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J Am Coll Cardiol, 2002; 40:2082-2089
© 2002 by the American College of Cardiology Foundation
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CLINICAL STUDY

Clinical restenosis after coronary stenting: perspectives from multicenter clinical trials

Donald E. Cutlip, MD, FACC*{dagger},*, Manish S. Chauhan, MD*, Donald S. Baim, MD, FACC*{ddagger}, Kalon K. L. Ho, MD, MSc, FACC*{dagger}, Jeffrey J. Popma, MD, FACC{ddagger}, Joseph P. Carrozza, MD, FACC{dagger}, David J. Cohen, MD, MSc, FACC*{dagger} and Richard E. Kuntz, MD, MSc, FACC*{ddagger}

* Harvard Clinical Research Institute, Boston, Massachusetts, USA
{dagger} Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
{ddagger} Brigham and Women’s Hospital, Boston, Massachusetts, USA

Manuscript received January 11, 2002; revised manuscript received April 23, 2002, accepted May 7, 2002.

* Reprint requests and correspondence: Dr. Donald E. Cutlip, Harvard Clinical Research Institute, 900 Commonwealth Avenue, Boston, Massachusetts 02215, USA.
dcutlip{at}hcri.harvard.edu

OBJECTIVES: We sought to evaluate clinical restenosis in a large population of patients who had undergone coronary stent placement.

BACKGROUND: One-year success after coronary stenting is limited mainly by restenosis of and requirement for repeat revascularization of the treated lesion.

METHODS: We studied 6,186 patients (6,219 lesions) pooled from several recently completed coronary stent trials. Clinical restenosis was defined using three different definitions: target lesion revascularization (TLR) beyond 30 days, target vessel revascularization (TVR) beyond 30 days, and target vessel failure (TVF), defined as TVR, any death, or myocardial infarction (MI) of the target vessel territory after hospital discharge.

RESULTS: By one year, 638 (12.2%) patients had TLR, 748 (14.3%) had TVR, and 848 (16.0%) had TVF, more than two-thirds higher than the rate of these end points at six months. The severity of angiographic restenosis (≥50% follow-up diameter stenosis [DS]) in 419 of 1,437 (29%) patients undergoing routine angiographic follow-up correlated directly with the likelihood of TLR (73% vs. 26% for >70% DS compared with <60% DS). Smaller pretreatment minimum lumen diameter (MLD), smaller final MLD, longer stent length, diabetes mellitus, unstable angina, and hypertension were independent predictors of TLR. Prior MI and current smoking were negative predictors.

CONCLUSIONS: At one year after stenting, most clinical restenosis reflected TLR, which was predicted by the same variables previously associated with an increased risk of angiographic restenosis. The lower absolute rate of clinical restenosis relative to angiographic restenosis was due to infrequent TLR in lesions with less severe (<60% DS) angiographic renarrowing.

Abbreviations and Acronyms
  BENESTENT
  Belgian Netherlands Stent study
  CEC
  Clinical Events Committee
  DS
  diameter stenosis
  MI
  myocardial infarction
  TLR
  target lesion revascularization
  TVR
  target vessel revascularization




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