Costa Francesco, Tijssen Jan G, Ariotti Sara, Giatti Sara, Moscarella Elisabetta, Guastaroba Paolo, De Palma Rossana, Andò Giuseppe, Oreto Giuseppe, Zijlstra Felix, Valgimigli Marco
Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands (F.C., S.A., F.Z., M.V.) Department of Clinical and Experimental Medicine, Policlinico "G. Martino", University of Messina, Italy (F.C., G.A., G.O.).
Department of Cardiology, Academic Medical Center, University of Amsterdam, The Netherlands (J.G.T.).
J Am Heart Assoc. 2015 Dec 7;4(12):e002524. doi: 10.1161/JAHA.115.002524.
Multiple scores have been proposed to stratify bleeding risk, but their value to guide dual antiplatelet therapy duration has never been appraised. We compared the performance of the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines), ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy), and HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) scores in 1946 patients recruited in the Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) and assessed hemorrhagic and ischemic events in the 24- and 6-month dual antiplatelet therapy groups.
Bleeding score performance was assessed with a Cox regression model and C statistics. Discriminative and reclassification power was assessed with net reclassification improvement and integrated discrimination improvement. The C statistic was similar between the CRUSADE score (area under the curve 0.71) and ACUITY (area under the curve 0.68), and higher than HAS-BLED (area under the curve 0.63). CRUSADE, but not ACUITY, improved reclassification (net reclassification index 0.39, P=0.005) and discrimination (integrated discrimination improvement index 0.0083, P=0.021) of major bleeding compared with HAS-BLED. Major bleeding and transfusions were higher in the 24- versus 6-month dual antiplatelet therapy groups in patients with a CRUSADE score >40 (hazard ratio for bleeding 2.69, P=0.035; hazard ratio for transfusions 4.65, P=0.009) but not in those with CRUSADE score ≤40 (hazard ratio for bleeding 1.50, P=0.25; hazard ratio for transfusions 1.37, P=0.44), with positive interaction (Pint=0.05 and Pint=0.01, respectively). The number of patients with high CRUSADE scores needed to treat for harm for major bleeding and transfusion were 17 and 15, respectively, with 24-month rather than 6-month dual antiplatelet therapy; corresponding figures in the overall population were 67 and 71, respectively.
Our analysis suggests that the CRUSADE score predicts major bleeding similarly to ACUITY and better than HAS BLED in an all-comer population with percutaneous coronary intervention and potentially identifies patients at higher risk of hemorrhagic complications when treated with a long-term dual antiplatelet therapy regimen.
URL: http://clinicaltrials.gov. Unique identifier: NCT00611286.
已经提出了多种评分系统来分层出血风险，但它们在指导双联抗血小板治疗持续时间方面的价值从未得到评估。我们比较了CRUSADE（不稳定型心绞痛患者能否通过早期实施ACC/AHA指南快速分层风险以抑制不良结局）、ACUITY（急性导管插入术和紧急干预分诊策略）和HAS-BLED（高血压、肾/肝功能异常、卒中、出血史或易感性、国际标准化比值不稳定、老年、同时使用药物/酒精）评分系统在1946例入选支架诱导内膜增生分级后延长双联抗血小板治疗研究（PRODIGY）患者中的表现，并评估了24个月和6个月双联抗血小板治疗组的出血和缺血事件。
使用Cox回归模型和C统计量评估出血评分系统的表现。使用净重新分类改善和综合辨别改善评估辨别力和重新分类能力。CRUSADE评分系统（曲线下面积0.71）和ACUITY评分系统（曲线下面积0.68）的C统计量相似，且高于HAS-BLED评分系统（曲线下面积0.63）。与HAS-BLED相比，CRUSADE评分系统（而非ACUITY评分系统）改善了大出血的重新分类（净重新分类指数0.39，P = 0.005）和辨别力（综合辨别改善指数0.0083，P = 0.021）。CRUSADE评分>40的患者中，24个月双联抗血小板治疗组的大出血和输血发生率高于6个月双联抗血小板治疗组（出血风险比2.69，P = 0.035；输血风险比4.65，P = 0.009），而CRUSADE评分≤40的患者则不然（出血风险比1.50，P = 0.25；输血风险比1.37，P = 0.44），存在正交互作用（分别为Pint = 0.05和Pint = 0.01）。对于大出血和输血，CRUSADE高分患者接受24个月而非6个月双联抗血小板治疗时，造成伤害所需治疗的患者数分别为17和15；总体人群中的相应数字分别为67和71。
我们的分析表明，在接受经皮冠状动脉介入治疗的所有患者中，CRUSADE评分系统预测大出血的能力与ACUITY相似，且优于HAS-BLED，并且可能识别出接受长期双联抗血小板治疗方案时出血并发症风险较高的患者。
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