Peripheral DES demonstrates high patency rate at 12 months
An investigational drug-eluting peripheral vascular stent was safe and effective at 12 months, according to findings presented at the Cardiovascular and Interventional Radiological Society of Europe annual meeting.
Researchers conducted the prospective, single-arm MAJESTIC trial of the peripheral vascular paclitaxel-eluting stent (Eluvia, Boston Scientific) in 57 patients with femoropopliteal artery lesions. The mean age of patients was 69 years and 83% were men. Mean lesion length was 70.8 mm, 46% of lesions were classified as total occlusions and 65% were identified as severely calcified, according to a press release.
The primary outcome was core laboratory-adjudicated primary patency at 9 months, defined as duplex ultrasound peak systolic velocity ratio of 2.5 or less, no target lesion revascularization and no bypass. Safety endpoints of interest included TLR and target limb major amputation. Follow-up continued at 12, 24 and 36 months.
Primary patency was 94.4% at 9 months (90% CI, 86.3-98.5) and 96.1% at 12 months, researchers reported.
At 12 months, 3.8% of patients had TLR, none had stent fractures and none underwent amputation, according to the release.
“Achieving a 96% primary patency rate at 1 year, with low major adverse events, is exceptional,” presenter Stefan Müller-Hülsbeck, MD, PhD, chairman of the Vascular Center Diako Flensburg and head of the department of diagnostic and interventional radiology/neuroradiology, Academic Hospitals, Flensburg, Germany, said in the release. “In my opinion, the sustained release of paclitaxel enabled by this technology could represent a significant advancement in the treatment of patients with peripheral arterial disease.”
The stent system is not yet approved for use in the United States. Patient enrollment in the global, pivotal IMPERIAL study will soon begin, according to the release from Boston Scientific. – by Erik Swain
Müller-Hülsbeck S, et al. Abstract 1505.3. Presented at: Cardiovascular and Interventional Radiology Society of Europe annual meeting; Sept. 26-30, 2015; Lisbon, Portugal.
Disclosure: Müller-Hülsbeck reports receiving consultant fees/travel fees/honoraria from Boston Scientific, GE and Terumo.