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J Am Coll Cardiol, 2005; 45:479-483, doi:10.1016/j.jacc.2004.10.060
© 2005 by the American College of Cardiology Foundation
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VIEWPOINT

Drug-eluting stents for diabetes mellitus

A rush to judgment?

Aloke V. Finn, MD*,*, Igor F. Palacios, MD*, Adnan Kastrati, MD{dagger} and Herman K. Gold, MD*

* Cardiac Unit, Massachusetts General Hospital, Boston, Massachusetts
{dagger} Deutsches Herzzentrum and 1. Med. Klinik rechts der Isar, Technische Universität München, Munich, Germany

Manuscript received July 25, 2004; revised manuscript received October 9, 2004, accepted October 18, 2004.

* Reprint requests and correspondence: Dr. Aloke V. Finn, Massachusetts General Hospital, 55 Fruit Street, Boston, Massachusetts 02114. (Email: afinn1{at}partners.org).

The two pivotal U.S. trials of drug-eluting stents do not establish the principle that these stents are superior to thin-strut bare-metal stents for preventing repeat revascularization in patients with diabetes. Neither study was adequately powered to make this determination. Moreover, both studies used thick-strut stents known to have high restenosis rates as controls. Low angiographic follow-up underestimates the true target lesion revascularization rate in the Polymer-Based Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease (TAXUS-IV) trial because of the high incidence of silent ischemia in patients with diabetes. Optimal therapy for diabetic coronary disease should include a comprehensive approach directed toward metabolic normalization in addition to local stent-based therapy.

Abbreviations and Acronyms
  BMS = bare-metal stent
  DES = drug-eluting stents
  ISAR-STEREO = Intracoronary Stenting and Angiographic Results-Strut Thickness Effect on Restenosis Outcomes trial
  PCI = percutaneous coronary intervention
  PES = paclitaxel-eluting stent
  PPAR = peroxisome proliferator-activated receptor
  RVD = reference vessel diameter
  SES = sirolimus-eluting stent
  SIRIUS = Sirolimus-coated BX Velocity Balloon-Expandable Stent in the Treatment of Patients With De Novo Coronary Artery Lesions
  TAXUS-IV = Polymer-Based Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease
  TLR = target lesion revascularization




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