ABSTRACT
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.
Subject(s)
Angioplasty, Balloon , COVID-19 , Peripheral Arterial Disease , Angioplasty, Balloon/adverse effects , Atherectomy , Coated Materials, Biocompatible , Humans , Paclitaxel/adverse effects , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Popliteal Artery/diagnostic imaging , Prospective Studies , Time Factors , Treatment Outcome , Vascular PatencyABSTRACT
The optimal management strategy of acute limb ischemia in non-ventilated patients with COVID-19 is uncertain. We propose that non-ventilated patients who develop COVID-19 related spontaneous arterial thrombosis with associated limb threat may be best suited with percutnaeous revascularization to achieve limb salvage. Herein we describe 5 cases of patients who had severely threatened limbs with complete thrombosis of all 3 tibial arteries who were treated with percutaneous revascularization. All 5 patients were felt to be facing inevitable amputation without revascularization should they survive their COVID hospitalization. We were able to achieve limb salvage in all 5 patients selected for therapy, although 2 ultimately succumbed to respiratory failure.