Limburgs Vaatcentrum Ziekenhuis Oost-Limburg, Genk, Belgium.
J Endovasc Ther. 2010 Oct;17(5):633-41. doi: 10.1583/09-2917MR.1.
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.
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.
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).
The Express LD Vascular stent is safe, effective, and non-inferior to the Palmaz stent for treatment of iliac artery stenosis.
报告 MELODIE 试验的 2 年结果，该试验评估了球囊扩张型 Express LD 血管支架治疗动脉粥样硬化性髂动脉疾病的安全性和有效性。
这是一项前瞻性、多中心、单臂试验，共纳入 151 例（113 例男性；平均年龄 60.1±8.4 岁）的 163 例新发或再狭窄髂动脉病变患者。主要终点为 6 个月时的血管造影平均管腔直径丢失百分比，与基于 Palmaz 支架发表结果的客观性能标准（OPC）进行比较。随访包括出院时、术后 30 天、术后 6、12 和 24 个月的踝肱指数（ABI）测量和症状评估（Fontaine 分级）。术后 6 个月行血管造影，术后 1 年和 2 年行 CT 血管造影（CTA）。
6 个月时平均管腔直径丢失百分比的主要终点为 16.2%（上限 95%置信区间为 19.1%），与 20%的 OPC 相比不劣效（p=0.006）。6 个月时的主要通畅率为 92.1%，2 年时为 87.8%。6 个月时的主要不良事件（MAE）发生率为 6.3%，2 年时为 10.2%。在 MAE 定义中包含的 3 种事件类型中，只有靶病变血运重建发生；无远端栓塞或器械相关或手术相关死亡发生。术前有 Fontaine Ⅱb 期或更差症状的患者比例从 84.1%改善至 2 年后的 16.8%（p<0.0001）。ABI 与基线相比，2 年后仍显著改善（0.85 比 0.63，p<0.0001）。
Express LD 血管支架治疗髂动脉狭窄安全、有效，且不劣于 Palmaz 支架。
