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(Circulation. 2007;116:2391-2398.)
© 2007 American Heart Association, Inc.

Interventional Cardiology

Outcomes of Stent Thrombosis and Restenosis During Extended Follow-Up of Patients Treated With Bare-Metal Coronary Stents

Brendan Doyle, MB, BCh; Charanjit S. Rihal, MD, MBA; Crochan J. O’Sullivan, MB, BCh; Ryan J. Lennon, MS; Heather J. Wiste, BA; Malcolm Bell, MB, BS, FRACP; John Bresnahan, MD; David R. Holmes, Jr, MD

From the Division of Cardiovascular Diseases, Department of Internal Medicine, Mayo Clinic College of Medicine, Rochester, Minn.

Correspondence to D.R. Holmes, Jr, MD, Mayo Clinic, 200 First St SW, Rochester, MN 55905. E-mail holmes.david{at}mayo.edu

Received April 3, 2007; accepted August 27, 2007.

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.

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