心肌梗死的血流储备分数指导下的多血管血管成形术。
Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction.
机构信息
From the Department of Cardiology, Maasstad Ziekenhuis, Rotterdam (P.C.S., B.M.B.-K.), and the Department of Cardiology, Haga Ziekenhuis, The Hague (C.E.S.) - both in the Netherlands; the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W., G.R.), the Department of Cardiology, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N.), and the Department of Cardiology, Klinikum Links der Weser, Bremen (R.H.) - all in Germany; the Department of Cardiology, Rigshospitalet, University of Oslo, Oslo (K.L.); the Department of Cardiology, György Hungarian Institute of Cardiology, Budapest, Hungary (Z.P.); the Department of Cardiology, Liberec Regional Hospital, Liberec, Czech Republic (D.H.); the Department of Cardiology, Miedziowe Centrum Zdrowia, Lubin, Poland (A.W.); the Department of Cardiology, Tan Tock Seng Hospital, Singapore (P.J.O.); and the Department of Cardiology, Gothenburg University Hospital, Gothenburg, Sweden (O.A., E.O.).
出版信息
N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18.
BACKGROUND
In patients with ST-segment elevation myocardial infarction (STEMI), the use of percutaneous coronary intervention (PCI) to restore blood flow in an infarct-related coronary artery improves outcomes. The use of PCI in non-infarct-related coronary arteries remains controversial.
METHODS
We randomly assigned 885 patients with STEMI and multivessel disease who had undergone primary PCI of an infarct-related coronary artery in a 1:2 ratio to undergo complete revascularization of non-infarct-related coronary arteries guided by fractional flow reserve (FFR) (295 patients) or to undergo no revascularization of non-infarct-related coronary arteries (590 patients). The FFR procedure was performed in both groups, but in the latter group, both the patients and their cardiologist were unaware of the findings on FFR. The primary end point was a composite of death from any cause, nonfatal myocardial infarction, revascularization, and cerebrovascular events at 12 months. Clinically indicated elective revascularizations performed within 45 days after primary PCI were not counted as events in the group receiving PCI for an infarct-related coronary artery only.
RESULTS
The primary outcome occurred in 23 patients in the complete-revascularization group and in 121 patients in the infarct-artery-only group that did not receive complete revascularization, a finding that translates to 8 and 21 events per 100 patients, respectively (hazard ratio, 0.35; 95% confidence interval [CI], 0.22 to 0.55; P<0.001). Death occurred in 4 patients in the complete-revascularization group and in 10 patients in the infarct-artery-only group (1.4% vs. 1.7%) (hazard ratio, 0.80; 95% CI, 0.25 to 2.56), myocardial infarction in 7 and 28 patients, respectively (2.4% vs. 4.7%) (hazard ratio, 0.50; 95% CI, 0.22 to 1.13), revascularization in 18 and 103 patients (6.1% vs. 17.5%) (hazard ratio, 0.32; 95% CI, 0.20 to 0.54), and cerebrovascular events in 0 and 4 patients (0 vs. 0.7%). An FFR-related serious adverse event occurred in 2 patients (both in the group receiving infarct-related treatment only).
CONCLUSIONS
In patients with STEMI and multivessel disease who underwent primary PCI of an infarct-related artery, the addition of FFR-guided complete revascularization of non-infarct-related arteries in the acute setting resulted in a risk of a composite cardiovascular outcome that was lower than the risk among those who were treated for the infarct-related artery only. This finding was mainly supported by a reduction in subsequent revascularizations. (Funded by Maasstad Cardiovascular Research and others; Compare-Acute ClinicalTrials.gov number, NCT01399736 .).
背景
在 ST 段抬高型心肌梗死（STEMI）患者中，经皮冠状动脉介入治疗（PCI）恢复梗死相关冠状动脉的血流可改善预后。非梗死相关冠状动脉的 PCI 应用仍存在争议。
方法
我们以 1:2 的比例将 885 例接受梗死相关冠状动脉直接 PCI 的 STEMI 伴多支血管病变患者随机分为两组，一组接受血流储备分数（FFR）指导的非梗死相关冠状动脉完全血运重建（295 例），另一组不进行非梗死相关冠状动脉血运重建（590 例）。两组均进行 FFR 检查，但在后者中，患者和其心内科医生均不了解 FFR 检查结果。主要终点是 12 个月时任何原因导致的死亡、非致死性心肌梗死、血运重建和脑血管事件的复合终点。直接 PCI 后 45 天内行临床指征明确的选择性血运重建不视为仅接受梗死相关冠状动脉血运重建组的事件。
结果
完全血运重建组有 23 例患者和未行完全血运重建的仅接受梗死相关动脉血运重建组有 121 例患者发生主要终点事件，分别相当于每 100 例患者 8 例和 21 例（风险比，0.35；95%置信区间[CI]，0.22 至 0.55；P<0.001）。完全血运重建组有 4 例患者死亡，仅接受梗死相关动脉血运重建组有 10 例患者死亡（1.4%比 1.7%）（风险比，0.80；95%CI，0.25 至 2.56），心肌梗死分别有 7 例和 28 例（2.4%比 4.7%）（风险比，0.50；95%CI，0.22 至 1.13），血运重建分别有 18 例和 103 例（6.1%比 17.5%）（风险比，0.32；95%CI，0.20 至 0.54），脑血管事件分别有 0 例和 4 例（0%比 0.7%）。有 2 例（均仅接受梗死相关治疗组）发生与 FFR 相关的严重不良事件。
结论
在 STEMI 伴多支血管病变患者中，直接 PCI 治疗梗死相关动脉的同时，行 FFR 指导的非梗死相关动脉完全血运重建可降低复合心血管结局风险，这一风险低于仅接受梗死相关动脉血运重建的患者。这一发现主要得益于随后血运重建的减少。（由 Maasstad 心血管研究等资助；Compare-Acute 临床试验。注册号：NCT01399736）。
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