Objective The OPTICARE (OPTImal CArdiac REhabilitation) randomised controlled trial compared two advanced and extended cardiac rehabilitation (CR) programmes to standard CR for patients with acute coronary syndrome (ACS). These programmes were designed to stimulate permanent adoption of a heart-healthy lifestyle. The primary outcome was the SCORE (Systematic COronary Risk Evaluation) 10-year cardiovascular mortality risk function at 18 months follow-up.
Methods In total, 914 patients with ACS (age, 57 years; 81% men) were randomised to: (1) 3 months standard CR (CR-only); (2) standard CR including three additional face-to-face active lifestyle counselling sessions and extended with three group fitness training and general lifestyle counselling sessions in the first 9 months after standard CR (CR+F); or (3) standard CR extended for 9 months with five to six telephone general lifestyle counselling sessions (CR+T).
Results In an intention-to-treat analysis, we found no difference in the SCORE risk function at 18 months between CR+F and CR-only (3.30% vs 3.47%; p=0.48), or CR+T and CR-only (3.02% vs 3.47%; p=0.39). In a per-protocol analysis, two of three modifiable SCORE parameters favoured CR+F over CR-only: current smoking (13.4% vs 21.3%; p<0.001) and total cholesterol (3.9 vs 4.3 mmol/L; p<0.001). The smoking rate was also lower in CR+T compared with the CR-only (12.9% vs 21.3%; p<0.05).
Conclusions Extending CR with extra behavioural counselling (group sessions or individual telephone sessions) does not confer additional benefits with respect to SCORE parameters. Patients largely reach target levels for modifiable risk factors with few hospital readmissions already following standard CR.
Trial registration number ClinicalTrials.gov NCT01395095; results.
- cardiac rehabilitation
- lifestyle modification
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MS and NH contributed equally.
Contributors MS, NtH, RJGvdB, RTvD: study design, data collection, data analysis, writing. MLG, HJS, EB: study design, data analysis, writing. MH: study design, writing.
Funding This was an investigator-initiated study; however, the CR+F and CR-only intervention programmes were cofinanced by Capri Cardiac Rehabilitation, Rotterdam, the Netherlands, and the CR+T intervention by the Netherlands health insurance company Zilveren Kruis.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Medical Ethics Committee of Erasmus Medical Center, Rotterdam, the Netherlands (MEC-2010-391).
Provenance and peer review Not commissioned; externally peer reviewed.