BACKGROUND There is ongoing uncertainty regarding the safety and efficacy of unfractionated heparin and bivalirudin when used for systemic anticoagulation in patients undergoing primary percutaneous coronary intervention (PPCI). This paper reports 12-month mortality from the HEAT-PPCI randomised trial. METHODS In this open-label, randomised controlled trial (RCT) we enrolled consecutive adults with suspected ST-elevation myocardial infarction (STEMI). Patients were randomised to heparin (bolus 70 U/kg) or bivalirudin (bolus 0.75 mg/kg followed by an infusion 1.75 mg/kg/h for the duration of the procedure). We report the pre-specified secondary outcome of all-cause mortality at 12 months. Mortality was classified as cardiovascular or not, blinded to treatment allocation. Deaths in the first 28 days were classified by formal event adjudication and later events classified from death certificates. RESULTS Mortality status at 12 months was obtained for 1805/1812 = 99.6% of participants. Overall mortality was 160/1812 = 8.9%. There were more deaths in those randomised to bivalirudin (95/902 = 10.5% vs 65/903 = 7.2%; HR 1.48; 95% CI 1.08 to 2.03; p = 0.015). Most deaths were classified as cardiovascular (71/902 = 7.9% in the bivalirudin group and 53/904 = 5.9% in the heparin group). The difference between the rates of cardiovascular deaths in each treatment group did not reach statistical significance: HR 1.35; 95% CI 0.95 to 1.93; p = 0.095. CONCLUSIONS At 12 months, treatment with bivalirudin, rather than heparin, was associated with a higher rate of all-cause mortality. Cardiovascular mortality was higher with bivalirudin although this difference was not statistically significant.

中文翻译：

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“在主要经皮冠状动脉介入治疗（HEAT-PPCI）试验中抗血栓治疗的效果如何”中有十二个月的死亡率。

背景技术对于进行初级经皮冠状动脉介入治疗（PPCI）的患者进行全身抗凝治疗时，普通肝素和比伐卢定的安全性和有效性尚存在不确定性。本文报告了HEAT-PPCI随机试验的12个月死亡率。方法在这项开放标签，随机对照试验（RCT）中，我们招募了连续的可疑ST抬高型心肌梗塞（STEMI）成人。患者随机接受肝素（推注70 U / kg）或比伐卢定（推注0.75 mg / kg，然后在整个过程中输注1.75 mg / kg / h）。我们报告了12个月时全因死亡率的预先指定的次要结果。死亡率被归类为心血管疾病与否，对治疗分配不了解。前28天的死亡通过正式事件裁决进行分类，后来的事件根据死亡证明进行分类。结果1805/1812年的12个月死亡率为99.6％。总死亡率为160/1812 = 8.9％。随机分配给比伐卢定的死亡人数更高（95/902 = 10.5％vs 65/903 = 7.2％; HR 1.48; 95％CI 1.08至2.03; p = 0.015）。大多数死亡归为心血管疾病（比伐卢定组为71/902 = 7.9％，肝素组为53/904 = 5.9％）。每个治疗组的心血管死亡率之间的差异未达到统计学显着性：HR 1.35；95％CI 0.95至1.93; p ＝ 0.095。结论在12个月时，比伐卢定而不是肝素治疗与全因死亡率较高相关。