Ultrasound‐assisted versus conventional catheter‐directed thrombolysis for acute iliofemoral deep vein thrombosis: 1‐year follow‐up data of a randomized‐controlled trial

Abstract

Background In patients with acute iliofemoral deep vein thrombosis (IFDVT), catheter-directed thrombolysis (CDT) aims to prevent the postthrombotic syndrome (PTS). Adding intravascular high-frequency, low-power ultrasound energy to CDT does not seem to improve the immediate thrombolysis results but its impact on clinical outcomes at 12 months is not known. Patients/Methods In this randomized-controlled trial, 48 patients (mean age 50 ± 21 years; 52% women) with acute IFDVT were randomized to conventional CDT (n = 24) or ultrasound-assisted CDT (USAT; n = 24). In both groups, a fixed-dose thrombolysis regimen (20 mg r-tPA over 15 h) was used, followed by routine stenting of residual venous obstruction. At 12 months, PTS and venous disease severity (Villalta score and revised Venous Clinical Severity Score [rVCSS]), disease-specific quality of live (QOL; CIVIQ-20) and duplex-sonographic outcomes were assessed. Results Among the 45 surviving patients, 40 (89%; 95% confidence interval [CI] 76-96%) patients were free from PTS (defined as Villalta score < 5 points; 83%, 95% CI 61-95% in the USAT and 96%, 95% CI 77-100% in the CDT group), with a similar mean total Villalta score of 2.3 ± 2.9 vs. 1.7 ± 1.6, and a mean total rVCSS of 3.0 ± 3.5 vs. 2.7 ± 2.9 in the USAT and the CDT groups, respectively. Both groups had good disease-specific QOL with a CIVIQ-20 score of 29.4 ± 11.8 vs. 26.1 ± 7.8, respectively. Primary (100% vs. 92%) and secondary (100% vs. 96%) iliofemoral patency rates and presence of femoro-popliteal venous reflux (39% vs. 33%) were similar in both groups. Conclusion The addition of intravascular ultrasound energy to conventional CDT for the treatment of acute IFDVT did not have any impact on relevant clinical or duplex sonographic outcomes, which were favorable in both study groups. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier:NCT01482273.

Rivaroxaban or vitamin-K antagonists following early endovascular thrombus removal and stent placement for acute iliofemoral deep vein thrombosis

“…Our results confirm the previous report from the pooled data of the randomized controlled BERNUTIFUL (BERN Ultrasound-assisted Thrombolysis for Ilio-Femoral deep vein thrombosis versUs standard catheter directed thromboLysis) trial, which reported an overall incidence of PTS at 12 months follow-up of 11%. [16] These results are in contrast with the relatively high incidence of PTS at 24 months in the interventional study arms of the CaVenT (41%) and ATTRACT (31%) trials, [3,10] which might be due to the much higher stent placement rate in the BERNUTIFUL trial (80%) and the present study. [16] Our study has several limitations.…”

“…During the study period, the stent placement rate in patients with IFDVT treated with early thrombus removal was 80%. [13,16] The registry and participant consent form were approved by the Swiss Ethics Committee on research involving humans. The study is registered on the National Institutes of Health website (ClinicalTrials.gov; identifier NCT02433054).…”

“…[13,37] In patients with thrombus extension into the popliteal veins or into the inferior vena cava, initial CDT was performed with a standard multi-sidehole catheter (e.g. Craigg- [13,16] In case of residual thrombi, either prolonged CDT or additional PMT using an AngioJet device (Boston Scientific, Minneapolis, MN, USA) was performed. If the thrombus burden was less extensive, single session PMT with an AngioJet device without prior CDT was an option.…”

“…[13] Venous patency rates 6-24 months after catheterbased thrombus removal with or without stent placement in patients with IFDVT ranged between 72% and 100%. [14][15][16] Based on the results of small randomized-controlled trials and prospective cohort studies, clinical practice guidelines suggest the use of early thrombus removal strategies and adjunctive use of venous stents for residual obstructive vein lesions as first-line therapy in selected patients with acute IFDVT and low bleeding risk. [17][18][19][20] Anticoagulation therapy remains the cornerstone for patients with DVT.…”

The ATTRACT Trial Becomes More Attractive

“…9 In addition, other groups have recently published similarly low rates of PTS, albeit after 1e2 years, and this appears to be the experience of most mature centres. 10,11 This problem of randomizing patients to low volume centres, still on the learning curve, has plagued many trials of intervention vs. medical therapy. This is similar to the experience of the introduction of clot removal techniques for both coronary disease and stroke where a cycle of improvement in technique and repeat of trials made early clot removal the standard of care.…”