DALLAS, Dec. 23 – Drug-coated stents are safe and effective at preventing death, heart attack or repeat procedures in "real world" patients who are often sicker or older than those selected for clinical trials, according to a study in today's rapid issue of Circulation: Journal of the American Heart Association.
The drug-coated stents were more effective than uncoated stents, just as they had been in clinical trials, said lead investigator Patrick W. Serruys, M.D., Ph.D., professor of cardiology at Erasmus Medical Center in Rotterdam, the Netherlands.
This "real world" research is important because patients in clinical trials of drug-coated stents "were a very select group, whereas this registry is an attempt to look at in an unselected population," Serruys said. "Sixty-eight percent of the patients in this study did not meet the selection criteria for the clinical trials."
Stents are tiny flexible wire mesh tubes that prop open blocked arteries in the heart. Drug-eluting stents are coated with slow-release drugs that help prevent cell re-growth that can re-narrow the artery.
These one-year results from the Rampamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry show that 9.7 percent of patients who received the drug-eluting stents had a major adverse cardiac event, compared with 14.8 percent of those treated with bare metal stents.
Only 3.7 percent of the patients treated with drug-eluting stents had a renarrowing of the treated vessel that required repeat procedures, while 10.9 percent of the patients in the bare-metal stent group required repeat interventions.
"The treatment effects – particularly the reduction of reinterventions – were similar across very different subgroups of patients," Serruys said. "The effect was the same in long lesions and short lesions, in small vessels, and in all kinds of anatomic settings."
The study included 508 patients with previously untreated blocked arteries who were treated with sirolimus-eluting Cypher stents. Four hundred fifty patients with similar blockages were treated with bare metal stents. About half of the patients admitted to both groups had acute coronary syndromes (heart attack or angina) and 16 percent in each group also had diabetes. Generally, patients selected for treatment with the coated stents were more likely to have multi-vessel disease, more complicated disease and required more stents than patients treated with uncoated stents.
"We have had basically two major steps in interventional cardiology," Serruys said. "The first was revascularization through percutaneous intervention with the angioplasty balloon in 1977 followed in 1986 by the introduction of the stent. The drug-eluting stent is the next major step."
In an accompanying editorial David P. Faxon, M.D., professor of medicine at the University of Chicago, wrote that the RESEARCH results "go a long way in reassuring the practitioner that drug-eluting stents are in fact safe and effective in a wide variety of patients undergoing 'real world' angioplasty." The next step should be a mandatory registry established by the Food and Drug Administration to report problems, he said.
Faxon also addressed recent FDA public notifications that warned physicians of sub-acute thrombosis (blood clot) and hypersensitivity reactions linked to using the Cordis Cypher Coronary Stent. "Thus far, 290 cases of sub-acute stent thrombosis have been reported and more than 60 patients have died. But the thrombosis rate is about 1 percent, which is similar to the expected rate for bare metal stents."
Serruys' co-authors are Pedro A. Lemos, M.D.; Ron T. van Domburg, Ph.D.; Francesco Saia, M.D.; Chourmouzios A. Arampatzis, M.D.; Angela Hoye, MB, ChB, MRCP; Muzaffer Degertekin, M.D.; Kengo Tanabe, M.D.; Joost Daemen; Tommy K.K. Liu, Eugene McFadden, M.B., ChB; Georgios Sianos, M.D., Ph.D.; Sjoerd H. Hofma, M.D.; Pieter C. Smits, M.D., Ph.D.; Willem J. van der Giessen, M.D., Ph.D.; and Pim de Feyter, M.D., Ph.D.
Materials provided by American Heart Association. Note: Content may be edited for style and length.
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