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The JET Registry is a real-world, prospective, multi-center registry designed to assess patient outcomes following the use of JetStream atherectomy (JS) for the treatment of de-novo or restenotic lesions in the femoropopliteal (FP) artery.
The JET Registry completed enrollment of 241 subjects at 37 U.S. investigational sites. Patients were enrolled if they had de novo or restenotic (non-stent) lesions in the FP artery, ≥70% stenosis or occlusion confirmed by angiography, lesion length ≥ 4.0 cm, at least one patent runoff vessel, and a baseline Rutherford category of 1-3. The primary effectiveness endpoint was binary restenosis at 12 months as defined by duplex ultrasound (DUS) derived peak systolic velocity ratio >2.5. Secondary endpoints included procedural success (≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy), and major adverse events (MAE) through 30 days as defined by amputation, death, target lesion/vessel revascularization (TLR/TVR), or angiographic distal embolization (DE) that required a separate intervention. Adjunctive stenting was left to the operators’ choice.
A total of 241 subjects were enrolled (mean age 67.1 ± 9.8 years and 66% male). Diabetes was present in 41.1% of patients. Mean lesion length was 16.4 ± 13.6 mm, de novo lesions comprised 91.9%, and pretreatment percent stenosis was 91.1 ± 9.8%. Embolic protection and adjunctive stenting was used in 22.4% and 34.8% of cases, respectively. Mean procedure time was 73.4 ± 37.5 min. Post JS stenosis was 44.4 ± 20.0% and post adjunctive treatment 9.8 ± 11.4%. Site reported procedural success was 98.3%. At 30 days, the MAE rate was 2.3% (5/219), including 2 TLR/TVR and 3 DE. At 12 months (n=177); 80.1% and 81.7% were free from MAE and TLR/TVR, respectively, by Kaplan-Meier analysis, and 77.2% (44/57) were free of restenosis.
A high procedural success rate is seen with the JS device in treatment of FP obstructive lesions with a favorable low TLR/TVR and restenosis rates at 1 year. Although patency rate is in line with other atherectomy devices, the data is limited by the reduced rate of DUS follow up at 1 year.