颅内 - B2LEED3S评分与接受抗血小板治疗的缺血性脑卒中患者颅内出血风险
The Intracranial-B2LEED3S Score and the Risk of Intracranial Hemorrhage in Ischemic Stroke Patients Under Antiplatelet Treatment.
作者信息
Amarenco Pierre, Sissani Leila, Labreuche Julien, Vicaut Eric, Bousser Marie Germaine, Chamorro Angel, Fisher Marc, Ford Ian, Fox Kim M, Hennerici Michael G, Mattle Heinrich, Rothwell Peter M, Steg Philippe Gabriel, Diener Hans-Christoph, Sacco Ralph L, Greving Jacoba P, Algra Ale
机构信息
Université Paris Diderot, Paris, France.
出版信息
Cerebrovasc Dis. 2017;43(3-4):145-151. doi: 10.1159/000453459. Epub 2017 Jan 14.
BACKGROUND
Chronic antiplatelet therapy in the post-acute phase of non-cardioembolic ischemic stroke is limited by the risk of intracranial hemorrhage (ICH) complications.
METHODS
We developed an ICH risk score based on the PERFORM trial cohort (n = 19,100), which included patients with a non-cardioembolic ischemic stroke or transient ischemic attack, and externally validated this score in one contemporary trial of very similar size and inclusion criteria, the PRoFESS trial (n = 20,332 patients). Outcome was ICH over 2 years. A Cox proportional-hazard regression analysis identified risk factors. Discrimination was quantified with c-statistics and calibration was assessed by comparing predicted and observed ICH risk in PERFORM and PRoFESS.
RESULTS
ICH occurred within 2 years in 263 (1.4%) patients in PERFORM trial and in 246 (1.2%) patients in PRoFESS trial. A 13-point score based on 9 items (Intracranial-B2LEED3S score - low body mass index, blood pressure, lacune, elderly, Asian ethnicity, coronary artery or cerebrovascular disease history, dual antithrombotic agent or oral anticoagulant, gender) was derived from the PERFORM trial. In PERFORM, the observed 2-year ICH risk varied from 0.75% in low-risk (score ≤2) to 2.44% in high-risk patients (score ≥5) with an acceptable calibration but a low discrimination both in PERFORM (c-statistic 0.64, 95% CI 0.61-0.68) and on external validation in PRoFESS (0.58, 95% CI 0.55-0.62).
CONCLUSION
The Intracranial-B2LEED3S score helps identify patients who are at a high risk of bleeding. However, other variables need to be identified to improve the score (e.g., microbleeds) (Clinical Trial Registration Information ISRCTN66157730). URL: http://www.isrctn.com/ISRCTN66157730?totalResults=5&pageSize=10&page=1&searchType=basic-search&offset=3&q=&filters=conditionCategory%3ACirculatory+System%2CrecruitmentCountry%3ATaiwan%2CrecruitmentCountry%3AAustria&sort=.
背景
非心源性缺血性卒中急性期后长期抗血小板治疗受颅内出血（ICH）并发症风险的限制。
方法
我们基于PERFORM试验队列（n = 19100）开发了一个ICH风险评分系统，该队列纳入了非心源性缺血性卒中或短暂性脑缺血发作患者，并在一项规模和纳入标准非常相似的当代试验PRoFESS试验（n = 20332例患者）中对该评分进行了外部验证。结局指标为2年内发生ICH。通过Cox比例风险回归分析确定风险因素。用c统计量对区分度进行量化，并通过比较PERFORM和PRoFESS中预测的和观察到的ICH风险来评估校准情况。
结果
PERFORM试验中263例（1.4%）患者在2年内发生ICH，PRoFESS试验中246例（1.2%）患者发生ICH。基于9项指标（颅内 - B2LEED3S评分 - 低体重指数、血压、腔隙性梗死、老年、亚洲种族、冠状动脉或脑血管疾病史、双重抗栓药物或口服抗凝剂、性别）得出了一个13分的评分系统。在PERFORM试验中，观察到的2年ICH风险在低风险患者（评分≤2）中为0.75%，在高风险患者（评分≥5）中为2.44%，校准情况尚可，但在PERFORM试验中的区分度较低（c统计量为0.64，95%CI 0.61 - 0.68），在PRoFESS试验中的外部验证中区分度也较低（0.58，95%CI 0.55 - 0.62）。
结论
颅内 - B2LEED3S评分有助于识别出血风险高的患者。然而，需要识别其他变量以改进该评分（如微出血）（临床试验注册信息ISRCTN66157730）。网址：http://www.isrctn.com/ISRCTN66157730?totalResults=5&pageSize=10&page=1&searchType=basic-search&offset=3&q=&filters=conditionCategory%3ACirculatory+System%2CrecruitmentCountry%3ATaiwan%2CrecruitmentCountry%3AAustria&sort=.
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