The ENVISAGE-TAVI AF trial demonstrated that Edoxaban’s non-inferiority to warfarin with regards to myocardial infarction (MI), ischaemic stroke, systemic thromboembolism, and valve thrombosis, in participants with atrial fibrillation (AF) after transcatheter aortic valve implantation (TAVI). However, the incidence of major bleeding was found to be higher with Edoxaban versus warfarin and its analogues.
Presented by Dr. George Dangas at the ESC 2021 virtual congress, this study assessed the efficacy and safety of Edoxaban versus warfarin and other vitamin K antagonists (VKAs) among patients undergoing TAVI with either pre-existing or new-onset AF.
1,426 participants across 14 countries and 173 centres were enrolled and randomised in an open-label 1:1 ratio to either Edoxaban (60mg daily) or VKA with an international normalised ratio (INR) goal of 2-3. Median follow-up was 540 days.
The primary efficacy outcome, all-cause mortality, MI, ischemic stroke, systemic thromboembolic event, valve thrombosis, or major bleeding, for edoxaban versus VKA, was 17.3/100 person-years (PY) vs. 16.5/100 PY (hazard ratio [HR] 1.05, 95% confidence interval [CI] 0.85-1.31, p = 0.01 for noninferiority). The primary safety endpoint, major bleeding: 9.7/100 PY versus 7/100 PY (HR 1.40, 95% CI 1.03-1.91, p = 0.93 for noninferiority).
Of note, increased risk of bleeding with edoxaban was mainly due to gastrointestinal bleeding and likely a reflection of the elderly and frail patient population enrolled. Results from this trial are similar to data with edoxaban in patients with AF not undergoing TAVI.
Source: Dangas G, et al. MASTER DAPT. Presented at: European Society of Cardiology Congress; Aug. 27-30, 2021 (virtual meeting).
Van Mieghem NM, Unverdorben M, Hengstenberg C, et al., on behalf of the ENVISAGE-TAVI AF Investigators. Edoxaban Versus Vitamin K Antagonist for Atrial Fibrillation After TAVR. N Engl J Med 2021;Aug 28:[Epub ahead of print].
Figure 1 (Top): Taken from the ESC Congress 2021. Visual abstract of the ENVISAGE-TAVI AF trial.