Capri Cardiac Rehabilitation, Rotterdam, Netherlands.
Department of Rehabilitation Medicine, Erasmus Medical Center, Rotterdam, Zuid-Holland, Netherlands.
Heart. 2018 Mar;104(5):430-437. doi: 10.1136/heartjnl-2017-311681. Epub 2017 Sep 27.
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.
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).
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).
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.
ClinicalTrials.gov NCT01395095; results.
OPICARE（优化心脏康复）随机对照试验比较了两种先进且扩展的心脏康复（CR）方案与急性冠状动脉综合征（ACS）患者的标准 CR。这些方案旨在刺激对健康心脏生活方式的永久采用。主要结局是 18 个月随访时 SCORE（系统冠状动脉风险评估）10 年心血管死亡率风险函数。
共有 914 名 ACS 患者（年龄 57 岁；81%为男性）被随机分为：（1）3 个月标准 CR（仅 CR）；（2）标准 CR 加三次额外的面对面积极生活方式咨询，以及标准 CR 后 9 个月内的三次小组健身训练和一般生活方式咨询（CR+F）；或（3）标准 CR 延长 9 个月，进行五到六次电话一般生活方式咨询（CR+T）。
意向治疗分析中，我们发现 CR+F 与仅 CR 之间在 18 个月时 SCORE 风险函数无差异（3.30% vs 3.47%；p=0.48），或 CR+T 与仅 CR 之间无差异（3.02% vs 3.47%；p=0.39）。在方案治疗分析中，三个可改变的 SCORE 参数中有两个有利于 CR+F 优于仅 CR：当前吸烟率（13.4% vs 21.3%；p<0.001）和总胆固醇（3.9 与 4.3 mmol/L；p<0.001）。与仅 CR 相比，CR+T 的吸烟率也更低（12.9% vs 21.3%；p<0.05）。
在标准 CR 基础上增加额外的行为咨询（小组会议或个人电话会议）不会在 SCORE 参数方面带来额外的益处。患者在标准 CR 后已经很少因再次住院而达到可改变危险因素的目标水平。
ClinicalTrials.gov NCT01395095；结果。
