A randomized clinical trial depicted that in adults (≥18 years) having deep vein thrombosis (DVT) who underwent a successful six-week treatment course, Rivaroxaban given for an extra 6 weeks minimized the risk of recurrent venous thromboembolism, primarily recurrent isolated distal DVT, over a two-year follow-up without raising major bleeding event risk.

Researchers sought to determine two distinct therapy durations of Rivaroxaban in 402 people suffering from symptomatic isolated distal DVT. In this placebo-controlled, double-blind trial, volunteers were given Rivaroxaban at the recommended dose for six weeks prior to being randomly allocated to get either 20 mg Rivaroxaban or a placebo once daily for an additional 6 weeks. The recruited subjects were followed up for twenty-four months.

Recurrent venous thromboembolism, characterized as the composite of advancement of isolated distal DVT, proximal DVT, recurrent isolated distal DVT, fatal pulmonary embolism, or symptomatic pulmonary embolism was the key efficacy endpoint during follow-up following randomization. Major bleeding following randomization until 2 days after the last dose of Rivaroxaban or placebo was the key safety endpoint. The decisions were made by a neutral committee.

A total of 200 people were given extra Rivaroxaban therapy at random, while 202 were given a placebo. In 81 (40%) and 86 (43%) patients, respectively, isolated distal DVT was reported to be unprovoked. Notably, 23 (11%) of the people in the Rivaroxaban group and 39 (19%) of the people in the placebo group had the primary efficacy endpoint (number needed to treat 13, relative risk 0.59).

In the Rivaroxaban group, 16 (8%) volunteers experienced recurrent isolated distal DVT, compared to 31 (15%) in the placebo group. Notably, 7 (3%) volunteers in the Rivaroxaban group and eight (4%) volunteers in the placebo group experienced proximal DVT or pulmonary embolism, respectively. Major bleeding incidents didn't occur.