JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study
Autor: | Nicolas W. Shammas, Nicholas Petruzzi, Steven Henao, Ehrin J. Armstrong, Thomas Shimshak, Subhash Banerjee, Faisal Latif, Britton Eaves, Thomas Brothers, Jaafer Golzar, Gail A. Shammas, Susan Jones-Miller, Lori Christensen, W. John Shammas |
---|---|
Rok vydání: | 2020 |
Předmět: |
Male
medicine.medical_specialty Atherectomy medicine.medical_treatment Rotational atherectomy Coronary Restenosis Peripheral Arterial Disease Restenosis medicine.artery medicine Humans Popliteal Artery Radiology Nuclear Medicine and imaging Prospective Studies Vascular Patency Aged Retrospective Studies Aged 80 and over Jet (fluid) business.industry Superficial femoral artery Middle Aged medicine.disease Popliteal artery Femoral Artery Treatment Outcome Atherectomy device Female Surgery Radiology In stent restenosis Cardiology and Cardiovascular Medicine business Angioplasty Balloon |
Zdroj: | Journal of Endovascular Therapy. 28:107-116 |
ISSN: | 1545-1550 1526-6028 |
Popis: | Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). Materials and Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR ( ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). Results: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. Conclusion: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR. |
Databáze: | OpenAIRE |
Externí odkaz: |