagulation and those who do not have an indication (Falk et al, 2017; Otto et al, 2021). For patients without an indication, the ACC (Otto et al, 2021) recommends “aspirin 75–100 mg daily is reasonable in the absence of other indication for oral anticoagulants (moderate recommendation); or dual antiplatelet therapy with aspirin 75–100 mg and clopidogrel 75 mg may be reasonable for 3–6 months (weak recommendation); or anticoagulation with a VKA to achieve an INR of 2.5 in patients at low risk of bleeding for at least 3 months (weak recommendation),” whereas the ESC (Falk et al, 2017) recommends “dual antiplatelet for the first 3–6 months followed by lifelong single antiplatelet, or single antiplatelet in the case of high bleeding risk.”. Aside from the consensus on 3-to-6-month dual antiplatelet therapy for TAVR patients who do not need oral anticoagulation, a detailed recommendation of oral anticoagulation for TAVR patients, especially for patients with an indication, remains unclear
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