Quality of life and functional recovery after venous stent placement for postthrombotic syndrome: insights from the ARIVA multinational randomized trial.

BACKGROUND: Postthrombotic syndrome (PTS) is a disabling complication of deep vein thrombosis and is associated with impaired functional status. OBJECTIVES: To assess the impact of stent placement for post-thrombotic syndrome on functional outcomes and quality of life. METHODS: The Aspirin Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis Among Patients with Postthrombotic Syndrome trial was a multinational, randomized study comparing rivaroxaban plus aspirin vs rivaroxaban monotherapy after venous revascularization for PTS. The Villalta score and the Chronic Venous Insufficiency Quality of Life Questionnaire-20 (CIVIQ-20) were assessed at randomization and during 6-month follow-up. A multivariable mixed-effects model was used to identify predictors of quality of life (QoL). RESULTS: Of 149 enrolled patients, 55% had moderate-to-severe PTS at baseline, according to the Villalta score. Compared with patients with mild PTS, they were characterized by longer stent segments, higher body mass index, and were more frequently smokers. The 6-month primary patency rate was similar between groups: 91.5% vs 95.5%, respectively. The improvement in PTS severity consisted of an overall mean reduction of -6.5 (SD 4.6) points, corresponding to a change of -8.5 (5.0) points among patients with moderate-to-severe PTS and -4 (2.6) points among patients with mild PTS after 6 months. Median CIVIQ-20 scores were lower, indicating worse QoL, among patients with moderate-to-severe PTS compared with mild PTS, consistently at baseline and all follow-up timepoints. Female sex and greater PTS severity were independently associated with worse QoL after adjustment for age, body mass index, treatment group, adverse events, and timepoint. CONCLUSION: Over the 6 months after endovascular treatment accessory to standard care for PTS, both PTS severity measured by the Villalta score and QoL measured by CIVIQ-20 improved. However, greater PTS severity and female sex were independently associated with worse QoL outcomes.