Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), published in The New England Journal of Medicine this week, found carotid artery stenting (CAS) is equally safe and as effective as carotid endarterectomy (CEA) for stroke prevention. The 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 four years) of both.
The overall safety and efficacy of the two procedures, based on the combined primary endpoint of stroke, heart attack and death, was largely the same, with equal benefits for both men and for women, and for patients who had previously had a stroke and for those who had not. There were also some notable differences. Investigators found:
- An especially noteworthy finding: CREST showed no significant differences between surgery and stents for the incidence of major or disabling stroke. The incidence of minor strokes (so-called mini-strokes) was higher for CAS; by definition, these were largely resolved shortly after the procedure. Patients treated with CEA, on the other hand, were twice as likely to suffer a heart attack (2.3 percent for surgery vs. 1.1 percent for stenting).
- This is an extremely important finding with significant implications for patients. Perioperative heart attacks after vascular surgery, including CEA, have been linked to a four times higher risk of dying during follow up (Landesberg G et al. J Amer Coll Cardiol 2003;42:1547-54). In contrast, the symptoms caused by minor strokes, as defined in the study, were those that resolved within 30 days.
- Improvement in training techniques for both vascular surgeons and interventional cardiologists contributed to the 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 interventionalists underwent screening to ensure adequate training and experience before they were permitted to enroll patients.
- The age of the patient made a difference - younger patients generally did better with stents, older patients generally did better with surgery. For patients 69 years and younger, stenting results were superior to surgical results; the younger the patient, the larger the stenting benefit. Conversely, for patients older than 70, surgical results were slightly better than stenting; the older the patient, the larger the surgery benefit.
The authors of the editorial accompanying the CREST study rightly conclude: "... given the lack of significant difference in the rate of long-term outcomes [for CAS and CEA], the individualization of treatment choices is appropriate." Currently, however, only high-risk patients who are not good candidates for surgery are able to receive a CAS procedure. SCAI believes the CREST data should convince the Centers for Medicare and Medicaid Services (CMS) to reopen its coverage decision to give patients an opportunity to choose their procedure and allow physicians to tailor treatments for the best possible outcome. The evidence now strongly supports "individualizing" treatment and offering stent coverage so more patients who may benefit from this safe, effective and less-invasive treatment have access to it.
REMARKS FROM SCAI LEADERS
"CREST represents a landmark trial. The most important finding is that both strategies - CAS and CEA - produce excellent results in patients at risk for stroke, and carry similarly low procedural risk," said Kenneth Rosenfield, M.D., FSCAI, an interventional cardiologist and section head for Vascular Medicine and Intervention at Massachusetts General Hospital. "There was no difference in major stroke between surgery and stenting. There were more heart attacks with surgery and more minor strokes with stenting. But, with a minor stroke, the symptoms are usually subtle and resolve relatively quickly - within 30 days. Fortunately, major disabling stroke, which can significantly impact a patient's quality of life, occurred very infrequently in both treatment arms. In fact, complications were very infrequent for both treatments. 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."
"The CREST data demonstrate the safety and efficacy of carotid artery stenting, reinforcing that this option should be available to more patients. We encourage the Centers for Medicare and Medicaid Services (CMS) to reopen its coverage decision on carotid stenting so more patients may benefit from a less-invasive option," said Christopher White, M.D., FSCAI, chairman, Department of Cardiology, and director of the Ochsner Heart & Vascular Institute, Ochsner Medical Center in New Orleans, and president-elect of the Society for Cardiovascular Angiography and Interventions. "Physicians should have the option to individualize treatment, given this data, to meet the varying needs of our patients.
"The CREST data suggest 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," said Larry S. Dean, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions, director of the University of Washington Medicine Regional Heart Center and professor of Medicine and Surgery at the University of Washington School of Medicine.