Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study

医学 临床终点 随机对照试验 糖尿病 严重肢体缺血 靶病变 不利影响 截肢 跛行 血运重建 腘动脉 外科 内科学 血管疾病 动脉疾病 心肌梗塞 经皮冠状动脉介入治疗 内分泌学
作者
Tanja Böhme,Tanja Zeller,Mehdi H. Shishehbor,Martin Werner,Marianne Brodmann,Helen Parise,Andrew Holden,Michael Lichtenberg,Sahil A. Parikh,Vikram S. Kashyap,Cody Pietras,Daniela Tı̂rziu,Ulrich Beschorner,Krishnan Ramanathan,Khusrow Niazi,Andreas Wali,Alexandra J. Lansky
出处
期刊:Journal of Endovascular Therapy [SAGE]
被引量:1
标识
DOI:10.1177/15266028231179589
摘要

The randomized Chocolate Touch Study demonstrated that in patients undergoing treatment of femoropopliteal artery lesions, the Chocolate Touch drug-coated balloon (DCB) was safe and had superior efficacy at 12 months compared with the Lutonix DCB. We report the prespecified diabetes subanalysis comparing outcomes among patients with and without diabetes mellitus (DM).Patients with claudication or ischemic rest pain (Rutherford class 2-4) were randomized to Chocolate Touch or Lutonix DCB. The primary efficacy endpoint was DCB success defined as primary patency at 12 months (peak systolic velocity ratio <2.4 by duplex ultrasound without clinically driven target lesion revascularization in the absence of bailout stenting). The primary safety endpoint was freedom from major adverse events at 12 months, a composite of target limb-related death, major amputation, or reintervention.A total of 313 patients (38% DM [n=119]) were randomized to either Chocolate Touch (n=66/152) or Lutonix DCB (n=53/161). Among patients with DM, DCB success was 77.2% and 60.5% (p=0.08), and in non-DM patients, DCB success was 80% and 71.3% (p=0.2114) for the Chocolate Touch and Lutonix DCB, respectively. The primary safety endpoint was similar for both cohorts regardless of DM status (interaction test, p=0.96).This randomized trial demonstrated similar safety and efficacy for the treatment of femoropopliteal disease with the Chocolate Touch DCB compared with using the Lutonix DCB regardless of DM status at 12 months.This substudy of the Chocolate Touch Study demonstrated similar safety and efficacy for treatment of femoropopliteal disease of the Chocolate Touch DCB compared with the Lutonix DCB regardless of diabetes (DM) status at 12 months. Endovascular therapy has become the therapy of choice for the treatment of most symptomatic femoropopliteal lesions regardless of DM status. These results give clinicians another option when treating femoropopliteal disease in this high-risk patient population.
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