Estimation of Costs
coronary artery disease
CORONARY ARTERY DISEASE
Health care resources used by each participant in the trial were obtained from the trial case report forms completed by trial investigators. The case report form captured the health resource consumption at baseline, 6 months, 12 months, and then on a yearly basis, with only postrandomization consumption included for analysis. Relevant health resources included revascularization, prescribed medications, HF hospital admissions and related treatments, implantable cardiac device implantation or upgrade, outpatient visits, and clinical investigations (eg, echocardiogram) during the first 2 years following randomization. HF hospitalizations, unplanned revascularizations, and implantable device information were collected yearly for 2 to 8 years. Unit costs for the health resources were obtained from National NHS Reference Costs databasesHealth care resource use was combined with relevant unit costs and aggregated to produce a total cost for each trial participant. Six distinct cost categories were defined: planned and unplanned revascularization procedures, medications, hospitalization, implanted devices, and clinical investigations (including hemoglobin, creatinine, cholesterol, low density lipoprotein, high density lipoprotein, triglyceride, B-type natriuretic peptide, hemoglobin A1c, and echocardiogram). Within the intervention arm, planned revascularization procedures encompassed the costs associated with the initial planned percutaneous coronary procedures and their subsequent stages. Unplanned revascularization is related to any subsequent unplanned PCIs or CABG procedures throughout trial follow-up. Medication costs are related to cardiac medication at randomization, at hospital discharge, and relevant assessment points of follow-up in both arms of the trial. The cost of medication was estimated according to the dosage and duration of each drug consumed. HF hospitalization costs include costs related to inpatient stays, as well as any associated diagnostic tests, procedures, and medication required within that admission. Implantable device costs encompassed the device itself (cardiac resynchronization therapy, cardiac resynchronization therapy with defibrillator, or implantable cardioverter defibrillator only) and all costs associated with its implantation or upgrade. Finally, clinical investigation costs were related to the diagnosis and management of coronary artery disease and HF, including costs associated with tests such as blood tests and echocardiograms (prerandomization eligibility testing was not considered).By estimating the costs associated with each of these categories, we aimed to provide a comprehensive understanding of the cost burden associated with treating patients with ILVD. Costs were expressed as total per-participant costs over the follow-up period.