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Effectiveness and safety of drug-eluting stents in Ontario

Tu J, Bowen J, Chiu M, Ko D, Austin P, He Y, Hopkins R, Tarride J, Blackhouse G, Lazzam C, Cohen E, Goeree R. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med.  2007; 357 (14): 1393-1402.

The placement of drug-eluting stents decreases the frequency of repeat revascularization procedures in patients undergoing percutaneous coronary intervention (PCI) in randomized clinical trials.  However, there is uncertainty about the effectiveness of drug-eluting stents, and increasing concern about their safety, in routine clinical practice.

 

From the Cardiac Care Network of Ontario’s population-based clinical registry of all patients undergoing PCI in Ontario, Canada, we identified a well-balanced cohort of 3,751 pairs of patients, matched on the basis of propensity score, who received either bare-metal stents alone or drug-eluting stents alone during an index PCI procedure between December 1, 2003 and March 31, 2005.  The primary outcomes of the study were the rates of target-vessel revascularization, myocardial infarction, and death.

 

The two-year rate of target-vessel revascularization was significantly lower among patients who received drug-eluting stents than among those who received bare-metal stents (7.4% vs. 10.7%, P<0.001).  Drug-eluting stents were associated with significant reductions in the rate of target-vessel revascularization among 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 three-year mortality rate was significantly higher in the bare-metal–stent group than in the drugeluting–stent group (7.8% vs. 5.5%, P<0.001), whereas the two-year rate of myocardial infarction was similar in the two groups (5.2% and 5.7%, respectively; P = 0.95).

 

Drug-eluting stents are effective in reducing the need for target-vessel revascularization in patients at highest risk for restenosis, without a significantly increased rate of death or myocardial infarction.


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