常规压力导丝评估与常规血管造影在冠心病患者管理中的比较：RIPCORD 2 试验。
Routine Pressure Wire Assessment Versus Conventional Angiography in the Management of Patients With Coronary Artery Disease: The RIPCORD 2 Trial.
机构信息
Liverpool Heart & Chest Hospital, UK (R.H.S., L.J.M., M.E., Y.H.A.-E., I.K.).
Coronary Research Group, University Hospital Southampton, UK (Z.N., N.C.).
出版信息
Circulation. 2022 Aug 30;146(9):687-698. doi: 10.1161/CIRCULATIONAHA.121.057793. Epub 2022 Aug 10.
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; =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; =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 (=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.
背景
在经皮冠状动脉介入治疗中，测量血流储备分数（FFR）具有明确的作用。我们检验了一个假说，即在诊断性有创冠状动脉造影阶段，与单独进行冠状动脉造影相比，对所有直径>2.25 毫米的冠状动脉进行系统性 FFR 评估在资源利用和生活质量方面更具优势。
方法
我们在英国的 17 个中心进行了一项开放标签、随机、对照试验，招募了 1100 名因稳定型心绞痛或非 ST 段抬高型心肌梗死而行有创冠状动脉造影检查的患者。患者被随机分配到单独进行冠状动脉造影（冠状动脉造影组）或在所有直径>2.25 毫米的冠状动脉进行系统性压力导丝评估（冠状动脉造影+FFR 组）。在 1 年时评估的主要转归指标是国民保健服务（NHS）医院的成本和生活质量。预先设定的次要转归指标包括临床事件。
结果
在冠状动脉造影+FFR 组中，检查的血管中位数为 4 条（四分位间距，3-5 条）。医院的中位成本相似：冠状动脉造影组为 4136 英镑（四分位间距，2613-7015 英镑）；冠状动脉造影+FFR 组为 4510 英镑（四分位间距，2721-7415 英镑；=0.137）。使用 EuroQol EQ-5D-5L 视觉模拟量表评估的生活质量中位数也没有差异：冠状动脉造影组为 75（四分位间距，60-87）；冠状动脉造影+FFR 组为 75（四分位间距，60-90；=0.88）。临床事件的数量如下：死亡 5 例，8 例；中风 3 例，4 例；心肌梗死 23 例，22 例；计划外血运重建 26 例，33 例，冠状动脉造影组的复合分层事件发生率为 8.7%（552 例中的 48 例），冠状动脉造影+FFR 组为 9.5%（548 例中的 52 例；=0.64）。
结论
与单独进行冠状动脉造影相比，系统性 FFR 评估策略并未显著降低成本或提高生活质量。
注册
临床试验
gov；唯一标识符：NCT01070771。
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