Economic Outcomes and Quality of Life After CABG or PCI for Multivessel Disease: The FAME 3 Trial.

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.

本研究旨在比较CABG与PCI在FAME（Fractional Flow Reserve vs Angiography for Multivessel Evaluation）3随机试验中的经济和生活质量结果，并确定它们的成本效益。

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.

FAME 3随机分配了1500名三支血管冠状动脉疾病患者接受冠状动脉旁路移植术(CABG)或使用佐他洛尔药物洗脱支架的分数流量储备指导下的经皮冠状动脉介入治疗(PCI)。

We documented resource use and quality of life over 5 years of follow-up.

我们在5年的随访期间记录了资源使用和生活质量。

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.

我们通过应用医疗保险报销率来计算所使用的资源成本，使用欧洲五维健康量表（EuroQOL EQ-5D）评估生活质量，从EQ-5D效用值计算质量调整生命年（QALYs），并使用多变量回归比较按治疗分配的结果。

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.

我们基于5年结果和预期寿命的预测计算了增量成本效益比，并在10,000次bootstrap重采样中评估了其可变性。

Results

Cumulative costs over 5 years were 30% higher in patients assigned to CABG (95% CI: 16%-46%; P < 0.001).

在被分配到冠状动脉旁路移植术（CABG）的患者中，5年累积成本高出30%（95%置信区间：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.

在经皮冠状动脉介入治疗（PCI）组（4.05 ± 0.84）和冠状动脉旁路移植术（CABG）组（4.03 ± 0.82）之间，5年的QALYs没有显著差异，尽管PCI后EQ-5D评分的改善速度更快。

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).

在入组时年龄小于65岁的患者中，被分配到经皮冠状动脉介入治疗（PCI）的患者在5年后更有可能就业（56%对比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.

在5年的时间里，与冠状动脉旁路移植术（CABG）相比，PCI具有更大的经济价值，66%的模拟结果显示PCI的成本更低且质量调整生命年（QALYs）更高，而CABG的成本效益增量比率在98%的自举模拟中超过了150,000美元/QALY的基准。

These findings were essentially unchanged in several lifetime projections based on the outcomes documented within the trial follow-up period.

这些发现基本上在几次基于试验随访期间记录的结果的终身预测中保持不变。

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.

使用佐他莫司药物洗脱支架的分数流量储备指导下的经皮冠状动脉介入治疗（PCI）为多支冠状动脉疾病（CAD）患者提供了比冠状动脉旁路移植术（CABG）更好的长期价值，且在显著降低费用的同时，临床结果相当。