PATIENT REPORTED OUTCOMES ASSOCIATED WITH NON-TREATMENT: A REAL-WORLD OUTCOMES EVALUATION OF ATRIAL FIBRILLATION PATIENTS NOT RECEIVING ORAL ANTICOAGULATION
Author(s)
Maria-Magdalena Balp, MASc, MD1, Yuchen Guo, PhD2, Sarah Grundy, MD2, Katherine Byrne, MA2.
1Novartis Pharma AG, Basel, Switzerland, 2Novartis Pharmaceuticals Ltd, London, United Kingdom.
1Novartis Pharma AG, Basel, Switzerland, 2Novartis Pharmaceuticals Ltd, London, United Kingdom.
OBJECTIVES: Oral anticoagulants (OAC) are widely prescribed for stroke prevention in atrial fibrillation (AF). The extent to which reasons for OAC non-use reflect patient perceptions of their health and wellbeing remains unclear.
METHODS: Data from the multi-country GARDENIA registry (AF patients not treated with OAC: NCT05421533) were descriptively analysed by baseline EQ5D-5L, Visual Analogue Scale (VAS), Fatigue Resistance Ambulation Illness Loss of weight (FRAIL) Scale domains and Investigator-provided primary reason for OAC non-use.
RESULTS: Of 704 patients, 91% had a primary reason for OAC non-use, most commonly previous patient bleeding (PB 19%), patient refusal (PR 18%), bleeding risk from underlying conditions (UC 17%), and history of falls/frailty (FF 12%). Investigators reported symptomatic AF in 38% of patients (PB 29%, PR 52%, UC 34%, FF 38%). VAS mean (SD) scores were PB 65.3 (21.0), PR 70.7 (19.1), UC 61.9 (20.7), FF 65.2 (23.8). The proportion reporting ‘moderate/severe/extreme’ by EQ5D-5L dimension was: Mobility - PB 50%, PR 26%, UC 38%, FF 59%; Self-care - PB 29%, PR 10%, UC 25%, FF 34%; Usual activities - PB 35%, PR 14%, UC 37%, FF 49%; Pain/discomfort - PB 34%, PR 34%, UC 30%, FF 43%; Anxiety/depression - PB 25%, PR 20%, UC 17%, FF 27%. The proportion reporting Fatigue some/most/all the time in the FRAIL Scale was PB 69%, PR 48%, UC 54%, FF 76%. Criteria presence across other domains: Resistance - PB 48%, PR 29%, UC 34%, FF 69%; Ambulation - PB 62%, PR 37%, UC 47%, FF 76%; Illness - PB 84%, PR 71%, UC 73%, FF 80%; Weight loss - PB 32%, PR 21%, UC 18%, FF 35%.
CONCLUSIONS: AF patients report diverse levels of disease burden by reason for OAC non-use. Divergence is noted between investigator- and patient-reported symptom levels. These findings warrant further research on implications for patient experience.
METHODS: Data from the multi-country GARDENIA registry (AF patients not treated with OAC: NCT05421533) were descriptively analysed by baseline EQ5D-5L, Visual Analogue Scale (VAS), Fatigue Resistance Ambulation Illness Loss of weight (FRAIL) Scale domains and Investigator-provided primary reason for OAC non-use.
RESULTS: Of 704 patients, 91% had a primary reason for OAC non-use, most commonly previous patient bleeding (PB 19%), patient refusal (PR 18%), bleeding risk from underlying conditions (UC 17%), and history of falls/frailty (FF 12%). Investigators reported symptomatic AF in 38% of patients (PB 29%, PR 52%, UC 34%, FF 38%). VAS mean (SD) scores were PB 65.3 (21.0), PR 70.7 (19.1), UC 61.9 (20.7), FF 65.2 (23.8). The proportion reporting ‘moderate/severe/extreme’ by EQ5D-5L dimension was: Mobility - PB 50%, PR 26%, UC 38%, FF 59%; Self-care - PB 29%, PR 10%, UC 25%, FF 34%; Usual activities - PB 35%, PR 14%, UC 37%, FF 49%; Pain/discomfort - PB 34%, PR 34%, UC 30%, FF 43%; Anxiety/depression - PB 25%, PR 20%, UC 17%, FF 27%. The proportion reporting Fatigue some/most/all the time in the FRAIL Scale was PB 69%, PR 48%, UC 54%, FF 76%. Criteria presence across other domains: Resistance - PB 48%, PR 29%, UC 34%, FF 69%; Ambulation - PB 62%, PR 37%, UC 47%, FF 76%; Illness - PB 84%, PR 71%, UC 73%, FF 80%; Weight loss - PB 32%, PR 21%, UC 18%, FF 35%.
CONCLUSIONS: AF patients report diverse levels of disease burden by reason for OAC non-use. Divergence is noted between investigator- and patient-reported symptom levels. These findings warrant further research on implications for patient experience.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR159
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory)