Department of Surgery, University of North Carolina, Chapel Hill, NC.
Department of Epidemiology, University of North Carolina, Chapel Hill, NC.
J Vasc Surg. 2022 Oct;76(4):1021-1029.e3. doi: 10.1016/j.jvs.2022.04.048. Epub 2022 Jun 11.
Females with peripheral arterial disease (PAD) treated with endovascular interventions have increased limb-based procedural complications compared with males. Little is known regarding long-term bleeding risk in these patients who often require long-term antiplatelet or anticoagulation therapy. We hypothesize that females have a higher incidence of bleeding events compared with males in the year after endovascular intervention for PAD.
Adults (aged ≥65 years) who underwent endovascular revascularization for PAD between 2008 and 2015 in Medicare claims data were identified. Patients were allocated by prescribed postprocedural antithrombotic therapy, including (1) antiplatelet therapy, (2) anticoagulation therapy, (3) dual antiplatelet and anticoagulation therapy, and (4) no prescription antithrombotic therapy. Bleeding events were classified as gastrointestinal, intracranial, hematoma, airway, or other. Crude and covariate-standardized 30-, 90-, and 365-day cumulative incidence of bleeding events, overall and by sex, were estimated using Aalen-Johansen estimators accounting for death as a competing risk. Sex differences were identified using Gray's test.
Of 31,593 eligible patients, 54% were females. Females were older (77.9 years vs 75.5 years) and tended to use antiplatelet therapy more often at 30, 90, and 365 days after the intervention. Clopidogrel was the most prescribed antiplatelet, and 32% of patients continued its use at 365 days. Anticoagulants were prescribed to 26.0% of patients at the time of the procedure, and only 8.8% continued anticoagulation at 365 days. Thirty-one percent of patients were diagnosed with a bleeding event within 1 year after the intervention. The cumulative incidence of any bleeding event during the postintervention period was higher in females compared with males with a risk difference of 3% between the sex cohorts (P < .01). Specifically, females had a higher incidence of gastrointestinal bleeding and hematoma (P < .01), but a lower incidence of airway-related bleeding at each time point as compared with males (P < .01).
Sex disparities in bleeding complications after endovascular intervention for PAD persist in the long term. Females are more likely to be readmitted with a bleeding complication up to 1 year after the procedure. Antithrombotic therapy disproportionately increases the risk of bleeding in females. Further research is necessary to understand the mechanisms responsible for abnormal coagulopathy in females after endovascular therapy.
与男性相比,接受血管内介入治疗的外周动脉疾病(PAD)女性患者肢体相关手术并发症发生率更高。对于这些患者,由于经常需要长期抗血小板或抗凝治疗,关于其长期出血风险知之甚少。我们假设,与男性相比,在接受 PAD 血管内介入治疗后的 1 年内,女性发生出血事件的发生率更高。
从医疗保险索赔数据中确定了 2008 年至 2015 年间接受 PAD 血管内血运重建治疗的成年人(年龄≥65 岁)。根据术后抗血栓治疗方案将患者分为(1)抗血小板治疗、(2)抗凝治疗、(3)双联抗血小板和抗凝治疗和(4)无抗血栓治疗。出血事件分类为胃肠道、颅内、血肿、气道或其他。使用 Aalen-Johansen 估计器估计 30 天、90 天和 365 天的累积出血事件发生率,包括粗累积发生率和协变量标准化累积发生率,同时将死亡视为竞争风险。使用 Gray 检验确定性别差异。
在 31593 名合格患者中,有 54%为女性。女性年龄更大(77.9 岁 vs 75.5 岁),并且在介入治疗后 30、90 和 365 天时更倾向于使用抗血小板治疗。氯吡格雷是最常用的抗血小板药物,32%的患者在 365 天时仍在使用。在手术时,有 26.0%的患者接受了抗凝治疗,而只有 8.8%的患者在 365 天时仍继续抗凝。31%的患者在介入治疗后 1 年内被诊断出出血事件。与男性相比,女性在术后期间任何出血事件的累积发生率更高,两个性别队列之间的风险差异为 3%(P<.01)。具体而言,女性发生胃肠道出血和血肿的发生率更高(P<.01),但与男性相比,每个时间点气道相关出血的发生率更低(P<.01)。
PAD 血管内介入治疗后出血并发症的性别差异在长期存在。女性在术后 1 年内更有可能因出血并发症再次入院。抗血栓治疗会不成比例地增加女性出血的风险。需要进一步研究以了解女性在血管内治疗后异常凝血的机制。