TORPEDO 2012.
| Methods | Study design: randomised controlled trial |
| Participants | Setting: hospital Country: United States of America Inclusion criteria: adult patients with symptomatic DVT, involving popliteal vein or more proximal venous segments, diagnosed by venous duplex sonography or multislice CT venography. The affected veins were divided into five segments, based on the anatomical involvement of DVT: inferior vena cava (IVC), right and left iliac veins, and right and left femoropopliteal veins Exclusion criteria: patients were excluded if they had serious bleeding in the previous 4 weeks, contra‐indication to unfractionated or low‐molecular weight heparin, or severe thrombocytopaenia (platelet count of < 30,000/mm³) |
| Interventions | Intervention 1: PEVI + anticoagulation. For acute DVT with otherwise preserved venous anatomy, thrombectomy was performed using any of the following: Angiojet DVX catheter (Medrad/Possis, Warrendale, PA), Trellis device (Bacchus Vascular, Santa Clara, CA), or manual aspiration with an 8‐F guide catheter. No preference was given to any thrombectomy device, and its use was based on operator discretion and device availability. For severe 'venosclerotic' disease with distorted anatomy, a venous conduit was created using balloon venoplasty and stents. If residual thrombus was more than 30% of the luminal area, an infusion catheter was placed and low‐dose thrombolytic therapy with tissue plasminogen activator (tPA) at 1 mg/hr delivered for 20 to 24 hr. In this scenario, the patient was brought back to the angiography suite for re‐evaluation after tPA administration Intervention 2: anticoagulation alone. Initial anticoagulation therapy consisted of subcutaneous enoxaparin at 1 mg/kg twice daily, administered subcutaneously. For those with renal insufficiency or concomitant massive PE, unfractionated heparin (UFH) was started at 80 IU/kg intravenously as loading dose, followed by 18 IU/hr, with subsequent adjustments to keep the activated partial thromboplastin time 1.5 to 2 times the baseline level. Warfarin was initiated on admission |
| Outcomes | Primary: post‐thrombotic syndrome and recurrence of VTE at 6 months Secondary: bleeding, duration of hospitalisation, reduction of leg oedema, reduction of skin induration, and patient's subjective perception of improvement |
| Notes | Authors were contacted for data on participants with iliofemoral DVT and for data stratified by pharmacomechanical thrombectomy. To date, no response has been received |
CT: computed tomography DVT: deep vein thrombosis PE: pulmonary embolism PEVI: percutaneous endovenous intervention VTE: venous thromboembolism