Drug-Eluting or Bare-Metal Stents for ST Elevation Myocardial Infarction Can Observational Data Balance the Risk Benefit Equation?

Abstract

The randomized clinical trials leading to initial approval of drug-eluting stents (DES) by the United States Food and Drug Administration were conducted by design in a homogeneous group of lower risk patients with mostly noncomplex coronary lesions.1,2 These studies demonstrated a clear benefit in the reduction of restenosis without any evidence of a safety concern during 1 year follow-up. Shortly after approval of the sirolimus and paclitaxel-eluting stents, safety and effectiveness was reported from small nonrandomized studies in a variety of more complex patient and lesion subgroups and resulted in a large proportion of so-called off-label usage.3,4 Article see p 176 Increased concern over the safety of acute DES implantation during primary percutaneous coronary intervention for ST elevation myocardial infarction (MI) left this indication as one of the last to gain widespread usage in favor of bare-metal stents (BMS). A study from Rotterdam comparing 186 consecutive patients receiving a DES from April 2002 to January 2003 with 183 patients receiving a BMS during an immediately preceding time interval demonstrated no increase in subacute stent thrombosis (0% versus 1.6%, P =0.10) and a significantly lower risk for major adverse cardiac events at 300 days (9.4% versus 17.0%, P =0.02) due to a markedly lower risk for target lesion revascularization (TLR) (1.1% versus 8.2%, P 80% penetration of DES among all percutaneous coronary intervention procedures by early 2006.6 Two small randomized trials of DES versus BMS conducted in Europe and published in September 2006, also showed no increase in stent thrombosis for DES within 1 year.7,8 In the summer of 2006, there were new concerns regarding late safety of DES with …