The PERFORMANCE II Trial: A Prospective Multicenter Investigation of a Novel Carotid Stent System

Background: Several randomized clinical trials have shown that the composite endpoint of death, stroke, and myocardial infarction (MI) is equivalent between carotid artery stenting and carotid endarterectomy. However, the risk of minor stroke has been consistently higher with carotid artery stenting. Objectives: The authors sought to evaluate the safety and effectiveness of a novel carotid stent system comprised of a stent, an adjustable integrated embolic filter and a postdilation balloon, in patients at elevated risk for adverse events from carotid endarterectomy. Methods: PERFORMANCE II (Protection against Emboli during caRotid artery stenting using a 3-in-1 delivery system comprised oF a pOst-dilation balloon, integRated eMbolic filter, and A Novel Carotid stEnt II) was a prospective, multicenter, single-arm study. The primary endpoint was the composite of major adverse events defined as death, all stroke, and MI within 30 days of the procedure, plus ipsilateral stroke through 12 months. Results: A total of 305 patients were enrolled at 32 centers in the United States and Europe. The mean age was 69.6 ± 7.5 years; 65.9% were male, and 20% were symptomatic. The mean lesion length was 19.1 ± 6.7 mm, and 34.5% of lesions were severely calcified. At 30 days, there were 4 minor strokes (1.3%), with no major strokes. There was 1 cardiac death on day 30, resulting in a stroke/death rate of 1.6% and a stroke/death/MI rate of 2.3%. The 12-month primary endpoint occurred in 2.8%; there were no major strokes, clinically driven target lesion revascularizations, stent thromboses, or neurological deaths. The 30-day all stroke plus ipsilateral stroke through 12 months rate was 1.8%. Conclusions: The rate of major adverse events was extremely low, demonstrating the study system is a safe, effective, and durable treatment option for high-risk patients.