Abstract
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±4.3 cm for JET + PCB and 11.2±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; Ranger, In.PACT; atherectomy; bailout stenting; dissections; drug-coated balloons; femoropopliteal; randomized trial; vessel prepping.
【저자키워드】 randomized trial, Jetstream, Ranger, In.PACT, atherectomy, bailout stenting, dissections, drug-coated balloons, femoropopliteal, vessel prepping., 【초록키워드】 COVID-19, Treatment, Mortality, outcome, Randomized, Patient, death, Follow-up, multicenter, exploratory, disease, patients, association, Analysis, Enrollment, two groups, lesions, primary end point, Boston, variable, TLR, vessel, Randomly, evaluated, was performed, provide, were used, assigned, reduction in, claudication, distal, intention to treat, JET, Medtronic, 【제목키워드】 Prospective, followed by, balloon, angioplasty, Result,