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

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.

Keywords:

• Jetstream
• atherectomy
• femoropopliteal
• vessel prepping
• drug coated balloons
• Ranger, In.PACT
• randomized trial
• dissections
• bailout stenting

Data Sharing Statement

The authors do not intend to share individual deidentified data unless requested for a specific pre-specified analysis or for auditing purposes by regulatory bodies. Aggregate data will be released on clinicaltrials.gov and part of an indexed publication and will be accessible to public.

Acknowledgments

JET-RANGER one-year follow up was published in Vasc Health Risk Manag. 2022 Aug 2;18:603-615.

The following JET-RANGER investigators have contributed to the study by recruiting patients into this clinical trial or participated in the CEC committee or core laboratory:

Investigators

Lawrence Garcia, MD. Steward Saint Elizabeth, Boston MA

Nicholas Petruzzi, MD, Atlantic Medical, New Jersey

Mathew Wooster, MD, Medical University South Carolina, South Carolina

Jack Chamberlin, MD, Alexian Brothers Hospital, Illinois

William B. Eaves, MD, Endovascular Technologies, Louisianna

Richard Kovach, MD, Deborah Heart and Lung, Brown Mills, New Jersey

Mohammad Mehdi Ansari, MD, Texas Tech University Health Science, TX

Esteban Henao, MD, New Mexico Heart Institute, New Mexico

Faisal Latif, MD, VA Oklahoma, OK

April Nedeau, MD, Central Maine Medical Center, Maine

CEC Committee

Jon Robken, MD, Interventional Cardiology

Param Singh, MD, Interventional Cardiology

Vijay Ranjendran, MD, Interventional Cardiology

Disclosure

Dr Nicolas Shammas receives educational and research grants from Boston Scientific, Angiodynamics, VentureMed group, Phillips, Bard/BD and is on the speaker Bureau of Janssen, Merck, Lilly, Amgen, Esperion, Kiniksa, Boehringer Ingelheim. The other authors report no conflicts of interest in this work.

Additional information

Funding

The study was supported by an unrestricted grant from Boston Scientific.