September 2, 2008 - The safety debate about drug-eluting stents (DES) is still ongoing and in these times of uncertainty about DES safety, a new study has shown DES markedly improves long-term survival, compared to modern bare-metal stents (BMS) in patients with acute ST-segment elevation myocardial infarction (STEMI).
Dr. Thorsten Grumann, of the University of Freiburg Department of Cardiology in Germany, explained the results of his study at the European Society of Cardiology 2008 Congress today. He said in the four-year investigation, DES demonstrated a significant reduction of mortality in this sick patient subset.
The study sought to present a subgroup analysis of patients with myocardial infarction followed long-term for a mean of four years in the Freiberg Stent Registry (FRIST), a single-centre registry in high volume tertiary referral cardiovascular centre. FRIST included complex coronary patients treated with DES and BMS in the University Hospital of Freiburg, Germany, according to nonselected inclusion criteria. For the first time, three drug eluting stents, namely Cypher, Taxus and Endeavor, were compared. The DES-groups were matched to a historical, contemporary BMS control group.
The primary study endpoint was overall survival. Cardiac and noncardiac death was also analyzed.
“We observed a significant survival benefit of patients who received DES compared with patients who received BMS in FRIST,” Dr. Grumann said.
The overall crude incidence for all-cause death was 7 percent (13 out of 186) in the DES-group and 24 percent (27 out of 112) in the BMS-group. Applying a multivariate Cox survival model with adjustment for existing baseline differences between the patient groups resulted in a relative risk of 0.42. That implies a 58 percent decrease of mortality risk in the DES population within the four-year observation period. The adjusted risk reduction with respect to cardiac death (-70 percent) was even more impressive. A number needed to treat analysis (NNT) looking at mortality indicated that if 30 patients were treated with a DES instead of a BMS in STEMI, one life could be saved.
“The analysis clearly favors DES implantation with a marked long term survival benefit in patients with myocardial infarction over BMS,” said Dr. Grumann.
Reduced total mortality for DES as compared to BMS, and a further reduction with respect to cardiac death suggests many patients can profit from “off-label” use of DES. Dr. Grumann said the registry shows for the first time that DES are not only equal, but superior to BMS when long-term survival is the primary concern in patients with STEMI. The data supports the TYPHOON-results but should be interpreted with caution until further randomized mortality trials have substantiated the reported findings.
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