Rivaroxaban treatment for six weeks versus three months in patients with symptomatic isolated distal deep vein thrombosis: randomised controlled trial. (23rd November 2022)

• Record Type: Journal Article
• Authors: Ageno, Walter; Bertù, Lorenza; Bucherini, Eugenio; Camporese, Giuseppe; Dentali, Francesco; Iotti, Matteo; Lessiani, Gianfranco; Parisi, Roberto; Prandoni, Paolo; Sartori, Michelangelo; Visonà, Adriana; Bigagli, Elisabetta; Palareti, Gualtiero
• Other Names: author non-byline.; Galgano Giuseppe author non-byline.; Zingaretti Oriana author non-byline.; Amitrano Maria author non-byline.; Mastroiacovo Daniela author non-byline.; Pinelli Mauro author non-byline.; Cosmi Benilde author non-byline.; Silingardi Mauro author non-byline.; Bigolin Paola author non-byline.; Zalunardo Beniamino author non-byline.; Porreca Ettore author non-byline.; Di Nisio Marcello author non-byline.; Pomero Fulvio author non-byline.; Mumoli Nicola author non-byline.; Avruscio Giampiero author non-byline.; Tonello Chiara author non-byline.; Imberti Davide author non-byline.; Benedetti Raffaella author non-byline.; Zanatta Nello author non-byline.; Veropalumbo Maria Rosaria author non-byline.; Ghirarduzzi Angelo author non-byline.; Pola Roberto author non-byline.; Porfidia Angelo author non-byline.; Marzolo Marco author non-byline.; Cuppini Stefano author non-byline.; Lodigiani Corrado author non-byline.; Banfi Elena author non-byline.; Gnerre Paola author non-byline.; Cappelli Roberto author non-byline.; Girardi Laura author non-byline.; Conte Giulia author non-byline.; Pegoraro Samuela author non-byline.; Hong Ngog Vo author non-byline.;
• Is Part Of: BMJ. Volume 379(2022)
• Publication Date: 2022-11-23
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610
• DOI: 10.1136/bmj-2022-072623
• Languages: English
• ISSNs: 0007-1447

Abstract

Abstract: Objective: To compare two different treatment durations of rivaroxaban in patients with symptomatic isolated distal deep vein thrombosis (DVT). Design: Randomised, double blind, placebo controlled clinical trial. Setting: 28 outpatient clinics specialising in venous thromboembolism. Participants: 402 adults (≥18 years) with symptomatic isolated distal DVT. Interventions: After receiving standard dose rivaroxaban for six weeks, participants were randomly assigned to receive rivaroxaban 20 mg or placebo once daily for an additional six weeks. Follow-up was for 24 months from study inclusion. Main outcomes measures: The primary efficacy outcome was recurrent venous thromboembolism during follow-up after randomisation, defined as the composite of progression of isolated distal DVT, recurrent isolated distal DVT, proximal DVT, symptomatic pulmonary embolism, or fatal pulmonary embolism. The primary safety outcome was major bleeding after randomisation until two days from the last dose of rivaroxaban or placebo. An independent committee adjudicated the outcomes. Results: 200 adults were randomised to receive additional rivaroxaban treatment and 202 to receive placebo. Isolated distal DVT was unprovoked in 81 (40%) and 86 (43%) patients, respectively. The primary efficacy outcome occurred in 23 (11%) patients in the rivaroxaban arm and 39 (19%) in the placebo arm (relative risk 0.59, 95% confidence interval 0.36 to 0.95; P=0.03, number needed to treat 13, 95% confidence interval 7 to 126). Recurrent isolated distal DVT occurred in 16 (8%) patients in the rivaroxaban arm and 31 (15%) in the placebo arm (P=0.02). Proximal DVT or pulmonary embolism occurred in seven (3%) patients in the rivaroxaban arm and eight (4%) in the placebo arm (P=0.80). No major bleeding events occurred. Conclusions: Rivaroxaban administered for six additional weeks in patients with isolated distal DVT who had an uneventful six week treatment course reduces the risk of recurrent venous thromboembolism, mainly recurrent isolated distal DVT, over a two year follow-up without increasing the risk of haemorrhage. Trial registration: EudraCT 2016-000958-36; ClinicalTrials.gov NCT02722447 .