Key result
Cardiac rehab trial tests non-inferiority against routine revascularization for stable angina symptom relief.
Why the study?
In the modern era, no studies have compared the effects of cardiac rehabilitation versus coronary revascularisation in patients with stable angina pectoris.
Does a 12-month multidisciplinary cardiac rehabilitation programme improve anginal complaints compared to coronary revascularisation in patients with stable angina pectoris on optimal medical treatment?
RCT (n=216)
Open-label
1:1 block randomization
Yes
Does a 12-month multidisciplinary cardiac rehabilitation programme improve anginal complaints compared to coronary revascularisation in patients with stable angina pectoris on optimal medical treatment?
This study protocol outlines an RCT comparing the efficacy of a 12-month multidisciplinary cardiac rehabilitation program versus coronary revascularization for reducing anginal complaints in patients with stable angina.
BACKGROUND: Currently, in the majority of patients with stable angina pectoris (SAP) treatment consists of optimal medical treatment, potentially followed by coronary angiography and subsequent coronary revascularisation if necessary". Recent work questioned the effectiveness of these invasive procedures in reducing re-events and improving prognosis. The potential of exercise-based cardiac rehabilitation on clinical outcomes in patients with coronary artery disease is well-known. However, in the modern era, no studies compared the effects of cardiac rehabilitation versus coronary revascularisation in patients with SAP. METHODS: In this multicentre randomised controlled trial, 216 patients with stable angina pectoris and residual anginal complaints under optimal medical treatment will be randomised to: 1) usual care (i.e., coronary revascularisation), or 2) a 12-month cardiac rehabilitation (CR) programme. CR consists of a multidisciplinary intervention, including education, exercise training, lifestyle coaching and a dietary intervention with a stepped decline in supervision. The primary outcome will be anginal complaints (Seattle Angina Questionnaire-7) following the 12-month intervention. Secondary outcomes include cost-effectiveness, ischemic threshold during exercise, cardiovascular events, exercise capacity, quality of life and psychosocial wellbeing. DISCUSSION: In this study, we will examine the hypothesis that multidisciplinary CR is at least equally effective in reducing anginal complaints as the contemporary invasive approach at 12-months follow-up for patients with SAP. If proven successful, this study will have significant impact on the treatment of patients with SAP as multidisciplinary CR is a less invasive and potentially less costly and better sustainable treatment than coronary revascularisations. TRIAL REGISTRATION: Netherlands Trial Register, NL9537. Registered 14 June 2021.
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Heutinck et al. (2023) conducted an RCT in Stable angina pectoris (n=216). Comprehensive cardiac rehabilitation programme vs. Usual care (coronary angiography and revascularisation) was evaluated on Change in angina symptoms (SAQ-7 score) from baseline to 12 months. A 12-month comprehensive cardiac rehabilitation program will be evaluated for non-inferiority compared to routine coronary revascularization in reducing anginal symptoms among patients with stable angina pectoris.
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