Prospective validation of the Bleeding Academic Research Consortium classification in the all-comer PRODIGY trial
Prospective validation of the Bleeding Academic Research Consortium classification in the all-comer PRODIGY trial
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DOI：
10.1093/eurheartj/ehu161
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发表时间：
2014-10-01
影响因子：
39.3
通讯作者：
Valgimigli, Marco
中科院分区：
文献类型：
--
作者：
Vranckx, Pascal;Leonardi, Sergio;Valgimigli, Marco
出血学术研究联盟（BARC）的分类已被共识提出，以标准化心血管临床试验中出血终点的定义和报告。有没有前瞻性的研究，其预后impairment.Methods和结果，我们探讨了相关的BARC定义的出血与死亡率和比较其预后价值对两个有效的出血量表：溶栓心肌梗死（TIMI）和全球利用链激酶和组织纤溶酶原激活剂闭塞的冠状动脉（GUSTO）规模。PRODIGY试验中的非冠状动脉旁路移植术（CABG）相关性眼睑闭合由设盲临床事件委员会前瞻性裁定，并根据多重统计模型进行分析。2年时，根据BARC 2、3或5型，143例患者（7.1%）发生出血;根据TIMI轻度或重度，50例患者（2.5%）发生出血;根据GUSTO中度或重度，61例患者（3.1%）发生出血。163例患者死亡（8.1%）。多变量建模后，BARC 2、3或5型出血与2年死亡率增加相关[风险比（HR）：3.77; 95%置信区间（CI）：2.37 - 5.98]。出血学术研究联盟3型或5型与2年死亡率增加相关（校正HR：7.72; 95% CI：4.75 - 12.54）与TIMI提供的相似（HR：7.64，95% CI：4.53 - 12.87）或GUSTO（HR：7.36，95% CI：4.38 - 12.34）标准。结论在当代，所有--近期经皮冠状动脉介入治疗试验中，可行的BARC滤过器与死亡风险增加相关，BARC 3型或5型滤过器提供了与TIMI或GUSTO量表造成的死亡风险相似。
Aims The Bleeding Academic Research Consortium (BARC) classification has been proposed by consensus to standardize bleeding endpoint definition and reporting in cardiovascular clinical trials. There are no prospective studies on its prognostic impact.Methods and results We explored the association of BARC-defined bleeding with mortality and compared its prognostic value against two validated bleeding scales: the Thrombolysis in Myocardial Infarction (TIMI) and the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) scales. Non-coronary artery bypass graft (CABG)-related bleedings within the PRODIGY trial were prospectively adjudicated by a blinded Clinical Event Committee and analysed according to multiple statistical modelling. At 2 years, bleeding occurred in 143 patients (7.1%) according to BARC Type 2, 3, or 5; in 50 patients (2.5%) according to TIMI minor or major; and in 61 patients (3.1%) according to GUSTO moderate or severe. One hundred sixty-three patients died (8.1%). After multivariable modelling, BARC Type 2, 3, or 5 bleeding was associated with increased 2-year mortality [hazard ratio (HR): 3.77; 95% confidence interval (CI): 2.37-5.98]. Bleeding Academic Research Consortium Type 3 or 5 was associated with an increased mortality rate at 2 years (adjusted HR: 7.72; 95% CI: 4.75-12.54) similar to that provided by TIMI (HR: 7.64,95% CI: 4.53-12.87) or GUSTO (HR: 7.36, 95% CI: 4.38-12.34) criteria.Conclusions In a contemporary, all-comer percutaneous coronary intervention trial actionable BARC bleedings were associated with increased risk of mortality with BARC Type 3 or 5 bleedings providing a similar mortality risk to that posed by TIMI or GUSTO scales.