ABSTRACT
In the USA, the drug-eluting stents (DES) (Cypher: Cordis, Miami, FL; and Taxus: Boston Scientific, Inc., Maple Ridge, MN) were approved by the Food and Drug Administration (FDA) for clinical use according to the same clinical and anatomical criteria that were used in the pivotal pre-approval trials (SIRIUS and TAXUS IV) (Box 8.1).1,2 However, over 50% of the patients in our clinical practice would not fit into these criteria.3,4
Clinical characteristics • Age <18 or >80 years • Acute or recent (<48 hours) MI including non-ST elevation MI • Left ventricular ejection fraction <30% • Unable to tolerate aspirin or ADP-receptor antagonist • Serum creatinine >2.0 mg/dl
Anatomical characteristics • Left main coronary artery lesion • Target lesion within bypass graft • Reference diameter <2.5 mm or >3.5 mm • Lesion length <10 or >28 mm • Angulated lesion (>60°) • Bifurcation lesion or side-branch involvement • Post-angioplasty restenosis or in-stent restenosis • Ostial lesion • Concomitant use of brachytherapy
Since the introduction of stents more than a decade ago, primary stent placement has become the standard strategy for a very broad range of clinical and anatomical indications, e.g. stable and unstable syndromes, or acute myocardial infarction (MI), complex coronary lesions, left main stenosis, and bypass graft. The long-term patency of stents has been limited by
restenosis until the availability of the DES. Accordingly, it is logical to consider expanding the indications of DES beyond those that were studied in the clinical trials.
