Safety and Efficacy of Rivaroxaban as Extended-Phase Anticoagulation in Patients with Cancer and Venous Thromboembolism: A Preliminary Data Analysis from the Mac Project

• Published in: Life (Basel, Switzerland) Vol. 12; no. 11; p. 1725
• Main Authors: Bernardi, Enrico, Camporese, Giuseppe, Bortoluzzi, Cristiano, Noventa, Franco, Ceccato, Davide, Tonello, Chiara, Vohong, Stefania, Campello, Elena, Simion, Chiara, Imbalzano, Egidio, Di Micco, Pierpaolo, Callegari, Elena, Simioni, Paolo
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 01.10.2022; MDPI
• Subjects: Analysis; Anticoagulants; Bleeding; Brief Report; Cancer; Cancer patients; cancer-related venous thromboembolism; Care and treatment; Confidence intervals; Data analysis; Dosage and administration; Drug therapy; Effectiveness; extended-phase anticoagulation; factor Xa inhibitors; Health aspects; Hemorrhage; Maximum likelihood method; Mortality; Patient outcomes; Patients; real-life; Rivaroxaban; Safety; Thromboembolism; Italy
• ISSN: 2075-1729; 2075-1729
• DOI: 10.3390/life12111725

Extended-phase anticoagulation with direct oral Xa inhibitors (OAXI) is suggested in patients with cancer-associated venous thromboembolism (CAT). We report on patients enrolled in the MAC (Monitoring AntiCoagulants) Project, given rivaroxaban as extended-phase anticoagulation after CAT. The primary efficacy outcome was the incidence of symptomatic recurrent VTE; the primary safety outcomes were incidence of major and non-major clinically relevant bleeding, adverse events, and all-cause mortality. The mean patients’ follow-up was 19 months (SD 16); 64/604 (11%) had CAT. Recurrent VTE occurred in 9.3% and in 8.1% of patients with and without CAT (OR 1.2, 95% CI 0.5 to 2.9; p = 0.6). Major bleeding occurred in 4.7% and in 2.6%, respectively (OR = 1.8, 95% CI 0.5 to 6.6, p = 0.4), and non-major clinically-relevant bleeding in 4.7% and in 4.1% (OR = 1.2, 95% CI 0.3 to 3.9, p = 0.7). The relative figures for fatal haemorrhage and all-cause death were 1.6% versus 0%, and 1.6% versus 0.4%. Rivaroxaban appears to be effective and safe as extended-phase anticoagulation in patients with CAT. The mean treatment period was 3-times the standard 6-month course.