Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial.

Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial.
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DOI:
10.1093/eurheartj/ehu338
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发表时间:
2015-01-07
影响因子:
39.3
通讯作者:
FAMOUS–NSTEMI investigators
FAMOUS–NSTEMI investigators
中科院分区:
医学1区
文献类型:
--
作者:
Layland J;Oldroyd KG;Curzen N;Sood A;Balachandran K;Das R;Junejo S;Ahmed N;Lee MM;Shaukat A;O'Donnell A;Nam J;Briggs A;Henderson R;McConnachie A;Berry C;FAMOUS–NSTEMI investigators

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我们评估了随机分配至血流储备分数 (FFR) 指导治疗或血管造影指导标准护理的非 ST 段抬高型心肌梗死 (NSTEMI) 患者的治疗和结果。我们对 350 名 NSTEMI 患者进行了一项前瞻性、多中心、平行组、1:1 随机对照试验,其中冠状动脉狭窄≥1 次,≥30% 的管腔直径通过肉眼评估(FFR 测量阈值)(NCT01764334)。 2011 年 10 月至 2013 年 5 月期间,在六家英国医院进行了招募。在 FFR 指导组 (n = 176) 中,向操作者披露了血流储备分数。在血管造影引导组中测量了血流储备分数,但未披露 (n = 174)。血流储备分数≤0.80是经皮冠状动脉介入治疗(PCI)或冠状动脉搭桥手术(CABG)血运重建的指征。从首次出现心肌缺血到进行血管造影的中位时间 (IQR) 为 3 (2, 5) 天。对于主要结局,FFR指导组中最初接受药物治疗的患者比例高于血管造影指导组[40例(22.7%)比23例(13.2%),差异95%(95% CI:1.4%、17.7%),P = 0.022]。血流储备分数披露导致 38 名 (21.6%) 患者的治疗方式在药物治疗、PCI 或 CABG 之间发生变化。 12 个月时,FFR 指导组的血运重建率仍然较低 [79.0 vs. 86.8%,差异 7.8% (−0.2%, 15.8%),P = 0.054]。各组之间的健康结果和生活质量没有统计学上的显着差异。在 NSTEMI 患者中,与 FFR 指导的治疗相比,血管造影指导的治疗与更高的冠状动脉血运重建率相关。有必要进行更大规模的试验来评估健康结果和成本效益。
We assessed the management and outcomes of non-ST segment elevation myocardial infarction (NSTEMI) patients randomly assigned to fractional flow reserve (FFR)-guided management or angiography-guided standard care. We conducted a prospective, multicentre, parallel group, 1 : 1 randomized, controlled trial in 350 NSTEMI patients with ≥1 coronary stenosis ≥30% of the lumen diameter assessed visually (threshold for FFR measurement) (NCT01764334). Enrolment took place in six UK hospitals from October 2011 to May 2013. Fractional flow reserve was disclosed to the operator in the FFR-guided group (n = 176). Fractional flow reserve was measured but not disclosed in the angiography-guided group (n = 174). Fractional flow reserve ≤0.80 was an indication for revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). The median (IQR) time from the index episode of myocardial ischaemia to angiography was 3 (2, 5) days. For the primary outcome, the proportion of patients treated initially by medical therapy was higher in the FFR-guided group than in the angiography-guided group [40 (22.7%) vs. 23 (13.2%), difference 95% (95% CI: 1.4%, 17.7%), P = 0.022]. Fractional flow reserve disclosure resulted in a change in treatment between medical therapy, PCI or CABG in 38 (21.6%) patients. At 12 months, revascularization remained lower in the FFR-guided group [79.0 vs. 86.8%, difference 7.8% (−0.2%, 15.8%), P = 0.054]. There were no statistically significant differences in health outcomes and quality of life between the groups. In NSTEMI patients, angiography-guided management was associated with higher rates of coronary revascularization compared with FFR-guided management. A larger trial is necessary to assess health outcomes and cost-effectiveness.
DOI: 10.1016/j.ahj.2013.07.011
发表时间: 2013-10-01
影响因子: 4.8
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期刊: CIRCULATION
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发表时间: 1996-06-27
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发表时间: 2013-01-01
影响因子: 2.8
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