Direct Oral Anticoagulant Use After Transcatheter Aortic Valve Replacement: A Case Series

Abstract

Background: Use of an anticoagulant after transcatheter aortic valve replacement (TAVR) has been increasing in practice after noted leaflet thrombosis on dual antiplatelet therapy. As the use of anticoagulation increases so does the number of poor warfarin candidates or warfarin intolerant patients. While direct oral anticoagulant (DOAC) use is increasing for other indications, there is a paucity of data for use after TAVR. The objective of this case series is to add to the available evidence for patients who may require a DOAC after TAVR. Methods: A single-center, retrospective observational case series was conducted including adults 18 years of age and older who received a DOAC after TAVR between November 2008 and June 2018 at Mayo Clinic Hospital—Rochester. All patients were identified as part of the Society of Thoracic Surgeons database. Results: Twenty-one patients were identified as having received a DOAC after TAVR. Median age was 83.5 years (interquartile range 77–87), with 71% males. Within this cohort, 20 patients (95.2%) had an alternative indication for anticoagulation of either atrial fibrillation or atrial flutter. Apixaban was prescribed in 66.7% of patients, followed by rivaroxaban (14.3%), dabigatran (9.5%), and edoxaban (4.8%). No thromboembolic events were reported. Three patients experienced a bleeding event, of which only 2 occurred in the 3 months immediately after TAVR. Conclusions: DOAC therapy after TAVR was generally safe and well tolerated. Taken in context of other retrospective studies, these data suggest that the presence of valvular heart disease, specifically TAVR in this case, should not preclude the use of DOACs.

Safety and Efficacy of Apixaban Following Bioprosthetic Valve Replacements: A Retrospective Evaluation

“…Researchers concluded similarly that apixaban particularly may represent a safe and effective alternative to warfarin in TAVR patients. 9 Within this case series, 95% of patients had an alternative indication for anticoagulation (atrial fibrillation or atrial flutter), which is in contrast with our study in which only 26% of patients carried an atrial fibrillation/flutter diagnosis. Furthermore, our study included TAVR patients in addition to mitral, tricuspid, and surgical aortic valve replacement patients, providing evidence on apixaban’s safety in the setting of additional valve surgeries.…”

“…Within a case series of 21 patients conducted by the Mayo Clinic Hospital, 15 patients received apixaban after TAVR. 9 In this case series, only 3 patients experienced a bleeding event, and no thromboembolic events were reported. Researchers concluded similarly that apixaban particularly may represent a safe and effective alternative to warfarin in TAVR patients.…”

“…This study focused solely on apixaban due to possible improved safety profile compared with other DOACs in this setting. 1,2,9,10 Patients were identified via electronic report of all valve surgeries performed at the hospital from January 1, 2015, to January 1, 2020. Exclusion criteria included those who were <19 years of age, pregnancy, prisoners, those who had only valvular repairs, and those with mechanical heart valves, as documented in either the history and physical note and/or cardiovascular surgeon’s clinical note.…”

“…8 A case series study completed by the Mayo Clinic considered the outcomes of patients who underwent TAVR who were also prescribed a DOAC, and found DOACs were generally safe and well-tolerated. 9 In a subset of the ARISTOTLE trial, patients who had a bioprosthetic valve replacement were randomized to apixaban. 10 Overall clinical event rates in this population were low, with no significant differences between apixaban and warfarin for any outcomes.…”

<p>Apixaban: An Update of the Evidence for Its Place in the Prevention of Stroke in Patients with Atrial Fibrillation</p>

“…31 In a second publication including 21 patients treated with NOAC for atrial fibrillation after TAVR, no thromboembolic event was reported. 32 Large randomized trials evaluating the efficacy and safety of NOACS in atrial fibrillation patients undergoing TAVR are ongoing. The ATLANTIS trial, a multicenter, randomized, phase IIIb, prospective, 16 Coleman et al 17 Yoa et al 18 Li et al 19 Study open-label, superiority study comparing standard of care (SOC Group) versus an apixaban-based strategy (Anti-Xa Group) after successful TAVR (ClinicalTrials.gov NCT 02664649) is ongoing.…”