急性心肌梗死合并心原性休克患者的 PCI 策略。
PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock.
机构信息
From Heart Center Leipzig, University Hospital, Leipzig (H.T., M.S., S.D.), Universitätsmedizin Mannheim, Mannheim (I.A.), University Heart Center Lübeck, Lübeck (G.F., S. de Waha, R.M.-S.), German Center for Cardiovascular Research (DZHK) (G.F., S. de Waha, R.M.-S., U.L., C.S., S.B.F., S.D.) and Universitätsklinikum Charité, Campus Benjamin Franklin (U.L., C.S.), Berlin, Universitätsklinikum Würzburg, Würzburg (P.N.), Klinikum der Eberhard-Karls-Universität Tübingen, Tübingen (T. Geisler), Klinikum Links der Weser, Bremen (A.F.), Helios Klinik Erfurt, Erfurt (H.L.), Ernst-Moritz-Arndt-Universität, Greifswald (S.B.F.), Universitäres Herzzentrum Regensburg, Regensburg (L.S.M.), and Institut für Herzinfarktforschung (S. Schneider, U.Z.) and Klinikum Ludwigshafen (U.Z.), Ludwigshafen - all in Germany; Academic Medical Center, Amsterdam (J.J.P.); University Medical Center Ljubljana, Ljubljana, Slovenia (M.N., T. Goslar); Institute of Cardiology, Warsaw, Poland (J.S.); Golden Jubilee National Hospital, Glasgow, United Kingdom (K.O.); Vilnius University Hospital Santaros Klinikos and Faculty of Medicine, Vilnius University, Vilnius, Lithuania (P.S.); Sorbonne Université Paris 6, ACTION Study Group, Centre Hospitalier Universitaire Pitié-Salpêtrière (G.M., O.B.), and Applied Research, Technology Transfer, Industrial Collaboration, Société Par Actions Simplifiée (P.T.), Paris; Wilhelminenspital, Department of Cardiology, and Sigmund Freud University, Medical School, Vienna (K.H.); University of Bern, Inselspital, Bern, Switzerland (S. Windecker); Manzoni Hospital, Lecco, Italy (S. Savonitto); and Universitair Ziekenhuis Antwerp, Antwerp, Belgium (C.V.).
出版信息
N Engl J Med. 2017 Dec 21;377(25):2419-2432. doi: 10.1056/NEJMoa1710261. Epub 2017 Oct 30.
BACKGROUND
In patients who have acute myocardial infarction with cardiogenic shock, early revascularization of the culprit artery by means of percutaneous coronary intervention (PCI) improves outcomes. However, the majority of patients with cardiogenic shock have multivessel disease, and whether PCI should be performed immediately for stenoses in nonculprit arteries is controversial.
METHODS
In this multicenter trial, we randomly assigned 706 patients who had multivessel disease, acute myocardial infarction, and cardiogenic shock to one of two initial revascularization strategies: either PCI of the culprit lesion only, with the option of staged revascularization of nonculprit lesions, or immediate multivessel PCI. The primary end point was a composite of death or severe renal failure leading to renal-replacement therapy within 30 days after randomization. Safety end points included bleeding and stroke.
RESULTS
At 30 days, the composite primary end point of death or renal-replacement therapy had occurred in 158 of the 344 patients (45.9%) in the culprit-lesion-only PCI group and in 189 of the 341 patients (55.4%) in the multivessel PCI group (relative risk, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P=0.01). The relative risk of death in the culprit-lesion-only PCI group as compared with the multivessel PCI group was 0.84 (95% CI, 0.72 to 0.98; P=0.03), and the relative risk of renal-replacement therapy was 0.71 (95% CI, 0.49 to 1.03; P=0.07). The time to hemodynamic stabilization, the risk of catecholamine therapy and the duration of such therapy, the levels of troponin T and creatine kinase, and the rates of bleeding and stroke did not differ significantly between the two groups.
CONCLUSIONS
Among patients who had multivessel coronary artery disease and acute myocardial infarction with cardiogenic shock, the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was lower among those who initially underwent PCI of the culprit lesion only than among those who underwent immediate multivessel PCI. (Funded by the European Union 7th Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).
背景
对于患有心原性休克的急性心肌梗死患者，通过经皮冠状动脉介入治疗（PCI）早期再通罪犯动脉可改善预后。然而，大多数心原性休克患者存在多支血管病变，对于非罪犯动脉的狭窄是否应立即进行 PCI 存在争议。
方法
本多中心试验将 706 例患有多支血管病变、急性心肌梗死和心原性休克的患者随机分为两种初始血运重建策略之一：仅对罪犯病变进行 PCI，选择性对非罪犯病变进行分期血运重建，或直接多支血管 PCI。主要终点是随机分组后 30 天内死亡或严重肾衰竭导致肾脏替代治疗的复合终点。安全性终点包括出血和卒中等。
结果
在 30 天内，仅罪犯病变 PCI 组的 344 例患者中有 158 例（45.9%）和多支血管 PCI 组的 341 例患者中有 189 例（55.4%）发生了死亡或肾脏替代治疗的复合主要终点（相对风险，0.83；95%置信区间 [CI]，0.71 至 0.96；P=0.01）。与多支血管 PCI 组相比，仅罪犯病变 PCI 组的死亡相对风险为 0.84（95%CI，0.72 至 0.98；P=0.03），肾脏替代治疗的相对风险为 0.71（95%CI，0.49 至 1.03；P=0.07）。血流动力学稳定的时间、儿茶酚胺治疗的风险和持续时间、肌钙蛋白 T 和肌酸激酶的水平以及出血和卒中等不良事件的发生率在两组之间没有显著差异。
结论
在心原性休克合并多支冠状动脉疾病的急性心肌梗死患者中，仅行罪犯病变 PCI 的患者与直接行多支血管 PCI 的患者相比，30 天内死亡或严重肾衰竭导致肾脏替代治疗的复合风险较低。（由欧盟第七框架计划和其他机构资助；CULPRIT-SHOCK 临床试验.gov 编号，NCT01927549）。
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