Division of Cardiovascular Medicine, Stanford University Medical Center, 300 Pasteur Dr, H2103, Stanford, CA 94305, USA.
Circulation. 2010 Dec 14;122(24):2545-50. doi: 10.1161/CIRCULATIONAHA.109.925396. Epub 2010 Nov 29.
The Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) study demonstrated significantly improved health outcomes at 1 year in patients randomized to multivessel percutaneous coronary intervention guided by fractional flow reserve (FFR) compared with percutaneous coronary intervention guided by angiography alone. The economic impact of routine measurement of FFR in this setting is not known.
In this study, 1005 patients were randomly assigned to FFR-guided or angiography-guided percutaneous coronary intervention and followed up for 1 year. A prospective cost-utility analysis comparing costs and quality-adjusted life-years was performed with a time horizon of 1 year. Quality-adjusted life-years were calculated with the use of utilities determined by the EuroQuol 5 dimension health survey with US weights. Direct medical costs included those of the index procedure and hospitalization and costs for major adverse cardiac events during follow-up. Confidence intervals for both quality-adjusted life-years and costs were estimated by the bootstrap percentile method. Major adverse cardiac events at 1 year occurred in 13.2% of those in the FFR-guided arm and 18.3% of those in the angiography-guided arm (P=0.02). Quality-adjusted life-years were slightly greater in the FFR-guided arm (0.853 versus 0.838; P=0.2). Mean overall costs at 1 year were significantly less in the FFR-guided arm ($14 315 versus $16 700; P<0.001). Bootstrap simulation indicated that the FFR-guided strategy was cost-saving in 90.74% and cost-effective at a threshold of US $50 000 per quality-adjusted life-years in 99.96%. Sensitivity analyses demonstrated robust results.
Economic evaluation of the FAME study reveals that FFR-guided percutaneous coronary intervention in patients with multivessel coronary disease is one of those rare situations in which a new technology not only improves outcomes but also saves resources. Clinical Trial Registration- URL: http://ClinicalTrials.gov. Unique identifier: NCT00267774.
多支血管病变患者经血流储备分数（FFR）指导的多支血管经皮冠状动脉介入治疗（FFR 指导的 PCI）与单纯经血管造影指导的 PCI 相比，1 年时健康结局显著改善。在这种情况下，常规测量 FFR 的经济影响尚不清楚。
在这项研究中，1005 例患者被随机分配到 FFR 指导或血管造影指导的 PCI 组，并随访 1 年。进行了一项前瞻性成本效用分析，比较了 1 年时间内的成本和质量调整生命年。使用欧洲五维健康调查（EuroQol 5 Dimension health survey）的效用值，结合美国权重计算质量调整生命年。直接医疗费用包括索引程序和住院的费用，以及随访期间主要不良心脏事件的费用。质量调整生命年和成本的置信区间通过自举百分比法估计。1 年时，FFR 指导组发生主要不良心脏事件的比例为 13.2%，血管造影指导组为 18.3%（P=0.02）。FFR 指导组的质量调整生命年稍高（0.853 比 0.838；P=0.2）。1 年时的总费用在 FFR 指导组显著较低（14315 美元比 16700 美元；P<0.001）。自举模拟表明，在 99.96%的情况下，FFR 指导策略的成本效益比阈值为每质量调整生命年 50000 美元时，在 90.74%的情况下是节省成本的。敏感性分析结果稳健。
对 FAME 研究的经济评估表明，多支血管病变患者经血流储备分数指导的经皮冠状动脉介入治疗是一种新技术，不仅改善了结果，而且节省了资源的罕见情况之一。
临床试验注册- URL：http://ClinicalTrials.gov。唯一标识符：NCT00267774。
