Background: Percutaneous coronary intervention (PCI) is frequently undertaken in patients with ischemic left ventricular systolic dysfunction (ILVD). The REVIVED-BCIS2 trial concluded that PCI did not reduce the incidence of all-cause death or heart failure (HF) hospitalization, however patients assigned to PCI reported better initial health-related quality of life than those assigned to optimal medical therapy (OMT) alone. The aim of this study was to assess the cost-effectiveness of PCI+OMT compared with OMT alone. Methods: REVIVED-BCIS2 was a prospective, multi-centre UK trial, which randomized patients with severe ILVD to either PCI+OMT or OMT alone. Healthcare resource use (including planned and unplanned revascularizations, medication, device implantation and HF hospitalizations) and health outcomes data (EQ-5D-5L questionnaire) on each patient were collected at baseline and up to 8 years post-randomization. Resource use was costed using publicly available national unit costs. Within trial mean total costs and quality-adjusted life years (QALYs) were estimated from the perspective of the UK health system. Cost-effectiveness was evaluated using estimated mean costs and QALYs in both groups. Regression analysis was used to adjust for clinically relevant predictors. Results: Between 2013 and 2020, 700 patients were recruited (mean age: PCI+OMT=70, OMT=68; male (%): PCI+OMT=87, OMT=88); median follow up was 3.4 years. Over all follow-up, patients undergoing PCI yielded similar health benefits at higher costs compared to OMT alone (PCI+OMT: 4.14 QALYs, £22,352; OMT alone: 4.16 QALYs; £15,569; Difference: -0.015; £6,782). For both groups most health resource consumption occurred in the first 2 years post-randomization. Probabilistic results showed that the probability of PCI being cost-effective was 0. Conclusions: Minimal difference in total QALYs was identified between arms and PCI+OMT was not cost-effective compared to OMT, given its additional cost. A strategy of routine PCI to treat ILVD does not appear to be a justifiable use of healthcare resource in the UK. Clinical Trial Registration: URL: https://clinicaltrials.gov/ Unique Identifier: NCT01920048.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)