At a press conference held at the recent Society of Interventional Radiology's (SIR) meeting in Seattle, WA, Dr Barry T Katzen, Baptist Cardiac and Vascular Institute, Miami, FL, presented preliminary one-year data from the multi-centre, single-arm Carotid Artery Stenting with Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS) trial, demonstrating that carotid stenting with embolic protection is safe and effective for patients at the highest risk for adverse events. The study also substantiates the low adverse event rates reported previously in the Stenting and Angioplasty with Protection in Patients at HIgh Risk for Endarterectomy (SAPPHIRE) trial.
"Patients with severely blocked carotid arteries are at high risk for stroke, but many patients with vascular disease are not good candidates for surgery. Now we know we can safely offer these high-risk patients carotid stenting, saving many people from future strokes," reported Katzen.
The CASES-PMS trial compared the outcomes of patients in the CASES-PMS trial to those of the SAPPHIRE trial stent cohort. High surgical-risk patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in native carotid arteries were enrolled. Stroke evaluation by a neurologist at 30 days and clinical follow-up to 12 months post-procedure were performed. Between September 2004 and October 2005, 1,493 patients were enrolled at 73 sites in the US. A total of 21.8% of patients were symptomatic and 78.2% were asymptomatic.
The trial, sponsored by Cordis (a Johnson & Johnson company), is designed to assess the outcomes of stenting with Cordis' Precise Nitinol Self-Expanding Stent, and AngioGuard XP Emboli Capture Guidewire System (Cordis). The 30-day results showed an major adverse event (MAE - death, stroke and heart attack) rate of 5.0% (74/1493) among patients treated with carotid stenting in CASES-PMS compared with 4.8% (8/167) of stent-treated patients in the randomised arm of the SAPPHIRE trial.
The CASES-PMS study is intended to validate the effectiveness of the training programme. Preliminary data indicate that physicians who completed the entire training programme demonstrated MAE and stroke rates that were comparable with those of the overall study. Overall, the rate of stroke at 30 days was 3.8% (56/1493) while the rate of stroke in patients treated by physicians who completed the entire training programme was 3.6% (3/223). According to the company, the outcomes show that the training programme is valuable and can contribute to patient safety in introducing a relatively new interventional procedure into the mainstream.
Kaplan-Meier estimates of the one-year cumulative MAE rate with CASES-PMS (11.9%) was similar to rates seen with the SAPPHIRE trial stent cohort (12.2%), and numerically lower than that seen in the surgical arm of SAPPHIRE (20.1%). Thirty-day stroke rate combined with ipsilateral stroke rate at one-year was 4.8% (7.0% in symptomatic patients and 4.2% in asymptomatic patients). Event rates were similar by academic vs. non-academic setting, operator volume, or physician training.
"We are excited to see a similar safety profile for physicians who were involved in the training programme at 73 different sites. This is an excellent model to introduce a new technique very safely into the mainstream, and will allow us to train more physicians, enabling more patients to have this important treatment to prevent stroke," concluded Katzen.
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