Impact of Educational Intervention on Anticoagulation Control Using SAMe-TT<inf>2</inf>2R<inf>2</inf> Score-Guided Strategy in Atrial Fibrillation

Abstract

Background: An educational-behavioral intervention has been shown to improve anticoagulation control with warfarin in atrial fibrillation (AF) patients, but widespread application may not be practical. The SAMe-TT2R2 score was formulated to identify the likelihood of achieving optimal time in therapeutic range (TTR). Objectives: The authors conducted a randomized controlled trial to evaluate the impact of a SAMe-TT2R2 score-guided strategy for an educational-behavioral intervention, compared with usual care on patient's anticoagulation control. Methods: Anticoagulant-naive adult AF patients were randomized to a SAMe-TT2R2 score-guided strategy or usual care. In the SAMe-TT2R2 score-guided strategy group, scores 0 to 2 received usual care, >2 received educational-behavioral intervention plus usual care. All received warfarin targeting international normalized ratio 2.0 to 3.0. Primary outcome was TTR at 12 months. Secondary outcomes included TTR at 6 months, thromboembolic and bleeding events, major adverse cardiovascular events at 12 months, and change in AF knowledge at 6 and 12 months. Results: A total of 320 patients (mean age 69.5 years; 48.8% female) were randomized to a SAMe-TT2R2 score-guided strategy plus usual care (n = 156) or usual care alone (n = 164). Mean CHA2DS2-VASc score and SAMe-TT2R2 score were 3.1 ± 1.4 and 3.3 ± 0.9, respectively. At 12 months, mean TTR was not significantly different between groups (41.0 [95% CI: 36.7-45.2] in the SAMe-TT2R2 score-guided strategy vs 40.2 [95% CI: 35.9-44.4] with usual care, and the difference between the 2 groups was 0.7 [95% CI: −5.2 to 6.6]). There were no significant differences in secondary outcomes. Conclusions: SAMe-TT2R2 score-guided strategy for an educational-behavioral intervention, compared with usual care did not significantly improve outcomes over 12 months. (Thai Clinical Trials Registry identification number TCTR20180711003)