心源休克患者经皮冠状动脉介入治疗策略的一年预后
One-Year Outcomes after PCI Strategies in Cardiogenic Shock.
机构信息
From Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig (H.T., M.S., A.J., S.D.), Universitätsmedizin Mannheim, Mannheim (I.A.), University Heart Center Lübeck, Lübeck (S.W.-T., R.M.-S., G.F., I.E.), German Center for Cardiovascular Research (I.A., S.W.-T., R.M.-S., G.F., I.E., U.L., C.S., A.J., 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; Wilhelminenpital, Department of Cardiology, and Sigmund Freud University, Medical School, Vienna (K.H.); the Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland (S.W., L.H.); Manzoni Hospital, Lecco, Italy (S. Savonitto); and Universitair Ziekenhuis Antwerp, Antwerp, Belgium (C.V.).
出版信息
N Engl J Med. 2018 Nov 1;379(18):1699-1710. doi: 10.1056/NEJMoa1808788. Epub 2018 Aug 25.
BACKGROUND
Among patients with acute myocardial infarction, cardiogenic shock, and multivessel coronary artery disease, the risk of a composite of death from any cause or severe renal failure leading to renal-replacement therapy at 30 days was found to be lower with percutaneous coronary intervention (PCI) of the culprit lesion only than with immediate multivessel PCI. We evaluated clinical outcomes at 1 year.
METHODS
We randomly assigned 706 patients to either culprit-lesion-only PCI or immediate multivessel PCI. The results for the primary end point of death or renal-replacement therapy at 30 days have been reported previously. Prespecified secondary end points at 1 year included death from any cause, recurrent myocardial infarction, repeat revascularization, rehospitalization for congestive heart failure, the composite of death or recurrent infarction, and the composite of death, recurrent infarction, or rehospitalization for heart failure.
RESULTS
As reported previously, at 30 days, the primary end point had occurred in 45.9% of the patients in the culprit-lesion-only PCI group and in 55.4% in the multivessel PCI group (P=0.01). At 1 year, death had occurred in 172 of 344 patients (50.0%) in the culprit-lesion-only PCI group and in 194 of 341 patients (56.9%) in the multivessel PCI group (relative risk, 0.88; 95% confidence interval [CI], 0.76 to 1.01). The rate of recurrent infarction was 1.7% with culprit-lesion-only PCI and 2.1% with multivessel PCI (relative risk, 0.85; 95% CI, 0.29 to 2.50), and the rate of a composite of death or recurrent infarction was 50.9% and 58.4%, respectively (relative risk, 0.87; 95% CI, 0.76 to 1.00). Repeat revascularization occurred more frequently with culprit-lesion-only PCI than with multivessel PCI (in 32.3% of the patients vs. 9.4%; relative risk, 3.44; 95% CI, 2.39 to 4.95), as did rehospitalization for heart failure (5.2% vs. 1.2%; relative risk, 4.46; 95% CI, 1.53 to 13.04).
CONCLUSIONS
Among patients with acute myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days was lower with culprit-lesion-only PCI than with immediate multivessel PCI, and mortality did not differ significantly between the two groups at 1 year of follow-up. (Funded by the European Union Seventh Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).
背景
在急性心肌梗死、心源性休克和多支冠状动脉疾病患者中，与即刻多支血管血运重建相比，罪犯病变血运重建仅与 30 天内任何原因死亡或导致肾脏替代治疗的严重肾功能衰竭的复合终点发生率较低。我们评估了 1 年的临床结果。
方法
我们将 706 例患者随机分为罪犯病变血运重建组和即刻多支血管血运重建组。30 天主要终点（任何原因死亡或肾脏替代治疗）的结果先前已报道。1 年的预设次要终点包括任何原因死亡、复发性心肌梗死、再次血运重建、充血性心力衰竭再住院、死亡或复发性梗死的复合终点、死亡、复发性梗死或心力衰竭再住院的复合终点。
结果
先前报道，30 天内，罪犯病变血运重建组有 45.9%的患者发生主要终点，多支血管血运重建组有 55.4%的患者发生（P=0.01）。1 年时，罪犯病变血运重建组有 172/344 例（50.0%）患者死亡，多支血管血运重建组有 194/341 例（56.9%）患者死亡（相对风险，0.88；95%置信区间[CI]，0.76 至 1.01）。罪犯病变血运重建组的复发性心肌梗死发生率为 1.7%，多支血管血运重建组为 2.1%（相对风险，0.85；95%CI，0.29 至 2.50），死亡或复发性心肌梗死的复合终点发生率分别为 50.9%和 58.4%（相对风险，0.87；95%CI，0.76 至 1.00）。罪犯病变血运重建组再次血运重建的发生率高于多支血管血运重建组（分别为 32.3%和 9.4%；相对风险，3.44；95%CI，2.39 至 4.95），心力衰竭再住院率也高于多支血管血运重建组（分别为 5.2%和 1.2%；相对风险，4.46；95%CI，1.53 至 13.04）。
结论
在急性心肌梗死合并心源性休克患者中，罪犯病变血运重建的 30 天内死亡或肾脏替代治疗风险低于即刻多支血管血运重建，两组在 1 年随访时的死亡率无显著差异。（由欧盟第七框架计划等资助；CULPRIT-SHOCK 临床试验。gov 编号，NCT01927549）。
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