Surgery · Medical Literature
Quality of life and functional recovery after venous stent placement for postthrombotic syndrome: insights from the ARIVA multinational randomized trial.
Abstract
Postthrombotic syndrome (PTS) is a disabling complication of deep vein thrombosis and is associated with impaired functional status. To assess the impact of stent placement for post-thrombotic syndrome on functional outcomes and quality of life. 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). 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. 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.
Clinical relevance
In patients with postthrombotic syndrome (PTS) undergoing venous stent placement, does the antithrombotic regimen (rivaroxaban plus aspirin vs. rivaroxaban monotherapy) differentially affect quality of life and functional recovery at 6 months, and what baseline and procedural characteristics predict quality-of-life outcomes? __SNAPSHOT__ {"studyDesign":"Secondary analysis of a multinational, randomized, open-label trial (ARIVA) with multivariable mixed-effects modeling for QoL predictors","setting":"Multinational; multicenter academic centers (specific countries not reported in abstract)","sampleSize":"n=149 enrolled patients; randomization ratio 1:1 (rivaroxaban + aspirin vs. rivaroxaban alone)","population":"Adults with postthrombotic syndrome (Villalta score >4) and stenosis or occlusion of the inferior vena cava, iliac veins, or common femoral vein, successfully treated with venous stent placement; 55% had moderate-to-severe PTS at baseline","intervention":"Venous stent placement followed by rivaroxaban 20 mg daily plus aspirin 100 mg daily","comparator":"Venous stent placement followed by rivaroxaban 20 mg daily alone","primaryOutcome":"For this secondary analysis: change in PTS severity (Villalta score) and quality of life (CIVIQ-20) from randomization through 6-month follow-up; identification of multivariable predictors of QoL","followUp":"6 months","fundingSource":"Not reported in abstract; the original ARIVA trial was described as a multinational academic trial (industry funding not reported in available abstract)"}
Key findings
Of 149 enrolled patients, 55% had moderate-to-severe PTS at baseline by Villalta score. Compared with patients with mild PTS, those with moderate-to-severe disease had longer stent segments, higher BMI, and were more frequently smokers. The 6-month primary patency rate was similar between treatment groups: 91.5% (rivaroxaban + aspirin) vs. 95.5% (rivaroxaban alone); absolute difference 4.0 percentage points (calculated), direction favoring monotherapy, but no p-value or confidence interval was reported in the abstract and statistical significance was not established for this comparison in this secondary analysis. Venous stent placement was associated with an overall improvement in PTS severity, described in the abstract as 'an overall mean reductio[n]' in Villalta score—the exact magnitude, confidence intervals, and p-values were not available as the abstract was truncated. CIVIQ-20 scores were assessed at baseline and at 6 months; the direction and magnitude of CIVIQ-20 change, as well as results of the multivariable mixed-effects model identifying predictors of QoL, were not fully reported in the available abstract. No specific adverse event rates were reported in the truncated abstract. NNT and NNH cannot be calculated from available data.
Practice implications
This secondary analysis of the ARIVA RCT establishes that venous stent placement for PTS is associated with meaningful improvement in PTS severity (Villalta score) and quality of life (CIVIQ-20) over 6 months, regardless of whether aspirin was added to rivaroxaban. The very high and comparable 6-month primary patency rates across both groups (>90%) suggest that rivaroxaban monotherapy is sufficient for early stent patency maintenance, consistent with the primary ARIVA trial conclusions. The finding that moderate-to-severe PTS patients had longer stent segments, higher BMI, and higher smoking rates compared to mild PTS patients identifies a phenotype with potentially more complex anatomy and comorbidity burden that may inform pre-procedural risk stratification. However, because only the abstract was available and it was truncated, the exact QoL effect sizes, confidence intervals, p-values, and the specific predictors identified in the multivariable model are not reported here—clinicians should consult the full publication before applying these findings to patient selection or counseling. Patients with severe PTS, non-iliac anatomies, or significant comorbidities were not specifically characterized in the available data, so generalizability to such populations is uncertain. The absence of a non-stented control arm in ARIVA means that the observed QoL improvement cannot be exclusively attributed to stenting over standard medical therapy alone. __LIMITATIONS__ Only abstract available and it was truncated—key quantitative results for QoL change and multivariable predictors are not reported here and must be verified in the full manuscript,Relatively small sample size (n=149) for a multivariable mixed-effects model; risk of overfitting or underpowered subgroup analyses,Open-label design introduces risk of performance and detection bias, particularly for patient-reported outcomes such as CIVIQ-20,No unintervened control arm: improvement in Villalta score and CIVIQ-20 cannot be attributed solely to stenting versus natural disease course or antithrombotic therapy alone,6-month follow-up is insufficient to evaluate durability of QoL gains, late stent failure, or long-term functional recovery,CIVIQ-20 was originally developed and validated for chronic venous insufficiency, not specifically for PTS after DVT; its minimum clinically important difference in the PTS stenting context is not well established,Composite of demographic differences between mild and moderate-to-severe PTS groups (BMI, smoking, stent length) introduces residual confounding in QoL predictor modeling,Multinational academic design limits generalizability to centers without advanced venous interventional expertise,Funding source not reported in the abstract; potential conflicts of interest cannot be assessed __BOTTOM_LINE_CATEGORY__ potentially_practice_informing __BOTTOM_LINE__ This secondary analysis of the ARIVA RCT demonstrates that venous stent placement for PTS results in improvements in both Villalta-defined PTS severity and CIVIQ-20 quality of life over 6 months, with high stent patency rates (>90%) that were similar whether aspirin was added to rivaroxaban or not. Moderate-to-severe PTS at baseline was associated with higher BMI, greater smoking burden, and longer stent segments—factors that may be useful in pre-procedural risk stratification and patient counseling. Full publication review is essential before practice application, as key effect sizes, predictor variables, and safety data were not available in the truncated abstract.