Why the study?
Because clinical trials evaluating stents or dual antiplatelet therapy have generally had narrow inclusion criteria, it was unclear how well their stent thrombosis rates reflect routine clinical practice with newer stents.
Population
Four thousand five hundred nine patients undergoing successful coronary stent implantation with dual antiplatelet therapy
Design
Retrospective database analysis
Follow-up
30 days
Answers are grounded in this paper and cite their sources.
Supports low early stent thrombosis rates with dual antiplatelet therapy in routine practice; extends trial data but leaves open generalizability to unselected populations.
Objectives The study examined the frequency, correlates, and outcome of patients with stent thrombosis within 30 days of stent placement. Background Patients in trials evaluating stents or dual antiplatelet therapy to prevent coronary stent thrombosis have generally had narrow inclusion criteria; the extent to which stent thrombosis rates in such trials represent current practice, particularly with the availability of newer stents, is unclear. Methods We performed a retrospective analysis of the Mayo Clinic Percutaneous Coronary Intervention database and identified all patients who received at least one coronary stent and dual antiplatelet therapy (aspirin and ticlopidine or clopidogrel for two to four weeks). Results Four thousand five hundred nine patients underwent successful coronary stent implantation and were treated with dual antiplatelet therapy between July 1, 1994, and April 30, 2000. Stent thrombosis occurred in 23 patients (0.51%; 95% confidence interval 0.32%, 0.76%) within 30 days of stent placement. Multivariate analysis using bootstrap model selection to avoid over-fitting the model indicated that only the number of stents placed was an independent correlate of stent thrombosis (odds ratio 1.80, p < 0.001). The frequency of death and frequency of nonfatal myocardial infarction (MI) among the 23 patients with stent thrombosis were 48% and 39%, respectively. Conclusions Stent thrombosis is even more rare in the current era than in earlier trials. Number of stents placed was an independent correlate of stent thrombosis. Most patients who suffer stent thrombosis either die or suffer MI.
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Orford et al. (2002) studied this question.
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