One-Year Outcomes in CASES-PMS Support CAS With Embolic Protection

June 29, 2010—Theodore L. Schreiber, MD, et al have published 1-year outcomes from the CASES-PMS (Carotid Artery Stenting With Emboli Protection Surveillance-Postmarketing Study) trial in the Journal of the American College of Cardiology (2010;56:49–57). CASES-PMS is a multicenter, prospective, single-arm, surveillance study of the Precise nitinol stent and Angioguard XP emboli capture guidewire (Cordis Corporation, Bridgewater, NJ). The study was designed to assess the safety and efficacy of carotid artery stenting (CAS) when performed by physicians with varied CAS experience utilizing a formal training program. The current investigation sought to determine if the excellent results achieved at 30 days would be sustained to 1 year.

As background for the study, the CASE-PMS investigators noted that before this, the pivotal (Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy) trial of the Precise and Angioguard XP devices demonstrated that CAS was not inferior to carotid endarterectomy when performed by physicians experienced in CAS.

In CASES-PMS, high-surgical-risk patients with de novo atherosclerotic or postendarterectomy restenotic lesions in native carotid arteries were enrolled at participating centers. Inclusion and exclusion criteria matched those of the SAPPHIRE trial. The primary endpoint was a composite of 30-day major adverse events including death, any stroke, or myocardial infarction.

A total of 1,492 patients were enrolled at 73 sites. The primary endpoint of 30-day major adverse events was 5%, meeting criteria for noninferiority to the prespecified objective performance criteria established by the SAPPHIRE trial.

The investigators reported that the 1-year cumulative percentage of MAE was 12.5% by Kaplan-Meier analysis. The rate of all strokes to 30 days plus ipsilateral stroke between 31 and 360 days with CASES-PMS (5.4%) was similar to the rate seen with the SAPPHIRE trial stent cohort (4.9%). There were no significant differences in outcomes at 1 year by symptom status and high-risk status.

The CASES-PMS investigators concluded that with the formalized training program used in this study, physicians with varied CAS experience can achieve similar short- and longer-term results to the highly experienced SAPPHIRE investigators.