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Previous Volume 356:1009-1019 March 8, 2007 Number 10 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Perspective by Maisel, W. H. Perspective by Farb, A. Editorial by Curfman, G. D. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article by Maisel, W. H. Related Article by Farb, A. PubMed Citation

ABSTRACT

Background Recent reports have indicated that there may be an increased risk of late stent thrombosis with the use of drug-eluting stents, as compared with bare-metal stents.

Methods We evaluated 6033 patients treated with drug-eluting stents and 13,738 patients treated with bare-metal stents in 2003 and 2004, using data from the Swedish Coronary Angiography and Angioplasty Registry. The outcome analysis covering a period of up to 3 years was based on 1424 deaths and 2463 myocardial infarctions and was adjusted for differences in baseline characteristics.

Results The two study groups did not differ significantly in the composite of death and myocardial infarction during 3 years of follow-up. At 6 months, there was a trend toward a lower unadjusted event rate in patients with drug-eluting stents than in those with bare-metal stents, with 13.4 fewer such events per 1000 patients. However, after 6 months, patients with drug-eluting stents had a significantly higher event rate, with 12.7 more events per 1000 patients per year (adjusted relative risk, 1.20; 95% confidence interval [CI], 1.05 to 1.37). At 3 years, mortality was significantly higher in patients with drug-eluting stents (adjusted relative risk, 1.18; 95% CI, 1.04 to 1.35), and from 6 months to 3 years, the adjusted relative risk for death in this group was 1.32 (95% CI, 1.11 to 1.57).

Conclusions Drug-eluting stents were associated with an increased rate of death, as compared with bare-metal stents. This trend appeared after 6 months, when the risk of death was 0.5 percentage point higher and a composite of death or myocardial infarction was 0.5 to 1.0 percentage point higher per year. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials.

Source Information

From the Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala (B.L., S.K.J., J.L., T.N., L.W.); and Linköping University Hospital, Linköping (U.S.) — both in Sweden.

This article (10.1056/NEJMoa067722) was published at www.nejm.org on February 12, 2007.

Address reprint requests to Dr. Lagerqvist at the Uppsala Clinical Research Center, Uppsala University Hospital, 751 85 Uppsala, Sweden, or at bo.lagerqvist{at}ucr.uu.se.

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