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Internal Medicine World Report
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From the International Symposium on Endovascular Therapy
MIAMI BEACH?The future of carotid?artery disease treatment for stroke prevention was the subject of a debate over the safety and efficacy of stenting compared with endarterectomy at the recent Inter?na?tional Symposium on Endo?vascular Therapy. Two experts presented the pros and cons for each modality.
Jay S. Yadav, MD, director of vascular intervention at the Cleveland Clinic Foundation Heart Center in Ohio, spoke in support of stenting, while Bruce A. Perler, MD, MBA, director of the vascular noninvasive laboratory at Johns Hopkins Medical Institute, Baltimore, advocated for carotid endarterectomy.
"Carotid endarterectomy has evolved over the past 50 years and is considered the gold standard of treatment for most patients with carotid artery disease...but with the availability now of minimally in?vasive subcutaneou scarotid stenting, the primacy of endarterectomy has been challenged. The fundamental question is whether there are sufficient data...to accept this as an equivalent or better treatment than endart?erectomy," Dr Perler told IMWR.
Dr Yadav countered that this question has already been answered by recent results from the Carotid Acculink/ Accunet Post Approval Trial to Uncover Rare Events (CAPTURE) and previous studies. "The finding was that you could train highly specialized physicians even in small hospitals on how to perform carotid stenting and get excellent results."?
The Acculink carotid system (Guidant) includes a micromesh filter basket on the end of a delivery catheter to catch any particles that may break off from the blockage during stent placement. Its ap?proval was based on the Acculink for Re?vas?cu?larization of Carotids in High-Risk Patients (ARCHeR) trial, which involved patients at high-risk for surgical procedures. Results from ARCHeR show?ed that the combined risk of death, stroke, and heart attack at 30 days after carotid stent?ing or surgery was <10% in the stenting group versus 15% in the surgery group.
Another ongoing study is the prospective, randomized Carotid Revascu?lar?ization En?dar?terectomy versus Stenting Trial (CREST), sponsored by the Na?tional Institute of Neurological Disorders and Stroke, which is looking at the efficacy of carotid stenting in lower-risk patients with symptomatic stenosis of <50% versus carotid endar?terectomy in preventing stroke, myocardial infarction (MI), and death in the month immediately after the procedure. Early CREST results suggest that the periprocedural risk of stroke and death after carotid stenting increases with age.
The Stenting and Angioplasty with Pro?tection in Patients at High Risk for En?darterectomy (SAPPHIRE) study demonstrated an advantage for stenting over en?dar?ter?ectomy, but overall the results were not significantly different. ?
Early results from CAPTURE, which was begun in October 2004, indicate that the rate of death, stroke, and MI within 30 days after carotid stenting was 5.1%, or nearly 40% lower than the 8.3% rate seen in ARCHeR. But CAPTURE data also showed a stroke and death rate of 5.7% with stenting, including a 1.6% rate of periprocedural death. ?
These data come from 1603 patients who were treated at 118 community US hospitals. The patients were examined by independent neurologists before the study began, as well as at 24 hours and 30 days after the procedure. The number of patients in any given community hospital was limited to 40, and only one third of the patient population was enrolled.
Dr Yadav considers CAPTURE?the largest and most rigorous real-world trial of carotid stenting?a landmark study. "It demonstrates for the first time that with proper training, carotid stenting can be performed with exemplary results by a variety of physicians in community hospital settings," he said. "The excellent results and the overall ease of use of the system make this a breakthrough treatment for stroke prevention in high-risk patients."
Dr Perler disagrees. "Other studies also show that the oldest patients, the ones you might think could benefit the most from carotid intervention, do very poorly with carotid stenting."
Dr Yadav maintains that Dr Perler is in the minority. "I don't think there is much debate. Most people are becoming convinced, as the evidence keeps mounting?.Stenting is a less invasive procedure than endarterectomy, and it is associated with lower morbidity and mortality. When we compare stenting with endarterectomy head-to-head, stenting has always been either better or at least comparable."