The efficacy and safety of novel oral anticoagulants versus vitamin k antagonist in transcatheter aortic valve replacement patients with indications for anticoagulation

Abstract

Abstract Introduction Thrombotic events from atrial fibrillation, clinical and subclinical leaflet thromboses continue to be a major concern in Transcatheter Aortic Valve Replacement (TAVR) patients despite technological advancement and operator expertise. The proportion of TAVR patients who have or eventually develop indications for anticoagulation is not negligible and thus may warrant oral anticoagulants. However, the choice of anticoagulation is this select patients remained debatable. Thus, this study was conducted to determine whether current collective data support the efficacy and safety of novel oral anticoagulants (NOACS) versus vitamin K antagonists (VKAs). Purpose Oral anticoagulation (OAC) is necessary but the patients who needed it the most have baseline high bleeding risks. Anticoagulation carries a high bleeding risk especially among majority of a typical post TAVR patients with indications for anticoagulation. The paucity of data among asian TAVR patients were propensity to bleed are prevailing issues with anticoagulation owing perhaps to genetic or race predisposition and lower body weights or BMI compared to non-Asian counterparts. Currently the high court is still out to settle the optimum choice of anti-thrombotic therapy after TAVR. With TAVR now being performed in our local setting, we find this a relevant issue, hence we conducted a meta-analysis. Methods A literature search from Pubmed, Embase, and Cochrane databases for relevant RCTs and observational studies published until February 2022 were conducted. The pooled estimates of all-cause mortality, stroke and major bleeding events were measured using RevMan version 5.4.1 software. Results Eleven eligible studies (9 observational studies and 2 RCTs) allocated 29,156 TAVR patients with indications for anticoagulation either to receive NOACS (n = 11,718) or VKAs (n = 17,468). The effect estimate using random effects model showed no significant differences in all-cause mortality (RR 0.79, 95% CI 0.42–2.25, p = 0.07), stroke (RR 0.96, 95% CI 0.54–2.79, p = 0.70), and major bleeding events (RR 0.82, 95% CI 0.48–1.44, p = 0.08) between the NOACs and VKAs treatment arms. Conclusion NOACs demonstrated non-inferiority over VKA in reducing all-cause mortality, stroke and major or life-threatening bleeding events in TAVR patients with indications for anticoagulation.