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Nicolas W Shammas, Gail Shammas, Lori Christensen, Sue Jones-Miller On behalf of the JET-RANGER InvestigatorsMidwest Cardiovascular Research Foundation, Davenport, IA, USACorrespondence: Nicolas W Shammas, Research Director, Midwest Cardiovascular Research Foundation, 630 E 4th Street, Suite A, Davenport, IA, 52801, USA, Email shammas@mchsi.comBackground: The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report.Methods: There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05.Results: Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window.Conclusion: JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms.Clinical Trial Registration: NCT03206762.Keywords: Jetstream, atherectomy, femoropopliteal, vessel prepping, drug coated balloons, Ranger, In.PACT, randomized trial, dissections, bailout stenting

Nicolas W Shammas,1 Bhaskar Purushottam,2 W John Shammas,1 Lori Christensen,1 Gail Shammas,1 Desyree Weakley,1 Sue Jones-Miller1 On behalf of the JET-RANGER Investigators1Midwest Cardiovascular Research Foundation, Davenport, IA, USA; 2Regional Health CR, Cardiovascular Medicine, Monument Health, Rapid City, SD, USACorrespondence: Nicolas W Shammas, Research Director, Midwest Cardiovascular Research Foundation, 630 East 4th Street, Suite A, Davenport, IA, USA, Email shammas@mchsi.comBackground: 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, atherectomy, femoropopliteal, vessel prepping, drug-coated balloons, Ranger, In.PACT, randomized trial, dissections, bailout stenting

The Venovo venous stent (BD/Bard Peripheral Vascular) is indicated to treat iliofemoral veno-occlusive disease. We present our own experience with the Venovo venous stent in treating iliac vein compression (ILVC).In this retrospective cohort, we included consecutive patients treated with the Venovo venous stent for ILVC at our center. Stent deployment and sizing were guided by intravascular ultrasound (IVUS). Minimal luminal areas at the compression before and after treatment were measured by IVUS. Clinical improvement was determined by symptoms reported by patients and the Clinical Etiologic Anatomic and Pathophysiologic (CEAP) score. The primary safety endpoint was freedom from acute venothromboembolic disease, stent migration, perforation, acute/subacute closure, and vascular complications. The primary safety endpoint was target-lesion revascularization at 1 year.A total of 50 consecutive patients (57 Venovo stents, 36 women, mean age, 59.8 ± 16.3 years) were included. IVUS-measured mean percent stenosis at the compression site was 64.8% ± 12.8%. Mean total stent length and diameter were 78.0 ± 54.0 mm and 17.1 ± 1.9 mm, respectively. The primary safety endpoint was met in all subjects. Procedural technical success was 100% (successful deployment with no complications). At 1 year, 83.8% of patients reported improvement in their symptoms. Freedom from total occlusion at 1 year was 100% (data available for n = 30 patients). Target-lesion revascularization (TLR) was 2% at 1 year due to 1 patient who had stent explantation from worsening ipsilateral left leg and back pain.In this single-center experience, the Venovo venous stent was safe and effective in treating ILVC with 98% freedom from TLR at a follow-up of 1 year. Improvement in symptoms was reported in the majority of patients.

In-stent restenosis (ISR) of the femoropopliteal artery remains a prevalent and challenging problem to treat. Debulking of ISR lesions with Excimer laser has shown superior results compared with balloon angioplasty. In this study we evaluate the safety and 6-month freedom from target lesion

Left main trifurcation coronary artery disease stenting is a challenging and complex percutaneous procedure that has been infrequently reported. We present our own experience with left main trifurcation stenting using the Taxus paclitaxel-eluting stent (Boston Scientific).Twenty consecutive left main trifurcation stenting procedures were performed in 2005 at our institution. The primary endpoint of the study was the combined endpoints of death, acute stent thrombosis and target lesion revascularization (TLR). Conditional logistic regression analysis was performed to determine the predictors of the primary endpoint using a number of variable combinations.The mean patient age was 71.7 +/- 8.9 years. The procedure was urgent in 10%, and the left main artery was unprotected in 95% of cases. Follow up was achieved in 17/20 (85%) patients, either from medical records or by phone calls. The follow-up median duration was 272 days (range 30 to 534 days). The primary endpoint was met in 5/17 (29.4%) patients. One of 19 patients (5.3%) had a sudden cardiac death 1 month after the procedure, 2/20 patients (10%) experienced an acute in-hospital stent thrombosis, and 2/17 (11.8%) patients underwent TLR. Conditional logistic regression analysis could not identify a relationship between the stenting method and the primary endpoint. The 2 patients who experienced in-hospital thrombosis were the only patients who received a clopidogrel load (600 mg) post-procedure after arrival to the floor, and were not on a glycoprotein IIb/IIIa inhibitor. All others received their clopidogrel either during the procedure (n = 7) or were on it chronically (n = 11). One patient with acute stent thrombosis did not have a kissing balloon performed post-stent deployment.Left main trifurcation stenting carries an overall high rate of adverse events and may need to be reserved for patients who are at high risk or who refuse bypass surgery. Overall TLR is low, but stent thrombosis remains a concern. Although we suspect that thrombosis could be related to failure to perform kissing balloon post-stent deployment and/or not receiving a clopidogrel load until after the procedure, the small number of patients in this study prevents us from making definite statistical conclusions about this observation.