Fractional flow reserve versus angiography in guiding management to optimize outcomes in non-ST-elevation myocardial infarction (FAMOUS-NSTEMI): Rationale and design of a randomized controlled clinical trial
Fractional flow reserve versus angiography in guiding management to optimize outcomes in non-ST-elevation myocardial infarction (FAMOUS-NSTEMI): Rationale and design of a randomized controlled clinical trial
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DOI：
10.1016/j.ahj.2013.07.011
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发表时间：
2013-10-01
影响因子：
4.8
通讯作者：
Oldroyd, Keith G.
中科院分区：
文献类型：
--
作者：
Berry, Colin;Layland, Jamie;Oldroyd, Keith G.
背景对于急性非ST段抬高心肌梗死（NSTEMI）患者，通常建议进行冠状动脉造影;但血管造影片的视觉解读是主观的。我们假设，冠状动脉狭窄严重程度的功能评估与压力敏感导丝（血流储备分数[FFR]）将有额外的诊断，临床和健康经济效用相比，血管造影引导的标准care.Methods和设计Aprospectivemulticenter平行组1：1随机对照优效性试验在350名NSTEMI患者>= 1冠状动脉狭窄>= 30%的严重程度（阈值血流储备分数测量）将进行。患者将在冠状动脉造影术后立即随机分配至FFR引导组或血管造影术引导组。然后，所有患者将在冠状动脉狭窄严重度>= 30%的所有血管中进行FFR测量，包括罪犯和非罪犯病变。血流储备分数将在血流储备分数引导组中公开以指导治疗，但在“血管造影引导”组中不公开。在FFR引导组中，
Background In patients with acute non-ST-elevation myocardial infarction (NSTEMI), coronary arteriography is usually recommended; but visual interpretation of the angiogram is subjective. We hypothesized that functional assessment of coronary stenosis severity with a pressure-sensitive guide wire (fractional flow reserve [FFR]) would have additive diagnostic, clinical, and health economic utility as compared with angiography-guided standard care.Methods and design Aprospectivemulticenter parallel-group 1:1 randomized controlled superiority trial in 350 NSTEMI patients with >= 1 coronary stenosis >= 30% severity (threshold for FFR measurement) will be conducted. Patients will be randomized immediately after coronary angiography to the FFR-guided group or angiography-guided group. All patients will then undergo FFR measurement in all vessels with a coronary stenosis >= 30% severity including culprit and nonculprit lesions. Fractional flow reserve will be disclosed to guide treatment in the FFR-guided group but not disclosed in the "angiography-guided" group. In the FFR-guided group, an FFR