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Long-term outcomes of patients receiving drug-eluting stents

From the Department of Medicine (Philpott, Galbraith, Traboulsi, Knudtson, Ghali) and the Department of Community Health Sciences, Centre for Health and Policy Studies (Southern, Clement, Ghali), University of Calgary, Calgary, Alta.APPROACH Clinical Steering Committee Edmonton: Drs. Ross Tsuyuki (chair), Wayne Tymchak, Michelle Graham, Arvind Koshal and Neil Brass Calgary: Drs. Michael Curtis, William A. Ghali, Merril L. Knudtson, Andrew Maitland, L. Brent Mitchell and Mouhieddin Traboulsi

Correspondence to: Dr. William A. Ghali, Departments of Medicine and Community Health Sciences, University of Calgary, 3330 Hospital Dr. NW, Calgary AB T2N 4N1; fax 403 210-3818; wghali{at}ucalgary.ca

Background: We sought to establish the long-term safety of drug-eluting stents compared with bare-metal stents in a usual care setting.

Methods: Using data from a prospective multicentre registry, we compared rates of death and of death or repeat revascularization during 3 years of follow-up of 6440 consecutive patients who underwent angioplasty with either drug-eluting or bare-metal stents between Apr. 1, 2003, and Mar. 31, 2006.

Results: Drug-eluting stents were inserted in 1120 patients and bare-metal stents in 5320. The drug-eluting stents were selected for patients who had a greater burden of comorbid illness, including diabetes mellitus (32.8% v. 20.8% in the bare-metal group, p < 0.001) and renal disease (7.4% v. 5.0%, p = 0.001). At 1-year follow-up, the drug-eluting stents were associated with a mortality of 3.0%, as compared with 3.7% with the bare-metal stents (adjusted odds ratio [OR] 0.62, 95% confidence interval [CI] 0.46–0.83). The rate of the composite outcome of death or repeat revascularization was 12.0% for the drug-eluting stents and 15.8% for the bare-metal stents (adjusted OR 0.40, 95% CI 0.33–0.49). In the subgroup of patients who had acute coronary syndromes, the adjusted OR for this composite outcome was 0.46 (95% CI 0.35–0.61). During the 3 years of observation, the relative risks for death and repeat revascularization varied over time. In year 1, there was an initial period of lower risk in the group with drug-eluting stents than in the group with bare-metal stents; this was followed by a shift toward outcome rates favouring bare-metal stents in years 2 and 3. The adjusted relative risk of the composite outcome of death or repeat revascularization associated with drug-eluting stents relative to bare-metal stents was 0.73 early in the first year of follow-up; it then rose gradually over time, to a peak of 2.24 at 3 years.

Interpretation: Drug-eluting stents are safe and effective in the first year following insertion. Thereafter, the possibility of longer term adverse events cannot be ruled out.

This article has been cited by other articles:

				S. E. Nissen Pioglitazone to Reduce Restenosis After Bare-Metal Stent Placement? J. Am. Coll. Cardiol. Intv., June 1, 2009; 2(6): 532 - 533. [Full Text] [PDF]

				P. Genereux MD and R. Mehran MD Are drug-eluting stents safe in the long term? Can. Med. Assoc. J., January 20, 2009; 180(2): 154 - 155. [Full Text] [PDF]

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