TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
J Am Coll Cardiol. 2013 May 7;61(18):1853-9. doi: 10.1016/j.jacc.2013.01.066. Epub 2013 Mar 7.
The present analysis reports on the pre-specified subgroup of ST-elevation myocardial infarction (STEMI) patients, in whom anticoagulant therapy has been of particular interest.
In ATLAS ACS-2-TIMI-51 (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction-51), rivaroxaban reduced cardiovascular events across the spectrum of acute coronary syndrome (ACS).
Seven thousand eight hundred seventeen patients in ATLAS ACS-2-TIMI 51 presented with a STEMI. After being stabilized (1 to 7 days), they underwent randomization to twice daily rivaroxaban 2.5 mg, rivaroxaban 5 mg, or placebo. Data are presented as 2-year Kaplan-Meier rates, and for intention-to-treat (ITT) and modified ITT (mITT) analyses.
Among STEMI patients, rivaroxaban reduced the primary efficacy endpoint of cardiovascular death, myocardial infarction, or stroke, compared with placebo (ITT: 8.4% vs. 10.6%, hazards ratio [HR]: 0.81, 95% confidence interval [CI]: 0.67 to 0.97, p = 0.019; mITT: 8.3% vs. 9.7%, HR: 0.85, 95% CI: 0.70 to 1.03, p = 0.09). This reduction emerged by 30 days (ITT and mITT: 1.7% vs. 2.3%, p = 0.042) and was evident in analyses that included events while patients received background dual antiplatelet therapies (ITT: 7.9% vs. 11.9%, p = 0.010; mITT: 7.7% vs. 10.1%, p = 0.061). In terms of the individual doses, rivaroxaban 2.5 mg reduced cardiovascular death (ITT: 2.5% vs. 4.2%, p = 0.006; mITT: 2.2% vs. 3.9%, p = 0.006), which was not seen with 5 mg of rivaroxaban. Rivaroxaban versus placebo increased non-coronary artery bypass grafting Thrombolysis In Myocardial Infarction major bleeding (2.2% vs. 0.6%, p < 0.001) and intracranial hemorrhage (0.6% vs. 0.1%, p = 0.015) without a significant increase in fatal bleeding (0.2% vs. 0.1%, p = 0.51).
In patients with a recent STEMI, rivaroxaban reduced cardiovascular events. This benefit emerged early and persisted during continued treatment with background antiplatelet therapies. Rivaroxaban compared with placebo increased the rate of major bleeding, but there was no significant increase in fatal bleeding. (An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome; NCT00809965).
本分析报告了预先设定的 ST 段抬高型心肌梗死（STEMI）患者亚组的情况，在该亚组中，抗凝治疗尤其受到关注。
在 ATLAS ACS-2-TIMI 51 研究（抗 Xa 治疗联合标准疗法治疗急性冠脉综合征-血栓溶解心肌梗死 51 例）中，利伐沙班降低了急性冠脉综合征（ACS）患者的心血管事件发生率。
ATLAS ACS-2-TIMI 51 研究中共有 7817 例 STEMI 患者。在稳定后（1 至 7 天），他们被随机分为每日两次接受利伐沙班 2.5mg、利伐沙班 5mg 或安慰剂治疗。数据以 2 年 Kaplan-Meier 率表示，并进行意向治疗（ITT）和改良 ITT（mITT）分析。
在 STEMI 患者中，与安慰剂相比，利伐沙班降低了心血管死亡、心肌梗死或卒中的主要疗效终点（ITT：8.4%比 10.6%，风险比[HR]：0.81，95%置信区间[CI]：0.67 至 0.97，p=0.019；mITT：8.3%比 9.7%，HR：0.85，95%CI：0.70 至 1.03，p=0.09）。这种降低在 30 天内出现（ITT 和 mITT：1.7%比 2.3%，p=0.042），并且在包括患者接受背景双联抗血小板治疗时的事件分析中是明显的（ITT：7.9%比 11.9%，p=0.010；mITT：7.7%比 10.1%，p=0.061）。就各个剂量而言，利伐沙班 2.5mg 降低了心血管死亡（ITT：2.5%比 4.2%，p=0.006；mITT：2.2%比 3.9%，p=0.006），而 5mg 利伐沙班则没有观察到这种情况。与安慰剂相比，利伐沙班增加了非冠状动脉旁路移植术血栓溶解心肌梗死主要出血（2.2%比 0.6%，p<0.001）和颅内出血（0.6%比 0.1%，p=0.015），但致命性出血没有显著增加（0.2%比 0.1%，p=0.51）。
在近期发生 STEMI 的患者中，利伐沙班降低了心血管事件。这种益处早期出现，并在继续接受背景抗血小板治疗期间持续存在。与安慰剂相比，利伐沙班增加了大出血的发生率，但致命性出血没有显著增加。（急性冠脉综合征患者利伐沙班的疗效和安全性研究；NCT00809965）。
