TY - JOUR
T1 - Impact of a comprehensive cardiac rehabilitation programme versus coronary revascularisation in patients with stable angina pectoris
T2 - study protocol for the PRO-FIT randomised controlled trial
AU - Heutinck, Joyce M.
AU - de Koning, Iris A.
AU - Vromen, Tom
AU - van Geuns, Robert-Jan M.
AU - Thijssen, Dick H. J.
AU - Kemps, Hareld M. C.
AU - On behalf of the PRO-FIT Research Group
AU - Adang, Eddy M.
AU - Geleijnse, Johanna M.
AU - van Gorp, Pieter
AU - van ‘t Hof, Arnoud W. J.
AU - Janssen, Veronica R.
AU - Jorstad, Harald T.
AU - Kraaijenhagen, Roderik A.
AU - Lammers, Jeroen
AU - de Man, Frits H. A. F.
AU - Nollen, Gijs J.
AU - van Ofwegen-Hanekamp, Clara E. E.
AU - Onkelinx, Steven
AU - Oostveen, Laurence M. L. C.
AU - Roes, Kit C. B.
AU - Sunamara, Madoka
AU - Tonino, Pim A. L.
N1 - 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. Publisher Copyright: © 2023, The Author(s).
PY - 2023/12/1
Y1 - 2023/12/1
N2 - 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.
AB - 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.
KW - Cardiac rehabilitation
KW - Chronic coronary syndrome
KW - Coronary artery disease
KW - Coronary revascularisation
KW - Cost-effectiveness
KW - Percutaneous coronary intervention
KW - Stable angina pectoris
UR - http://www.scopus.com/inward/record.url?scp=85158947826&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12872-023-03266-z
DO - https://doi.org/10.1186/s12872-023-03266-z
M3 - Article
C2 - 37147562
SN - 1471-2261
VL - 23
JO - BMC Cardiovascular Disorders
JF - BMC Cardiovascular Disorders
IS - 1
M1 - 238
ER -