DeCamillo Deborah, Haymart Brian, Kong Xiaowen, Kaatz Scott, Ali Mona A, Barnes Geoffrey D
Division of Cardiovascular Medicine, Department of Internal Medicine, Frankel Cardiovascular Center, University of Michigan, Ann Arbor, MI, USA.
Division of Vascular and Cardiovascular Medicine, University of Michigan, Arbor Lakes, Building 3, Floor 3 (MCORRP) 4251 Plymouth Road, Ann Arbor, MI, 48105, USA.
J Thromb Thrombolysis. 2023 May;55(4):680-684. doi: 10.1007/s11239-023-02777-y. Epub 2023 Jan 30.
Safety and efficacy of direct oral anticoagulants (DOAC) in low weight patients with atrial fibrillation (AF) is unclear due to few low body weight patients enrolled in clinical trials. To assess bleeding and thrombotic event rates for patients with AF that are prescribed apixaban and have a low versus normal body weight. We analyzed patients with AF prescribed apixaban from 2017 to 2020 with at least 12 months of follow-up. Patients were divided into low [< 60 kg (kg)] and normal (60-100 kg) weight cohorts. Bleeding and thrombotic event rates were compared. Poisson regression and Cox proportional hazard models were used to estimate adjusted adverse event rates. A total of 545 patients met inclusion criteria. In the unadjusted analysis, there was an increase in non-major bleeding events requiring an Emergency Department visit more often in the low versus normal weight cohort (10.8 versus 7.4 per 100 patient-years, p = 0.15). Thrombotic event rates also occurred more often in the lower versus normal weight cohort (2.4 versus 0.9 per 100 patient-years, p = 0.09). However, adjusted analysis found no statistically significant difference in bleeding or thrombotic events between low and normal weight cohorts. The adjusted hazard ratio for bleeding was similar between the two weight cohorts. The use of apixaban in low body weight patients was not associated with higher rates of bleeding or thrombotic events, compared to those with normal body weight, after adjusting for potential confounding covariates. Larger studies may offer further insight into the overall safety and efficacy of DOAC therapy in these patients.
由于参与临床试验的低体重患者较少，直接口服抗凝剂（DOAC）在低体重房颤（AF）患者中的安全性和有效性尚不清楚。为了评估服用阿哌沙班的低体重与正常体重房颤患者的出血和血栓形成事件发生率。我们分析了2017年至2020年服用阿哌沙班且至少随访12个月的房颤患者。患者被分为低体重组[<60千克（kg）]和正常体重组（60 - 100千克）。比较出血和血栓形成事件发生率。使用泊松回归和Cox比例风险模型估计调整后的不良事件发生率。共有545名患者符合纳入标准。在未调整分析中，低体重组与正常体重组相比，需要急诊科就诊的非大出血事件有所增加（每100患者年分别为10.8次和7.4次，p = 0.15）。低体重组的血栓形成事件发生率也高于正常体重组（每100患者年分别为2.4次和0.9次，p = 0.09）。然而，调整分析发现低体重组与正常体重组之间在出血或血栓形成事件上没有统计学上的显著差异。两个体重组之间出血的调整后风险比相似。在调整潜在混杂协变量后，与正常体重患者相比，低体重患者使用阿哌沙班与更高的出血或血栓形成事件发生率无关。更大规模的研究可能会进一步深入了解DOAC疗法在这些患者中的总体安全性和有效性。
