Laganà Alessandro, Assanto Giovanni Manfredi, Masucci Chiara, Passucci Mauro, Donzelli Livia, Serrao Alessandra, Baldacci Erminia, Santoro Cristina, Chistolini Antonio
Hematology, Department of Translational and Precision Medicine, Sapienza University of Rome, Italy.
Haematology and Stem Cell Transplant Unit, A. O. San Camillo Forlanini (LR), Rome, Italy.
Mediterr J Hematol Infect Dis. 2024 Mar 1;16(1):e2024020. doi: 10.4084/MJHID.2024.020. eCollection 2024.
Direct oral anticoagulants (DOACs) are widely used for the treatment and secondary prophylaxis of venous thromboembolism (VTE). Nowadays, DOACs represent the gold standard for long-term anticoagulation, with low-intensity DOACs administration becoming increasingly used worldwide in such scenario. Albeit low-intensity apixaban and rivaroxaban are approved for clinical usage as secondary VTE prophylaxis, there are few literature data regarding their efficacy and safety with a long follow-up.
The aim of our study was to evaluate the efficacy and safety of low-dose DOACs for VTE secondary prophylaxis in patients at high risk of VTE recurrence.
We retrospectively evaluated patients who required long-term anticoagulant secondary prophylaxis to prevent recurrent VTE, treated with apixaban 2.5 mg BID or rivaroxaban 10 mg daily with a follow-up ≥ 12 months.
The examined patients were 323. The median low-dose DOAC administration time was 25.40 months (IQR 13.93-45.90). Twelve (3.7%) VTE recurrences were observed; 21 bleeding events were registered (6.5%), including one episode of Major bleeding (MB) (0.3%), 8 Clinically relevant nonmajor bleeding (CRNMB) (2.5%) and 12 minor bleeding (3.7%). No statistically significant difference in the rate of VTE recurrence and/or bleeding events emerged between the rivaroxaban and apixaban groups. Patients included in the study for multiple episodes of VTE presented a significantly higher risk of a new VTE recurrence during low-intensity DOAC.
Our data suggest that low-dose DOACs may be effective and safe in secondary VTE prophylaxis in patients at high risk of VTE recurrence; however, attention might be needed in their choice in such a scenario for patients who experienced multiple episodes of VTE.
直接口服抗凝剂(DOACs)广泛用于静脉血栓栓塞症(VTE)的治疗和二级预防。如今,DOACs是长期抗凝的金标准,低强度DOACs给药在全球范围内越来越多地用于这种情况。尽管低强度阿哌沙班和利伐沙班已被批准用于临床作为VTE二级预防,但关于其长期随访的疗效和安全性的文献数据很少。
我们研究的目的是评估低剂量DOACs对VTE复发高危患者进行VTE二级预防的疗效和安全性。
我们回顾性评估了需要长期抗凝二级预防以预防复发性VTE的患者,这些患者接受阿哌沙班2.5毫克每日两次或利伐沙班10毫克每日一次治疗,随访时间≥12个月。
共检查了323例患者。低剂量DOACs的中位给药时间为25.40个月(四分位间距13.93 - 45.90)。观察到12例(3.7%)VTE复发;记录了21例出血事件(6.5%),包括1例大出血(MB)(0.3%)、8例临床相关非大出血(CRNMB)(2.5%)和12例小出血(3.7%)。利伐沙班组和阿哌沙班组之间在VTE复发率和/或出血事件发生率上没有出现统计学显著差异。因多次VTE发作而纳入研究的患者在低强度DOAC治疗期间出现新的VTE复发的风险显著更高。
我们的数据表明,低剂量DOACs对VTE复发高危患者进行VTE二级预防可能是有效和安全的;然而,对于经历过多次VTE发作的患者,在这种情况下选择使用时可能需要谨慎。