Efficacy and Safety of NOACs Compared With VKAs for Patients With Atrial Fibrillation After Transcatheter Aortic Valve Implantation: A System Review and Meta-Analysis.

Review Efficacy and Safety of NOACs Compared With VKAs for Patients With Atrial Fibrillation After Transcatheter Aortic Valve Implantation: A System Review and Meta-Analysis Clinical and Applied Thrombosis/Hemostasis Volume 28: 1-9 © The Author(s) 2022 Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/10760296221145168 journals.sagepub.com/home/cat Junye Ge, MD1, Wenqiang Han, MD, PhD1, Chuanzhen Ma, MD1, Kellina Maduray, MD1 , Tongshuai Chen, MD, PhD1, and Jingquan Zhong, MD, PhD, FACC1,2 Abstract Novel oral anticoagulants (NOACs) are preferentially recommended in patients with nonvalvular atrial fibrillation (AF) for stroke prevention over vitamin K antagonists (VKAs). However, the evidence regarding the efficacy and safety of NOACs versus VKAs after transcatheter aortic valve implantation (TAVI) in patients with AF is very rare. Pubmed, Embase, Web of science, and Cochrane Databases were searched for eligible studies published before May 19, 2022. A total of 11 studies were included in this meta-analysis involving 27 107 patients. Regarding primary outcomes, there were no differences between NOACs and VKAs in all-cause mortality (RR: 0.84, 95% CI: (0.69, 1.02)) and stroke (RR: 1.00, 95% CI: (0.85, 1.19)). With respect to secondary outcomes, NOACs were associated with reduced incidence of bleeding (RR: 0.77, 95% CI: (0.71, 0.83)) and intracranial bleeding (RR: 0.57, 95% CI: (0.39, 0.83)), whereas no significant differences were found in major or life-threatening bleeding (RR: 0.98, 95% CI: (0.82, 1.17)) and myocardial infarction (RR: 1.37, 95% CI: (0.83, 2.26)). Our meta-analysis revealed the safety and efficacy of NOACs may be superior to VKAs in AF patients undergoing TAVI. Keywords transcatheter aortic valve implantation, atrial fibrillation, anticoagulant, novel oral anticoagulant, vitamin K antagonist Date received: 30 September 2022; revised: 12 November 2022; accepted: 29 November 2022. 1 Introduction Transcatheter aortic valve implantation (TAVI) has become the preferred strategy for the treatment of symptomatic severe aortic stenosis in older adults, with indications broadened to include intermediate or low-risk patients.1,2 Atrial fibrillation (AF) is one of the most common persistent arrhythmias, with an annually increasing incidence, which is known to be closely associated with aortic stenosis.3-5 The prevalence of previous AF is as high as 51.1% among patients undergoing TAVI, whereas the new-onset AF rate ranges from 1% to 32%, increasing the risk of thromboembolic and bleeding events.5,6 The The Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, The State and Shandong Province Joint Key Laboratory of Translational Cardiovascular Medicine, Department of Cardiology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China 2 Department of Cardiology, Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University, Qingdao, China Corresponding Authors: Jingquan Zhong, Department of Cardiology, Qilu Hospital Affiliated to Shandong University, 107 Wen Hua Xi Road, Jinan 250012, China. Email: Tongshuai Chen, Department of Cardiology, Qilu Hospital Affiliated to Shandong University, 107 Wen Hua Xi Road, Jinan 250012, China. Email: . Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage). 2 majority of AF patients require oral anticoagulants (OACs), such as vitamin K antagonists (VKAs) or novel oral anticoagulants (NOACs), on a long-term basis to reduce thromboembolic events. Due to their superior efficacy and safety, NOACs has been widely used in clinical practice, which has become the preferred choice for stroke prevention in patients with nonvalvular AF.7,8 Currently, evidence regarding the efficacy and safety of NOACs versus VKAs after TAVI in patients with AF is very rare, thereby under debate. Throughout the available clinical evidence, the results were also controversial. A multicenter European study enrolled 962 patients undergoing TAVI, more than 99% of whom suffered from AF.9 The findings revealed that the composite outcomes, including any cerebrovascular event, all-cause mortality, and myocardial infarction, were significantly higher in NOACs than in VKAs during 1-year follow-up. In contrast, the largest observational study, including 21 131 AF patients from America, compared the clinical outcomes of NOACs versus VKAs after TAVI.10 The results demonstrated that the AF patients prescribed NOACs experienced lesser bleeding, intracranial hemorrhage or death events with comparable stroke events after TAVI during 1-year follow-up. On the one hand, some studies proved that NOACs were inferior to VKAs with increased composite outcomes or major bleeding events9,11; on the other hand, others supported that NOACs were equivalent or superior to VKAs in all-cause mortality, stroke, bleeding, and so on for patients with AF after TAVI.10,12,13 Due to the large difference in results, we analyzed the available clinical studies9-19 data to systematically evaluate the efficacy and safety of NOACs versus VKAs after TAVI in patients with AF to provide a reference for clinical treatment. Methods This meta-analysis was performed on the basis of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.20 A review protocol was not registered for this meta-analysis. Search Strategy Pubmed, Embase, Web of science, and Cochrane Databases were fully searched for eligible studies published before May 19, 2022. The detailed search strategy is summarized in Table 1 in the online supplementary materials. Study Selection and Quality Assessment The inclusion criteria: (1) The subjects were TAVI recipients with AF (AF patients >90% of the total subjects). (2) The study included comparisons between NOACs and VKAs groups. The exclusion criteria: (1) No-AF patients or AF patients <90% of the total subjects. (2) Studies that failed to report relevant data regarding NOACs and VKAs groups. The study quality was independently assessed by two authors based on the Newcastle-Ottawa Scale21 (observational study) or Cochrane Collaboration Risk of Clinical and Applied Thrombosis/Hemostasis Bias Tool22 (randomized controlled trial). Any inconsistencies were determined after discussion by two authors. Data Extraction and Summary Outcomes The required data were independently extracted by the two authors, including first author’s name, year, country, male proportion, number of patients, CHA2DS2-VASc score, HAS-BL (...truncated)