When “More” is not “Better”

Once again, it appears that ‘more’ medical care is not necessarily the ‘best’ medical care.

A recent study published in the New England Journal of Medicine reports results from a federally funded trial designed to prevent a subsequent stroke in high-risk patients.  Half the patients were randomized to receive intensive medical management; the other half was treated with intensive medical management plus stenting of a major intracranial artery using the Styker Corporation’s Wingspan stent system.   Aggressive medical management was defined as aspirin, clopidogrel 75 mg/day for 90 days after enrollment, an antihypertensive, rosuvastatin, and a lifestyle management program.

Based on data from earlier trials and two clinical registries, the researchers anticipated that stenting would reduce the risk of recurrent stroke or death by 35% over 2 years.

In fact, the opposite occurred.

Over slightly less than a year of follow-up, 20.5% of the stented patients died or had a stroke, compared with 11.5% of those receiving medical therapy alone.   Based on these results, the study stopped enrolling patients, issued a clinical alert and announced that all currently enrolled patients would be followed for up to 2 years.

It’s not clear why the stented patients had such unexpectedly poor results.  It may be that people in this study were at higher risk and had less severe lesions than the patients in the registries.  Or perhaps the trial’s rigorous patient monitoring system was able to identify more strokes than were detected in the registries.

Some experts in the field contend that the trial patients received more aggressive management of their risk factors than most patients receive. However, the authors concluded that intensive medical management alone can be duplicated in clinical practice.   And according to the deputy director of the agency that funded the trial, the National Institute of Neurological Disorders and Stroke, “Although technological advances have brought intracranial stenting into practice, we have now learned that, when tested in a large group, this particular device did not lead to a better health outcome.”

Managing patients with medicine and lifestyle is far less ‘glamorous’ than the high-tech stenting option.  However, until clinical research is able to determine which—if any—patients are the best candidates for intracarotid stenting, medical management is the more prudent strategy. And at a cost of $3400 per year versus more than $20,000 per year–and the potential loss of life–we can’t afford the alternative.

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