CANOPY: Carotid artery stenting safe, effective in standard-risk patients in a real-world setting

A carotid artery stenting system was safe and effective at 1 year in a postapproval study of patients at standard risk for adverse events from carotid endarterectomy, according to findings presented at VIVA 14.

The multicenter, nonrandomized, single-arm CANOPY study of the carotid artery stenting system (RX Acculink, Abbott) was a real-world follow-up study after the completion of the CREST randomized trial. It is the only contemporary and adjudicated postmarket carotid artery stenting study in patients at standard risk for adverse events from carotid endarterectomy, D. Christopher Metzger, MD, from Wellmont CVA Heart Institute, Kingsport, Tenn., said at a press conference.

Metzger and colleagues enrolled 1,203 patients with symptomatic or asymptomatic obstructive carotid artery disease; those with features known to be high risk for carotid endarterectomy were excluded.

The primary endpoint was a composite of death and stroke at 30 days and ipsilateral stroke between 31 days and 1 year. This endpoint was compared with a performance goal based on results from the CREST pivotal trial and other carotid artery stenting data, Metzger said. The performance goal was set at 8.4%, based on a 1-year point estimate of 5.4% plus a 3% noninferiority margin, he said.

The 1-year event rate was 4.4% with an upper CI of 5.4%, which was favorable to the performance goal of 8.4% (P<.0001), according to results presented.

At 30 days, the rate of death and stroke was 3.4%, lower than the 4.4% in the CREST trial, Metzger said. The rate was 5.8% in symptomatic patients, 2.5% in asymptomatic patients, and was primarily driven by minor stroke, according to the researchers.

In a multivariant Cox regression analysis, independent predictors of death or stroke at 30 days included symptomatic carotid artery disease (HR=2.37; 95% CI, 1.27-4.41) and use of multiple stents (HR=3.29; 95% CI, 1.29-8.39). Age older than 80 years was not a predictor.

“CANOPY provides yet further support of carotid stenting as an alternative treatment in patients with obstructive carotid artery disease who are at standard risk of bad outcomes” from carotid endarterectomy, Metzger said.

For more information:

Metzger DC. Late-Breaking Clinical Trials. Presented at: VIVA 14; Nov. 4-7, 2014; Las Vegas.

Disclosure: Metzger reports receiving honoraria from Abbott Vascular and Medtronic for speaking and proctor courses.