This article is more than 5 years old. Information may no longer be current.
MAJESTIC: Peripheral DES system deemed safe, effective at 3 years
Click Here to Manage Email Alerts
Patients treated with a paclitaxel-eluting vascular stent system had a positive safety profile and low rates of reintervention, according to the 3-year results of the MAJESTIC study, presented at the Annual Congress of Cardiovascular and Interventional Radiological Society of Europe.
“Currently, evaluation of drug-eluting stent technology in real-world scenarios beyond well-defined study inclusion and exclusion criteria for the treatment of long femoropopliteal lesions is ongoing. Providing these data will help to understand better DES technology for the application in daily practice,” Stefan Müller-Hülsbeck, MD, PhD, from the department of diagnostic and interventional radiology and neurology at Ev.-Luth. Diakonissenanstalt zu Flensburg, Germany, told Cardiology Today’s Intervention. “The use of self-expanding DES in below-the-knee arteries for critical limb ischemia treatment will be of certain interest and might be a field of future research.”
In the prospective, multicenter, single-arm, open-label study, Müller-Hülsbeck and colleagues evaluated the safety and efficacy of the DES (Eluvia, Boston Scientific) in 57 patients with femoropopliteal artery lesions who had chronic lower limb ischemia and de novo or restenotic lesions ( 70% stenosis) in the native superficial femoral or proximal popliteal artery.
At 24 months, researchers found a primary patency rate of 83.5% with 91% of patients experiencing symptomatic and hemodynamic improvement.
At 36 months, researchers observed:
a freedom from target lesion revascularization rate of 85.3%;
no target limb major amputations;
two deaths at 1 year after the procedure (unrelated to study device or procedure); and
no stent fractures.
“The low TLR rate observed in the MAJESTIC trial through 3 years supports the long-term durability of treatment with the Eluvia paclitaxel-eluting stent in the femoropopliteal segment,” Müller-Hülsbeck said in an interview. “In addition to demonstrating good outcomes for patients who receive this treatment, the lack of need for repeat procedures may help to lessen concern about implanting a stent as a first-line treatment.” – by Dave Quaile
Reference:
Müller-Hülsbeck S, et al. Free Paper Session: FP 2306. Presented at: Annual Congress of Cardiovascular and Interventional Radiological Society of Europe; Sept. 16-20, 2017; Copenhagen, Denmark.
Disclosure: Müller-Hülsbeck reports he is a consultant for Boston Scientific and Terumo.