Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction: Cost-Effectiveness Analysis of the REVIVED-BCIS2 Trial

Abstract

Background: Percutaneous coronary intervention (PCI) is frequently undertaken in patients with ischemic left ventricular systolic dysfunction. The REVIVED (Revascularization for Ischemic Ventricular Dysfunction)-BCIS2 (British Cardiovascular Society-2) trial concluded that PCI did not reduce the incidence of all-cause death or heart failure 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, multicenter UK trial, which randomized patients with severe ischemic left ventricular systolic dysfunction to either PCI+OMT or OMT alone. Health care resource use (including planned and unplanned revascularizations, medication, device implantation, and heart failure hospitalizations) and health outcomes data (EuroQol 5-dimension 5-level 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 the 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 years, OMT=68 years; male (%): PCI+OMT=87, OMT=88); median follow-up was 3.4 years. Over all follow-ups, patients undergoing PCI yielded similar health benefits at higher costs compared with OMT alone (PCI+OMT: 4.14 QALYs, £22 352; OMT alone: 4.16 QALYs, £15 569; difference: -0.015, £6782). 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: A minimal difference in total QALYs was identified between arms, and PCI+OMT was not cost-effective compared with OMT, given its additional cost. A strategy of routine PCI to treat ischemic left ventricular systolic dysfunction does not seem to be a justifiable use of health care resources in the United Kingdom.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01920048.

Keywords: coronary artery disease; heart failure; humans; myocardial revascularization; percutaneous coronary intervention.

Figure 1.

Breakdown mean total costs by treatment group over all years. Planned revascularizations, medication, and clinical test information were not collected from 2years onward. BL indicates baseline; HF, heart failure; OMT, optimal medical therapy; and PCI, percutaneous coronary intervention.

Figure 2.

Postimputation EuroQol 5-dimension (EQ-5D) score time trend by treatment group across follow-up (excluding those who have died). Shaded areas represent 95% CIs. BL indicates baseline; OMT, optimal medical therapy; and PCI, percutaneous coronary intervention.

Figure 3.

Cost-effectiveness plane with probabilistic sensitivity analysis results. £20 000 is the UK threshold and £82 000 is the US threshold using the current official exchange rate of £0.81. QALY indicates quality-adjusted life-year.