Department of Cardiology, Heart Center, Boston Children's Hospital, Harvard School of Medicine, Boston, Massachusetts, USA; Harvard School of Medicine, Boston, Massachusetts, USA.
Department of Cardiology, Heart Center, Boston Children's Hospital, Harvard School of Medicine, Boston, Massachusetts, USA; Harvard School of Medicine, Boston, Massachusetts, USA.
J Thromb Haemost. 2023 Jun;21(6):1601-1609. doi: 10.1016/j.jtha.2023.03.005. Epub 2023 Mar 14.
Direct oral anticoagulants use in pediatric cardiology is poorly defined.
We present the largest experience of apixaban use in children with heart disease, using weight- and level-based dosing.
Retrospective single-center analysis of cardiac patients ≤19 years treated with apixaban. Patients were evaluated for safety (clinically relevant non-major [CRNM] or major bleeding; thrombotic events) and effectiveness (thrombus improvement by imaging). Peak drug-specific anti-Xa chromogenic assay results ("apixaban levels") were analyzed.
Over 3 years (5/2018-9/2021), 219 children, median age 6.8 years (0.3-19), median weight 20.8 kg (4.8-160) received apixaban, totaling 50,916 patient days. Of them, 172 (79%) warranted thromboprophylaxis and 47 (21%) thrombosis treatment (with 10 arterial, 19 venous, 15 intracardiac, and 3 pulmonary). The median initial peak apixaban level was 165 ng/mL (23-474; n = 125) in the prophylaxis subgroup and 153 ng/mL (30-450; n = 33) in the treatment subgroup; dosage was adjusted in response to levels in 25% of the patients. There were 4 bleeding safety events (3 CRNM; 1 major, hemoptysis complicating empyema); the serious bleeding event rate was 2.9 per 100 patient-years of apixaban. Minor bleeding events (42) were noted in 18 patients, with an additional 2 having leukopenia, 1 transaminitis, and 3 rashes. An improvement in thrombosis was seen in 95% of the treated patients with available follow-up imaging (37/39 patients).
Apixaban use was feasible with a low rate of adverse events across a diverse pediatric cardiac population using commercially available tablets dosed to weight and adjusted based on peak apixaban levels.
直接口服抗凝剂在儿科心脏病学中的应用尚未明确。
我们报告了使用阿哌沙班治疗心脏病儿童的最大经验，使用基于体重和水平的剂量。
回顾性分析了 2018 年 5 月至 2021 年 9 月期间在我院接受阿哌沙班治疗的≤19 岁心脏病患者。评估患者的安全性（临床相关非重大[CRNM]或重大出血；血栓事件）和有效性（影像学检查显示血栓改善）。分析了特定药物的最大抗 Xa 显色测定结果（“阿哌沙班水平”）。
在 3 年期间（2018 年 5 月至 2021 年 9 月），共 219 名儿童（中位年龄 6.8 岁[0.3-19]，中位体重 20.8kg[4.8-160]）接受了阿哌沙班治疗，总共有 50916 患者天。其中，172 例（79%）需要进行血栓预防，47 例（21%）需要进行血栓治疗（10 例动脉血栓，19 例静脉血栓，15 例心内血栓，3 例肺内血栓）。预防亚组的初始最大阿哌沙班水平中位数为 165ng/ml（23-474；n=125），治疗亚组为 153ng/ml（30-450；n=33）；根据 25%的患者的水平调整了剂量。有 4 例出血安全性事件（3 例 CRNM；1 例为大出血，伴脓胸合并咯血）；严重出血事件发生率为每 100 患者年阿哌沙班 2.9 例。18 例患者出现轻微出血事件（42 例），另外 2 例出现白细胞减少、1 例转氨升高、3 例皮疹。在有随访影像学资料的治疗患者中，95%的患者血栓得到改善（37/39 例）。
在使用市售片剂按体重给药并根据阿哌沙班水平调整剂量的情况下，在接受各种儿科心脏病治疗的儿童中，阿哌沙班的应用是可行的，且不良事件发生率较低。
