ABSTRACT
BACKGROUND: The use of thrombolytic therapy in the treatment of thrombosed infrainguinal native arteries and bypass grafts has increased over the years. Main limitation of this treatment modality, however, is the occurrence of bleeding complications. Low intensity ultrasound (US) has been shown to accelerate enzymatic thrombolysis, thereby reducing therapy time. So far, no randomized trials have investigated the application of US-accelerated thrombolysis in the treatment of thrombosed infra-inguinal native arteries or bypass grafts. The DUET study (Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thrombo-embolic infrainguinal disease) is designed to assess whether US-accelerated thrombolysis will reduce therapy time significantly compared with standard catheter-directed thrombolysis. METHODS/DESIGN: Sixty adult patients with recently (between 1 and 7 weeks) thrombosed infrainguinal native arteries or bypass grafts with acute limb ischemia class I or IIa, according to the Rutherford classification for acute ischemia, will be randomly allocated to either standard thrombolysis (group A) or US-accelerated thrombolysis (group B). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is the duration of catheter-directed thrombolysis needed for uninterrupted flow in the thrombosed infrainguinal native artery or bypass graft, with outflow through at least 1 crural artery. DISCUSSION: The DUET study is a randomized controlled trial that will provide evidence of whether US-accelerated thrombolysis will significantly reduce therapy time in patients with recently thrombosed infrainguinal native arteries or bypass grafts, without an increase in complications. TRIAL REGISTRATION: Current Controlled Trials ISRCTN72676102.
Subject(s)
Catheterization, Peripheral , Fibrinolytic Agents/administration & dosage , Ischemia/therapy , Lower Extremity/blood supply , Research Design , Thromboembolism/therapy , Thrombolytic Therapy , Ultrasonic Therapy , Adult , Catheterization, Peripheral/adverse effects , Combined Modality Therapy , Fibrinolytic Agents/adverse effects , Hospitals, Teaching , Humans , Infusions, Intra-Arterial , Ischemia/drug therapy , Ischemia/physiopathology , Netherlands , Thromboembolism/drug therapy , Thromboembolism/physiopathology , Thrombolytic Therapy/adverse effects , Time Factors , Treatment Outcome , Ultrasonic Therapy/adverse effects , Vascular PatencyABSTRACT
Atherosclerosis of femoropopliteal arteries is an important cause of morbidity and mortality. Percutaneous transluminal angioplasty (PTA) has only limited success in treating these arteries, mainly because of the high rate of recurrent stenosis. Cryoplasty has been proposed as a technique which might improve treatment outcome. This study reports our single-center experience with cryoplasty. Thirty-two claudicants, 33 arteries, in whom conservative therapy failed, were consecutively included. Duplex ultrasound (US), angiography, and ankle-brachial index (ABI) measurement were performed before the procedure; ABI and duplex US, 2 weeks and 3, 6, and 12 months after the procedure. Patients' symptoms were categorized according to the Rutherford classification. Lesions were classified as TASC A, B, or C according to angiographic appearance. Differences in ABI before and after the procedure were defined as significant at p < 0.05 by paired t-test. Patency was evaluated using duplex US by determining the peak systolic velocity ratio. Sixteen TASC A lesions, 13 TASC B lesions, and 4 TASC C lesions were included. ABI improved significantly for TASC A lesions 2 weeks and 3 months postprocedure. Patency after 2 weeks, 6 months, and 12 months was 93%, 67%, and 64% for TASC A lesions, 83%, 31%, and 31% for TASC B lesions, and 100%, 50%, and 33% for TASC C lesions, respectively. In conclusion, cryoplasty has good immediate success rates and patency rates similar to the results of conventional PTA in the literature.
