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

Nicolas W Shammas; Gail Shammas; Lori Christensen; Sue Jones-Miller; JET-RANGER Investigators

doi:10.2147/VHRM.S403177

Back

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

Journal article

Open access

Peer reviewed

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

Nicolas W Shammas, Gail Shammas, Lori Christensen, Sue Jones-Miller and JET-RANGER Investigators

Vascular health and risk management, Vol.19, pp.133-137

01/01/2023

DOI: 10.2147/VHRM.S403177

PMCID: PMC10015974

PMID: 36936551

Files and links (1)

url

https://doi.org/10.2147/VHRM.S403177View

Published (Version of record) Open Access

Abstract

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. 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. 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. 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. NCT03206762.

Angioplasty, Balloon - adverse effects

Atherectomy

Carcinoma, Renal Cell

Femoral Artery - diagnostic imaging

Femoral Artery - surgery

Humans

Kidney Neoplasms

Neoplasm Recurrence, Local

Paclitaxel - adverse effects

Peripheral Arterial Disease - diagnostic imaging

Peripheral Arterial Disease - therapy

Popliteal Artery

Prospective Studies

Time Factors

Treatment Outcome

Vascular Patency

Details

Title: Subtitle: Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study
Creators: Nicolas W Shammas - Midwest Cardiovascular Research Foundation
Gail Shammas - Midwest Cardiovascular Research Foundation
Lori Christensen - Midwest Cardiovascular Research Foundation
Sue Jones-Miller - Midwest Cardiovascular Research Foundation
JET-RANGER Investigators
Resource Type: Journal article
Publication Details: Vascular health and risk management, Vol.19, pp.133-137
DOI: 10.2147/VHRM.S403177
PMID: 36936551
PMCID: PMC10015974
ISSN: 1176-6344
eISSN: 1178-2048
Language: English
Date published: 01/01/2023
Academic Unit: Internal Medicine
Record Identifier: 9984691530302771

Metrics

4 Record Views

5 Times Cited - Web of Science

See more details