Stents and surgery were both safe and effective at preventing strokes in people whose severely narrowed neck arteries put them in danger, according to results of a government-sponsored trial being released today. Surgery patients suffered somewhat fewer strokes.
People whose clogged carotid arteries restrict the blood flowing to their brains have had limited choices for avoiding what is sometimes called a "brain attack." After taking medications and making lifestyle changes to improve their cardiovascular health, they could have surgery to open up the arteries. Or, if they were poor candidates for surgery because their blockage was hard to get at or they had another serious condition, federal regulations allowed stents -- tiny metal scaffolds -- to be placed in their arteries, propping them open to reduce their chances of a stroke. Previous studies have demonstrated that both surgery and stents reduce the risk of stroke.
Stents may soon become an option for more people, based on results of a large trial being presented today at the American Heart Association's International Stroke Conference in San Antonio. The study, funded by the National Institute of Neurological Disorders and Stroke and stent-maker Abbott, has not been published in a scientific journal yet, meaning it has not undergone peer review customary before publication. But a Boston researcher calls its findings good news for patients.
"What's amazing and what's important about this trial is that all patients across the board did well with both therapies. That's new information," Dr. Kenneth Rosenfield said in an interview. An interventional cardiologist, he was a co-leader of the trial at Massachusetts General Hospital, one of its 117 sites. He is a paid member of Abbott's scientific advisory board. "It's a seminal trial with important results that will absolutely have an effect on practice patterns."
The Carotid Revascularization Endarterectomy vs. Stenting Trial, known as CREST, randomly assigned more than 2,500 people to receive either stents or surgery. All the patients had severely narrowed neck arteries; half had already had minor strokes or milder events called transient ischemic attacks. Their average age was 69 and they were followed for up to four years.
The researchers were tracking three outcomes after the procedures: stroke, heart attack, or death. There were some differences in the short term, however, when most complications occur: There were more heart attacks in the surgical group -- 2.3 percent compared to 1.1 percent in the stent group -- and there were more strokes in the stent group -- 4.1 percent compared to 2.3 percent in the surgical group in the weeks after their procedures. Also, a year after the procedure, people who had strokes said they affected their quality of life more than people who had heart attacks.
"[Stents] may offer a reasonable alternative to [surgery], particularly in patients who prefer a less invasive procedure, and in younger patients," Dr. Wesley S. Moore, former chief of vascular surgery at the University of California at Los Angeles and a co-principal investigator for surgery in the trial, said in a statement. "However, it should be kept in mind that for the endpoint of stroke, [surgery] has been shown to be the safer procedure. It is when heart attacks are added that the results of the two procedures become similar."
The age of the patient also appeared to be a factor. People under 70 did better with stents while people over 70 did better with surgery. Rosenfield said those results should be looked at with caution because the difference was most apparent in people over 80, who made up only about 10 percent of the study population. The strength of the study as a whole comes from its size, he said. "This is a landmark trial. This is the granddaddy, the largest, most rigorous trial of this therapy that's been performed to date in North America and it represents the highest level of evidence."
If the Food and Drug Administration approves stents for use in all patients with severely narrowed neck arteries, it will give patients a choice to discuss with their doctors. Both procedures carry their own risks of stroke, heart attack, or death, so they should be weighed against the benefit of later reduced risk, Rosenfield said. "No matter which you use to get the artery open, they both appear to be very durable therapies."
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|White Coat Notes covers the latest from the health care industry, hospitals, doctors offices, labs, insurers, and the corridors of government. Chelsea Conaboy previously covered health care for The Philadelphia Inquirer. Write her at firstname.lastname@example.org. Follow her on Twitter: @cconaboy.|
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