Division of Cardiovascular Medicine (W.F.F., M.A.H.) and the Department of Health Research and Policy (D.S., D.B.B., M.A.H.), Stanford University School of Medicine, Stanford, CA; Catharina Hospital, Eindhoven, The Netherlands (N.H.J.P., P.A.L.T.); Cardiovascular Center Aalst, Aalst, Belgium (E.B., B.D.B.); and Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland and CTU Bern, Department of Clinical Research, University of Bern, Switzerland (P.J.).
Circulation. 2013 Sep 17;128(12):1335-40. doi: 10.1161/CIRCULATIONAHA.113.003059. Epub 2013 Aug 14.
The Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 2 trial demonstrated a significant reduction in subsequent coronary revascularization among patients with stable angina and at least 1 coronary lesion with a fractional flow reserve ≤0.80 who were randomized to percutaneous coronary intervention (PCI) compared with best medical therapy. The economic and quality-of-life implications of PCI in the setting of an abnormal fractional flow reserve are unknown.
We calculated the cost of the index hospitalization based on initial resource use and follow-up costs based on Medicare reimbursements. We assessed patient utility using the EQ-5D health survey with US weights at baseline and 1 month and projected quality-adjusted life-years assuming a linear decline over 3 years in the 1-month utility improvements. We calculated the incremental cost-effectiveness ratio based on cumulative costs over 12 months. Initial costs were significantly higher for PCI in the setting of an abnormal fractional flow reserve than with medical therapy ($9927 versus $3900, P<0.001), but the $6027 difference narrowed over 1-year follow-up to $2883 (P<0.001), mostly because of the cost of subsequent revascularization procedures. Patient utility was improved more at 1 month with PCI than with medical therapy (0.054 versus 0.001 units, P<0.001). The incremental cost-effectiveness ratio of PCI was $36 000 per quality-adjusted life-year, which was robust in bootstrap replications and in sensitivity analyses.
PCI of coronary lesions with reduced fractional flow reserve improves outcomes and appears economically attractive compared with best medical therapy among patients with stable angina.
多支血管病变血流储备分数与血管造影术（FAME）2 试验表明，与最佳药物治疗相比，在稳定型心绞痛和至少 1 处狭窄程度≥50%血流储备分数（FFR）≤0.80 的病变中接受经皮冠状动脉介入治疗（PCI）的患者，随后发生冠状动脉血运重建的比例显著降低。FFR 异常患者行 PCI 的经济和生活质量影响尚不清楚。
我们根据初始资源使用情况计算了索引住院的费用，并根据医疗保险报销情况计算了随访成本。我们使用美国 EQ-5D 健康调查量表在基线和 1 个月时评估患者效用，并假设在 3 年内，1 个月时的效用改善呈线性下降，从而预测质量调整生命年。我们根据 12 个月的累计成本计算了增量成本效益比。在 FFR 异常的情况下，PCI 的初始成本明显高于药物治疗（9927 美元比 3900 美元，P<0.001），但在 1 年的随访过程中，这一差异缩小至 2883 美元（P<0.001），主要是因为随后的血运重建手术费用。与药物治疗相比，1 个月时 PCI 患者的效用提高更多（0.054 单位比 0.001 单位，P<0.001）。PCI 的增量成本效益比为每质量调整生命年 36000 美元，在 bootstrap 复制和敏感性分析中均具有稳健性。
与最佳药物治疗相比，在稳定型心绞痛患者中，对 FFR 降低的冠状动脉病变进行 PCI 可改善预后，并且在经济上具有吸引力。
