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Usefulness of Rivaroxaban for Secondary Prevention of Acute Coronary Syndrome in Patients With History of Congestive Heart Failure (from the ATLAS-ACS-2 TIMI-51 Trial)

机译:蓖麻毒素对充血性心力衰竭历史患者急性冠状动脉综合征的二次预防(来自阿特拉斯 - ACS-2 Timi-51试验)

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摘要

Patients with both acute coronary syndromes (ACS) and congestive heart failure are at an increased risk of recurrent cardiovascular (CV) events attributed in part to both excess thrombin generation and impaired fibrinolysis. We hypothesized that patients with the overlap of ACS and CHF would thus derive particular benefit from antithrombotic therapy with rivaroxaban. ATLAS-ACS-2 Thrombolysis in Myocardial Infarction-51 was a double-blind, multicenter, phase 3 clinical trial that randomized patients within 7 days of an ACS event to standard of care plus either rivaroxaban 2.5 mg BID, 5 mg BID, or placebo (n?=?15,526). In this post hoc subgroup analysis, subjects with a history of CHF at randomization (n?=?1,694) were evaluated. Among subjects with a history of CHF, both rivaroxaban doses reduced the primary composite end point of CV death, myocardial infarction, or stroke (2.5 mg BID vs placebo: hazard ratio [HR] 0.59, 95% confidence interval [CI] (0.42, 0.81), p?=?0.001; 5 mg BID vs placebo: HR 0.61, 95% CI (0.44, 0.84), p?=?0.002; p interaction?=?0.006). Both doses of rivaroxaban reduced CV mortality (rivaroxaban 2.5 mg BID vs placebo: 4.1% vs 9.0%, HR 0.45, 95% CI [0.27, 0.74], p?=?0.002; rivaroxaban 5 mg BID vs placebo: 5.8% vs 9.0%, HR 0.62, 95% CI [0.40, 0.96], p?=?0.031) as well as all-cause mortality. There was no significant increase in noncoronary artery bypass graft-related Thrombolysis in Myocardial Infarction major bleeding with either dose of rivaroxaban as compared with placebo (rivaroxaban 2.5 mg BID?=?0.4% vs rivaroxaban 5 mg BID?=?1.1% vs placebo?=?0.5%). Rivaroxaban also did not increase either intracranial hemorrhage or fatal bleeding. In conclusion, in ACS subjects with a history of CHF, secondary prevention with rivaroxaban reduced the composite of CV death, myocardial infarction, or stroke without an increase in noncoronary artery bypass graft-related major bleeding. These findings require further prospective evaluation in an adequately powered phase 3 study.
机译:急性冠状动脉综合征(ACS)和充血性心力衰竭的患者处于复发性心血管(CV)事件的风险增加,其归因于过量凝血酶产生和纤维蛋白溶解受损。我们假设ACS和CHF重叠的患者因此将从Rivaroxaban的抗血栓疗法中得出特殊的益处。 Atlas-ACS-2在心肌梗塞-51中的溶栓 - 51是一款双盲,多中心,第3期临床试验,可在ACS事件的7天内随机化患者对护理标准加上Rivaroxaban 2.5mg Bid,5毫克出价或安慰剂(n?=?15,526)。在该后HOC子组分析中,评估随机化历史历史的受试者(N?=?1,694)。在具有CHF历史的受试者中,罗昔扎班剂剂量减少了CV死亡,心肌梗死或中风的主要复合终点(2.5mg BID VS安慰剂:危害比[HR] 0.59,95%置信区间[CI](0.42, 0.81),p?= 0.001; 5 mg BID VS安慰剂:HR 0.61,95%CI(0.44,0.84),P?= 0.002; P互动?=?0.006)。毛茸草的两种剂量降低了Cv死亡率(蓖麻毒素2.5mg BID VS安慰剂:4.1%vs 9.0%,HR 0.45,95%CI [0.27,0.74],P?= 0.002; Rivaroxaban 5 Mg Bid VS安慰剂:5.8%VS 9.0 %,HR 0.62,95%CI [0.40,0.96],P?= 0.031)以及全导致的死亡率。与安慰剂相比,在心肌梗死中无血管动脉旁路接枝溶栓与多种剂量蓖麻毒素(raivaroxaban 2.5mgβ=α.0.4%vs rivaroxaban 5mg BID?=?1.1%VS安慰剂? =?0.5%)。 Rivaroxaban还没有增加颅内出血或致命出血。总之,在ACS受试者的患者历史上,具有蓖麻毒性,心肌梗死或中风的复合物的二次预防,而不会增加非吞咽动脉旁路移植物相关的重大出血。这些发现需要在充分发放第3期研究中进行进一步的预期评估。

著录项

  • 来源
    《The American Journal of Cardiology》 |2018年第11期|共6页
  • 作者单位

    PERFUSE Study Group Cardiovascular Division Department of Medicine Beth Israel Deaconess Medical;

    Cardiovascular Division Department of Medicine Brigham and Women's Hospital Harvard Medical;

    PERFUSE Study Group Cardiovascular Division Department of Medicine Beth Israel Deaconess Medical;

    PERFUSE Study Group Cardiovascular Division Department of Medicine Beth Israel Deaconess Medical;

    Cardiovascular Division Department of Medicine Brigham and Women's Hospital Harvard Medical;

    Cardiovascular Division Department of Medicine Brigham and Women's Hospital Harvard Medical;

    Cardiovascular Division Department of Medicine Brigham and Women's Hospital Harvard Medical;

    Cardiovascular Division Department of Medicine Brigham and Women's Hospital Harvard Medical;

    Cardiovascular Division Department of Medicine Brigham and Women's Hospital Harvard Medical;

    Cardiovascular Division Department of Medicine Brigham and Women's Hospital Harvard Medical;

    PERFUSE Study Group Cardiovascular Division Department of Medicine Beth Israel Deaconess Medical;

  • 收录信息
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 心脏、血管(循环系)疾病;
  • 关键词

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