Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study

• Published in: Vascular health and risk management Vol. 18; pp. 603 - 615
• Main Authors: Shammas, Nicolas W, Purushottam, Bhaskar, Shammas, W. John, Christensen, Lori, Shammas, Gail, Weakley, Desyree, Jones-Miller, Sue
• Format: Journal Article
• Language: English
• Published: Macclesfield Dove Medical Press Limited 31.08.2022; Taylor & Francis Ltd; Dove; Dove Medical Press
• Subjects: Amputation; Analysis; Angioplasty; atherectomy; bailout stenting; Bailouts; Catheters; COVID-19; dissections; drug coated balloons; Embolization; Endarterectomy; Enrollments; femoropopliteal; Health aspects; in.pact; jetstream; Laboratories; Massachusetts; Medical equipment and supplies industry; Medical test kit industry; Mortality; Original Research; Paclitaxel; Patients; randomized trial; ranger; Stents; target lesion revascularization; Thrombosis; Transluminal angioplasty; Ultrasonic imaging; United States; Veins & arteries; vessel prepping; United States; Massachusetts
• ISSN: 1178-2048; 1176-6344; 1178-2048
• DOI: 10.2147/VHRM.S371177

Background: It is unknown at this time whether Jetstream atherectomy (JET) and paclitaxel-coated balloon (PCB) provides a superior outcome to balloon angioplasty (PTA) followed by PCB in treating femoropopliteal (FP) arterial disease. Methods: The JET-RANGER study was a multicenter (eleven US centers) randomized trial, core lab-adjudicated, designed to demonstrate the superiority of JET + PCB versus PTA + PCB in treating FP arterial disease. The study intended to enroll 255 patients, but was stopped early because of poor enrollment due to COVID-19 and concerns about the association of paclitaxel with mortality. The data are thus considered exploratory. A total of 47 patients (48 lesions) with claudication (80.9%) or rest pain/ulcerations (19.2%) were randomly assigned 2:1 to JET + PCB (n=31) or PTA + PCB (n=16). The In.PACT (Medtronic) and Ranger (Boston Scientific) PCBs were used. Freedom from target-lesion revascularization (TLR) was evaluated at 1 year. Analysis was performed on intention to treat. Results: Mean lesion length was 10.8[+ or -]4.3 cm for JET + PCB and 11.2[+ or -]7.6 cm for PTA + PCB (P=0.858). There were no other differences in demographic or angiographic variables between the two groups. Procedural success was superior with JET + PCB (87.1%) vs PTA + PCB alone (52.9%; P=0.0147). Overall bailout stenting rate was 17% (0 JET + DCB versus 50% PCB, P<0.0001). There was no distal embolization requiring treatment. There was no amputation or death in either group. Using KM analysis, the primary end point of freedom from TLR (bailout stent considered a TLR) at 1 year was 100% and 43.8% (P<0.0001) for JET + PCB versus PTA + PCB, respectively. When bailout stent was not considered a TLR, freedom from TLR was 100% and 93.7%, respectively (P=0.327). Conclusion: A high rate of freedom from TLR was seen in the JET + PCB arm and the PTA + DCB arm at 1-year follow-up, with a significant reduction in bailout stenting following vessel prepping with the Jetstream. Keywords: Jetstream, atherectomy, femoropopliteal, vessel prepping, drug-coated balloons, Ranger, In.PACT, randomized trial, dissections, bailout stenting