BACKGROUND & AIMS The safety of different antithrombotic strategies for patients with 1 or more indication for antithrombotic drugs has not been determined. We investigated the risk and time frame for gastrointestinal bleeding (GIB) in patients prescribed different antithrombotic regimens. We proposed that risk would increase over time and with combination regimens, especially among elderly patients. METHODS We performed a retrospective analysis of nationwide claims data from privately insured and Medicare Advantage enrollees who received anticoagulant and/or antiplatelet agents from October 1, 2010, through May 31, 2017. Patients were stratified by their prescriptions (anticoagulant alone, antiplatelet alone, or a combination) and by their primary diagnosis (atrial fibrillation, ischemic heart disease, or venous thromboembolism). The 1-year GIB risk was estimated using parametric time-to-event survival models and expressed as annualized risk and number needed to harm (NNH). RESULTS Our final analysis included 311,211 patients (mean ages, 67 years for monotherapy and 69.8 years for combination antithrombotic therapy). There was no significant difference in the proportion of patients with bleeding after anticoagulant or antiplatelet monotherapy (∼3.5%/year). Combination antithrombotic therapy increased GIB risk compared with anticoagulant (NNH, 29) or antiplatelet (NNH, 31) monotherapy, regardless of the patients' diagnosis or time point analyzed. Advancing age was associated with increasing 1-year probability of GIB. Patients prescribed combination therapy were at the greatest risk for GIB, especially after the age of 75 years (GIB occurred in 10%-17.5% of patients/y). CONCLUSIONS In an analysis of nationwide insurance and Medicare claims data, we found GIB to occur in a higher proportion of patients prescribed combinations of anticoagulant and antiplatelet agents compared with monotherapy. Among all drug exposure categories and cardiovascular conditions, the risk of GIB increased with age, especially among patients older than 75 years.

中文翻译：

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胃肠道出血的风险随着抗血栓药物和患者年龄的组合而增加。

背景与目的 对于具有 1 个或多个抗血栓药物适应症的患者，不同抗血栓策略的安全性尚未确定。我们调查了服用不同抗血栓治疗方案的患者发生胃肠道出血 (GIB) 的风险和时间范围。我们提出风险会随着时间的推移和联合方案而增加，尤其是在老年患者中。方法 我们对 2010 年 10 月 1 日至 2017 年 5 月 31 日期间接受抗凝剂和/或抗血小板药物的私人保险和 Medicare Advantage 登记者的全国索赔数据进行了回顾性分析。或组合）和他们的初步诊断（心房颤动、缺血性心脏病或静脉血栓栓塞）。1 年 GIB 风险是使用参数事件发生时间生存模型估计的，并表示为年化风险和需要伤害的数量 (NNH)。结果 我们的最终分析包括 311,211 名患者（平均年龄，单药治疗 67 岁，联合抗栓治疗 69.8 岁）。抗凝或抗血小板单药治疗后出血患者的比例没有显着差异（~3.5%/年）。与抗凝剂（NNH，29）或抗血小板（NNH，31）单药治疗相比，联合抗血栓治疗增加了 GIB 风险，无论患者的诊断或分析的时间点如何。随着年龄的增长，GIB 的 1 年概率增加。接受联合治疗的患者发生 GIB 的风险最大，尤其是在 75 岁之后（每年 10%-17.5% 的患者发生 GIB）。结论 在对全国保险和医疗保险索赔数据的分析中，我们发现与单药治疗相比，在处方抗凝剂和抗血小板药物联合治疗的患者中发生 GIB 的比例更高。在所有药物暴露类别和心血管疾病中，GIB 的风险随着年龄的增长而增加，尤其是在 75 岁以上的患者中。