Key result
PCI plus OMT fails to improve cost-effectiveness over OMT alone in ischemic LV dysfunction.
Why the study?
The cost-effectiveness of PCI added to optimal medical therapy compared with optimal medical therapy alone in patients with ischemic left ventricular systolic dysfunction was uncertain.
Does percutaneous coronary intervention added to optimal medical therapy improve cost-effectiveness compared to optimal medical therapy alone in patients with severe ischemic left ventricular systolic dysfunction?
RCT (n=700)
Open-label
Randomized
Yes
Does percutaneous coronary intervention added to optimal medical therapy improve cost-effectiveness compared to optimal medical therapy alone in patients with severe ischemic left ventricular systolic dysfunction?
Mean Difference: -0.015 (95% CI -0.385–0.355)
Absolute Event Rate: 4.14% vs 4.16%
Routine percutaneous coronary intervention in addition to optimal medical therapy for severe ischemic left ventricular systolic dysfunction is not cost-effective compared to medical therapy alone.
PCI should not be added routinely in ischemic LV dysfunction to avoid excess costs without QALY gains; reinforces medical therapy alone as preferred.
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.
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Chivardi et al. (2023) conducted an RCT in Severe ischemic left ventricular systolic dysfunction (n=700). Percutaneous coronary intervention (PCI) plus optimal medical therapy vs. Optimal medical therapy alone was evaluated on Quality-adjusted life-years (QALYs) (MD -0.015, 95% CI -0.385 to 0.355). PCI plus optimal medical therapy was not cost-effective compared to medical therapy alone for ischemic left ventricular dysfunction, yielding similar QALYs (MD -0.015) at a higher cost (£6,782).
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