Outcomes of drug-coated balloon angioplasty in patients with dyslipidemia in the BIOLUX P-III registry: A subgroup analysis.

IF 1 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE
Vascular Pub Date : 2024-08-19 DOI:10.1177/17085381241275795
James Evan Dodd, Joseph Hanna, Marianne Brodmann, Jonathan Golledge, Thomas Zeller, Matej Moscovic, Johannes Dahm, Nicola Troisi, Gunnar Tepe, Jacqueline Wong, Natalie C Ward, Bibombe Patrice Mwipatayi
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引用次数: 0

Abstract

Objectives: The aim of this study was to assess the mid-term outcomes of the use of drug-coated balloons (DCBs) to treat infrainguinal peripheral arterial disease (PAD) in patients with dyslipidemia.

Methods: BIOLUX P-III is a prospective, international, multicenter, all-comers registry-based study that was conducted at 44 sites with follow-ups at 6, 12 and 24 months. The present study is a subgroup analysis comparing the outcomes associated with endovascular revascularization with those associated with Passeo-18 lux DCBs in patients with and without dyslipidemia. The proportions of patients free from major adverse events (defined as device- or procedure-related mortality within 30 days, clinically driven target lesion revascularization (CD-TLR) and major target limb amputation), target vessel revascularization, and patient-reported outcomes within 24 months postintervention were compared between the two groups.

Results: A total of 876 patients with symptomatic PAD who underwent peripheral revascularization with DCBs and had information on their dyslipidemia status were included; 588 of those patients had dyslipidemia. There was no difference in the proportion of patients free from MAEs between the groups. The percentages of patients who were 6, 12 and 24 months free from CD-TLR were significantly lower in the dyslipidemia group than in the nondyslipidemia group (86.3% vs 91.9% at 2 years, p = .0183). Similarly, the percentage of patients free from target vessel revascularization was lower in the dyslipidemia group at all timepoints (83.3% vs 89.3% at 2 years, p = .0203). There was no difference in mortality or major or minor limb amputation rates. Other secondary outcomes were similar between the groups.

Conclusions: Compared to those without dyslipidemia, patients with symptomatic PAD and dyslipidemia who underwent revascularization with a Passeo-18 lux DCB had greater rates of CD-TLR and TVR. However, having dyslipidemia did not increase the risk of mortality or limb amputation.

Clinical trial registration: NCT02276313.

BIOLUX P-III 登记中血脂异常患者接受药物涂层球囊血管成形术的疗效:亚组分析。
研究目的本研究旨在评估使用药物涂层球囊(DCB)治疗血脂异常患者腹股沟下外周动脉疾病(PAD)的中期疗效:BIOLUX P-III 是一项以登记为基础的前瞻性国际多中心研究,在 44 个地点进行,随访时间为 6、12 和 24 个月。本研究是一项亚组分析,比较了血脂异常和无血脂异常患者进行血管内再通术与使用Passeo-18勒克斯DCB的相关结果。研究比较了两组患者在干预后24个月内无重大不良事件(定义为30天内与设备或手术相关的死亡率、临床驱动的靶病变血运重建(CD-TLR)和主要靶肢截肢)、靶血管血运重建和患者报告结果的比例:共纳入了876名接受DCB外周血管重建术的无症状PAD患者,其中588名患者患有血脂异常。两组患者无 MAEs 的比例没有差异。血脂异常组患者在 6、12 和 24 个月内无 CD-TLR 的比例明显低于非血脂异常组(2 年时分别为 86.3% 和 91.9%,P = 0.0183)。同样,在所有时间点上,血脂异常组患者未发生靶血管再通的比例均低于非血脂异常组(2 年时分别为 83.3% 和 89.3%,P = 0.0203)。死亡率、主要或次要肢体截肢率没有差异。两组患者的其他次要结果相似:结论:与没有血脂异常的患者相比,有症状的PAD和血脂异常患者接受Passeo-18勒克斯DCB血管再通术后,CD-TLR和TVR的发生率更高。然而,血脂异常并不会增加死亡率或肢体截肢的风险:临床试验注册:NCT02276313。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Vascular
Vascular 医学-外周血管病
CiteScore
2.30
自引率
9.10%
发文量
196
审稿时长
6-12 weeks
期刊介绍: Vascular provides readers with new and unusual up-to-date articles and case reports focusing on vascular and endovascular topics. It is a highly international forum for the discussion and debate of all aspects of this distinct surgical specialty. It also features opinion pieces, literature reviews and controversial issues presented from various points of view.
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