The Mo.Ma proximal cerebral protection device, used in combination with FDA-approved carotid stents in high-surgical risk subjects, resulted in excellent safety and effectiveness outcomes compared with a performance goal derived from previous carotid stenting trials, based on the ARMOUR trial, presented May 6 at the 33rd annual Society for Cardiovascular Angiography and Interventions (SCAI) conference in San Diego.
|Slideshow | ARMOUR|
|Robert M. Bersin, MD, MPH, FACC, FSCAI
Medical Director, Endovascular Services
Seattle Cardiology and Swedish Medical Center
The ARMOUR trial is a pivotal, prospective, multi-center, non-randomized trial to evaluate the safety and effectiveness of cerebral protection with the Mo.Ma device in high-surgical risk subjects undergoing carotid artery stenting (CAS).
Robert M. Bersin, MD, medical director of endovascular services for Seattle Cardiology and Swedish Medical Center, both in Seattle, and colleagues said that a total of 262 subjects (225 ITT, 37 roll-in) were enrolled at 25 investigational sites in the U.S. (20) and the European Union (five) between September 2007 and February 2009.
For the ITT population, mean age was 74.7 years and 66.7 percent were male, the researchers reported. Symptomatic subjects comprised 15.1 percent of the population and 28.9 percent of the subjects were octogenarians.
The procedure was successful without major adverse cardiovascular or cerebrovascular events (MACCE), such as MI, stroke or death in 93 percent of patients. Within 30 days of stenting, the combined MACCE rate was 2.7 percent, far lower than the 13 percent that was predicted on the basis of experience with filter protection devices. The major stroke rate was less than 1 percent.
In addition, patients who were experiencing stroke-like symptoms at the time of the procedure had no higher MACCE rate than the overall group, whereas a doubling of the MACCE rate is typical in symptomatic patients treated with filter protection devices, Bersin said. Finally, among patients older than 75 years, the MACCE rate was just 2.3 percent.
The ARMOUR study showed that when the Mo.Ma protection device was placed upstream of a blockage in the carotid arteries, the one-month risk of MI, stroke or death was approximately 75 percent lower than would be typical with a downstream filter.
“The MO.MA device protects the brain before we ever touch the lesion,” said Bersin. “The idea that carotid stenting is not safe in the elderly no longer applies…This device is a game-changer.”
The device success for the Mo.Ma device was 98.2 percent, according to the researchers. Technical success was 94.6 percent and procedural success was 93.2 percent. The access site complication rate was 3.1 percent.
The ARMOUR study was funded by Invatec (recently acquired by Medtronic), but Bersin reported no conflicts of interest.