Background: The optimal revascularization approach in patients with heart failure with reduced ejection fraction (HFrEF) and ischemic heart disease ("ischemic cardiomyopathy") is unknown. Physician preferences regarding clinical equipoise for mode of revascularization and their willingness to consider offering enrollment in a randomized trial to patients with ischemic cardiomyopathy have not been characterized.
Methods: We conducted two anonymous online surveys: 1) a clinical case scenario-based survey to assess willingness to offer clinical trial enrollment for a patient with ischemic cardiomyopathy (overall response rate to email invitation 0.45 %), and 2) a Delphi consensus-building survey to identify specific areas of clinical equipoise (overall response rate to email invitation 37 %).
Results: Among 304 physicians responding to the clinical case scenario-based survey, the majority were willing to offer the opportunity for clinical trial enrollment to a prototypical patient with ischemic cardiomyopathy (92 %), and felt that a finding of non-inferiority for PCI vs. CABG would influence their clinical practice (78 %). Among 53 physicians responding to the Delphi consensus-building survey, the median appropriateness rating for CABG was significantly higher than that of PCI (p < 0.0001). In 17 scenarios (11.8 %), there was no difference in CABG or PCI appropriateness ratings, suggesting clinical equipoise in these settings.
Conclusions: Our findings demonstrate willingness to consider offering enrollment in a randomized clinical trial and areas of clinical equipoise, two factors that support the feasibility of a randomized trial to compare clinical outcomes after revascularization with CABG vs. PCI in selected patients with ischemic cardiomyopathy, suitable coronary anatomy and co-morbidity profile.
Keywords: Clinical equipoise; Coronary artery disease; Heart failure; Ischemic cardiomyopathy; Revascularization.