Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study

Overview

Journal Vasc Health Risk Manag

Publisher Dove Medical Press

Specialty Cardiology & Vascular Diseases

Date 2023 Mar 20

PMID 36936551

Authors

Nicolas W Shammas

Gail Shammas

Lori Christensen

Sue Jones-Miller

Affiliations

Soon will be listed here.

Abstract

Background: The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report.

Methods: There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05.

Results: Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window.

Conclusion: JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms.

Clinical Trial Registration: NCT03206762.

Citing Articles

Jetstream Atherectomy with Paclitaxel-Coated Balloons: 3-Year Outcomes of the Prospective Randomized JET-RANGER Study.

Shammas N, Shammas G, Jones-Miller S Int J Angiol. 2025; 34(1):56-59.

PMID: 39944148 PMC: 11813604. DOI: 10.1055/s-0044-1791546.

Clinical outcomes and risk factors associated with drug-coated balloon treatment for femoropopliteal artery disease in patients on maintenance hemodialysis.

Ito R, Ishii H, Oshima S, Nakayama T, Sakakibara T, Kakuno M Heart Vessels. 2024; 39(11):921-927.

PMID: 38780638 DOI: 10.1007/s00380-024-02416-3.

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