Effectiveness and Safety of Drug-Eluting Stents in Ontario
Jack V. Tu, M.D., Ph.D., James Bowen, B.Sc.Phm., M.Sc., Maria Chiu, M.Sc., Dennis T. Ko, M.D., M.Sc., Peter C. Austin, Ph.D., Yaohua He, M.D., Ph.D., Robert Hopkins, M.A., Jean-Eric Tarride, Ph.D., Gord Blackhouse, M.B.A., M.Sc., Charles Lazzam, M.D., Eric A. Cohen, M.D., and Ron Goeree, M.A.
Background The placement of drug-eluting stents decreases thefrequency of repeat revascularization procedures in patientsundergoing percutaneous coronary intervention (PCI) in randomizedclinical trials. However, there is uncertainty about the effectivenessof drug-eluting stents, and increasing concern about their safety,in routine clinical practice.
Methods From the Cardiac Care Network of Ontario's population-basedclinical registry of all patients undergoing PCI in Ontario,Canada, we identified a well-balanced cohort of 3751 pairs ofpatients, matched on the basis of propensity score, who receivedeither bare-metal stents alone or drug-eluting stents aloneduring an index PCI procedure between December 1, 2003, andMarch 31, 2005. The primary outcomes of the study were the ratesof target-vessel revascularization, myocardial infarction, anddeath.
Results The 2-year rate of target-vessel revascularization wassignificantly lower among patients who received drug-elutingstents than among those who received bare-metal stents (7.4%vs. 10.7%, P<0.001). Drug-eluting stents were associatedwith significant reductions in the rate of target-vessel revascularizationamong patients with two or three risk factors for restenosis(i.e., presence of diabetes, small vessels [<3 mm in diameter],and long lesions [20 mm]) but not among lower-risk patients.The 3-year mortality rate was significantly higher in the bare-metal–stentgroup than in the drug-eluting–stent group (7.8% vs. 5.5%,P<0.001), whereas the 2-year rate of myocardial infarctionwas similar in the two groups (5.2% and 5.7%, respectively;P=0.95).
Conclusions Drug-eluting stents are effective in reducing theneed for target-vessel revascularization in patients at highestrisk for restenosis, without a significantly increased rateof death or myocardial infarction.
Source Information
From the Institute for Clinical Evaluative Sciences (J.V.T., M.C., D.T.K., P.C.A., Y.H.) and Sunnybrook Health Sciences Centre, University of Toronto (J.V.T., D.T.K., E.A.C.) — both in Toronto; McMaster University, St. Joseph's Healthcare, Hamilton, Ont. (J.B., R.H., J.-E.T., G.B., R.G.); and Trillium Health Sciences Centre, Mississauga, Ont. (C.L.) — all in Canada.
Address reprint requests to Dr. Tu at the Institute for Clinical Evaluative Sciences, G106-2075 Bayview Ave., Toronto, ON M4N 3M5, Canada, or at tu{at}ices.on.ca.
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