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

PRO-FIT Research Group, Joyce M. Heutinck (Corresponding author), Hareld M.C. Kemps, Pieter van Gorp

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Samenvatting

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.

Originele taal-2Engels
Artikelnummer238
Aantal pagina's13
TijdschriftBMC Cardiovascular Disorders
Volume23
Nummer van het tijdschrift1
DOI's
StatusGepubliceerd - mei 2023

Bibliografische nota

Funding Information:
This study is mostly funded by a ZonMW grant (grant number 555003209) and partially funded by AstraZeneca B.V., Novo Nordisc B.V. and Daiichi Sankyo Nederland B.V. All sponsors have no role in the protocol development, data collection, analysis and interpretation and have no role in writing the manuscript.

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