Four-year follow-up of the Choice of Health Options In prevention of Cardiovascular Events randomized controlled trial.

Abstract

Objective: To determine if the improved risk factor profile at 1 year attributed to the Choice of Health Options In prevention of Cardiovascular Events (CHOICE) program was maintained at 4 years.

Design: Single-blind randomized controlled trial with post-hoc 476 months follow-up (76% complete).

Setting: Australian tertiary referral hospital.

Patients: Two hundred and eight acute coronary syndrome survivors.

Interventions: Acute coronary syndrome survivors not accessing cardiac rehabilitation (CR) were randomized to control (n=72) or CHOICE (n=72) comprising the tailored risk factor reduction packaged as a clinic visit and 3 months phone support. A contemporary CR reference group were also recruited (n=64). Blinded risk assessment occurred at baseline, 1 and 4 years.

Main outcome measures: Total cholesterol, systolic blood pressure, smoking status, physical activity.

Results: One year improvements in all the modifiable risk factors achieved in CHOICE were maintained at 4 years. CHOICE and control were well-matched at baseline. At 4 years, there was a trend towards lower total cholesterol in CHOICE compared with controls (mean 4.0±0.1 vs. 4.2±0.1 mmol/l, P=0.05), significantly better systolic blood pressure (mean 132.2±2.1 vs. 136.8±2.0 mmHg, P=0.01), physical activity scores (1200±209 vs. 968±196 metabolic equivalent min/week, P=0.02) and proportion with three or more risk factors above national targets (20 vs. 42%,P=0.02). Participants in CHOICE were at higher baseline risk than CR but at 4 years they had similar risk factor profiles.

Conclusion: Participants in CHOICE maintained favorable changes in coronary risk profile at 4 years compared with control, indicating that CHOICE is an effective long-term intervention among those not accessing facility-based CR.