Alexander T Cohen, Amol D Dhamane, Xuejun Liu, Risho Singh, Stella Han, Robert Stellhorn, Jane Wang, Xuemei Luo
{"title":"延长阿哌沙班与低分子量肝素治疗癌症相关静脉血栓栓塞症的有效性和安全性。","authors":"Alexander T Cohen, Amol D Dhamane, Xuejun Liu, Risho Singh, Stella Han, Robert Stellhorn, Jane Wang, Xuemei Luo","doi":"10.6004/jnccn.2024.7016","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Limited real-world evidence is available comparing the safety and effectiveness of apixaban and low-molecular-weight heparins (LMWHs) for preventing recurrent venous thromboembolism (VTE) in patients with active cancer receiving anticoagulation in an extended treatment setting. This study evaluated the risk of bleeding and recurrent VTE in patients with cancer-associated VTE who were prescribed apixaban or LMWH for ≥3 months.</p><p><strong>Methods: </strong>A US commercial claims database was used to identify adult patients with VTE and active cancer who initiated apixaban or LMWH 30 days following the first VTE diagnosis and had ≥3 months of continuous enrollment and 3 months of primary anticoagulation treatment. Patients were followed from the day after the end of primary anticoagulation treatment until the earliest of: date of disenrollment, discontinuation of index anticoagulant, switch to another anticoagulant, or end of the study period. Inverse-probability treatment weighting (IPTW) was used to balance treatment cohorts. Incidence rates (IRs) for the outcomes were calculated per 100 person-years (PY). Cox proportional hazard models were used to evaluate the adjusted risk of recurrent VTE, major bleeding (MB), and clinically relevant nonmajor bleeding (CRNMB).</p><p><strong>Results: </strong>A total of 13,564 apixaban- and 2,808 LMWH-treated patients were analyzed. Post-IPTW, the treatment cohorts were balanced. Patients receiving apixaban had lower adjusted IRs for recurrent VTE (4.1 vs 9.6 per 100 PY), MB (6.3 vs 12.6), and CRNMB (26.1 vs 36.0) versus LMWH (P<.0001 for all comparisons) during the follow-up period. Patients on apixaban had a lower adjusted risk of recurrent VTE (hazard ratio [HR], 0.42; 95% CI, 0.34-0.53), MB (HR, 0.50; 95% CI, 0.41-0.61), and CRNMB (HR, 0.76; 95% CI, 0.68-0.85) versus LMWH.</p><p><strong>Conclusions: </strong>Extended anticoagulation treatment of ≥3 months with apixaban was associated with lower rates of recurrent VTE, MB, and CRNMB compared with LMWH in adults with cancer-associated VTE.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 6","pages":"397-403"},"PeriodicalIF":14.8000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and Safety of Extended Treatment Apixaban Versus Low-Molecular-Weight Heparin in Cancer-Associated Venous Thromboembolism.\",\"authors\":\"Alexander T Cohen, Amol D Dhamane, Xuejun Liu, Risho Singh, Stella Han, Robert Stellhorn, Jane Wang, Xuemei Luo\",\"doi\":\"10.6004/jnccn.2024.7016\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Limited real-world evidence is available comparing the safety and effectiveness of apixaban and low-molecular-weight heparins (LMWHs) for preventing recurrent venous thromboembolism (VTE) in patients with active cancer receiving anticoagulation in an extended treatment setting. This study evaluated the risk of bleeding and recurrent VTE in patients with cancer-associated VTE who were prescribed apixaban or LMWH for ≥3 months.</p><p><strong>Methods: </strong>A US commercial claims database was used to identify adult patients with VTE and active cancer who initiated apixaban or LMWH 30 days following the first VTE diagnosis and had ≥3 months of continuous enrollment and 3 months of primary anticoagulation treatment. Patients were followed from the day after the end of primary anticoagulation treatment until the earliest of: date of disenrollment, discontinuation of index anticoagulant, switch to another anticoagulant, or end of the study period. Inverse-probability treatment weighting (IPTW) was used to balance treatment cohorts. Incidence rates (IRs) for the outcomes were calculated per 100 person-years (PY). Cox proportional hazard models were used to evaluate the adjusted risk of recurrent VTE, major bleeding (MB), and clinically relevant nonmajor bleeding (CRNMB).