Boston Scientific has announced the three-year results from the MAJESTIC trial for the Eluvia paclitaxel-eluting vascular stent system at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), in Copenhagen, Denmark.
Data demonstrated that in this study, long-term treatment durability was experienced among patients whose femoropopliteal arteries were treated with the Eluvia stent system.
The prospective, single-arm, multicentre clinical trial enrolled 57 patients with symptomatic lower limb ischaemia 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. (Updated primary patency data point of 83.5% at two years reflects adjudicated data as a result of additional patient follow-up at three years, the company states). Previously reported primary patency for MAJESTIC at two years was 78.2%. 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.”
IMPERIAL trial
In addition to the MAJESTIC trial, Boston Scientific recently completed enrolment 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.
The Eluvia Stent System received CE mark in February of 2016 and is an investigational device and not available for sale in the USA.
