Editorials |
From the Beth Israel Deaconess Medical Center and Harvard Clinical Research Institute, Harvard Medical School, Boston, Mass.
Correspondence to Donald E. Cutlip, MD, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215. E-mail dcutlip@bidmc.harvard.edu
Key Words: Editorials myocardial infarction restenosis stents thrombosis
An extract of the first 250 words of the full text is provided, because this article has no 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<0.01).5 Based partly on these limited data, DES use increased substantially also in patients with ST elevation MI in the United States and contributed to the >80% penetration of DES among all percutaneous coronary intervention procedures by
Related Article
Circ Cardiovasc Interv 2008 1: 176-184.
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