急性冠状动脉综合征后连续心电图检测到的缺血：来自MERLIN-TIMI 36（雷诺嗪改善非ST段抬高型急性冠状动脉综合征缺血的代谢效率-心肌梗死溶栓治疗36）试验的观察结果

Ischemia detected on continuous electrocardiography after acute coronary syndrome: observations from the MERLIN-TIMI 36 (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction 36) trial.

作者信息

Scirica Benjamin M, Morrow David A, Budaj Andrzej, Dalby Anthony J, Mohanavelu Satishkumar, Qin Jie, Aroesty Julian, Hedgepeth Chester M, Stone Peter H, Braunwald Eugene

机构信息

TIMI Study Group, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.

出版信息

J Am Coll Cardiol. 2009 Apr 21;53(16):1411-21. doi: 10.1016/j.jacc.2008.12.053.

DOI:10.1016/j.jacc.2008.12.053

PMID:19371824

Abstract

OBJECTIVES

The purpose of this study was to assess the relationship between ischemia detected on continuous electrocardiographic (cECG) recording and cardiovascular outcomes after acute coronary syndrome (ACS).

BACKGROUND

The small size of prior studies evaluating cECG prevented full evaluation of the risk associated with ischemia across subpopulations and compared with other methods of risk stratification. Ranolazine, a new antianginal agent, reduces ischemic symptoms in patients with chronic angina and after ACS but the anti-ischemic effect, as detected by cECG, is not known.

METHODS

In all, 6,560 patients hospitalized with non-ST-segment elevation ACS were randomly assigned to ranolazine or placebo in the MERLIN-TIMI 36 (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction 36) trial. The cECG was performed for 7 days after randomization. Outcomes were followed for a median of 348 days. Clinical events that occurred during cECG recording were excluded from analysis.

RESULTS

A total of 6,355 (97%) patients had cECG recordings evaluable for ischemia analysis. Patients with >or=1 episode of ischemia on cECG (n = 1,271, 20%) were at increased risk of cardiovascular death (7.7% vs. 2.7%, p < 0.001), MI (9.4% vs. 5.0%, p < 0.001), and recurrent ischemia (17.5% vs. 12.3%, p < 0.001). The relationship with cardiovascular death was independent of baseline characteristics or elevated biomarkers (adjusted hazard ratio: 2.46, p < 0.001). Ischemia on cECG was associated with significantly worse outcomes in several subgroups. Ranolazine did not reduce the rate of ischemia detected on cECG (19.9% vs. 21.0%, hazard ratio: 0.93, p = 0.21).

CONCLUSIONS

In more than 6,300 patients with ACS, ischemia detected on cECG occurred frequently and was strongly and independently associated with poor cardiovascular outcomes, including cardiovascular death. Continuous ECG monitoring to detect ischemia after ACS may help to identify patients at increased risk. (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes [MERLIN]; NCT00099788).

摘要

目的

本研究旨在评估急性冠状动脉综合征（ACS）后连续心电图（cECG）记录中检测到的缺血与心血管结局之间的关系。

背景

既往评估cECG的研究规模较小，无法全面评估各亚组中与缺血相关的风险，也无法与其他风险分层方法进行比较。雷诺嗪是一种新型抗心绞痛药物，可减轻慢性心绞痛患者及ACS后患者的缺血症状，但通过cECG检测到的抗缺血效果尚不清楚。

方法

在MERLIN-TIMI 36（非ST段抬高急性冠状动脉综合征应用雷诺嗪减少缺血的代谢效率——心肌梗死溶栓试验36）试验中，共有6560例因非ST段抬高ACS住院的患者被随机分配至雷诺嗪组或安慰剂组。随机分组后进行7天的cECG检查。对患者进行了为期348天的中位数随访。cECG记录期间发生的临床事件被排除在分析之外。

结果

共有6355例（97%）患者的cECG记录可用于缺血分析。cECG上出现≥1次缺血发作的患者（n = 1271，20%）发生心血管死亡（7.7%对2.7%，p < 0.001）、心肌梗死（MI，9.4%对5.0%，p < 0.001）和复发性缺血（17.5%对12.3%，p < 0.001）的风险增加。与心血管死亡的关系独立于基线特征或生物标志物升高（调整后风险比：2.46，p < 0.001）。cECG上的缺血在几个亚组中均与显著更差的结局相关。雷诺嗪并未降低cECG检测到的缺血发生率（19.9%对21.0%，风险比：0.93，p = 0.21）。