Influence of thrombolytic therapy, with or without intra-aortic balloon counterpulsation, on 12-month survival in the SHOCK trial.
Influence of thrombolytic therapy, with or without intra-aortic balloon counterpulsation, on 12-month survival in the SHOCK trial.
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SHOCK 试验中溶栓治疗（有或没有主动脉内球囊反搏）对 12 个月生存率的影响。
DOI：
10.1016/s0002-8703(03)00392-2
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发表时间：
2003
期刊：
影响因子：
--
通讯作者：
SHOCKInvestigators
中科院分区：
文献类型：
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作者：
French,JohnK;Feldman,HenryA;Assmann,SusanF;Sanborn,Timothy;Palmeri,SebastianT;Miller,David;Boland,Jean;Buller,ChristopherE;Steingart,Richard;Sleeper,LynnA;Hochman,JudithS;SHOCKInvestigators
背景：在实验研究中，溶栓治疗(TT)和主动脉内球囊反搏(IABP)联合应用可增加冠状动脉舒张期血流量，为联合应用治疗急性心肌梗死(MI)合并心源性休克提供了理论依据。方法和结果在休克试验中随机抽取302例心肌梗死合并心源性休克患者，其中16例有绝对禁忌证。在随机分配到初始药物稳定治疗(IMS)的150名患者中，63%的患者按照建议接受了TT，而在152名随机分配到紧急血管重建的患者中，这一比例为49%，在这些患者中，如果可以立即进行血管造影术，则不推荐使用TT。86%的患者使用了IABP部署，这是推荐的方案。接受TT的患者和未接受TT的患者严重出血率相似(31%比26%，P=0.37)。在随机分配到IMS的患者中，TT与12个月存活率的改善有关(未调整的死亡风险比，0.59；P=.01；经年龄和既往MI调整的死亡风险比，0.62；P=.02)。在随机分配到紧急血管重建术的患者中，TT与12个月存活率的改善无关(未经调整的死亡风险比，0.93；P=.76；根据年龄和既往MI调整后的死亡风险比，1.06，P=.81)。TT和随机化组P值的交互作用检验为0.16，通过治疗组分配，没有足够的统计能力来证明TT对12个月存活率的差异。结论在休克试验中随机分配到IMS的患者中，TT与改善12个月存活期相关，并不显著增加严重出血的风险。
BACKGROUNDThe enhancement of diastolic coronary blood flow by the combination of thrombolytic therapy (TT) and intra-aortic balloon counterpulsation (IABP) in experimental studies provides a rationale for their combined use in acute myocardial infarction (MI) complicated by cardiogenic shock. We examined the relation between TT (with and without IABP) and 12-month survival in the SHould We Emergently Revascularize Occluded Coronaries for Cardiogenic ShocK (SHOCK) Trial.METHODS AND RESULTSAmong 302 patients with myocardial infarction and cardiogenic shock who were randomized in the SHOCK Trial, 16 had absolute contraindications to TT. Among 150 patients randomly assigned to initial medical stabilization (IMS), 63% received TT, as recommended per protocol, compared with 49% of 152 patients randomly assigned to emergency revascularization, in whom TT was not recommended if immediate angiography was available. IABP deployment, which was protocol-recommended, was used in 86% of patients. The rate of severe bleeding was similar in patients receiving TT and in those not receiving TT (31% vs 26%, P = .37). Among patients randomly assigned to IMS, TT was associated with improved 12-month survival (unadjusted mortality hazard ratio, 0.59; P = .01; mortality hazard ratio adjusted for age and prior MI, 0.62; P = .02). TT was not associated with improved 12-month survival among patients randomly assigned to emergency revascularization (unadjusted mortality hazard ratio, 0.93; P = .76; mortality hazard ratio adjusted for age and prior MI, 1.06, P = .81). The test for interaction of TT and randomization group P value was .16, and there was insufficient statistical power to demonstrate a differential effect of TT on 12-month survival by treatment group assignment.CONCLUSIONSAmong patients randomly assigned to IMS in the SHOCK Trial, TT was associated with improved 12-month survival and did not significantly increase the risk of severe bleeding.