Washington, D.C.—The Mo.Ma Ultra proximal cerebral protection device (Invatec/Medtronic) used in combination with FDA approved carotid stents in high surgical risk subjects resulted in excellent safety and effectiveness outcomes, according to the ARMOUR trial presented at the annual conference of Cardiovascular Research Technologies (CRT), Feb. 21-23.
This poster presentation was chosen as the top abstract at this year’s CRT.
ARMOUR, led by Gary M. Ansel, MD, from the MidWest Cardiology Research Foundation in Columbus, Ohio, is a pivotal, prospective, multicenter, non-randomized trial to evaluate the safety and effectiveness of cerebral protection device in high-surgical risk subjects undergoing carotid artery stenting.
All study participants underwent percutaneous revascularization of the carotid artery using the Mo.Ma device and a stent approved by the FDA for carotid artery stenting. The researchers followed up at pre-discharge and at 30 days post-procedure.
Ansel and colleagues enrolled 262 subjects (225 ITT, 37 roll-in) at 25 investigational sites (20 in the U.S. and five in the European Union) between September 2007 and February 2009. For the ITT population, mean age was 74.7 years and 66.7 percent were male. Symptomatic subjects comprised 15.1 percent of the population and 28.9 percent of the subjects were octogenarians.
The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) within 30 days of stent implantation. The researchers defined MACCE as any MI, stroke or death through 30 days post-procedure as adjudicated by the Clinical Events panel. They compared results to a performance goal of 13 percent for the 30-day MACCE composite rate, which was derived from previous carotid stenting trials. Secondary endpoints included device, technical and procedural success.
Ansel and colleagues reported that the 30-day MACCE rate was 2.7 percent, “well beneath the performance goal of 13 percent.” The major stroke rate through 30 days was less than 1 percent. The device success for the Mo.Ma was 98.2 percent. Technical success was 94.6 percent and procedural success was 93.2 percent. The access site complication rate was 3.1 percent.
In their conclusion, the researchers noted that the outcomes in this trial were compared to a performance goal derived from previous carotid stenting trials.