Drug-Eluting Stent Mortality Meta-Analysis - Drug-Eluting Stent Mortality Meta-Analysis - Presented at TCT 2006

Description:

The goal of the study was to evaluate treatment with drug-eluting stents (DES) compared with bare-metal stents (BMS) on mortality among randomized trials of DES in patients undergoing percutaneous coronary intervention (PCI) for de novo coronary lesions.

Study Design

Study Design:

Mean Follow Up: 3-4 years

Primary Endpoints:

Mortality (total, cardiac, and noncardiac)

Drug/Procedures Used:

Data were drawn from 17 randomized trials of DES compared with BMS. Endpoints evaluated were total mortality, cardiac mortality, and noncardiac mortality. Trials had to be randomized with follow-up of ≥1 year to be included in the meta-analysis.

Principal Findings:

Total mortality at 1 year did not differ between BMS compared with DES (odds ratio [OR] 0.94, 95% confidence interval [CI] 0.66-1.34) or for the individual type of stents: sirolimus-eluting stents (SES) OR 0.86, 95% CI 0.49-1.51; paclitaxel-eluting stents (PES) OR 0.98, 95% CI 0.64-1.48. At 3 years, total mortality trended toward higher rates with DES compared with BMS (OR 1.25, 95% CI 0.91-1.73) as well as with SES versus BMS (OR 1.48, 95% CI 0.91-2.42).

Cardiac mortality at 3 years did not differ with DES versus BMS (OR 1.00, 95% CI 0.62-1.60). Noncardiac mortality at 3 years was directionally but not significantly higher with DES versus BMS (OR 1.45, 95% CI 0.93-2.25). However, for the individual stent type comparison, SES was associated with significantly higher rates of noncardiac death compared with BMS at both 2 years (OR 2.74, 95% CI 1.22-6.13, p < 0.05) and 3 years (OR 2.04, 95% CI 1.00-4.15, p < 0.05).

Interpretation:

In a meta-analysis of 17 randomized trials of patients undergoing PCI for de novo coronary lesions, treatment with DES was not associated with a significant difference in total mortality at 3 years, but was associated with increased noncardiac mortality with SES compared with BMS.

Randomized trials of DES compared with BMS in de novo coronary lesions have consistently shown reductions in the need for repeat revascularization due to restenosis. However, none has been adequately powered to evaluate harder endpoints of death or myocardial infarction (MI). Restenosis, while a negative consequence of PCI, is a nonfatal event.

The present meta-analysis demonstrates a potential but nonsignificant hazard in late mortality with DES, possibly attributable to higher late stent thrombosis. Longer-term follow-up from these trials will provide further insight, as will a more detailed analysis of the specific causes of death. Another recent meta-analysis presented at European Society of Cardiology Scientific Congress 2006 demonstrated higher rates of long-term death or Q-wave MI with SES compared with BMS. However, a meta-analysis presented at TCT of a subset of randomized trials showed higher late stent thrombosis but no difference in death or MI.

References:

Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis. Eur Heart J 2006:epub before print.

Presented by Dr. A.J. Nordmann at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.

Presented by Dr. A.J. Nordmann, European Society of Cardiology Scientific Congress, September 2006.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina

Keywords: Paclitaxel, Cause of Death, Myocardial Infarction, Coronary Restenosis, Metals, Thrombosis, Drug-Eluting Stents, Sirolimus, Stents, Percutaneous Coronary Intervention


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