Diabetic Subset Results From MAJESTIC Study Presented for Boston Scientific's Eluvia Drug-Eluting Vascular Stent System

November 2, 2015—Prof. Stefan Müller-Hülsbeck, MD, presented 12-month results including new data from a subset of diabetic patients from the MAJESTIC trial during the first Late-Breaking Trials session at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

The MAJESTIC trial is a prospective, single-arm clinical study designed to evaluate the performance of the Eluvia drug-eluting vascular stent system (Boston Scientific Corporation) for treating femoropopliteal artery lesions. The Eluvia stent is composed of Boston Scientific’s Innova self-expanding nitinol stent platform coated with an active layer that includes paclitaxel.

Eligible patients, who were enrolled at investigative sites in Europe, Australia, and New Zealand, had chronic lower limb ischemia and de novo or restenotic lesions ≤ 110 mm in length in the native superficial femoral artery and/or proximal popliteal artery. Primary patency was defined as duplex ultrasound peak systolic velocity ratio of ≤ 2.5 and the absence of target lesion revascularization (TLR) or bypass. Major adverse events (MAEs) included all-cause death through 1 month, target limb major amputation, and TLR. Of the 57 patients in the study, the average age was 69 years of age at baseline, and 35% had diabetes. Mean lesion length was 70.8 ± 28.1 mm, and 46% of the lesions were occluded. 

The investigators found that the 12-month primary patency rate was 96.1% (49/51), and the Kaplan-Meier estimate was 96.4%. Primary patency was 100% (14/14) among patients with diabetes. The MAE rate through 12 months was 3.8% (2/53) overall and 0% among patients with diabetes. Both MAEs were TLRs; no deaths through 1 month or amputations through 12 months were reported. No stent fractures were identified at 12 months upon analysis by the angiographic core lab.

MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent, including those with diabetes, sustained a high patency rate and low MAE rate through 12 months, concluded the investigators.