At the 56th Annual American College of Cardiology Scientific Session, New Orleans, LA, Dr William A Gray, Columbia University Medical Center, NY, presented 30-day results from two studies that confirmed that carotid stenting can be performed with positive results by physicians with a variety of background experience in real-world (non-clinical trial) settings in patients who are not favourable candidates for surgery.
According to Gray, the interim results from the first 1,500 patients enrolled in Emboshield and Xact Post Approval Carotid Stent Trial (EXACT) and from the first 600 patients enrolled in Carotid Acculink/Accunet Post Approval Trial to Uncover Rare Events (CAPTURE) 2, "Reaffirm that carotid stenting is a safe, effective minimally-invasive treatment option for patients with carotid artery disease who may be at risk of experiencing adverse events from surgery. The results also suggest that patient outcomes are improving over time as the practice of carotid stenting increases."
The primary endpoint of death, stroke and heart attack at 30 days was 4.6% in EXACT and 5.2% in CAPTURE 2 and the trials also showed a low rate of 30-day major stroke and/or death in patients treated (1.8% in EXACT, 1.3% in CAPTURE 2). The EXACT post-approval study utilises Abbott's Xact Rapid Exchange Carotid Stent System and Emboshield BareWire Rapid Exchange Embolic Protection System. CAPTURE 2 utilises the company's Acculink Carotid Stent System and Accunet Embolic Protection System.
"The results of our most recent post market studies are very encouraging, and suggest continued progress in improving carotid stenting outcomes," said Chuck Foltz, vice president, Abbott Vascular. "We are proud of our leadership in carotid stenting trials, with more than 10,000 patients enrolled in Abbott trials in the United States. These studies demonstrate that carotid stenting is making a difference in the lives of patients."
As previously reported by Interventional News, in February 2007 the CMS proposed expanding carotid stenting coverage, whereby certain high-risk surgical Medicare patients who have a severe carotid blockage and have not yet experienced stroke or a transient ischaemic attack would, for the first time, have access to carotid artery stenting.
Abbott's next-generation Emboshield PRO Embolic Protection System, currently available in Europe, is under safety and effectiveness evaluation in PROTECT, a new US clinical trial which recently began enrolling patients. The study will include 320 high surgical risk patients at 50 US clinical sites. Patients will be evaluated at 30 days following stent placement to gather safety and efficacy data to support a 510(k) application to the FDA for Emboshield PRO.
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