Background:Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone.Methods:We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non–ST-segment–elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events.Results:In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3–5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613–£7015); and angiography+FFR, £4510 (£2721–£7415; P=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60–87); and angiography+FFR, 75 (interquartile range, 60–90; P=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (P=0.64).Conclusions:A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01070771.

中文翻译：

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冠状动脉疾病患者管理中的常规压力丝评估与常规血管造影术：RIPCORD 2 试验

背景：血流储备分数 (FFR) 的测量在指导经皮冠状动脉介入治疗中具有明确的作用。我们检验了这样一个假设，即在诊断性有创冠状动脉造影阶段，系统的 FFR 指导的冠状动脉疾病评估在资源利用和生活质量方面优于单独的血管造影评估。方法：我们进行了一项开放式研究- 在 17 个英国中心进行的标签、随机、对照试验，招募了 1100 名接受侵入性冠状动脉造影术以调查稳定性心绞痛或非 ST 段抬高型心肌梗死的患者。患者被随机分配接受单独的血管造影（血管造影）或血管造影并对所有直径>2.25 mm 的心外膜血管进行系统压力丝评估（血管造影+FFR）。1 年时评估的共同主要结局是国民健康服务医院费用和生活质量。预先指定的次要结果包括临床事件。结果：在血管造影 + FFR 组中，检查的血管中位数为 4（四分位数范围，3-5）。住院费用中位数相似：血管造影术，4136 英镑（四分位距，2613 英镑至 7015 英镑）；血管造影+FFR，4510英镑（2721-7415英镑；P = 0.137）。使用 EuroQol EQ-5D-5L 的视觉模拟量表，生活质量的中位数没有差异：血管造影，75（四分位间距，60-87）；和血管造影 + FFR，75（四分位距，60-90；P = 0.88）。临床事件的数量如下：死亡，5 对 8；笔画，3对4；心肌梗塞，23 比 22；和计划外的血运重建，26 对 33，血管造影的复合分层事件率为 8.7%（552 例中的 48 例），而血管造影 +FFR 的复合分层事件率为 9.5%（548 例中的 52 例）（P = 0.64）。结论：系统性 FFR 评估策略与单独的血管造影术相比，并未显着降低成本或改善生活质量。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT01070771。