The PERFORMANCE II Trial: A Prospective Multicenter Single Arm Investigation of the Neuroguard IEP® 3-in-1 Carotid Stent System with Integrated Embolic Protection. Stent Durability and Patency at 2 years
Presenter
D. Chris Metzger, M.D., FSCAI, OhioHealth Heart & Vascular Physicians, Dublin, OH
Elizabeth Saylors, Contego Medical, Inc., Raleigh, NC and D. Chris Metzger, M.D., FSCAI, OhioHealth Heart & Vascular Physicians, Dublin, OH
Keywords: Carotid/TCAR, Embolic Protection, Imaging & Physiology and Peripheral Artery Disease (PAD)
Background
The PERFORMANCE II Study is a prospective, multicenter, single-arm, open-label study to evaluate the safety and effectiveness of the Neuroguard IEP® 3-in-1 Carotid Stent System with Integrated Embolic Protection for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA).
Methods
305 patients were enrolled at 32 sites in the United States and Europe. The primary endpoint was the 30-day rate of MAE, defined as death, all stroke and myocardial infarction (MI) within 30 days of the index procedure, plus ipsilateral stroke through 12 months of the procedure. Events were adjudicated by an independent clinical events committee.
Results
20% of patients were symptomatic, and 43.5% were diabetic. 230 (75%) patients presented physiologic high-risk criteria, 75 (25%) patients had anatomic high-risk criteria, and 85 (28%) had both. The mean target lesion stenosis was 85%, and 35% were severely calcified. In an intention-to-treat analysis (ITT), the 30-day stroke rate was 1.3% (4), the death/stroke rate was 1.6% (5), and the death/stroke/MI rate was 2.3% (7). The rate of 30-day all stroke plus ipsilateral stroke through 1 year was 1.8% (5), all of which were minor. There were no major strokes, stent thromboses, or neurological deaths through 2 years. Independent analysis of angiographic and duplex ultrasound imaging was performed by imaging analysis by the Yale Cardiovascular Research Group Angiographic Core Laboratory. The rate of in-stent restenosis (ISR) at 1 year was 3.65%, and 3.85% at 2 years. There was no clinically driven TLR (CD-TLR) at 1 year, and 1 (0.36%) at 2 years.
Conclusions
These 2-year results of the PERFORMANCE II study demonstrate the remarkable procedural safety and long-term durability of the Neuroguard stent in high-surgical-risk patients. Despite a 43.5% rate of diabetes and 34.5% rate of severe calcification, the 3.85% rate of ISR and 0.36% rate of CD TLR at 2 years were very low.