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Latest Findings on Stents

More data on the risks and benefits of drug-eluting and bare metal stents

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
  

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).

— Howard C. Herrmann, MD

Dr. Herrmann is Professor of Medicine and Director, Interventional Cardiology and Cardiac Catheterization Laboratories, University of Pennsylvania Medical Center, Philadelphia.

Published in Journal Watch General Medicine March 1, 2007

Citation(s):

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.

• Original article (Subscription may be required)
• Medline abstract (Free)

Stone GW et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 2007 Mar 8; 356:998-1008.

• Original article (Subscription may be required)
• Medline abstract (Free)

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.

• Original article (Subscription may be required)
• Medline abstract (Free)

Mauri L et al. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007 Mar 8; 356:1020-9.

• Original article (Subscription may be required)
• Medline abstract (Free)

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.

• Original article (Subscription may be required)
• Medline abstract (Free)

Maisel WH. Unanswered questions — Drug-eluting stents and the risk of late thrombosis. N Engl J Med 2007 Mar 8; 356:981-4.

• Original article (Subscription may be required)
• Medline abstract (Free)

Farb A and Boam AB. Stent thrombosis redux — The FDA perspective. N Engl J Med 2007 Mar 8; 356:984-7.

• Original article (Subscription may be required)
• Medline abstract (Free)

Curfman GD et al. Drug-eluting coronary stents — Promise and uncertainty. N Engl J Med 2007 Mar 8; 356:1059-60.

• Original article (Subscription may be required)
• Medline abstract (Free)