Are NOACs as safe and efficient as VKA regarding thromboembolic prophylaxis and major bleeding in patients with surgical bioprosthesis and atrial fibrillation within 3 months of surgery?

Abstract

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: ‘Are NOACs as safe and efficient as vitamin K antagonist regarding thromboembolic prophylaxis and major bleeding in patients with surgical bioprosthesis and atrial fibrillation within 3 months of surgery?’ Altogether more than 324 papers were found using the reported search, of which 6 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The RIVER and ENAVLE trials showed non-inferiority of rivaroxaban (regarding mean time free from composite of death, major cardiovascular events or major bleeding at 12 months) and edoxaban (composite of death, clinical thromboembolic events or asymptomatic intracardiac thrombosis; and major bleeding) when compared with vitamin K antagonist. These studies include a low number of patients within 3 months of index surgery and overall low statistical power regarding this particular subgroup of patients. Data derived from lower evidence studies are compatible with the aforementioned findings. The available evidence suggests that non-vitamin K antagonist anticoagulants are as safe and as efficient as vitamin K antagonist regarding thromboembolic prophylaxis and bleeding event rates in patients with surgical bioprosthesis and atrial fibrillation within 3 months of bioprosthesis implantation. However, this evidence is derived from a limited number of studies with important methodological limitations. Expanding non-vitamin K antagonist anticoagulant recommendation to the early postoperative period warrants more confirmatory research.

Oral anticoagulation following bioprosthetic SAVR in patients with atrial fibrillation: what’s the current status of NOACs?

“…In summary, Magro and Sousa-Uva [ 7 ] have confirmed information from current guidelines, calling for more confirmatory evidence regarding the use of NOACs in the early postoperative period in patients receiving a BHV. Unfortunately, the observed data quality requires further multicentre RCTs to better understand the safety and efficacy of different NOACs as an anticoagulation strategy in the immediate postoperative period.…”

“…In this issue of the journal, Magro and Sousa-Uva [ 7 ] report the results of a systematic literature search and critical appraisal of available evidence to answer an essential clinical question of whether the efficacy and safety of NOACs are similar to VKAs within 3 months of surgical implantation of a BHV in those patients with AF. The noteworthy findings of the research by Magro and Sousa-Uva [ 7 ] can be summarized as follows:…”

“…Would NOACs be the future standard of care for specific patients with surgical BHV replacement and baseline indication for OAC? The critical appraisal by Magro and Sousa-Uva [ 7 ] showed no significant differences in safety and efficacy outcomes across subgroups, including those treated with NOACs in the early and later stages. Studies included in the present review were not designed among patients with specific types of AF; therefore, it is unknown whether the effects of NOACs differ among patients with longstanding persistent, paroxysmal, and new-onset postoperative AF.…”