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ICTUS(不稳定型冠状动脉综合征的有创与保守治疗)试验的 5 年临床结果:非 ST 段抬高型急性冠状动脉综合征患者早期有创与选择性有创治疗的随机比较。

5-year clinical outcomes in the ICTUS (Invasive versus Conservative Treatment in Unstable coronary Syndromes) trial a randomized comparison of an early invasive versus selective invasive management in patients with non-ST-segment elevation acute coronary syndrome.

机构信息

Department of Cardiology, Cardiac Catheterization Laboratory B2-137, Academic Medical Center-University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.

出版信息

J Am Coll Cardiol. 2010 Mar 2;55(9):858-64. doi: 10.1016/j.jacc.2009.11.026. Epub 2010 Jan 4.

Abstract

OBJECTIVES

We present the 5-year clinical outcomes according to treatment strategy with additional risk stratification of the ICTUS (Invasive versus Conservative Treatment in Unstable coronary Syndromes) trial.

BACKGROUND

Long-term outcomes may be relevant to decide treatment strategy for patients presenting with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) and elevated troponin T.

METHODS

We randomly assigned 1,200 patients to an early invasive or selective invasive strategy. The outcomes were the composite of death or myocardial infarction (MI) and its individual components. Risk stratification was performed with the FRISC (Fast Revascularization in InStability in Coronary artery disease) risk score.

RESULTS

At 5-year follow-up, revascularization rates were 81% in the early invasive and 60% in the selective invasive group. Cumulative death or MI rates were 22.3% and 18.1%, respectively (hazard ratio [HR]: 1.29, 95% confidence interval [CI]: 1.00 to 1.66, p = 0.053). No difference was observed in mortality (HR: 1.13, 95% CI: 0.80 to 1.60, p = 0.49) or MI (HR: 1.24, 95% CI: 0.90 to 1.70, p = 0.20). After risk stratification, no benefit of an early invasive strategy was observed in reducing death or spontaneous MI in any of the risk groups.

CONCLUSIONS

In patients presenting with NSTE-ACS and elevated troponin T, we could not demonstrate a long-term benefit of an early invasive strategy in reducing death or MI. (Invasive versus Conservative Treatment in Unstable coronary Syndromes [ICTUS]; ISRCTN82153174).

摘要

目的

我们根据 ICTUS(不稳定型冠状动脉综合征的侵入性与保守性治疗)试验的治疗策略,并进行额外的风险分层,呈现 5 年的临床结果。

背景

对于出现非 ST 段抬高型急性冠状动脉综合征(NSTE-ACS)和高肌钙蛋白 T 的患者,长期结果可能与决定治疗策略有关。

方法

我们将 1200 名患者随机分配至早期侵入性或选择性侵入性策略。结果是死亡或心肌梗死(MI)及各自组成部分的复合终点。风险分层采用 FRISC(不稳定型冠状动脉疾病快速血运重建风险评分)风险评分。

结果

在 5 年随访中,早期侵入性组和选择性侵入性组的血运重建率分别为 81%和 60%。累积死亡或 MI 发生率分别为 22.3%和 18.1%(风险比[HR]:1.29,95%置信区间[CI]:1.00 至 1.66,p=0.053)。死亡率(HR:1.13,95%CI:0.80 至 1.60,p=0.49)或 MI(HR:1.24,95%CI:0.90 至 1.70,p=0.20)均无差异。经风险分层后,在任何风险组中,早期侵入性策略都无法观察到降低死亡或自发性 MI 的获益。

结论

在出现 NSTE-ACS 和高肌钙蛋白 T 的患者中,我们无法证明早期侵入性策略在降低死亡或 MI 方面具有长期获益。(不稳定型冠状动脉综合征的侵入性与保守性治疗[ICTUS];ISRCTN82153174)。

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