Combination of Rotarex Thrombectomy and Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-Stent Restenosis.

Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8703941 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1615-5947 (Electronic) Linking ISSN: 08905096 NLM ISO Abbreviation: Ann Vasc Surg Subsets: MEDLINE

Publication: <2007->: Netherlands : Elsevier
Original Publication: Detroit : [Published by Expansion scientifique française for Annals of Vascular Surgery, Inc. and Association pour la promotion de la chirurgie vasculaire, Paris, c1986-

Coated Materials, Biocompatible* ; Femoral Artery*/diagnostic imaging ; Femoral Artery*/physiopathology ; Popliteal Artery*/diagnostic imaging ; Popliteal Artery*/physiopathology ; Stents* ; Vascular Access Devices*; Angioplasty/*instrumentation ; Angioplasty, Balloon/*instrumentation ; Peripheral Arterial Disease/*therapy ; Thrombectomy/*methods; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Angioplasty/adverse effects ; Angioplasty, Balloon/adverse effects ; Combined Modality Therapy ; Exercise Tolerance ; Female ; Humans ; Male ; Middle Aged ; Peripheral Arterial Disease/diagnostic imaging ; Peripheral Arterial Disease/physiopathology ; Prospective Studies ; Recovery of Function ; Recurrence ; Registries ; Retreatment ; Risk Factors ; Thrombectomy/adverse effects ; Time Factors ; Vascular Patency ; Walking ; Young Adult

Background: The optimal treatment method for femoropopliteal (FP) artery in-stent restenosis (ISR) remains controversial. We assess the efficacy and safety of combination of Rotarex thrombectomy and drug-coated balloon (DCB) for the treatment of FP ISR.
Methods: From June 2016 to July 2017, 32 patients with FP ISR who underwent combination of Rotarex thrombectomy and DCB angioplasty were included in a prospective registry. The primary end point was primary patency of the target lesion defined as a peak systolic velocity ratio <2.4 documented by duplex ultrasound at 12 months without clinically driven target lesion revascularization (CD-TLR). The secondary outcome measure was the rate of major adverse limb events. The primary functional end point was assessed using the Walking Impairment Questionnaire (WIQ).
Results: Twenty-nine (90.6%) patients completed 12-month follow-up. Mean ankle-brachial index was 0.45 ± 0.14 at baseline and 0.84 ± 0.12 at 12 months (P < 0.05). The WIQ score was 30.45 ± 21.14 at baseline and 52.68 ± 29.75 at 12 months (P < 0.05). The Kaplan-Meier estimate of the primary patency rate at 12 months was 86.2% (25/29), and freedom from CD-TLR rate at 12 months was 89.7% (26/29).
Conclusions: The data suggest that combination of Rotarex thrombectomy and DCB for treatment of FP ISR is safe and effective with satisfying primary patency rate and freedom from CD-TLR rate at 12-month follow-up.
(Copyright © 2019 Elsevier Inc. All rights reserved.)

0 (Coated Materials, Biocompatible)

Date Created: 20190511 Date Completed: 20191223 Latest Revision: 20191223

20221213

10.1016/j.avsg.2019.02.018

31075447