Seiler Eva, Limacher Andreas, Mean Marie, Beer Hans-Jürg, Osterwalder Joseph, Frauchiger Beat, Righini Marc, Aschwanden Markus, Matter Christian M, Banyai Martin, Kucher Nils, Staub Daniel, Lämmle Bernhard, Rodondi Nicolas, Squizzato Alessandro, Aujesky Drahomir
Eva Seiler, Department of General Internal Medicine, Bern University Hospital, Inselspital, Freiburgstrasse 8, 3010 Bern, Switzerland, Tel.: +41 632 2111, Fax: +41 632 3743, E-mail:
Thromb Haemost. 2017 Aug 24;117(10). doi: 10.1160/TH17-03-0162.
Existing clinical scores do not perform well in predicting bleeding in elderly patients with acute venous thromboembolism (VTE). We sought to derive an easy-to-use clinical score to help physicians identify elderly patients with VTE who are at high-risk of bleeding during extended anticoagulation (>3 months). Our derivation sample included 743 patients aged ≥65 years with VTE who were enrolled in a prospective multicenter cohort study. All patients received extended anticoagulation with vitamin K antagonists. We derived our score using competing risk regression, with the time to a first major bleeding up to 36 months of extended anticoagulation as the outcome, and 17 candidate variables as predictors. We used bootstrapping methods for internal validation. Sixty-six (9 %) patients suffered major bleeding. The clinical score is based on seven clinical factors (previous bleeding, active cancer, low physical activity, anemia, thrombocytopenia, antiplatelet drugs/NSAIDs, and poor INR control). Overall, 48 % of patients were classified as low-risk, 37 % as moderate-risk, and 15 % as high-risk of bleeding. The rate of major bleeding was 1.4 events in low-risk, 5.0 events in moderate-risk, and 12.2 events per 100 patient-years in high-risk patients. The c-statistic was 0.78 at 3 months and 0.71 at 36 months of extended anticoagulation. Model calibration was excellent (p=0.93). Internal validation showed similar results. This simple clinical score accurately identified elderly patients with VTE who are at high risk of major bleeding and who may not benefit from extended anticoagulation. Further validation of the score is important before its implementation into practice. The study is registered to https://clinicaltrials.gov as NCT00973596.
现有的临床评分在预测老年急性静脉血栓栓塞症（VTE）患者出血情况方面表现不佳。我们试图得出一种易于使用的临床评分，以帮助医生识别在延长抗凝治疗（>3个月）期间有高出血风险的老年VTE患者。我们的推导样本包括743名年龄≥65岁的VTE患者，他们参与了一项前瞻性多中心队列研究。所有患者均接受维生素K拮抗剂延长抗凝治疗。我们使用竞争风险回归得出评分，将延长抗凝治疗长达36个月时首次发生大出血的时间作为结局，17个候选变量作为预测因素。我们使用自抽样法进行内部验证。66名（9%）患者发生大出血。该临床评分基于七个临床因素（既往出血、活动性癌症、低体力活动、贫血、血小板减少、抗血小板药物/非甾体抗炎药以及国际标准化比值（INR）控制不佳）。总体而言，48%的患者被归类为低出血风险，37%为中度风险，15%为高出血风险。低风险患者大出血发生率为每100患者年1.4次事件，中度风险为5.0次事件，高风险患者为12.2次事件。在延长抗凝治疗3个月时c统计量为0.78，36个月时为0.71。模型校准良好（p=0.93）。内部验证显示了相似的结果。这种简单的临床评分准确识别了有大出血高风险且可能无法从延长抗凝治疗中获益的老年VTE患者。在该评分应用于实际临床之前，进一步验证很重要。该研究已在https://clinicaltrials.gov注册，注册号为NCT00973596。
