On the back of these results, Stephan Müller-Hülsbeck announced the commencement of an international multicentre randomised controlled trial that will compare the Eluvia drug-eluting vascular stent system (Boston Scientific) with Zilver PTX, the drug-eluting stent system from Cook Medical. The principal investigators will be Müller-Hülsbeck (Flensburg, Germany) and William Gray (New York, USA).
As presented at CIRSE 2015, the MAJESTIC results through 12 months showed that patients treated with the Eluvia drug-eluting stent sustained a high primary patency rate of 96.1 %, a low major adverse events rate of 3.8% and 0 stent fractures.
Stephan Müller-Hülsbeck, Department of Diagnostic and Interventional Radiology / Neuroradiology, Flensburg, Germany
MAJESTIC set out to evaluate the performance of the Eluvia drug-eluting vascular stent system for treating femoropopliteal artery lesions. The study is a prospective, single-arm, multicentre clinical trial. Eligible patients had chronic lower limb ischemia and de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery. The primary efficacy endpoint was core laboratory-adjudicated 9-month primary patency (i.e., duplex ultrasound peak systolic velocity ratio of ≤2.5 and the absence of target lesion revascularisation [TLR] or bypass).
Major adverse events (MAEs) included all-cause death through one month, target limb major amputation through nine months, and TLR through nine months. Follow-up continues at one, two, and three years.
The mean age (±SD) of the patients (N=57) was 69±3 years, and 83% were males; 35% had diabetes. Baseline Rutherford category was 2 for 35%, 3 for 61%, and 4 for 4% of patients. Mean lesion length was 70.8±28.1mm, and 65% had severe calcification. Per cent diameter stenosis was 86.3%±16.2%, and 46% had total occlusions.
At nine months, primary patency was 94.4% (90% CI, 86.3% and 98.5%). The major adverse events rate was 3.6% (2/55).