Results Show Mo.Ma Is Safe and Effective for High-Surgical-Risk Patients Undergoing CAS

October 22, 2009—Investigators for the ARMOUR (Proximal Protection with the Mo.Ma Device During Carotid Stenting) trial report that using the Mo.Ma Ultra proximal protection device (Invatec, Inc., Bethlehem, PA) for carotid artery stenting (CAS) in high-surgical-risk patients with US Food and Drug Administration (FDA)–approved carotid stents is safe and effective. L. Nelson Hopkins, MD, coprincipal investigator of the study, presented the ARMOUR trial's results at the Vascular Interventional Advances meeting in Las Vegas, Nevada.

The ARMOUR study is a prospective, multicenter, single-arm, investigational device exemption trial to evaluate the safety and effectiveness of the Mo.Ma Ultra device for cerebral protection in high-surgical-risk CAS candidates with any FDA-approved carotid stent. The trial's primary endpoints were major adverse cardiac and cerebrovascular events (MACCE)—defined as myocardial infarction [MI], stroke, and death—at 30 days. The study enrolled 257 patients (220 intention to treat [ITT] and 37 roll-in) in 25 sites (20 in the United States, five in Europe).

Of the ITT patients enrolled, 56.1% were older than 75 years; 14.5% had coronary artery disease in two or more vessels; 7.7% had carotid endarterectomy restenosis; 5% had hostile neck anatomy; 4.5% had severe pulmonary disease; 4.1% had Canadian Cardiovascular Society class III or IV angina or unstable angina; 3.2% had a high cervical lesion; 2.7% had class III to IV congestive heart failure; 2.7% had cervical immobility; and 0.5% had an MI less than 6 weeks before.

The results show a 30-day MACCE rate of 2.7% for ITT patients and 2.3% overall. There were no MIs, and a 0.9% death rate for ITT patients and 0.8% overall. The stroke rate for ITT patients was 2.3% (1.4% minor, 0.9% major) and 1.9% overall (1.2% minor, 0.8% major). The MACCE rates, procedural and at discharge, were 1.5% for ITT patients and overall, respectively. In the ITT patients, 16.4% had site-reported serious adverse events, including access site complications (3.1%), hypotension (2.7%), anemia (1.8%), and renal failure (1.3%). There were no unanticipated adverse device effects.

The Mo.Ma device success rate was 98.2%; the technical success rate was 94.6%, and the procedural success rate was 93.2%. At 30 days, the restenosis rate was 1.6%, and the target lesion revascularization rate was 0%. Dr. Hopkins concluded that proximal embolic protection might be beneficial to symptomatic patients undergoing CAS.