Author:
Setiawan Budi,Budianto Widi,Sukarnowati Tri Wahyu,Rizky Daniel,Pangarsa Eko Adhi,Santosa Damai,Sudoyo Aru Wisaksono,Winarni Tri Indah,Riwanto Ignatius,Setiabudy Rahajuningsih Dharma,Suharti Catharina
Abstract
Abstract
Background
Deep vein thrombosis (DVT) is a common complication in cancer. Although thromboprophylaxis in cancer patients is recommended by the guidelines, clinicians’ use of thromboprophylaxis remains limited due to cost, bleeding complications, and reluctance to give injectable anticoagulants. Inflammation plays essential roles in the pathogenesis of cancer-associated thrombosis. Owing to its ability to decrease proinflammatory cytokines, statins have anti-inflammatory properties. Thus, statins can be possibly utilized as thromboprophylaxis therapy in cancer patients undergoing chemotherapy.
Objective
To compare the effectiveness of atorvastatin and rivaroxaban for DVT prevention in high-risk thrombosis patients with cancer undergoing chemotherapy.
Methods
Double-blind, randomized controlled trial involving cancer patients with high-risk of thrombosis undergoing chemotherapy. We randomly assigned patients without deep-vein thrombosis at screening to receive atorvastatin 20 mg or rivaroxaban 10 mg daily for up to 90 days. Doppler ultrasonography was performed 90 days following chemotherapy to diagnose DVT. Average cost-effectiveness analysis was performed to analyze the cost of atorvastatin compared to rivaroxaban.
Results
Of the eighty six patients who underwent randomization, primary efficacy end point was observed in 1 of 42 patients (2.3%) in the atorvastatin group and in 1 of 44 (2.2%) in the rivaroxaban group (Odds Ratio [OR], 0.953; 95% confidence interval [CI], 0.240 to 3.971; p = 1.000). There was a significant difference in the incidence of major bleeding, 2 of 42 patients (4.8%) in the atorvastatin group and 12 of 44 (27.3%) in the rivaroxaban group (OR, 0.257; 95% CI, 0.07 to 0.94; p = 0.007). The average cost-effectiveness ratio of using atorvastatin was lower than that of rivaroxaban.
Conclusion
Atorvastatin did not differ significantly from rivaroxaban in reducing the incidence of DVT, lower bleeding risk, and cost-effectiveness for thromboprophylaxis in high-risk thrombosis patients with cancer undergoing chemotherapy. The presence of limited statistical power and wide confidence intervals in this study needs further study to strengthen the efficacy of atorvastatin as DVT prophylaxis in cancer patients.
Trial registration
ISRCTN71891829, Registration Date: 17/12/2020.
Publisher
Springer Science and Business Media LLC
Reference56 articles.
1. Timp JF, Braekkan SK, Versteeg HH, Cannegieter SC. Epidemiology of cancer-associated venous thrombosis. Blood. 2013;122(10):1712–24.
2. Angchaisuksiri P. Cancer-associated thrombosis in Asia. Thromb J. 2016;14:130–63.
3. Setiawan B, Pangarsa EP, SG, Suharti C. Incidence of asymptomatic deep vein thrombosis in cancer patients in Kariadi Hospital. In: Programme Book Pre and Post the 2018 Highlights of American Society of Hematology (ASH) in Asia Pasific (HOA-APAC). Bali; 2018. p. 80.
4. Sutandyo N, Tobing DL, Kardinah. Risk Factors of Deep Vein Thrombosis in Cancer Patients. Iran J Blood Cancer. 2018;10(4):117–23.
5. Kirwan CC, Mccollum CN, Mcdowell G, Byrne GJ. Investigation of proposed mechanisms of chemotherapy-induced venous thromboembolism : endothelial cell activation and procoagulant release due to apoptosis. Clin Appl Thromb. 2015;2(5):420–7.
Cited by
2 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献