ESC: Increased Mortality Erased in Latest Drug-Eluting Stent Data from Swedish Registry

September 2, 2007

VIENNA -- Time and more patients shrank the 18% three-year statistically significant risk of mortality for drug-eluting coronary stents, compared with bare-metal devices, to a non-significant 1% at four years, Swedish registry researchers reported here today.

VIENNA, Sept. 2 -- Time and more patients shrank the 18% three-year statistically significant risk of mortality for drug-eluting coronary stents, compared with bare-metal devices, to a non-significant 1% at four years, Swedish registry researchers reported here today.

"This is good news for patients, but there are still a number of questions for physicians," said Stefan James, M.D., of the Uppsala Clinical Research Center, who reported the four-year results from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), at the European Society of Cardiology meeting.

Bare-metal stents were associated with a significantly higher risk of early events, while drug-eluting stents were associated with a continuous low risk of late stent thrombosis -- about 0.5% per year, Dr. James said in an interview.

Although the late stent-thrombosis risk "remained the same as we reported earlier," the addition of earlier events from roughly 15,000 more patients diminished the net effect of that trend so that "the increased risk was no longer significant," he said.

Moreover, he said drug-eluting stents reduced restenosis by about 50% compared with bare metal stents, but that worked out to an "absolute reduction of 3.5%, which is much less in this real world setting than the reduction in angiographic restenosis reported in stent trials."

Dr. James said symptomatic or clinical restenosis was a much more important benchmark than angiographic restenosis, which often causes no symptoms or functional impairment.

Spencer B. King, III, M.D. of Atlanta Piedmont Hospital, an American College of Cardiology spokesperson, agreed that the findings were reassuring for patients, and he speculated that "they may reflect better use of drug-eluting stents in terms of better patient selection and improved use of antiplatelet therapy."

Dr. James said that patients added in 2005 probably received six months of dual antiplatelet therapy-current U.S. recommendations are for 12 months of clopidogrel and aspirin-as well as improved stent technology, better operator technique, and more careful selection of patients.