SCAI Calls for Expanded Coverage for Carotid Artery Stenting

May 26, 2010—The Society for Cardiovascular Angiography and Interventions (SCAI) stated that the results from the CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) study published by Thomas G. Brott, MD, et al online ahead of print in the New England Journal of Medicine should convince the Centers for Medicaid & Medicare Services (CMS) to reopen its coverage decision to give carotid artery stenosis patients an opportunity to choose carotid artery stenting (CAS) and allow physicians to tailor treatments for the best possible outcome. The evidence now strongly supports individualizing treatment and offering stent coverage so that more patients who may benefit from this safe, effective, and less-invasive treatment can have access to it, SCAI stated.

“The CREST data demonstrate the safety and efficacy of CAS, reinforcing that this option should be available to more patients,” commented SCAI President-elect Christopher White, MD. “We encourage CMS to reopen its coverage decision on carotid stenting so more patients may benefit from a less-invasive option. Physicians should have the option to individualize treatment, given this data, to meet the varying needs of our patients."

SCAI noted that the CREST study is the largest and most rigorous randomized stroke prevention trial ever undertaken, and its findings are the strongest evidence to date for clinical equality and long-term durability (out to 4 years) of both CAS and carotid endarterectomy (CEA).

SCAI stated that an especially noteworthy finding was that there were no significant differences between CEA and CAS in the incidence of major or disabling stroke. Whereas the incidence of minor strokes was higher for CAS, these were, by definition, largely resolved shortly after the procedure. Patients treated with CEA, on the other hand, were twice as likely to suffer a myocardial infarction. This finding has significant implications for patients. According to SCAI, perioperative myocardial infarction after vascular surgery, including CEA, has been linked to a four times higher risk of death during follow-up in a study by Giori Landesberg, MD, et al published in the Journal of the American College of Cardiology (2003;42:1547–1554). In contrast, the symptoms caused by minor strokes, as defined in the study, were those that resolved within 30 days.

Furthermore, SCAI stated that improvement in training techniques for both surgeons and interventionists contributed to better outcomes for patients in both arms of the CREST trial compared with previous European trials, which allowed inexperienced operators to be tutored during stent placement. In CREST, both the surgeons and the interventionists underwent screening to ensure adequate training and experience before they were permitted to enroll patients.

Finally, SCAI remarked that the age of the patient made a difference. For patients aged 69 years and younger, CAS results were superior to surgical results; the younger the patient, the larger the stenting benefit. Conversely, for patients older than 70, CEA results were slightly better than CAS.

SCAI President Larry S. Dean, MD, commented, “The CREST data suggest that a larger group of patients, especially younger patients, are good candidates for carotid stenting. As stroke is a major cause of death in the United States, trials such as CREST add to our body of knowledge on how to best treat patients to address their individual needs so they may lead full and productive lives."

“CREST represents a landmark trial. The most important finding is that both strategies produce excellent results in patients at risk for stroke and carry similarly low procedural risk,” added Kenneth Rosenfield, MD. “These results indicate that patients who need their carotid artery opened will now have two options, stenting or surgery; the decision between these two must be individualized based on the patient's preference, age, medical condition, and anatomic suitability for CAS and CEA.”