Direct Oral Anticoagulants (DOACs) are Non-Inferior to Vitamin K Antagonists for Patients Undergoing Transcatheter Aortic Valve Replacement with Indications of Anticoagulation

Jia Wang; Feng-Ying Zhang; Li Liu; Mang-Mang Pan; Chi Zhang; Jin Chen; Yuan Bian; Hou-Wen Lin; Zhi-Chun Gu

doi:10.31083/j.rcm2310346

Direct Oral Anticoagulants (DOACs) are Non-Inferior to Vitamin K Antagonists for Patients Undergoing Transcatheter Aortic Valve Replacement with Indications of Anticoagulation

Rev Cardiovasc Med. 2022 Oct 17;23(10):346. doi: 10.31083/j.rcm2310346. eCollection 2022 Oct.

Authors

Jia Wang¹, Feng-Ying Zhang², Li Liu¹, Mang-Mang Pan¹, Chi Zhang¹, Jin Chen², Yuan Bian³, Hou-Wen Lin¹, Zhi-Chun Gu^{1

4}

Affiliations

¹ Department of Pharmacy, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, 200127 Shanghai, China.
² Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, 610041 Chengdu, Sichuan, China.
³ Personalized Drug Therapy Key Laboratory of Sichuan Province, Department of Pharmacy, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, 610072 Chengdu, Sichuan, China.
⁴ Drug Clinical Comprehensive Evaluation Group, Shanghai Pharmaceutical Association, 200040 Shanghai, China.

Abstract

Background: The best anticoagulation choice for patients undergoing transcatheter aortic valve replacement (TAVR) with indications of oral anticoagulation (OAC) remains uncertain. We carried out a comprehensive analysis adopting updated evidence that investigated the efficacy and safety of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in this population.

Methods: A systematic search has been conducted through PubMed, Embase, and Cochrane Library to collect randomized controlled trials (RCTs) and real-world studies comparing the therapy outcomes of DOACs with VKAs in patients undergoing TAVR with indications of OAC up to Dec 2021. Included studies reported all-cause mortality, bleeding, stroke, or composite endpoint. A random-effects model was used and followed a sensitivity analysis based on the heterogeneity. In addition, five scenario analyses were performed to robust our findings.

Results: Our analysis included 11 articles enrolling a total of 8934 patients undergone TAVR with indications of OAC (DOACs group = 3890, VKAs group = 5044). Pooled analysis revealed no significant different risk of all-cause mortality (aHR: 0.95, 95% CI: 0.65-1.39, $I^{2}$ : 90.6%), stroke (aHR: 0.86, 95% CI: 0.55-1.35, $I^{2}$ : 44.3%), bleeding (aHR: 0.83, 95% CI: 0.61-1.13, $I^{2}$ : 76.3%), and composite endpoint (aHR: 1.05, 95% CI: 0.88-1.24, $I^{2}$ : 11.7%) in the DOACs and VKAs groups. Various forms of death, stroke and bleeding, including cardiovascular death (aHR: 0.92, 95% CI: 0.64-1.33, $I^{2}$ : 34.1%), hemorrhagic stroke (aHR: 0.63, 95% CI: 0.23-1.75, $I^{2}$ : 22.7%), ischemic stroke (aHR: 0.79, 95% CI: 0.56-1.15, $I^{2}$ : 0.0%), transient ischemic attack (aHR: 0.75, 95% CI: 0.40-1.41, $I^{2}$ : 0.0%), major or life-threatening bleeding (aHR: 0.96, 95% CI: 0.74-1.24, $I^{2}$ : 27.9%), and minor bleeding (aHR: 0.90, 95% CI: 0.52-1.57, $I^{2}$ : 54.3%), also showed similar rates among DOACs and VKAs groups. The results based on five scenarios confirmed the said findings.

Conclusions: Compared with VKAs, the efficacy and safety of DOACs were comparable for treating TAVR patients combined with anticoagulation indications. Further large-scale RCTs investigating more detailed scenarios are still needed to confirm the optimal anticoagulation strategy.

Keywords: anticoagulation; apixaban; edoxaban; hemorrhage; thromboembolism; valve replacement.