Department of Cardiology, Catharina Hospital Eindhoven, Eindhoven, Netherlands; Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands.
Cardiovascular Center Aalst, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium; Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
Lancet. 2015 Nov 7;386(10006):1853-60. doi: 10.1016/S0140-6736(15)00057-4. Epub 2015 Aug 30.
In the Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) study, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) improved outcome compared with angiography-guided PCI for up to 2 years of follow-up. The aim in this study was to investigate whether the favourable clinical outcome with the FFR-guided PCI in the FAME study persisted over a 5-year follow-up.
The FAME study was a multicentre trial done in Belgium, Denmark, Germany, the Netherlands, Sweden, the UK, and the USA. Patients (aged ≥ 18 years) with multivessel coronary artery disease were randomly assigned to undergo angiography-guided PCI or FFR-guided PCI. Before randomisation, stenoses requiring PCI were identified on the angiogram. Patients allocated to angiography-guided PCI had revascularisation of all identified stenoses. Patients allocated to FFR-guided PCI had FFR measurements of all stenotic arteries and PCI was done only if FFR was 0·80 or less. No one was masked to treatment assignment. The primary endpoint was major adverse cardiac events at 1 year, and the data for the 5-year follow-up are reported here. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00267774.
After 5 years, major adverse cardiac events occurred in 31% of patients (154 of 496) in the angiography-guided group versus 28% (143 of 509 patients) in the FFR-guided group (relative risk 0·91, 95% CI 0·75-1·10; p=0·31). The number of stents placed per patient was significantly higher in the angiography-guided group than in the FFR-guided group (mean 2·7 [SD 1·2] vs 1·9 [1·3], p<0·0001).
The results confirm the long-term safety of FFR-guided PCI in patients with multivessel disease. A strategy of FFR-guided PCI resulted in a significant decrease of major adverse cardiac events for up to 2 years after the index procedure. From 2 years to 5 years, the risks for both groups developed similarly. This clinical outcome in the FFR-guided group was achieved with a lower number of stented arteries and less resource use. These results indicate that FFR guidance of multivessel PCI should be the standard of care in most patients.
St Jude Medical, Friends of the Heart Foundation, and Medtronic.
在多血管病变的血流储备分数与血管造影评估（FAME）研究中，与血管造影指导的经皮冠状动脉介入治疗（PCI）相比，血流储备分数（FFR）指导的 PCI 在长达 2 年的随访中改善了预后。本研究旨在探讨 FAME 研究中 FFR 指导的 PCI 是否在 5 年随访中持续存在良好的临床结果。
FAME 研究是一项在比利时、丹麦、德国、荷兰、瑞典、英国和美国进行的多中心试验。患有多血管冠状动脉疾病的患者（年龄≥18 岁）被随机分配接受血管造影指导的 PCI 或 FFR 指导的 PCI。在随机分组之前，通过血管造影确定需要 PCI 的狭窄部位。被分配到血管造影指导的 PCI 组的患者对所有确定的狭窄部位进行血运重建。被分配到 FFR 指导的 PCI 组的患者对所有狭窄的动脉进行 FFR 测量，如果 FFR 为 0.80 或更低，则仅进行 PCI。没有人对治疗方案进行掩饰。主要终点是 1 年时的主要不良心脏事件，这里报告的是 5 年随访的数据。分析采用意向治疗。该试验在 ClinicalTrials.gov 注册，编号为 NCT00267774。
5 年后，血管造影指导组 31%（496 例中的 154 例）患者发生主要不良心脏事件，FFR 指导组 28%（509 例中的 143 例）患者发生（相对风险 0.91，95%CI 0.75-1.10；p=0.31）。血管造影指导组患者每例放置的支架数量明显高于 FFR 指导组（平均 2.7[SD 1.2] vs 1.9[1.3]，p<0.0001）。
这些结果证实了 FFR 指导的多血管疾病患者 PCI 的长期安全性。FFR 指导的 PCI 策略可显著降低指数手术后 2 年内的主要不良心脏事件风险。从 2 年到 5 年，两组的风险发展相似。FFR 指导组的这些临床结果是通过较少的支架血管和较少的资源使用实现的。这些结果表明，FFR 指导的多血管 PCI 应成为大多数患者的标准治疗方法。
美敦力公司、圣犹达医学公司、心脏基金会之友。
