Low-Dose vs High-Dose Paclitaxel-Coated Balloons for Femoropopliteal Lesions,JACC: Cardiovascular Interventions

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Low-Dose vs High-Dose Paclitaxel-Coated Balloons for Femoropopliteal Lesions
JACC: Cardiovascular Interventions ( IF 11.7 ) Pub Date : 2022-09-28 , DOI: 10.1016/j.jcin.2022.08.004
Sabine Steiner ₁ , Andrej Schmidt ₂ , Thomas Zeller ₃ , Gunnar Tepe ₄ , Marcus Thieme ₅ , Lars Maiwald ₆ , Henrik Schröder ₇ , Wulf Euringer ₈ , Corneliu Popescu ₉ , Klaus Brechtel ₁₀ , Steffen Brucks ₁₁ , Erwin Blessing ₁₂ , Johannes Schuster ₁₃ , Ralf Langhoff ₁₄ , Sebastian Schellong ₁₅ , Norbert Weiss ₁₆ , Ulrich Beschorner ₁₇ , Tim Wittig ₂ , Dierk Scheinert ₂

Affiliation

Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany; Helmholtz Institute for Metabolic, Obesity and Vascular Research of Helmholtz Zentrum München at the University of Leipzig and University Hospital Leipzig, Leipzig, Germany.
Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany.
Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Department of Radiology, RoMed Clinic Rosenheim, Rosenheim, Germany.
Department of Angiology, Regiomed Gefäßzentrum Sonneberg, Sonneberg, Germany.
Department of Angiology, Kreiskrankenhaus Torgau, Torgau, Germany.
Gemeinschaftspraxis für Radiologie am Jüdischen Krankenhaus Berlin, Berlin, Germany.
Department of Radiology, Herz- und Gefäßzentrum, Bad Bevensen, Bad Bevensen, Germany.
Department of Angiology, Diakoniekrankenhaus Halle, Halle, Germany.
Gemeinschaftspraxis für Radiologie am Franziskus Krankenhaus Berlin, Berlin, Germany.
Angiologikum Hamburg, Hamburg, Germany.
Department of Angiology, SRH Klinikum Karlsbad Langensteinbach, Karlsbad, Germany.
Kreiskrankenhaus Delitzsch, Kliniken Delitzsch und Eilenburg, Delitzsch, Germany.
Department of Angiology, Center for Internal Medicine I, Campus Clinic Brandenburg, Brandenburg Medical School Theodor Fontane, Brandenburg an der Havel, Germany.
Department of Angiology, Medical Clinic 2, Municipal Hospital of Dresden, Dresden, Germany.
Division of Angiology, Department of Internal Medicine III, University Hospital, Dresden, Germany.
coreLab Black Forest, Bad Krozingen, Germany.

Background

So far only 1-year data have been reported for direct comparisons of paclitaxel-coated balloons (PCBs) using different coating technologies.

Objectives

The aim of this study was to report the 24-month results on the efficacy and safety of low-dose vs high-dose PCBs with nominal paclitaxel densities of 2.0 and 3.5 μg/mm² and different coating technologies for femoropopliteal interventions from the COMPARE (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease) trial. Procedural characteristics of clinically driven (CD) target lesion revascularization (TLR) were analyzed.

Methods

Within a prospective, multicenter, clinical trial, 414 patients with symptomatic femoropopliteal lesions (Rutherford categories 2-4, maximum lesion length 30 cm) were randomly assigned in a 1:1 ratio to endovascular treatment with either a low-dose (Ranger) or a high-dose (IN.PACT) PCB after stratification for lesion length. Two-year follow-up included assessment of primary patency (defined as absence of CD TLR or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, and functional and clinical outcomes.

Results

At 2 years, the Kaplan-Meier estimates of primary patency were 70.6% and 71.4% for the low-dose and high-dose PCBs (log-rank P = 0.96), respectively. One major amputation occurred in the high-dose group, and rates of all-cause mortality (3.6% vs 2.2%; P = 0.55) and CD TLR (17.3% vs 13.0%; P = 0.31) were similar between the groups. Among a total of 57 CD TLRs, 44.6% were performed for reocclusion and 28.1% for in-stent restenosis. Functional and clinical benefits over baseline were sustained in both groups.

Conclusions

The 2-year results of the COMPARE trial demonstrate a sustained treatment benefit of both low-dose and high-dose PCBs for femoropopliteal interventions including a wide range of lesion lengths. (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease; NCT02701543)

中文翻译：

低剂量与高剂量紫杉醇涂层球囊治疗股腘病变

背景

到目前为止，仅报告了 1 年的数据来直接比较使用不同涂层技术的紫杉醇涂层球囊 (PCB)。

目标

本研究的目的是报告低剂量与高剂量 PCB 的有效性和安全性的 24 个月结果，标称紫杉醇密度为 2.0 和 3.5 μg/mm ²以及来自 COMPARE 的股腘动脉干预的不同涂层技术（比较 I 试验研究治疗有症状的股腘动脉疾病的受试者）试验。分析了临床驱动 (CD) 靶病变血运重建 (TLR) 的程序特征。

方法

在一项前瞻性、多中心、临床试验中，414 名有症状的股腘病变患者（卢瑟福分类 2-4，最大病变长度 30 厘米）以 1:1 的比例随机分配到血管内治疗组，接受低剂量（Ranger）或病灶长度分层后的高剂量 (IN.PACT) PCB。两年的随访包括评估主要通畅性（定义为无 CD TLR 或二元再狭窄，通过双重超声检查峰值收缩速度比 > 2.4）、安全性以及功能和临床结果。

结果

2 年时，Kaplan-Meier 估计低剂量和高剂量 PCB 的初级通畅率分别为 70.6% 和 71.4%（对数秩P = 0.96）。高剂量组发生了一次大截肢，全因死亡率（3.6% 对 2.2%；P = 0.55）和 CD TLR（17.3% 对 13.0%；P = 0.31）在各组之间相似。在总共 57 个 CD TLR 中，44.6% 进行了再闭塞，28.1% 进行了支架内再狭窄。两组的功能和临床益处均超过基线。