Patient-Reported Outcomes Using Win Ratio Analysis: A Post Hoc Analysis from the Randomized ENVISAGE-TAVI AF Trial

The previous report on patient-reported outcome findings of the ENVISAGE-TAVI atrial fibrillation (AF) (NCT02943785) trial demonstrated improved patient experience for edoxaban versus vitamin K antagonists (VKAs). This post hoc analysis aimed to provide insights on the patient-reported outcome findings of ENVISAGE-TAVI AF using a win ratio (WR) approach to understand key drivers of treatment differences. This analysis included patients who received edoxaban or VKAs and had evaluable Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) assessments from ENVISAGE-TAVI AF. The PACT-Q2 assesses treatment convenience (13 items) and satisfaction (7 items). PACT-Q2 data at months 3 and 12 were analyzed using the WR. Patient-to-patient pairs (one from each group) were compared based on predefined outcome rules; a “win,” “loss,” or “tie” was determined for edoxaban in each pairwise comparison. The WR (95% confidence interval [CI]) for edoxaban was calculated as the total number of pairs with a win divided by that of pairs with a loss. WR >1 indicates a more favorable patient experience for edoxaban versus VKAs. Edoxaban was associated with a higher probability of improved overall treatment convenience and satisfaction compared with VKAs at months 3 (WR [95% CI], 1.87 [1.58 to 2.22]) and 12 (WR [95% CI], 2.01 [1.70 to 2.38]). This difference was driven by 18 of 20 PACT-Q2 items, showing a significantly higher probability of meaningfully better outcomes with edoxaban. In conclusion, this WR analysis demonstrated that meaningfully better treatment convenience and satisfaction were more likely with edoxaban than with VKAs in patients with AF after transcatheter aortic valve replacement.