Were safer, more effective than bare metal ones, study shows
MONDAY, Nov. 10 (HealthDay News) -- Drug-coated stents appear to be superior to bare metal stents in both efficacy and safety in patients with diabetes, new research shows.
"I would say consistently from randomized trials that there is clear efficacy and clear reduction for repeat revascularization procedures [with drug-coated stents]," said senior study author Dr. Laura Mauri, an assistant professor of medicine at Brigham and Women's Hospital and Harvard Medical School. "That is now also augmented by the fact that there is excellent safety in patients who have a similar ability to take dual antiplatelet therapy."
"That's an important caveat," Mauri added. "I think we have to judge our patients and get to know them as individuals and make determinations on a case-by-case basis. I wouldn't make a blanket statement, but, in general, there is great benefit to the use of drug-eluting stents in diabetic patients, and there does not seem to be a trade-off."
Mauri presented the findings Monday at the American Heart Association's (AHA) annual scientific sessions in New Orleans.
The safety of drug-coated stents versus conventional bare metal stents has been a matter of controversy for years.
Diabetics have a higher prevalence of ischemic heart disease than the general population, but percutaneous coronary intervention (PCI) has limitations in this group, including a higher rate of restenosis and subsequent heart attack and death.
"There is controversy regarding selecting PCI as a treatment for patients with diabetes," said Dr. David Williams, with Brown University and Rhode Island Hospital in Providence. "One of the major shortcomings of PCI in this patient subset has been a relatively high need to perform repeat revascularization. Drug-eluting stents may offer a potential advantage in that regard, but there is some concern as to whether they are as safe as bare metal stents."
Mauri presented three-year follow-up data for a subgroup of about 5,000 diabetic patients undergoing PCI with stenting to reopen blocked vessels.
Two-thirds of the patients were treated with drug-eluting stents, and one-third were treated with bare metal stents.
There was an absolute reduction of around 5 percent in the need for repeat procedures in the target vessel and a small, but significant and surprising, decrease in death and subsequent heart attacks.
"It's appropriate to conclude that drug-eluting stents are superior to bare metal stents in patients with diabetes in regard to reducing the need for repeat revascularization. It also appears to be safe," Williams said. "Whether there's actually a benefit in terms of death and heart attack, I would say this is a provocative finding but not firmly established. This report indicates that probably the selection of bare metal stents over drug-eluting stents will be based on the ability of patients to take dual antiplatelet therapy for a sustained period of time."
A second study, from French researchers, presented at the meeting detailed a way to give individually tailored doses of Plavix (clopidogrel) to patients who had undergone PCI that still reduced the risk of blood clots.
Plavix is a notoriously tricky drug to deliver, as individual responses vary tremendously.
"We prescribe clopidogrel in a one-size-fits-all approach," explained AHA spokeswoman Dr. Nieca Goldberg. "They were looking at a way to individualize the drug."
"The message is 'yes, we can perform a therapeutic window for platelet therapy to avoid MACE [major adverse cardiovascular events] in patients," said senior study author Dr. Franck Paganelli, a professor of medicine in the division of cardiology at Hopital Nord, University of Marseille School of Medicine, in France.
"Trying to identify a loading dose using a lab test is a very creative idea," said AHA spokesman Dr. Elliott Antman. "We have to have a lot more information about the integrity of lab tests and how we should use them."
The authors of this study based their dosing on an index of platelet activity in patients undergoing stent placement.
The American Heart Association has more on PCI.
SOURCES: Nov. 10, 2008, news conference with Laura Mauri, M.D., assistant professor, medicine, Brigham and Women's Hospital and Harvard Medical School, Boston; David Williams, M.D., Rhode Island Hospital and Brown University, Providence; Franck Pagnelli, M.D., Ph.D., professor, medicine, division of cardiology, Hopital Nord, University of Marseille School of Medicine, France; Elliott Antman, M.D., Brigham and Women's Hospital and Harvard Medical School, Boston; Nieca Goldberg, M.D., American Heart Association spokeswoman and clinical associate professor, medicine, and medical director, Women's Heart Program, New York University
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