CHICAGO - A new analysis that takes two large-scale views of drug-coated-stent studies helps support the notion that the devices do not carry a greater risk of heart attack or death than bare-metal stents, and are better at avoiding repeat procedures.
The so-called meta-analysis studies, one covering more than 9,000 patients in randomized trials and another covering more than 170,000 patients in registry studies, was led by doctors at Columbia University Medical Center. It will be presented late today during a meeting in Chicago held by the Cardiovascular Research Foundation, and in advance of the American College of Cardiology's annual conference.
The analysis comes as stent-implanting doctors and manufacturers in the market for the tiny, drug-coated scaffolds for heart arteries try to recover from a bruising period of reduced procedures and sales.
The market was hit hard in 2006, amid worries about a slightly increased risk of dangerous, late-developing clots associated with coated stents and higher chances for serious events. But more recent studies have cast coated stents in a better light, quelling some concerns.
Some of the more favorable data came in registry studies -- studies that attempt to cover "real-world" situations, but don't have the same rigid controls and patient selection as randomized studies. Researchers behind the latest data pulled those studies together to see if the trends were still consistent, said Ajay Kirtane, an interventional cardiologist at New York-Presbyterian Hospital/Columbia University Medical Center.
The meta-analysis of the registry data showed a 20 percent reduction in deaths among patients getting coated stents, and an 11 percent reduction in heart attacks. While that 20 percent reduction may be an outlier, and there are limitations to this type of analysis, the message is clear, Kirtane said.
"We clearly aren't hurting anybody here" by using coated stents, he said Thursday.
Kirtane led the study with Gregg Stone, also of Columbia University Medical Center, and the chairman of the Cardiovascular Research Foundation, which is an independent, nonprofit academic institution. Stone has received research grants from big stent makers, and ran the key trials for Boston Scientific Corp., which makes stents in Maple Grove, and for Abbott Laboratories Inc.
Kirtane is an adviser for Fridley-based Medtronic Inc., and a consultant and speaker for Medtronic and Abbott. The meta-analysis didn't have outside funding, Kirtane said.
