Impact of a comprehensive cardiac rehabilitation programme versus coronary revascularization in patients with stable angina pectoris: protocol for the PRO-FIT randomised controlled trial

Abstract

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): ZonMW: The Netherlands Organisation for Health Research and Development Background Stable angina pectoris (SAP) is a highly common condition. Despite optimal medical treatment (OMT) patients often remain symptomatic and at high risk for cardiovascular morbidity and mortality. In daily practice the standard treatment consists of OMT usually followed by an invasive strategy, consisting of coronary angiography and subsequent coronary revascularization. However, recent studies showed that these costly and invasive procedures do not result in superior effects on re-events and prognosis as compared to drug therapy alone in patients with SAP. On the other hand, the effect of lifestyle-related interventions on vascular function and the progression of atherosclerotic coronary artery disease is well-known. Yet, contemporary RCTs comparing lifestyle interventions with coronary revascularization in patients with SAP are lacking. Purpose To compare the impact of a 12-month cardiac rehabilitation (CR) programme versus a routinely applied invasive approach (including coronary angiography and subsequent coronary revascularization) on anginal complaints and cost-effectiveness in SAP patients. We hypothesize that CR is at least equally effective as an invasive approach. Methods 216 SAP patients with residual anginal complaints under OMT will be randomized to usual care or a 12-month CR intervention aiming at angina relief and sustainable behavioural change for long-lasting improvement in cardiovascular health. The CR programme consists of multiple lifestyle interventions including an exercise programme, a dietary intervention and a psychoeducation module with a stepped decline in guidance by health care professionals. Patients in the CR group will receive access to an online platform, a chatbot and a smartwatch enabling patients and professionals to monitor the progress and adherence to lifestyle advices. During the first 3 months patients will receive face to face guidance, the next 3 months will consist of telerehabilitation using the smartwatch with weekly video consulting and the last 6 months will be focussed on relapse prevention and guidance on demand. The primary outcome will be the quantity of anginal complaints (evaluated by the Seattle Angina Questionnaire-7) following the 12-month intervention. Secondary outcomes include cost-effectiveness, the ischemic threshold during exercise, cardiovascular events, exercise capacity, quality of life and psychosocial wellbeing. Future implications This will be the first study evaluating a comprehensive disease-specific multimodal lifestyle intervention as a primary treatment for patients with SAP. If proven successful this study will have a great impact on the daily care of these patients as coronary revascularizations can partly be replaced by a less invasive, less costly and better sustainable treatment.