Clinical Impact of Intravascular Ultrasound-Guided Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Lesions.

BACKGROUND

Treatment with a fluoropolymer-based drug-eluting stent (FP-DES has been widely applied to the contemporary femoropopliteal practice with durable outcomes. Nevertheless, the impact of intravascular ultrasound (IVUS) utilization on clinical outcomes after FP-DES implantation has not been determined.

OBJECTIVES

This study aimed to investigate the impact of IVUS on 1-year clinical outcomes after FP-DES) implantation for femoropopliteal lesions in patients with symptomatic peripheral artery disease.

METHODS

As a subanalysis of the CAPSICUM (contemporary outcomes after paclitaxel-eluting peripheral stent implantation for symptomatic lower limb ischemia with superficial femoral or proximal popliteal lesion) study, the present investigation analyzed 1,091 patients with symptomatic peripheral artery disease who underwent endovascular therapy with FP-DES for femoropopliteal lesions. One-year clinical outcomes were compared between patients treated with IVUS and those treated without IVUS after propensity score matching. The primary outcome measure was 1-year restenosis. The incidence of aneurysmal degeneration was also assessed.

RESULTS

A total of 843 (77.2%) patients underwent IVUS-guided FP-DES implantation. After propensity score matching, the 1-year restenosis was not significantly different between the groups (11.5% [95% CI: 9.1%-14.0%] vs 15.5% [95% CI: 10.9%-20.1%]; P = 0.22). The frequency of aneurysmal degeneration at 1 year was significantly higher in the IVUS group than in the non-IVUS group (19.8% [95% CI: 16.3%-23.4%] vs 7.1% [95% CI: 3.3%-11.0%]; P < 0.001). IVUS use was associated with a lower restenosis risk in patients with chronic total occlusion but not in those without (P for interaction = 0.044).

CONCLUSIONS

The present study revealed that 1-year restenosis risk was not significantly different between the 2 groups, whereas the incidence of aneurysmal degeneration was significantly higher in the IVUS group.

Informations de copyright

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures The CAPSICUM study was supported by the Research Association for Lower Limb Artery Revascularization (LIBERAL) and sponsored by the following companies (in alphabetical order): Boston Scientific Japan K.K., OrbusNeich Foundation, Terumo Corp., and Kaneka Medix Corporation. The funding companies played no role in the design of the study, selection of the enrolled patients, treatment strategy, revascularization procedures or equipment, or in the collection, analysis, and interpretation of the data. Drs Iida and Soga have received consulting honoraria from Boston Scientific. Drs Yamaoka, Fujihara, Kawasaki, Ichihashi, and Kozuki have received remuneration from Boston Scientific Japan K.K. Dr Sakata received honoraria from Otsuka Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Medtronic Japan, and Boehringer Ingelheim Japan; a research grant from Edwards Lifesciences, FUJIFILM RI Pharma, REGiMMUNE, and Roche Diagnostics; and a scholarship (educational) grant/endowed chair from Otsuka Pharmaceutical, Johnson & Johnson, St. Jude Medical Japan, Daiichi Sankyo, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Teijin Pharma Limited, Boehringer Ingelheim Japan, Bayer Yakuhin, BIOTRONIK Japan, Boston Scientific, and Medtronic Japan. Dr Mano has received a research grant from Abbott Vascular Japan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.