A comparison of pharmacomechanical catheter-directed thrombolysis versus anticoagulation alone in the prevention of postthrombotic syndrome following acute lower limb deep-vein thrombosis

Introduction: Postthrombotic syndrome (PTS) occurs in 20%-60% of patients after acute deep-vein thrombosis (DVT) treated with anticoagulation alone. Residual thrombus after DVT leads to ambulatory venous hypertension which consequently causes PTS. Thus, evacuating the clot during DVT itself might prevent PTS - the "Open Vein Hypothesis." Pharmacomechanical catheter-directed thrombolysis (PCDT) evacuates the thrombus working on this very hypothesis. PCDT is usually performed using specialized devices which are expensive and not easily available in our country. In this study, we describe a method to perform PCDT using a commonly available and inexpensive guiding catheter in an aim to prevent PTS after DVT. Aims and Objectives: This study aimed to evaluate if in acute DVT, our method of PCDT reduces the occurrence of PTS, as compared to anticoagulation alone. Design: This is a prospective, randomized, comparative, cohort study. Study Period: The study was conducted from June 2016 to May 2017 with 1-year follow-up. Materials and Methods: Patients presenting with acute DVT of <3 weeks' duration who met the inclusion criteria were included in this study. They were subsequently randomized to receive either anticoagulation alone or PCDT which was performed in our vascular cath lab using a 7 Fr. guiding catheter to physically macerate and aspirate the clot with simultaneous instillation of fibrinolytic therapy (recombinant tissue plasminogen activator [RT-PA]) in the thrombus. Results: The technical success rate was 96%. The mean total dose of RT-PA used was 20.24 mg. The need for venoplasty/stenting was 76%. The rates of major bleeding in the both the groups were similar at 4% At 1-year follow-up, the following results were obtained: The deep vein patency was 84% in the PCDT group as compared to 16 % in anticoagulation only group(controls) (P< 0.001). Deep vein reflux was noted in 16 % of patients in the PCDT group as compared to 52% in the controls (P = 0.016). Furthermore, the PTS (measured by Villalta scale) was seen in 16% in the PCDT group as compared to 48 % in the controls (P = 0.032). Conclusions: Our method of PCDT is safe and effective as it reduces the occurrence of PTS with preservation of valvular competence and vein patency as compared to anticoagulation alone.