Carl-Erik Slagsvold

Catheter‐directed thrombolysis vs. anticoagulant therapy alone in deep vein thrombosis: results of an open randomized, controlled trial reporting on short‐term patency

Summary.  Background: Approximately one in four patients with acute proximal deep vein thrombosis (DVT) given anticoagulation and compression therapy develop post‐thrombotic syndrome (PTS). Accelerated removal of thrombus by thrombolytic agents may increase patency and prevent PTS. Objectives: To assess short‐term efficacy of additional catheter‐directed thrombolysis (CDT) compared with standard treatment alone. Patients and methods: Open, multicenter, randomized, controlled trial. Patients (18–75 years) with iliofemoral DVT and symptoms < 21 days were randomized to receive additional CDT or standard treatment alone. After 6 months, iliofemoral patency was investigated using duplex ultrasound and air‐plethysmography assessed by an investigator blinded to previous treatment. Results: One hundred and three patients (64 men, mean age 52 years) were allocated additional CDT (n = 50) or standard treatment alone (n = 53). After CDT, grade III (complete) lysis was achieved in 24 and grade II (50%–90%) lysis in 20 patients. One patient suffered major bleeding and two had clinically relevant bleeding related to the CDT procedure. After 6 months, iliofemoral patency was found in 32 (64.0%) in the CDT group vs. 19 (35.8%) controls, corresponding to an absolute risk reduction (RR) of 28.2% (95% CI: 9.7%–46.7%; P = 0.004). Venous obstruction was found in 10 (20.0%) in the CDT group vs. 26 (49.1%) controls; absolute RR 29.1% (95% CI: 20.0%–38.0%; P = 0.004). Femoral venous insufficiency did not differ between the two groups. Conclusions: After 6 months, additional CDT increased iliofemoral patency from 36% to 64%. The ongoing long‐term follow‐up of this study will document whether patency is related to improved functional outcome.

Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial

BACKGROUND Post-thrombotic syndrome is a common complication after acute proximal deep vein thrombosis (DVT) and is associated with reduced quality of life and a substantial cost burden. In the 2-year results of the CaVenT study, additional catheter-directed thrombolysis reduced the risk of post-thrombotic syndrome by 14% compared with conventional therapy, but did not affect quality of life. In this study we report results at the 5-year follow-up, aiming to assess whether findings for post-thrombotic syndrome and quality of life have persisted. METHODS Between Jan 3, 2006, and Dec 22, 2009, we recruited patients aged 18-75 years with a first-time high proximal leg DVT from 20 hospitals in the Norwegian southeastern health region. With sealed envelopes, participants were randomly assigned (1:1) to standard treatment with compression stockings and anticoagulants (control group) or to standard treatment plus catheter-directed thrombolysis with alteplase within 21 days from symptom onset. Pre-specified outcomes in this analysis were post-thrombotic syndrome at 5 years as assessed with the Villalta score and scores for quality of life at 5 years with EQ-5D and the disease-specific VEINES-QOL/Sym. Analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00251771. FINDINGS At 5 year follow-up (last date Oct 14, 2014), data were available for 176 patients (84% of the 209 patients originally randomised)--87 originally assigned to catheter-directed thrombolysis and 89 originally assigned to the control group. 37 patients (43%; 95% CI 33-53) allocated to catheter-directed thrombolysis developed post-thrombotic syndrome, compared with 63 (71%; 95% CI 61-79) allocated to the control group (p<0·0001), corresponding to an absolute risk reduction of 28% (95% CI 14-42) and a number needed to treat of 4 (95% CI 2-7). Four (5%) patients assigned to catheter-directed thrombolysis and one (1%) to standard treatment had severe post-thrombotic syndrome (Villalta score ≥ 15 or presence of an ulcer). Quality-of-life scores with either assessment scale did not differ between the treatment groups. INTERPRETATION Additional catheter-directed thrombolysis resulted in a persistent and increased clinical benefit during follow-up for up to 5 years, supporting the use of additional catheter-directed thrombolysis in patients with extensive proximal DVT. However, allocation to this therapy did not lead to better quality of life. The optimal endovascular thrombolytic approach needs further investigation. FUNDING Southeastern Norway Regional Health Authority, the Research Council of Norway, University of Oslo, Oslo University Hospital.

Determinants of early and long-term efficacy of catheter-directed thrombolysis in proximal deep vein thrombosis.

PURPOSE Catheter-directed thrombolysis (CDT) for proximal deep vein thrombosis (DVT) effectively enhances clot removal and recently has been shown to reduce the development of postthrombotic syndrome (PTS). This study was performed to identify potential markers for early and long-term efficacy of CDT, adverse events, and their interrelationship. MATERIALS AND METHODS Patients aged 18-75 years (mean, 54 y; 33 women) with first-time proximal DVT and symptoms up to 21 days were included in subanalyses in an open, multicenter, randomized, controlled trial. Early efficacy was assessed with a thrombus score based on daily venography. Six-month and 2-year follow-up included iliofemoral patency assessed with duplex ultrasound and air plethysmography, and PTS was assessed with the Villalta scale. RESULTS A mean clot resolution of 82%±25 was achieved in 92 patients. Successful lysis (ie,≥50%) was obtained in 83 patients. Early efficacy was equal for femoral and iliofemoral thrombus and not related to thrombus load before CDT, symptom duration, or predisposing risk factors. Lower thrombus score at completion of CDT was associated with increased patency at 24 months (P = .040), and increased patency after 6 and 24 months was correlated with reduced development of PTS after 24 months (P<.001). Bleeding complications were mainly related to the puncture site, and popliteal vein access led to fewer bleeding incidents. CONCLUSIONS Comp, this is a Clinical Study article, so, as noted on the TOC, the Conclusions section of the abstract gets listed on the TOC. CDT via popliteal access was safe, effectively removed clots, and restored iliofemoral patency. Preprocedure evaluation did not identify patients who did not benefit from treatment. Early efficacy and follow-up patency are of importance to reduce the risk for PTS.

Surgical treatment of chronic venous insufficiency

BACKGROUND Patients with chronic venous insufficiency (CVI) may develop serious symptoms such as pain, oedema, venous claudication and leg ulcers. Conventional therapy includes compression therapy, elevation of the extremities, and in some cases surgical elimination of superficial varicose veins. This article presents and discusses surgical treatment (reconstructive deep venous surgery and transplantation) and endovascular therapy (percutaneous recanalization of post-thrombotic deep venous occlusions). MATERIAL AND METHODS The article is based on literature identified through non-systematic searches in the PubMed and Cochrane databases. RESULTS After reconstructive deep venous surgery, ulcer healing is reported in 60-78 % of cases and clinical improvement in 90 %. After such surgery, the median ulcer-free period seems to be longer in primary (congenital, familial), 54 months, than in secondary (after deep vein thrombosis) chronic venous insufficiency (18 months). Recanalization of deep venous occlusions is successful in 90 % of patients who have undergone endovascular treatment of venous claudication and leg ulcer. INTERPRETATION Reconstructive deep venous surgery constitutes a real treatment choice for patients with chronic venous insufficiency for whom conventional measures have failed. The benefits are ulcer-free periods, clinical improvement, return to work and improved quality of life.