Quantitative PET coronary flow capacity and comprehensive management of chronic CAD: Lessons from the randomized CENTURY trial.

BACKGROUND AND AIMS: Randomized trials in chronic coronary artery disease (CAD) tested single interventions of lifestyle, medical treatment, or revascularization. The randomized CENTURY trial tested a comprehensive strategy integrating intense lifestyle modification, medical treatment and revascularization reserved for severely reduced coronary flow capacity (CFC) by positron emission tomography (PET), for reducing death, myocardial infarction and revascularization compared with referring-cardiologist-directed standard community care.

METHODS: Participants with high risk factors, suspected or known CAD were randomly assigned to comprehensive or standard care. Rest-stress PET quantified CFC for physiological CAD severity at baseline, 2 and 5 years. Comprehensive care group reviewed PET results with frequent clinic visits and open 24/7 phone/email support. Standard care lacked supportive contact with blinded PET results, unblinded for severely reduced CFC with high mortality risk for potential revascularization.

RESULTS: Of 1028 randomized participants, 515 were assigned to comprehensive care and 513 to standard care for the 5-year protocol with additional follow-up over next 5 to 11 years. Comprehensive vs standard care significantly decreased summed risk factor score at 5-years (P < 0.0001), all-cause death (4.7% vs. 8.2%; P = 0.023), death or MI (7.0% vs. 11.1%; P = 0.024), late revascularization (9.6% vs 14.8%; P = 0.011) and major adverse cardiac events (20.5% vs 29.9%; P = 0.0006). Only 56 of 1028 (5.4%) CENTURY patients had revascularization within 90 days guided by CFC severity, thereby reassuring and motivating patients and physicians for safely pursuing preventive risk factor goals while reserving angiogram-revascularization for high-risk, severe CFC. Intensity of adherence to comprehensive risk factor control during 5-years associated with additional significantly reduced death, MI and revascularizations over next 5 to 11 years.

CONCLUSIONS: The randomised CENTURY trial demonstrates that comprehensive integrated lifestyle modification and optimal medical treatment with revascularization reserved for severely reduced CFC significantly reduced death, death or MI, and revascularization at 5 years and potentially over extended 5 to 11 years of non-predefined follow-up. (ClinicalTrials.gov NCT00756379).