MAJESTIC Data Shows Long-Term Freedom From Revascularization With Boston Scientific's Eluvia Stent System
September 18, 2017—Boston Scientific Corporation announced that the 3-year results from the MAJESTIC trial for the company's Eluvia paclitaxel-eluting vascular stent system were presented at CIRSE 2017, the annual congress of the Cardiovascular and Interventional Radiological Society of Europe held September 16–20 in Copenhagen, Denmark. The data demonstrated the long-term treatment durability of the Eluvia device for the treatment of femoropopliteal arteries.
According to the company, the prospective, single-arm, multicenter clinical trial enrolled 57 patients with symptomatic lower limb ischemia and lesions in the superficial femoral artery or proximal popliteal artery. Primary patency through 2 years was 83.5% (reflecting adjudicated data as a result of additional patient follow-up at 3 years; previously reported primary patency for MAJESTIC at 2 years was 78.2%), with 91% of patients experiencing no or mild symptoms associated with claudication or pain while walking.
At 3 years, the findings demonstrated a sustained benefit of this therapy, with 85.3% of patients experiencing freedom from target lesion revascularization.
In Boston Scientific's announcement, MAJESTIC Principal Investigator Professor Stefan Müller-Hülsbeck, MD, commented, “Over the course of the MAJESTIC trial, the majority of the patients, including those with relatively challenging lesions, have remained largely symptom-free. The sustained drug release enabled by the polymer-based stent can be credited with reduced reinterventions over a 3-year period, as well as establishing a long-term safety profile in the femoropopliteal arteries.”
Boston Scientific also noted the completion of enrollment of 485 patients in the randomized, head-to-head IMPERIAL trial, which will assess the safety and efficacy of the Eluvia stent system compared with the Zilver PTX stent (Cook Medical). Initial results are expected to become available in 2018 and will be used to support regulatory submissions in the United States and Japan.
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.