MAJESTIC Trial Evaluates Long-Term Treatment Durability for Eluvia Stent

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Submitted on Fri, 12/01/2017 - 12:10
eluvia stent

Long-term results from the MAJESTIC trial show treatment durability through 3 years for treatment of femoropopliteal lesions.

Previous results showed that the Eluvia Drug-Eluting Vascular Stent System (Boston Scientific) had a high patency rate at 1 year, as well as a low reintervention rate and good clinical improvement. The system combines paclitaxel with a biocompatible fluoropolymer coating on a stent scaffold, with the goal of releasing the drug over a period of time.

The MAJESTIC trial was a prospective, multicenter trial with a single arm. Included in the study were 57 patients with symptomatic lower limb ischemia (Rutherford category 2, 3, or 4) and lesions in the superficial femoral artery or proximal popliteal artery. Forty-six percent of the lesions were occluded, and patients had a mean lesion length of 70.8 ± 28.1 mm.

At 2 years posttreatment, primary patency was measured. Primary patency was defined as duplex ultrasound peak systolic velocity ratio of ≤2.5, as well as a lack of target lesion revascularization or need to undergo bypass. Safety was monitored through the third year.

After 2 years, there was an estimated primary patency rate of 83.5%, with 48 of 53 (90.6%) of patients maintaining an improved Rutherford class. A 3-year Kaplan Meier estimate of freedom from target lesion revascularization was 85.3%. During the monitoring period, there were no stent fractures or major target limb amputations.

The authors noted that the MAJESTIC study was limited by small sample size and single arm design, as well as lesion length that was comparable to other trials but not to longer lesions seen in clinical practice. The ongoing IMPERIAL trial should overcome these limitations, they said.

Reference

Müller-Hülsbeck S, Keirse K, Zeller T, Schroë H, Diaz-Cartelle J. Long-term results from the MAJESTIC trial of the eluvia paclitaxel-eluting stent for femoropopliteal treatment: 3-year follow-up. Cardiovasc Intervent Radiol. 2017;40(12):1832-1838.