More than 2,500 patients around the nation took part in the study, whose results were announced today at the International Stroke Conference in San Antonio. The University of Rochester Medical Center was one of 117 sites nationally and the only site of the study in Rochester. The study was funded mainly by the National Institute of Neurological Disorders and Stroke, with some support from Abbott, the maker of the stents.
Forty people in Rochester took part in the nine-year CREST study – the Carotid Revascularization Endarterectomy vs. Stenting Trial. Investigators compared the safety and effectiveness of two treatments for blocked carotid arteries in the neck. Those arteries supply blood from the heart to the brain, and a blockage in either artery is a major cause of stroke.
In Rochester, physicians Craig Narins, M.D., and Karl Illig, M.D., led a team of investigators who did the procedures and analyzed the results. In the more established procedure, carotid endarterectomy, surgeons cleared blocked blood flow in the arteries. The newer procedure is known as carotid artery stenting and involves threading a stent and expanding a small protective device in the artery to widen the blocked area and capture any dislodged plaque.
Generally up to now, stenting has been used only in patients considered at very high risk for having complications during surgery. CREST looked specifically at people who were at risk for stroke but could have undergone either surgery or stenting.
In San Antonio today, CREST officials announced that the procedures appear to be equally safe and effective for both men and women, as well as for patients who had a previous stroke compared to those who had never had a stroke.
“Stents are approved for use to clear the carotid arteries in people who are at very high risk for complications from surgery, but this is the first very large, randomized study to look at a broader group of people who are at risk for stroke. This study brings stenting to the forefront as a possible alternative to surgery,” said Narins, who led the study in Rochester. “These are complementary therapies, and both have great safety records that continue to improve.”
In CREST, approximately half the participants had recent symptoms due to carotid disease such as a minor stroke, or a transient ischemic attack, indicating a high risk for future stroke. The other half had no symptoms but were found to have narrowing of the carotid artery on one of a variety of tests assessing carotid narrowing and plaque. Such patients are at much lower risk of stroke than those with symptoms.
Though the two procedures appear to be equally safe and effective, there were a few differences. Patients who had surgery were about twice as likely to have a heart attack as those who had stents, while patients who had stenting were nearly twice as likely to have a stroke following the procedure than those who had surgery. The study also found that stenting was slightly more successful in people age 69 and younger, while surgery was slightly better in patients age 70 and older.
The study’s leaders noted that both procedures are very effective and continue to improve. In the surgical group, for instance, the rate of stroke and death was the lowest ever reported in a large stroke prevention trial.
“The results very much mirror what we have seen in Rochester in the past several years,” said Illig, professor of Surgery and chief of the Division of Vascular Surgery.
“Both stenting and surgery are very durable and remain effective in patients for a long time. This data has been a long time coming, but it was worth it. It clarifies the picture a great deal for physicians, and may ultimately mean another option for many patients as well,” added Illig, who is president of the Peripheral Vascular Surgical Society.
Narins, Illig and their colleagues at the University of Rochester Medical Center are now taking part in another similar study, known as ACT1, comparing the two treatments in patients at risk for stroke. The study is sponsored by Abbott.
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