The three-year results from the MAJESTIC trial for Boston Scientific’s Eluvia paclitaxel-eluting vascular stent system at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE; 16-20 September, Copenhagen, Denmark). The data demonstrated that in this study, long-term treatment durability was experienced among patients whose femoropopliteal arteries were treated with the Eluvia system.
The prospective, single-arm, multicentre clinical trial enrolled 57 patients with symptomatic lower limb iscahemia and lesions in the superficial femoral artery or proximal popliteal artery. Primary patency through two years was 83.5% with 91% of patients experiencing no or mild symptoms associated with claudication, or pain while walking. Results at three years demonstrated a sustained benefit of this therapy, with 85.3% of patients experiencing freedom from target lesion revascularisation (TLR).
“Over the course of the MAJESTIC trial, the majority of the patients, including those with relatively challenging lesions, have remained largely symptom-free,” said Stefan Müller-Hülsbeck, principal investigator at the Vascular Center Diako Flensburg and head of the Department of Diagnostic and Interventional Radiology/Neuroradiology, Academic Hospitals Flensburg, Germany. “The sustained drug release enabled by the polymer-based stent can be credited with reduced reinterventions over a three-year period, as well as establishing a long-term safety profile in the femoropopliteal arteries.”
In addition to the MAJESTIC trial, Boston Scientific recently completed enrollment of 485 patients in the randomised, head-to-head IMPERIAL trial, which will assess the safety and efficacy of the Eluvia stent system compared to the Zilver PTX stent (Cook Medical). Initial results, expected to become available in 2018, will be used to support regulatory submissions in the USA and Japan.
“It is reassuring to see the demonstrated long-term durability of the Eluvia stent system and we look forward to continuing to expand the clinical knowledge within the peripheral application of drug-eluting technologies,” said Jeff Mirviss, president, Peripheral Interventions, Boston Scientific. “We are fully committed to advancing therapies that can benefit patients suffering from lower limb ischaemia, a group that is often times lacking successful treatment options that help avoid the possibility of experiencing amputations.”
The Eluvia stent system received CE mark in February of 2016 and is an investigational device and not available for sale in the USA.