Abstract 12618: Cluster Randomized Controlled Trial to Test The Effect of a Multifaceted Comprehensive Cardiovascular Care Intervention on Clinical Outcomes in Atrial Fibrillation Patients Receiving Dabigatran

Abstract

Background Most atrial fibrillation (AF) patients have coexisting cardiovascular diseases that worsen prognosis and complicate management. Our aim was to test the effect of a multifaceted intervention, for physicians and patients, on quality of comprehensive cardiovascular care and clinical outcomes in anticoagulated clinical trial AF patients.

Methods/Results Clinical centres participating in RELY-ABLE, an extended follow-up study of AF patients receiving dabigatran, were randomized to receive the intervention, or not. The intervention encompassed computer-assisted decision support using clinical data audit to generate individual patient feedback letters, sent to the investigator with the request to send a copy to the patient and discuss. Letters addressed achievement of guideline-recommended targets for control of blood pressure, cholesterol and HbA1c, rhythm and rate control, aspirin use, heart failure therapy and smoking. Centres also received feedback report cards regarding practice performance. Primary outcome was a composite of vascular death, stroke, myocardial infarction, systemic embolism, major bleeding and cardiovascular hospitalization, during 28 months of follow-up. In 34 participating countries, 269 practices were randomized to Intervention and 276 to Control, enrolling 3,010 and 2,853 AF patients respectively. Overall, mean age (standard deviation) was 73 (8) years, 35% were female, 82% had hypertension, 32% coronary artery disease, 23% heart failure and 26% diabetes. At baseline, 78.3% (10.8) of all relevant guideline-recommended targets were met in the Intervention group and 77.6% (10.2) in Control. No difference was observed for the primary outcome between Intervention (12.7/100 person years) and Control (12.1/100 person years; p=0.47). The secondary outcome of % change in achievement of guideline-recommended treatment targets since baseline was also comparable (Intervention 0.0% (11.4) versus Control 0.2% (11.3); p=0.82).

Conclusion A multifaceted intervention encompassing computer-assisted decision support, individual patient audit and feedback and practice performance feedback, targeting comprehensive cardiovascular care for anticoagulated AF patients, did not improve clinical outcomes.