Express LD Vascular Stent in the Treatment of Iliac Artery Lesions: 24-Month Results from the Melodie Trial

• Published in: Journal of endovascular therapy 2010-10, Vol.17 (5), p.633-641
• Main Authors: Stockx, Luc, Poncyljusz, Wojciech, Krzanowski, Marek, Schroë, Herman, Allocco, Dominic J., Dawkins, Keith D.
• Format: Article
• Language: English
• Subjects: Aged; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Ankle Brachial Index; Arterial Occlusive Diseases - diagnosis; Arterial Occlusive Diseases - physiopathology; Arterial Occlusive Diseases - therapy; Canada; Constriction, Pathologic; Europe; Female; Humans; Iliac Artery - diagnostic imaging; Iliac Artery - physiopathology; Male; Middle Aged; Mortality; Prospective Studies; Prosthesis Design; Stainless steel; Stents; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Vascular Patency; Veins & arteries
• ISSN: 1526-6028; 1545-1550
• DOI: 10.1583/09-2917MR.1

Purpose: To report the 2-year results of the MELODIE trial, which evaluated the safety and effectiveness of the balloon-expandable Express LD Vascular stent for the treatment of atherosclerotic iliac artery disease. Methods: This prospective, multicenter, single-arm trial enrolled 151 patients (113 men; mean age 60.1±8.4 years) with 163 de novo or restenotic iliac lesions. The primary endpoint, 6-month angiographic mean percent loss of luminal diameter, was compared to an objective performance criterion (OPC) based on published results with the Palmaz stent. Follow-up included ankle-brachial index (ABI) measurement and symptom assessment (Fontaine classification) at discharge, 30 days, and 6, 12, and 24 months. Arteriography was performed at 6 months and computed tomographic angiography (CTA) at 1 and 2 years. Results: The primary endpoint of 6-month mean percent luminal diameter loss was 16.2% (upper 95% confidence boundary of 19.1%) and non-inferior to the 20% OPC (p=0.006). Primary patency was 92.1% at 6 months and 87.8% at 2 years. The rate of major adverse events (MAE) was 6.3% at 6 months and 10.2% at 2 years. Of the 3 event types included in the definition of MAE, only target lesion revascularization occurred; no distal embolization or device- or procedure-related deaths were recorded. The percent of patients with Fontaine stage IIb symptoms or worse improved from 84.1% before the procedure to 16.8% at 2 years (p