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Recent reports comparing drug-eluting stents with bare metal stents have suggested potentially greater risks for stent thrombosis and for death and myocardial infarction with drug-eluting stents. However, very low event rates and variable definitions of stent thrombosis complicate comparisons within individual trials. Five studies (published in the March 8 New England Journal of Medicine), encompassing 19 randomized trials, yielded these findings:
A slightly lower risk for stent thrombosis with drug-eluting than with bare metal stents before 1 year, but a significantly higher risk after 1 year, representing an absolute disadvantage of about 0.5% to 1.0% with drug-eluting stents
No difference in stent thrombosis between sirolimus-eluting and paclitaxel-eluting stents
Documentation that even some drug-eluting stent recipients on long-term dual antiplatelet therapy experienced late stent thrombosis
No statistically significant difference in death or MI between bare metal stents and either sirolimus-eluting or paclitaxel-eluting stents
A marked reduction in target-vessel revascularization with drug-eluting stents
A tendency toward higher mortality with sirolimus-eluting stents than with bare metal stents in diabetes patients
Spaulding C et al. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007 Mar 8; 356:989-97.
Stone GW et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 2007 Mar 8; 356:998-1008.
Kastrati A et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007 Mar 8; 356:1030-9.
Mauri L et al. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007 Mar 8; 356:1020-9.
Lagerqvist B et al. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 2007 Mar 8; 356:1009-19.
Maisel WH. Unanswered questions — Drug-eluting stents and the risk of late thrombosis. N Engl J Med 2007 Mar 8; 356:981-4.
Farb A and Boam AB. Stent thrombosis redux — The FDA perspective. N Engl J Med 2007 Mar 8; 356:984-7.
Curfman GD et al. Drug-eluting coronary stents — Promise and uncertainty. N Engl J Med 2007 Mar 8; 356:1059-60.
Comment
Two accompanying perspective articles note that these randomized trials tended to enroll patients with the simplest lesions. However, current usage patterns suggest that as many as 60% of stent procedures are performed for off-label indications such as saphenous-vein graft lesions, bifurcations, acute MI, chronic occlusions, and multivessel disease — situations in which the risk for stent thrombosis may be particularly high. For now, drug-eluting stents should be reserved for patients at greatest risk for restenosis who can receive long-term dual antiplatelet therapy (Journal Watch Feb 15 2007).