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Tuesday, 19 October 2004

This presentation is part of: Poster Session - Clinical Strategies; Judgment and Decison Making

A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS WITH CORONARY DRUG-ELUTING STENTS

Manu Sondhi, MD, MBA, Amitha Jagannath, BS, and John Wong, MD. Tufts-New England Medical Center, Clinical Decision Making, Informatics and Telemedicine, BOSTON, MA

Purpose: To quantify current risks and benefits of coronary drug-eluting stents compared with bare-metal stents.

Methods: Literature search of Medline 1996-2004 and abstracts from major conferences were used. Data relating to death, myocardial infarction (MI), target lesion revascularization (TLR), restenosis, and need for repeat percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG) were extracted from randomized, controlled trials of drug-eluting stents. The DerSimonian and Laird random effects model was used to calculate risk differences (RD).

Results: In all, 13 trials involving 4813 patients were identified but not all contributed to each endpoint. Most patients were 58-64 year old, male, hypercholesterolemic, hypertensive, non-smokers and non-diabetic. Drug-eluting stents compared with bare-metal stents did not significantly affect the baseline risk of death of 1% (CI 0.6% to 1.4%) or death or MI of 4% (CI 3% to 5%). Drug-eluting stents had a baseline risk of restenosis of 8% (CI 7% to 9%) and TLR of 5% (CI 4% to 6%). Drug-eluting stents compared with bare-metal stents reduced the absolute risk of restenosis by 23%, TLR by 9%, repeat PTCA by 12% and CABG by 1%. Paclitaxel-eluting stents significantly reduced (P<0.001) the risk of restenosis to 9% (RD –14%, CI –9% to –20%) and TLR to 4% (RD –7%, CI –3% to –11%) compared with bare-metal stents. Similarly, sirolimus-eluting stents compared with bare-metal stents reduced the risk of restenosis to 4% (RD –33%, CI –25% to –41%) and TLR to 4% (RD –17%, CI –14% to –20%).

Conclusions: Coronary drug-eluting stents significantly reduce the rates of restenosis and the need for repeat revascularization when compared with bare-metal stents.


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