on November 5, 2007
Published online before print November 5, 2007, doi: 10.1161/CIRCULATIONAHA.107.707331
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Submitted on April 3, 2007
From the Division of Cardiovascular Diseases, Department of Internal Medicine, Mayo Clinic College of Medicine, Rochester, Minn. * To whom correspondence should be addressed. E-mail: holmes.david{at}mayo.edu.
Background—Concern regarding risk of late thrombosis after "off-label" treatment with drug-eluting stents has prompted increased use of bare-metal stents (BMS) in current practice. The sequelae of late BMS failures, however, have been poorly characterized. Methods and Results—We performed a retrospective study of 4503 consecutive patients treated with at least 1 BMS and dual antiplatelet therapy between 1994 and 2000. The cumulative incidence of stent thrombosis was 0.5% at 30 days (95% CI, 0.3% to 0.7%), 0.8% at 1 year (95% CI, 0.6% to 1.1%), and 2.0% at 10 years (95% CI, 1.5% to 2.5%). Risk of late (30 days to 1 year) and very late (>1 year) BMS thrombosis was increased among patients considered off label for drug-eluting stent use (P=0.024). When saphenous vein graft interventions were excluded, however, risk after off-label use was not significantly increased (P=0.23). Other correlates included vein graft intervention, prior myocardial infarction (MI), peripheral vascular disease, and ulcerated lesion (P<0.001). Mortality was markedly increased after late and very late BMS thrombosis, particularly during the first 30 days (hazard ratios, 22 [95% CI, 3.1 to 159] and 40 [95% CI, 15 to 107], respectively). The 10-year incidence of clinical restenosis was 18.1% (95% CI, 16.5% to 19.7%), presenting with MI in 2.1% (95% CI, 1.6% to 2.6%). Restenosis presenting with MI was associated with increased mortality compared with no restenosis (hazard ratio, 2.37; P<0.001) and with restenosis with a non-MI presentation (hazard ratio, 2.42; P<0.001). Conclusions—The incidence of BMS thrombosis and of MI caused by restenosis during extended follow-up is significant. Both complications are associated with mortality.
Accepted on August 27, 2007
Outcomes of Stent Thrombosis and Restenosis During Extended Follow-Up of Patients Treated With Bare-Metal Coronary Stents
Brendan Doyle MB, BCh,
Key words: myocardial infarction • restenosis • stents • thrombosis
Related Article:
Circulation 2007 116: 2359.
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