</p><p><strong>Results: </strong>A total of 13,564 apixaban- and 2,808 LMWH-treated patients were analyzed. Post-IPTW, the treatment cohorts were balanced. Patients receiving apixaban had lower adjusted IRs for recurrent VTE (4.1 vs 9.6 per 100 PY), MB (6.3 vs 12.6), and CRNMB (26.1 vs 36.0) versus LMWH (P<.0001 for all comparisons) during the follow-up period. Patients on apixaban had a lower adjusted risk of recurrent VTE (hazard ratio [HR], 0.42; 95% CI, 0.34-0.53), MB (HR, 0.50; 95% CI, 0.41-0.61), and CRNMB (HR, 0.76; 95% CI, 0.68-0.85) versus LMWH.</p><p><strong>Conclusions: </strong>Extended anticoagulation treatment of ≥3 months with apixaban was associated with lower rates of recurrent VTE, MB, and CRNMB compared with LMWH in adults with cancer-associated VTE.</p>\",\"PeriodicalId\":17483,\"journal\":{\"name\":\"Journal of the National Comprehensive Cancer Network\",\"volume\":\"22 6\",\"pages\":\"397-403\"},\"PeriodicalIF\":14.8000,\"publicationDate\":\"2024-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the National Comprehensive Cancer Network\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.6004/jnccn.2024.7016\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the National Comprehensive Cancer Network","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.6004/jnccn.2024.7016","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景:阿哌沙班和低分子量肝素(LMWH)在预防长期接受抗凝治疗的活动性癌症患者复发性静脉血栓栓塞症(VTE)方面的安全性和有效性比较的实际证据有限。本研究评估了接受阿哌沙班或 LMWH 治疗≥3 个月的癌症相关 VTE 患者的出血和复发性 VTE 风险:方法:利用美国商业索赔数据库来识别首次 VTE 诊断后 30 天开始使用阿哌沙班或 LMWH 的 VTE 和活动性癌症成年患者,这些患者的连续入组时间≥3 个月,且接受了 3 个月的主要抗凝治疗。患者的随访时间从基础抗凝治疗结束的次日开始,直至下列最早出现的日期:退出研究、停用指标抗凝剂、换用另一种抗凝剂或研究期结束。采用反概率治疗加权(IPTW)来平衡治疗队列。结果的发病率(IR)按每 100 人-年(PY)计算。采用 Cox 比例危险模型评估复发性 VTE、大出血(MB)和临床相关非大出血(CRNMB)的调整风险:共分析了13564名接受阿哌沙班治疗的患者和2808名接受LMWH治疗的患者。IPTW后,两组患者的治疗效果均衡。与 LMWH 相比,接受阿哌沙班治疗的患者复发性 VTE(4.1 vs 9.6 per 100 PY)、MB(6.3 vs 12.6)和 CRNMB(26.1 vs 36.0)的调整后 IR 值较低:在癌症相关 VTE 成人患者中,与 LMWH 相比,阿哌沙班延长抗凝治疗时间≥3 个月可降低复发性 VTE、MB 和 CRNMB 的发生率。
Effectiveness and Safety of Extended Treatment Apixaban Versus Low-Molecular-Weight Heparin in Cancer-Associated Venous Thromboembolism.
Background: Limited real-world evidence is available comparing the safety and effectiveness of apixaban and low-molecular-weight heparins (LMWHs) for preventing recurrent venous thromboembolism (VTE) in patients with active cancer receiving anticoagulation in an extended treatment setting. This study evaluated the risk of bleeding and recurrent VTE in patients with cancer-associated VTE who were prescribed apixaban or LMWH for ≥3 months.
Methods: A US commercial claims database was used to identify adult patients with VTE and active cancer who initiated apixaban or LMWH 30 days following the first VTE diagnosis and had ≥3 months of continuous enrollment and 3 months of primary anticoagulation treatment. Patients were followed from the day after the end of primary anticoagulation treatment until the earliest of: date of disenrollment, discontinuation of index anticoagulant, switch to another anticoagulant, or end of the study period. Inverse-probability treatment weighting (IPTW) was used to balance treatment cohorts. Incidence rates (IRs) for the outcomes were calculated per 100 person-years (PY). Cox proportional hazard models were used to evaluate the adjusted risk of recurrent VTE, major bleeding (MB), and clinically relevant nonmajor bleeding (CRNMB).
Results: A total of 13,564 apixaban- and 2,808 LMWH-treated patients were analyzed. Post-IPTW, the treatment cohorts were balanced. Patients receiving apixaban had lower adjusted IRs for recurrent VTE (4.1 vs 9.6 per 100 PY), MB (6.3 vs 12.6), and CRNMB (26.1 vs 36.0) versus LMWH (P<.0001 for all comparisons) during the follow-up period. Patients on apixaban had a lower adjusted risk of recurrent VTE (hazard ratio [HR], 0.42; 95% CI, 0.34-0.53), MB (HR, 0.50; 95% CI, 0.41-0.61), and CRNMB (HR, 0.76; 95% CI, 0.68-0.85) versus LMWH.
Conclusions: Extended anticoagulation treatment of ≥3 months with apixaban was associated with lower rates of recurrent VTE, MB, and CRNMB compared with LMWH in adults with cancer-associated VTE.
期刊介绍:
JNCCN—Journal of the National Comprehensive Cancer Network is a peer-reviewed medical journal read by over 25,000 oncologists and cancer care professionals nationwide. This indexed publication delivers the latest insights into best clinical practices, oncology health services research, and translational medicine. Notably, JNCCN provides updates on the NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®), review articles elaborating on guideline recommendations, health services research, and case reports that spotlight molecular insights in patient care.
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