PROFIT: Will Patients with stable coROnary artery disease beneFIT more from a multimodal prevention and lifestyle program than percutaneous coronary intervention (PCI)?
BACKGROUND: Stable angina pectoris (SAP) is a highly common condition in the Netherlands. Despite optimal medical treatment patients often remain symptomatic and at risk for cardiovascular morbidity and mortality. In daily practice often an invasive strategy with percutaneous coronary interventions is applied in these patients. However in a large recent trial and meta-analysis, this costly and invasive procedure did not show beneficial effects on symptoms or prognosis in patients with SAP. An important reason for the high patient burden in these patients might be the non-adherence to healthy lifestyle advices. The potential of lifestyle-related interventions on progression of coronary artery disease is well-known but contemporary RCT’s comparing lifestyle interventions with PCI are lacking. To optimize the long-term clinical effects and wide-scale implementation, these interventions should have a sound physiological basis, be personalized to a patients’ needs and preferences, include effective behavioral change strategies and be easily accessible in the current healthcare system.
1) To compare the impact of a comprehensive lifestyle management intervention (PRO-FIT) with PCI as a first line therapy after optimal medical therapy in SAP patients on clinical outcomes.
2) To evaluate the cost-effectiveness of PRO-FIT compared to routine invasive care in SAP patients, to perform a budget-impact analysis and to evaluate implementation barriers.
STUDY DESIGN: Multicenter randomized controlled trial.
STUDY POPULATION: Patients with stable angina pectoris and residual anginal symptoms under optimal medical treatment.
INTERVENTION: A comprehensive lifestyle intervention (PRO-FIT) aiming at angina relief on the short-term and sustainable behavioral change for long-lasting improvement in cardiovascular health. PRO-FIT will consist of multiple lifestyle interventions including at least an exercise program and a dietary intervention with a stepped decline in guidance to encourage the sustainability of behavioral change.
USUAL CARE/CONTROL: A routine invasive strategy referring to the standard care as it is given in daily care nowadays. This means that the treating cardiologist determines whether it is necessary for these patients to undergo PCI. Also these patients will receive basic lifestyle advices.
• AIM 1: The primary outcome will be the ischemic threshold (WATT) during exercise at 1 year. The secondary outcomes will be major adverse cardiovascular events, health related quality of life, physical fitness, cardiovascular health, angina complaints and psychosocial wellbeing.
• AIM 2 Economic evaluation with a cost-effectiveness analysis with the costs per difference in ischemic threshold as outcome measure and a cost-utility analysis with the costs per quality adjusted life-year (QALY) as outcome over a one year time period. A budget impact analysis (BIA) will be performed to gain insight into the financial implications of implementation of PRO-FIT and implementation barriers will be evaluated by a qualitative study.
SAMPLE SIZE Sample size calculation for the primary endpoint based on a superiority design was performed with an estimated true difference in improvement in ischemic threshold after 1 year between the intervention and control group of 10±28 Watt. 74 experimental and control subjects need to be studied to be able to reject the null hypothesis that the population means are equal (power = 0.9 and alpha =0.025). Accounting for dropout and loss to follow-up after 1 year 93 subjects need to be included in both groups.
NOVELTY Unique to PRO-FIT is that it is:
1) Disease-specific with an exercise and dietary interventions aimed at improving cardiovascular health and reducing the risk at recurrent events)
2) Focused on behavioral change by individual goal setting, personalized telerehabilitation and social gamification
3) Easily accessible and scalable by using a primary care physical therapy network and a stepped care approach.
SCIENTIFIC BREAKTHROUGH The PRO-FIT study will be the first study evaluating a comprehensive disease-specific multimodal lifestyle intervention as a standard treatment for patients with stable angina pectoris. If proven successful this will have a great impact on the daily care of these patients as PCI can largely be replaced by a less invasive, less costly and better sustainable treatment.
IMPLEMENTATION Nationwide implementation of the PRO-FIT intervention is challenging as a paradigm shift for both patients and cardiologists is required. To maximize the chance of successful implementation, collaboration has been established with a network of primary care physical therapists (ClaudicatioNET) with nationwide coverage, patient interest organization “Harteraad” and the Dutch Society of Cardiology.