West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom; BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.
Am Heart J. 2013 Oct;166(4):662-668.e3. doi: 10.1016/j.ahj.2013.07.011. Epub 2013 Aug 27.
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.
A prospective multicenter 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 ≤0.80 will be an indication for revascularization by percutaneous coronary intervention or coronary artery bypass surgery, as appropriate. The primary outcome is the between-group difference in the proportion of patients allocated to medical management only compared with revascularization. Secondary outcomes include the occurrence of cardiac death or hospitalization for myocardial infarction or heart failure, quality of life, and health care costs. The minimum and average follow-up periods for the primary analysis are 6 and 18 months, respectively.
Our developmental clinical trial will address the feasibility of FFR measurement in NSTEMI and the influence of FFR disclosure on treatment decisions and health and economic outcomes.
在急性非 ST 段抬高型心肌梗死（NSTEMI）患者中，通常建议进行冠状动脉造影；但血管造影的视觉解读具有主观性。我们假设，与基于血管造影的标准治疗相比，使用压力感应导丝进行冠状动脉狭窄严重程度的功能评估（血流储备分数[FFR]）将具有附加的诊断、临床和健康经济效用。
这是一项前瞻性多中心平行组 1:1 随机对照优效性试验，纳入 350 例至少有 1 处狭窄程度≥30%（FFR 测量阈值）的 NSTEMI 患者。患者在冠状动脉造影后立即随机分为 FFR 指导组或血管造影指导组。所有患者均将接受所有狭窄程度≥30%的血管 FFR 测量，包括罪犯病变和非罪犯病变。FFR 将在 FFR 指导组中公开以指导治疗，但在“血管造影指导”组中不公开。在 FFR 指导组中，FFR≤0.80 将作为经皮冠状动脉介入治疗或冠状动脉旁路移植术的指征。主要结局是与血管造影指导组相比，仅接受药物治疗的患者比例在两组之间的差异。次要结局包括心脏死亡或因心肌梗死或心力衰竭住院、生活质量和医疗保健费用。主要分析的最小和平均随访时间分别为 6 个月和 18 个月。
我们的开发性临床试验将解决在 NSTEMI 中进行 FFR 测量的可行性以及 FFR 披露对治疗决策和健康及经济结局的影响。
