Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI
Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI
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DOI：
10.1056/nejmoa1616540
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发表时间：
2017-05-11
影响因子：
158.5
通讯作者：
Frobert, O.
中科院分区：
文献类型：
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作者：
Gotberg, M.;Christiansen, E. H.;Frobert, O.
背景瞬时无波比(IFR)是用来评估冠状动脉狭窄程度的指标。该指数已经在小规模试验中与分数流量储备(FFR)进行了测试，发现这两个指标具有类似的诊断准确性。然而，缺乏与使用IFR相关的临床结果的研究。我们的目的是评估IFR在后续主要心脏不良事件的发生率方面是否不逊于FFR。方法：我们利用瑞典冠状动脉造影和血管成形术注册中心进行了一项多中心、随机、对照、开放标签的临床试验。共有2037名患有稳定性心绞痛或急性冠状动脉综合征的参与者被随机分配到在IFR或FFR引导下接受血管重建术，这些患者有冠状动脉狭窄的生理学指导评估的指征。结果主要终点事件发生在IFR组68例(6.7%)和FFR组61例(6.1%)(事件发生率差异，0.70个百分点；95%可信区间[CI]，-1.52.8；非劣势P=0.007；危险比1.12；95%CI，0.791.58；P=0.53)；事件发生率差异的95%可信区间上限落在预先指定的3.2个百分点的非劣势范围内。主要亚组之间的结果相似。心肌梗死、靶病变血运重建、再狭窄和支架血栓的发生率在两组之间没有显著差异。在手术过程中，FFR组患者报告胸部不适的比例显著高于IFR组。结论在稳定性心绞痛或急性冠脉综合征患者中，IFR引导的血运重建策略在12个月的主要心脏不良事件发生率方面并不逊色于FFR引导的血运重建策略。
BACKGROUNDThe instantaneous wave-free ratio (iFR) is an index used to assess the severity of coronary-artery stenosis. The index has been tested against fractional flow reserve (FFR) in small trials, and the two measures have been found to have similar diagnostic accuracy. However, studies of clinical outcomes associated with the use of iFR are lacking. We aimed to evaluate whether iFR is noninferior to FFR with respect to the rate of subsequent major adverse cardiac events.METHODSWe conducted a multicenter, randomized, controlled, open-label clinical trial using the Swedish Coronary Angiography and Angioplasty Registry for enrollment. A total of 2037 participants with stable angina or an acute coronary syndrome who had an indication for physiologically guided assessment of coronary-artery stenosis were randomly assigned to undergo revascularization guided by either iFR or FFR. The primary end point was the rate of a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization within 12 months after the procedure.RESULTSA primary end-point event occurred in 68 of 1012 patients (6.7%) in the iFR group and in 61 of 1007 (6.1%) in the FFR group (difference in event rates, 0.7 percentage points; 95% confidence interval [CI], -1.5 to 2.8; P = 0.007 for noninferiority; hazard ratio, 1.12; 95% CI, 0.79 to 1.58; P = 0.53); the upper limit of the 95% confidence interval for the difference in event rates fell within the prespecified noninferiority margin of 3.2 percentage points. The results were similar among major subgroups. The rates of myocardial infarction, target-lesion revascularization, restenosis, and stent thrombosis did not differ significantly between the two groups. A significantly higher proportion of patients in the FFR group than in the iFR group reported chest discomfort during the procedure.CONCLUSIONSAmong patients with stable angina or an acute coronary syndrome, an iFR-guided revascularization strategy was noninferior to an FFR-guided revascularization strategy with respect to the rate of major adverse cardiac events at 12 months.