MARCH 3, 2009
Drug Therapy Gains Favor to Avert Stroke
By THOMAS M. BURTON
WSJ
A major study nearing completion is expected to help resolve a longstanding debate over whether surgery or the insertion of a flexible stent is the better way to prevent stroke for people with blocked arteries in the neck. But the study doesn't aim to answer another pressing question: How many patients may be better off avoiding those risky procedures altogether? An influential group of doctors say there is growing evidence that certain drugs could be of benefit greater than or equal to surgery or stents in preventing stroke -- with much reduced risk. These drugs include statins -- commonly associated with treating high cholesterol -- as well as blood-pressure medications and anticlotting drugs such as aspirin. The problem, these doctors say, is that unless a single study is done in which patients are randomly assigned to one of the three therapies, it's impossible to judge what is the best option for most patients.
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At issue are strokes caused when clots or fatty plaque in the carotid arteries begin to impede blood flow to the brain. A glob of this debris can dislodge, float up into the brain and block any of several small arteries there. Brain-tissue death can begin quickly, leaving patients with a range of outcomes from mild impairment to paralysis or death. Doctors say carotid-artery blockage plays a role in as many as half the 780,000 strokes that occur in the U.S. each year. Other factors that cut oxygen flow to the brain account for the remainder.
Surgery has long been used to excise the plaque, and medical experts estimate about 178,000 carotid operations are done in the U.S. each year. In recent years, stents, which are designed to press plaque against the artery wall to permit blood flow, have become increasingly common as a substitute for surgery. Today, there are about 30,000 carotid-stent procedures performed each year.
It's impossible to know how many patients are prescribed drugs to help prevent stroke. In recent years, evidence has been accumulating that drugs can play powerful roles in noninvasively keeping plaque from growing, and there is some evidence drugs might also be able to reduce plaque. A 2006 study of the statin Lipitor in 1,007 patients at high risk for stroke and with carotid blockage found the group taking the drug had a 33% reduced risk of stroke compared with those on placebo. At the International Stroke Conference in San Diego last week, researchers presented stroke-specific data from the recent heart-disease prevention trial known as Jupiter, which involved 17,802 patients. Patients taking Crestor, another statin generically called rosuvastatin, had a 48% decrease in risk of stroke, the researchers said.
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Walter J. Koroshetz, deputy director of the NIH's National Institute of Neurological Disorders and Stroke, said the agency is continuing discussions with doctors who urge funding for such a trial. He concurred that such a three-part study would need to involve very large numbers of patients and would be expensive. "For us to go into that, there has got to be a lot of enthusiasm on the part of the medical community," he said... More recently, carotid stents have gained acceptance by some doctors as a less-invasive way to get essentially the same benefits as surgery in certain patients. The main study that led to their Food and Drug Administration approval, funded by Johnson & Johnson in 2004, concluded that the J&J stent was "non-inferior" to surgery, meaning that statistically it delivered the same level of benefits. The study was small, involving 334 patients.
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http://online.wsj.com/article/SB123604022901114761.html (subscription)