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

Abstract

Word countAbstract : 246 Main text: 2836 4 Abstract Background and Objectives: The ATTRACT trial reported that pharmacomechanical catheterdirected thrombolysis (PCDT) did not reduce postthrombotic syndrome (PTS), but reduced moderate-to-severe PTS and the severity of PTS symptoms. In this analysis, we examine the effect of PCDT in patients with femoral-popliteal DVT (without involvement of more proximal veins). Patients/Methods: Within the ATTRACT trial, 300 patients had deep vein thrombosis (DVT) involving the femoral vein without involvement of the common femoral or iliac veins and were randomized to receive PCDT with anticoagulation or anticoagulation alone (No PCDT). Patients were followed for 24 months. Results: From 6 to 24 months, between the PCDT vs. No PCDT arms, there was: no difference in any PTS (Villalta scale ≥5: Risk Ratio [RR]=0.97; 95% confidence interval [CI], 0.75 to 1.24); moderate-or-severe PTS (Villalta scale ≥10: RR=0.93; 95% CI, 0.57 to 1.52; severity of PTS scores; or general or disease-specific quality of life (p >0.5 for all comparisons). From baseline to both 10 days and 30 days, there was no difference in improvement of leg pain or swelling between treatment arms. From baseline to 10 days, major bleeding occurred in three vs. none (p=0.06) and any bleeding occurred in eight vs. two (p=0.032) PCDT vs. No PCDT patients. Over 24 months, recurrent venous thromboembolism occurred in 16 PCDT and 12 No PCDT patients (p=0.24).Conclusion: In patients with femoral-popliteal DVT, PCDT did not improve short-or long-term efficacy outcomes, but it increased bleeding. Therefore, PCDT should not be used as initial treatment of femoral-popliteal DVT. (NCT00790335).

Editor's Choice – European Society for Vascular Surgery (ESVS) 2021 Clinical Practice Guidelines on the Management of Venous Thrombosis

“…233 However, no benefit was observed in patients with femoropopliteal DVT. 234 There are several limitations identified with the ATTRACT and CAVA trials. Given the lack of statistical power for the stratified analyses, the ATTRACT investigators recommended that these findings should be confirmed in future research.…”

Global guidelines trends and controversies in lower limb venous and lymphatic disease

“…A recently published sub-analysis of the ATTRACT trial looked at the femoro-popliteal cases specifically and demonstrated that, for this subgroup of patients, performing pharmaco-mechanical catheter-directed thrombolysis is of no benefit and is associated with an increased bleeding risk (P = 0.032). 250 Sub-analysis on the ilio-femoral cases of the ATTRACT trial, showed that pharmaco-mechanical catheter-directed thrombolysis did not influence the overall occurrence of PTS or recurrent venous thromboembolism. However, it significantly reduced early symptoms (P < 0.01) and, over 24 months, it reduced PTS severity scores (P < 0.01) and resulted in greater improvement in venous disease-specific quality of life (P = 0.029).…”

Thrombosis and Haemostasis 2019 Editor's Choice Papers

“…In a prospective nationwide cohort study, they suggested that anticoagulant therapy should be restricted to patients having disseminated intravascular coagulation and high disease severity simultaneously. Also stressing the importance to accurately define target groups, the study from Kearon et al 17 presented an analysis of a sub-group of patients with femoral-popliteal deep vein thrombosis from the recent ATTRACT randomised trial. Although pharmacomechanical interventions combined with thrombolytic therapy, can rapidly remove thrombus and improve outcomes in patients with acute deep vein thrombosis, these benefits could not be observed among the sub-group for whom this was even associated with increased bleeding.…”