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J Am Coll Cardiol, 1998; 32:590-595
© 1998 by the American College of Cardiology Foundation
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CLINICAL STUDIES

Long-term analysis of conventional coronary balloon angioplasty and an initial "stent-like" result

The NHLBI PTCA registry

David R. Holmes, Jr., MD, FACC*, Kevin E. Kip, MSPH{dagger}, Wanlin Yeh, MS{dagger}, Sheryl F. Kelsey, PhD{dagger}, Katherine M. Detre, MD, DrPH, FACC{dagger}, David O. Williams, FACC{ddagger} for the Investigators of the NHLBI PTCA Registry

* Mayo Clinic, Rochester, Minnesota, USA
{dagger} Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
{ddagger} Brown University/Rhode Island Hospital, Providence, Rhode Island, USA

Manuscript received January 15, 1998; revised manuscript received April 27, 1998, accepted May 8, 1998.

Address for correspondence: Kevin E. Kip, University of Pittsburgh, Graduate School of Public Health, Epidemiology Data Coordinating Center, 127 Parran Hall, 130 DeSoto Street, Pittsburgh, Pennsylvania
kip{at}edc.gsph.pitt.edu

Objectives. We examined the influence of an initial "stent-like" result on long-term outcome in patients in the 1985–86 NHLBI PTCA Registry.

Background. Stent use in selected patients is associated with improved angiographic and short-term clinical outcome; however, due to potential for in-stent restenosis and high costs of stents, there is interest in a strategy of more optimal dilatation to achieve a "stent-like" result without a stent. The long-term outcome of patients with a "stent-like" percutaneous transluminal coronary angioplasty (PTCA) remains unknown.

Methods. Ten-year outcome was compared between 225 successfully treated patients with and 1,764 successfully treated patients without an initial "stent-like" result (≥1 lesion dilated to ≤10% stenosis). The sample had 75% and 80% power, respectively, to detect an absolute difference of 8% in the 10-year rate of death and myocardial infarction (MI) between the two groups.

Results. Ten-year rates of death and MI were similar between the stent-like and non–stent-like groups (22.3% vs. 22.2%, 17.6% vs. 17.9%), however, there was less target lesion revascularization in the stent-like group (30.2% vs. 36.8%). In subgroup analysis of patients with multivessel disease, those with a stent-like result had less follow-up bypass surgery (25.2% vs. 32.7%), yet more repeat PTCA (53.8% vs. 42.7%). These findings were unaffected by adjustment for differences in baseline characteristics between the two patient groups.

Conclusions. Achievement of an initial stent-like result via balloon angioplasty alone may not appreciably reduce the long-term risk of death or MI, nor confer equivalent clinical benefit as achieving a stent-like result with a stent.

Abbreviations and Acronyms
  CABG = coronary artery bypass graft surgery
  ECG = electrocardiogram
  MI = myocardial infarction
  MVD = multivessel disease
  NHLBI = National Heart, Lung, and Blood Institute
  NSL = non–stent-like result
  PTCA = percutaneous transluminal coronary angioplasty
  SL = stent-like result
  SVD = single vessel disease
  TLR = target lesion revascularization




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