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<0.0001). The 2-year ABI remained significantly improved compared to baseline (0.85 versus 0.63, p<0.0001). CONCLUSION: The Express LD Vascular stent is safe, effective, and non-inferior to the Palmaz stent for treatment of iliac artery stenosis.
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<0.0001). The 2-year ABI remained significantly improved compared to baseline (0.85 versus 0.63, p<0.0001). CONCLUSION: The Express LD Vascular stent is safe, effective, and non-inferior to the Palmaz stent for treatment of iliac artery stenosis.
Authors: Woong Gil Choi; Seung Woon Rha; Cheol Ung Choi; Eung Ju Kim; Dong Joo Oh; Yoon Hyung Cho; Sang Ho Park; Seung Jin Lee; Ae Yong Hur; Young Guk Ko; Sang Min Park; Ki Chang Kim; Joo Han Kim; Min Woong Kim; Sang Min Kim; Jang Ho Bae; Jung Min Bong; Won Yu Kang; Jae Bin Seo; Woo Yong Jung; Jang Hyun Cho; Do Hoi Kim; Ji Hoon Ahn; Soo Hyun Kim; Ji Yong Jang Journal: Trials Date: 2016-06-25 Impact factor: 2.279