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Five-year economic and quality of life outcomes favor PCI with zotarolimus stents over CABG in 3-vessel CAD

Five-year economic and quality of life outcomes favor PCI with zotarolimus stents over CABG in 3-ves…
Photo by Ben Maffin / Unsplash
Key Takeaway
Consider PCI with zotarolimus stents for 3-vessel CAD given lower costs and similar QALYs versus CABG.

This randomized trial evaluated patients with 3-vessel coronary artery disease. The study population included 1,500 patients. The setting details were not reported. The intervention involved fractional flow reserve-guided percutaneous coronary intervention using zotarolimus drug-eluting stents. The comparator was coronary artery bypass grafting. The primary outcomes assessed were economic and quality of life outcomes over a five-year follow-up period.

The primary outcome measured cumulative costs over five years. Patients assigned to CABG incurred costs that were 30% higher than those in the PCI group. The 95% confidence interval for this difference was 16% to 46%. The p-value was less than 0.001. This indicates a statistically significant difference in economic burden favoring the PCI strategy.

Quality-adjusted life years over five years did not differ significantly between the two groups. The absolute numbers reported were 4.05 plus or minus 0.84 for PCI and 4.03 plus or minus 0.82 for CABG. No p-value or confidence interval was reported for this specific comparison, but the direction was no significant difference.

EQ-5D scores improved more rapidly after PCI compared to CABG. The specific rates of improvement were not numerically detailed in the results provided. Employment status at five years was assessed in patients under 65 years old. The PCI group had an employment rate of 56%, while the CABG group had a rate of 47%. The p-value for this difference was 0.025.

Economic value replications indicated that PCI had greater economic value than CABG. In 66% of replications, PCI demonstrated lower costs and higher QALYs. Incremental cost-effectiveness ratios for CABG were found to be above the $150,000 per QALY benchmark. This threshold was exceeded in 98% of bootstrap replications.

Safety and tolerability findings were not reported in the provided data. Adverse events, serious adverse events, discontinuations, and general tolerability were not reported. The study limitations were not reported. Funding or conflicts of interest were not reported. Causality notes and certainty notes were not reported.

These results suggest that PCI with zotarolimus stents may provide economic benefits over CABG for selected patients with 3-vessel disease. The lack of significant difference in QALYs supports the economic advantage of PCI. However, the absence of reported safety data limits the ability to fully assess the risk-benefit profile. Questions remain regarding long-term durability and safety in broader populations. Clinical decisions should weigh these economic findings against individual patient risk factors and preferences.

Study Details

Study typeRct
Sample sizen = 1,500
EvidenceLevel 2
Follow-up60.0 mo
PublishedApr 2026
View Original Abstract ↓
BACKGROUND: Previous studies have found coronary artery bypass grafting (CABG) to be cost-effective compared with percutaneous coronary intervention (PCI) among patients with multivessel coronary artery disease (CAD), but their comparative effectiveness and economic outcomes may have changed. OBJECTIVES: This study sought to compare the economic and quality of life outcomes of CABG vs PCI and determine their cost-effectiveness in the FAME (Fractional Flow Reserve vs Angiography for Multivessel Evaluation) 3 randomized trial. METHODS: FAME 3 randomly assigned 1,500 patients with 3-vessel CAD to either CABG or fractional flow reserve-guided PCI using zotarolimus drug-eluting stents. We documented resource use and quality of life over 5 years of follow-up. We calculated costs by applying Medicare reimbursement rates to resources used, assessed quality of life using the EuroQOL EQ-5D, calculated quality-adjusted life-years (QALYs) from EQ-5D utility values, and used multivariable regression to compare outcomes by treatment assignment. We calculated the incremental cost-effectiveness ratio based on 5-year outcomes and also on projected life expectancies, and assessed its variability in 10,000 bootstrap replications. RESULTS: Cumulative costs over 5 years were 30% higher in patients assigned to CABG (95% CI: 16%-46%; P < 0.001). QALYs over 5 years did not differ significantly between the PCI (4.05 ± 0.84) and CABG groups (4.03 ± 0.82), although EQ-5D scores improved more rapidly after PCI. Patients <65 years of age at enrollment assigned to PCI were more likely to be employed at 5 years (56% vs 47%; P = 0.025). PCI had greater economic value than CABG over 5 years, with lower costs and higher QALYs in 66% of replications, and incremental cost-effectiveness ratios for CABG above the $150,000/QALY benchmark in 98% of bootstrap replications. These findings were essentially unchanged in several lifetime projections based on the outcomes documented within the trial follow-up period. CONCLUSIONS: Fractional flow reserve-guided PCI using zotarolimus drug-eluting stents provides significantly better long-term value than CABG for treatment of patients with multivessel CAD, with equivalent clinical outcomes at substantially lower cost.
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