N Engl J Med:心肌梗死患者FFR引导的完全或单纯PCI

29天前 来源:N Engl J Med

本文由小咖机器人翻译整理

期刊来源:N Engl J Med

原文链接:https://doi.org/10.1056/NEJMoa2314149

摘要内容如下:

背景

血流储备分数(FFR)指导的完全血运重建对ST段抬高型心肌梗死(STEMI)和多支冠状动脉疾病患者的益处尚不清楚。

方法

在这项多国、基于登记的随机试验中,我们将接受罪犯病变直接经皮冠状动脉介入治疗(PCI)的STEMI或极高危非STEMI(NSTEMI)和多支血管病变患者分为两组,一组接受血流储备分数(FFR)指导的非罪犯病变完全血运重建,另一组不接受进一步血运重建。主要转归是任何原因导致的死亡、心肌梗死或非计划性血运重建的复合结果。两个关键的次要结果是任何原因导致的死亡或心肌梗死和非计划性血运重建的复合结果。

结果

共有1542名患者接受了随机分组,其中764名患者接受了血流储备分数引导的完全血运重建,778名患者接受了单纯病变经皮冠状动脉介入治疗。中位随访时间为4.8年(四分位间距为4.3至5.2),完全血运重建组中有145名患者(19.0%)发生了主要结局事件,仅有原发病变组中有159名患者(20.4%)发生了主要结局事件(风险比为0.93;95%置信区间[CI],0.74至1.17;P=0.53)。至于次要转归,在任何原因导致的死亡或心肌梗死复合因素中未观察到明显的组间差异(风险比为1.12;95%CI,0.87至1.44)或非计划性血运重建(风险比,0.76;95%置信区间,0.56至1.04)。安全性结果没有明显的组间差异。

结论

在ST段抬高型心肌梗死(STEMI)或极高危非ST段抬高型心肌梗死(NSTEMI)和多支冠状动脉疾病患者中,在4.8年时,血流储备分数(FFR)指导下的完全血运重建与单纯病变PCI相比,并未降低任何原因导致的死亡、心肌梗死或非计划性血运重建的复合风险。(由瑞典研究委员会和其他机构资助;完整的Revasc ClinicalTrials.gov编号,NCT02862119。)

英文原文如下:

Abstracts

BACKGROUND  The benefit of fractional flow reserve (FFR)-guided complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease remains unclear.

METHODS  In this multinational, registry-based, randomized trial, we assigned patients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel disease who were undergoing primary percutaneous coronary intervention (PCI) of the culprit lesion to receive either FFR-guided complete revascularization of nonculprit lesions or no further revascularization. The primary outcome was a composite of death from any cause, myocardial infarction, or unplanned revascularization. The two key secondary outcomes were a composite of death from any cause or myocardial infarction and unplanned revascularization.

RESULTS  A total of 1542 patients underwent randomization, with 764 assigned to receive FFR-guided complete revascularization and 778 assigned to receive culprit-lesion-only PCI. At a median follow-up of 4.8 years (interquartile range, 4.3 to 5.2), a primary-outcome event had occurred in 145 patients (19.0%) in the complete-revascularization group and in 159 patients (20.4%) in the culprit-lesion-only group (hazard ratio, 0.93; 95% confidence interval [CI], 0.74 to 1.17; P = 0.53). With respect to the secondary outcomes, no apparent between-group differences were observed in the composite of death from any cause or myocardial infarction (hazard ratio, 1.12; 95% CI, 0.87 to 1.44) or unplanned revascularization (hazard ratio, 0.76; 95% CI, 0.56 to 1.04). There were no apparent between-group differences in safety outcomes.

CONCLUSIONS  Among patients with STEMI or very-high-risk NSTEMI and multivessel coronary artery disease, FFR-guided complete revascularization was not shown to result in a lower risk of a composite of death from any cause, myocardial infarction, or unplanned revascularization than culprit-lesion-only PCI at 4.8 years. (Funded by the Swedish Research Council and others; FULL REVASC ClinicalTrials.gov number, NCT02862119.).

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