MAJESTIC 3-Year Data Published for Boston Scientific's Eluvia DES
October 11, 2017—The 3-year results of the MAJESTIC first-in-human study of the Eluvia paclitaxel-eluting vascular stent system (Boston Scientific) for treating femoropopliteal artery lesions were published by Stefan Müller-Hülsbeck, MD, et al online in CardioVascular and Interventional Radiology. The data were recently presented at CIRSE 2017, the annual congress of the Cardiovascular and Interventional Radiological Society of Europe held September 16–20 in Copenhagen, Denmark.
As summarized in CardioVascular and Interventional Radiology, the prospective, single-arm, multicenter clinical trial enrolled 57 patients with symptomatic lower limb ischemia (Rutherford category 2, 3, or 4) and lesions in the superficial femoral artery or proximal popliteal artery. The mean lesion length was 70.8 ± 28.1 mm, and 46% of lesions were occlusions.
Efficacy measures at 2 years included primary patency, defined as duplex ultrasound peak systolic velocity ratio of ≤ 2.5 and the absence of target lesion revascularization (TLR) or bypass. Safety monitoring through 3 years included adverse events and TLR.
The primary patency rate was estimated as 83.5% (Kaplan-Meier analysis) at 24 months, and 90.6% (48/53) of patients maintained an improvement in Rutherford class. At 36 months, the Kaplan-Meier estimate of freedom from TLR was 85.3%. No stent fractures were identified, and no major target limb amputations occurred.
The MAJESTIC results demonstrated long-term treatment durability among patients whose femoropopliteal arteries were treated with the paclitaxel-eluting Eluvia stent, concluded the investigators in CardioVascular and Interventional Radiology.
The Eluvia stent system received European CE Mark approval in February 2016. In the United States, Eluvia is an investigational device and is not available for sale, advised the company.