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May 4, 1994

Restenosis Trials Suggest Role For Remodeling

JAMA. 1994;271(17):1302-1305. doi:10.1001/jama.1994.03510410014006

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CONTROLLED TRIALS are causing researchers to rethink restenosis.

The reclogging of arteries that have been cleared with balloon angioplasty or a similar procedure vexes about one third of the 350 000 or more patients who undergo such procedures in the United States each year. Traditional thought and many failed therapeutic approaches have been based on the notion that merely the return of plaque, or intimal hyperplasia, is responsible.

"We have had several dozen new therapies introduced enabling clinicians to obtain the same unsatisfactory results of 10 years ago but by a greater variety and more costly methods," says Martin Leon, MD, director of cardiovascular research at the Washington (DC) Hospital Center.

Controlled trials of several of these drugs and procedures are revealing that reducing plaque does not necessarily reduce restenosis. Animal studies suggest that the amount of intimal hyperplasia that forms after angioplasty explains only a fraction of restenosis. How

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