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

Christian Hengstenberg¹, Nicolas M Van Mieghem², Rosa Wang³

¹Division of Cardiology, Department of Internal Medicine II, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.

The American Journal of Cardiology

|January 1, 2026

Summary

Edoxaban significantly improved patient convenience and satisfaction compared to vitamin K antagonists (VKAs) after transcatheter aortic valve replacement, according to the ENVISAGE-TAVI AF trial. This finding highlights edoxaban

Keywords:

Edoxaban atrial fibrillation patient-reported outcome transcatheter aortic valve replacement treatment convenience treatment satisfaction win ratio

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Area of Science:

Cardiology
Pharmacology
Patient-Reported Outcomes

Background:

Previous ENVISAGE-TAVI AF trial reports indicated superior patient experience with edoxaban over vitamin K antagonists (VKAs).
Understanding the specific drivers of these patient-reported outcome (PRO) differences is crucial for clinical decision-making.

Purpose of the Study:

To conduct a post hoc analysis of the ENVISAGE-TAVI AF trial PRO data.
To utilize a win ratio (WR) approach to identify key factors contributing to treatment differences between edoxaban and VKAs.
To assess patient convenience and satisfaction using the Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2).

Main Methods:

Analysis of PACT-Q2 data (treatment convenience and satisfaction items) at 3 and 12 months from the ENVISAGE-TAVI AF trial.
Application of the win ratio (WR) methodology to compare patient-to-patient pairs between edoxaban and VKA groups.
Calculation of WR with 95% confidence intervals (CI) to quantify the probability of a more favorable outcome with edoxaban.

Main Results:

Edoxaban demonstrated a significantly higher probability of improved overall treatment convenience and satisfaction compared to VKAs.
At 3 months, the WR was 1.87 (95% CI, 1.58-2.22), and at 12 months, it was 2.01 (95% CI, 1.70-2.38).
This benefit was driven by 18 of 20 PACT-Q2 items, indicating meaningfully better outcomes across multiple aspects of treatment experience with edoxaban.

Conclusions:

The win ratio analysis confirms that edoxaban offers meaningfully better treatment convenience and satisfaction compared to VKAs in patients with atrial fibrillation post-transcatheter aortic valve replacement.
These findings reinforce the clinical value of edoxaban in improving the overall patient experience in this population.