Late Breaking: Clinical Safety and Efficacy of Rotational Atherectomy: Real-world Data on Jetstream

On Thursday morning, interventional cardiologist Dr Mohammad Ansari presented late-breaking information on the clinical safety and efficacy of rotational atherectomy. The Jet Ranger study looked at Jetstream atherectomy (Boston Scientific) + drug-coated balloon (DCB) vs angioplasty + DCB in the treatment of symptomatic femoropopliteal arterial disease. The primary objective of the study looked at effectiveness (target lesion revascularization [TLR] at 1 year) and safety (major adverse events [MAE] at 30 days: unplanned amputation, total mortality, or TLR at 30 days). 

Dr Ansari reviewed the study’s inclusion criteria. Patients in the study had a Rutherford Clinical Category of 2 to 4; evidence at the target lesion of 70% or more de novo stenosis of 10 cm length or more, or any chronic total occlusion in the SFA and/or popliteal artery, or grade 2 or higher calcification as defined by the peripheral arterial calcium scoring system; had evidence of at least 1 runoff vessel to the ankle/foot of the limb to be treated that did not have significant (<70%) stenosis during the index procedure; had a reference vessel diameter of 4 to -7 mm; and a true lumen crossing. Exclusion criteria included a GFR over 30 mL/min or creatinine of 2.5 or greater, including dialysis patients; cliotazol use; had a stroke within 3 months prior to index procedure; had a myocardial infarction within 1 month prior to index hospitalization use of other atherectomy devices; had in-stent restenosis of the target lesion; and P3 segments of the popliteal vessel. 

Dr Ansari noted that the original study was designed for superiority of Jetstream atherectomy + DCB vs  angioplasty + DCB with bailout stenting considered as TLR in the primary endpoint. There were 25 sites in the United States, but several sites dropped out. The institutional review board placed the study on hold at most of the site, and during COVID-19 the research was put on hold and the he Jet Ranger study had to be stopped for lack of continued grant support.

In conclusion, Dr Ansari indicated that Jetstream atherectomy + DCB appears to yield similar freedom from TLR when compared with atherectomy + DCB in FP de novo complex disease post index procedure with overall very low TLR in both groups at 1 year. Atherectomy + DCB results in a high bailout stenting rate, due mostly to a higher residual narrowing over 30%. Walking Impairment Questionnaire score and Rutherford category, as well as ankle-brachial index changes, were significant compared to baseline and were similar between the 2 groups and sustained at 1-year follow-up. There was no distal embolization, death, or amputation in both groups. Dr Ansari reminded everyone that the early termination of the study renders these results exploratory.