Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Pulmonary and Critical Care Medicine, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
J Thromb Haemost. 2024 Dec;22(12):3542-3551. doi: 10.1016/j.jtha.2024.09.003. Epub 2024 Sep 14.
The ONCO DVT study (Edoxaban for 12 Months Versus 3 Months in Patients With Cancer With Isolated Distal Deep Vein Thrombosis) revealed superiority of 12-month relative to 3-month edoxaban treatment for the thrombotic risk in cancer-associated isolated distal deep vein thrombosis. However, it is unknown whether the superiority could be common in different modified Ottawa score subgroups.
To identify more preferable candidates for extended anticoagulation in patients with cancer-associated isolated distal deep vein thrombosis using the modified Ottawa score.
In this post-hoc subgroup analysis of the ONCO DVT study, we stratified 601 patients into the low (≤-1, N = 126), intermediate (0, N = 323), and high (≥1, N = 152) modified Ottawa score subgroups and compared clinical outcomes between the 12-month and 3-month edoxaban treatment groups.
The cumulative incidence of symptomatic recurrent venous thromboembolism or venous thromboembolism-related death was not different between the 12-month and 3-month edoxaban treatment groups in the low score subgroup (0.0% vs 2.2%), whereas it was lower in the 12-month than in the 3-month edoxaban treatment group in the intermediate (0.8% vs 7.6%) and high (3.1% vs 15.6%) score subgroups. There were no significant differences in the cumulative incidences of the major bleeding between the 12-month and 3-month edoxaban treatment groups in the low (10.1% vs 7.6%), intermediate (8.8% vs 5.0%), and high (13.9% vs 12.6%) score subgroups.
A 12-month compared with 3-month edoxaban treatment showed a lower risk of thrombotic events in patients with cancer-associated isolated distal deep vein thrombosis in the intermediate and high modified Ottawa score subgroups but not in the low score subgroup, suggesting a limited benefit of extended anticoagulation therapy beyond 3 months in patients with low modified Ottawa score.
ONCO DVT 研究(癌症合并孤立性远端深静脉血栓患者使用依多沙班治疗 12 个月与 3 个月的疗效对比)表明,与 3 个月依多沙班治疗相比,12 个月依多沙班治疗可降低癌症合并孤立性远端深静脉血栓患者的血栓风险。然而,目前尚不清楚这种优越性是否在不同改良 Ottawa 评分亚组中普遍存在。
使用改良 Ottawa 评分确定癌症合并孤立性远端深静脉血栓患者中更适合延长抗凝治疗的人群。
本项 ONCO DVT 研究的事后亚组分析中,我们将 601 例患者分为低(≤-1,N=126)、中(0,N=323)和高(≥1,N=152)改良 Ottawa 评分亚组,并比较了 12 个月和 3 个月依多沙班治疗组之间的临床结局。
低评分亚组中,12 个月依多沙班治疗组与 3 个月依多沙班治疗组之间,症状性复发性静脉血栓栓塞或静脉血栓栓塞相关死亡的累积发生率无差异(0.0% vs 2.2%),而在中(0.8% vs 7.6%)和高(3.1% vs 15.6%)评分亚组中,12 个月依多沙班治疗组的累积发生率较低。低(10.1% vs 7.6%)、中(8.8% vs 5.0%)和高(13.9% vs 12.6%)评分亚组中,12 个月依多沙班治疗组与 3 个月依多沙班治疗组之间主要出血的累积发生率无显著差异。
与 3 个月依多沙班治疗相比,在中、高改良 Ottawa 评分亚组中,癌症合并孤立性远端深静脉血栓患者接受 12 个月依多沙班治疗血栓事件风险较低,但在低评分亚组中无此获益,提示改良 Ottawa 评分低的患者延长抗凝治疗 3 个月以上获益有限。