Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study.

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.

[Hybrid revascularization in a patient with Covid-19 and chronic limb ischemia stage IV]. / Gibridnaya revaskulyarizatsiya u patsienta s COVID-19, khronicheskoi ishemiei nizhnei konechnosti IV stepeni.

The authors report hybrid treatment of a patient with angina pectoris class II, multiple previous reconstructive interventions on the aortofemoral segment and chronic ischemia of the left lower limb stage IV and concomitant COVID-19. Coronary angiography was performed after regression of infectious disease under antiviral therapy. Occlusion of the left anterior descending artery was observed that required LAD stenting. On the next day, hybrid revascularization of the lower extremities was implemented: thrombectomy and endarterectomy from the branch of the aorto-femoral bypass graft and deep femoral artery at the first stage, stenting of the orifice of proximal branch of aorto-femoral bypass graft at the second stage, endarterectomy from superficial femoral artery, recanalization and stenting of superficial femoral artery and popliteal artery at the third stage and prosthetic- femoral bypass with autologous vein at the fourth stage. Postoperative angiography revealed patent stents and no residual stenoses. The choice in favor of these procedures and step-by-step approach has been substantiated. The authors emphasized effectiveness and safety of this treatment strategy.