Abstract 3468: Clinical Safety and Long-Term Efficacy of Drug Eluting versus Bare Metal Stents in Acute ST-Elevation Myocardial Infarction
Background: One of the major shortcomings of coronary stents is in-stent restenosis. Drug-eluting stents (DES) are widely used to reduce intimal hyperplasia and as consequence, the incidence of restenosis. However, there are little data on their use in acute STEMI regarding long-term outcome. We, therefore, investigated safety and efficacy of DES compared to bare metal stents (BMS) in patients with STEMI.
Methods: From May 2003 to August 2004, consecutive patients with STEMI undergoing emergency PCI with stent implantation at the University Hospital Basel were included. Based on a 2:1 randomization scheme, patients received either drug-eluting stents (n=142, 66%, sirolimus-eluting Cypher stent SES, n=75, or paclitaxel-eluting Taxus stent PES, n=67) or the cobalt-chromium based third-generation Vision BMS stent (n=75, 34%). The follow-up included major adverse cardiac events (MACE: death, myocardial infarction, and target vessel revascular-ization TVR) at 18 months.
Results: Overall, 217 patients (mean age 62.2+/-13.0 years, 80% male) were included in this study. Demographic, clinical, and angiographic characteristics at baseline did not differ between the DES and BMS groups. Also, there was no difference in average stent length (DES: 40+/-22 mm, BMS: 37+/-20 mm) and number of stents implanted (DES: 2.1+/-1.2; BMS: 2.1+/-1.2). At 18 months, the incidence rate of MACE was higher in the BMS group 16.0%, n=12) than in the DES group (7.7%, n=11, odds ratio 2.27, 95% CI 0.95–5.4, p=0.06). This trend in favour of DES was seen for all components of MACE (death 7.7% vs. 16.0%, reinfarction 2.1% vs. 4.0%, and TVR 3.5% vs. 8.0%). Subgroup comparison of the two DES’s showed no significant differences between SES and PES.
Conclusions: There was a strong trend to better long-term outcome with the use of DES compared to BMS for the treatment of acute myocardial infarction with no superiority of one of the DES’s. The use of DES was feasible and safe in the patient population. Larger studies in STEMI patients are needed to determine if subgroups may profite particularly.