Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis

Abstract

Background: The ATTRACT Trial previously reported that pharmacomechanical catheterdirected thrombolysis (PCDT) did not prevent the post-thrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis (DVT). In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral DVT. Methods: Within a large multicenter randomized trial, 391 patients with acute DVT involving the iliac and/or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes. Results: Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale ≥5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio (RR)=0.95; 95% confidence interval (CI), 0.78-1.15; p=0.59). PCDT led to reduced PTS severity as shown by: lower mean Villalta and Venous Clinical Severity Scores [VCSS] (p<0.01 for comparisons at 6, 12, 18, and 24 months); and fewer patients with moderate-or-severe PTS (Villalta scale ≥10 or ulcer: 18% versus 28%; RR 0.65; 95% CI 0.45-0.94, p=0.021) or severe PTS (Villalta scale ≥15 or ulcer: 8.7% versus 15%; RR 0.57; 95% CI 0.32-1.01, p=0.048; and VCSS ≥8: 6.6% versus 14%; RR 0.46; 95% CI 0.24-0.87, p=0.013). From baseline, PCDT led to greater reduction in leg pain and swelling (p<0.01 for comparisons at 10 and 30 days) and greater improvement in venous diseasespecific QOL (VEINES-QOL unit difference 5.6 through 24 months, p=0.029), but no difference in generic QOL (p > 0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% (p=0.32), and recurrent VTE over 24 months was observed in 13% versus 9.2% (p=0.21). Conclusions: In patients with acute iliofemoral DVT, PCDT did not influence the occurrence of PTS or recurrent VTE. However, PCDT significantly reduced early leg symptoms and, over 24 Comerota et al.

Pharmacomechanical Catheter-Directed Thrombolysis in Acute Femoral–Popliteal Deep Vein Thrombosis: Analysis from a Stratified Randomized Trial

“…This suggests that, as we have reported elsewhere, improvements in these outcomes with PCDT was confined to the iliofemoral DVT subgroup. (13) The CAVENT (Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis) trial, which evaluated 209 patients, reported that catheter-directed thrombolysis reduced the risk of PTS at 2 and 5 years but did not report findings separately for patients with femoral-popliteal (required involvement "above mid-thigh level") and iliofemoral DVT. (14;15) Our analysis has several limitations.…”

“…(5;6) The Villalta scale rates the severity, from 0 to 3, of five patient-reported symptoms (pain, cramps, heaviness, pruritus, paresthesia) and six clinician-observed signs (edema, skin induration, hyperpigmentation, venous ectasia, redness, pain during calf compression). Points for symptoms and signs are summed into a total score (range 0-33), and patients can be categorized as having no PTS (score 0-4), mild PTS (score 5-9), moderate PTS (score [10][11][12][13][14] or severe PTS (score >14, or presence of ulcer). Patients were also counted as having PTS if they had an unplanned endovascular procedure to treat severe venous symptoms more than 6 months after randomization, unless there was a Villalta <5 in the preceding 4 weeks.…”

Post-thrombotic syndrome prevention – do we really know the predictive factors?

“…In the study cohort (patients with proximal DVT including also ilio-femoral DVT) the rate of PTS (assessed by the means of the Villalta score) was 46.7 % in the thrombolysis arm and 48.2 % in anticoagulation group (p = 0.56) with higher rate of the major bleedings in the patients treated by thrombolytic treatment (1.7 % vs 0.3 %; p = 0.049). New published data with further analyses of ATTRACT results, regarding the group of the patients with DVT limited to the ilio-femoral segment (52). In this subpopulation the local thrombolysis was associated with a reduced rate of moderate and severe PTS (Villalta > 9) occurrence after 24 months of follow up (thrombolysis: 18 % vs anticoagulation: 28 %; p = 0.021).…”

Update on early thrombus removal for iliofemoral deep vein thrombosis

“…A new publication from the ATTRACT study has now shed more light on the trial with an analysis of the subgroup with iliofemoral disease alone with 196 patients in the PCDT group and 195 patients in the control group (34). These analyses are acknowledged by the authors to be limited by a less substantial power to detect differences in outcome compared to the overall trial and a substantial loss of patients to follow-up.…”