Interventional cardiology and intracoronary stents - A changing practice: approved vs. nonapproved indications

David Holmes, Malcolm R. Bell, David R. Holmes III, Peter B. Berger, John F. Bresnahan, LaVon N. Hammes, Diane E. Grill, Kirk N. Garratt

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Our objective was to document change in stent usage in s single practice over time and to study 'off-label' compared to Food and Drug Administration (FDA)-approved indications. Although only two intracoronary stents have been approved by the FDA, the relatively limited approved indications do not account for the dramatic increase in stent implantation. This increase has important implications for patient health care delivery. This study of stent usage in a single center over a 36-mo period included all patients treated with coronary stents at the Mayo Clinic from January 1993-December 1995, and evaluated the relative difference in frequency between 'off-label' and FDA- approved indications for implantation. During the 36-mo period of study, 3,614 interventional procedures were done and one or more stents were placed in 25.4% of patients. The proportion of patients receiving stents increased throughout this time: during the first 6-mo period, stents were placed in 6.2% of procedures; during the last 6-mo period, stents were placed in 46.3% of procedures, an eightfold increase. During the final 6 mo, an unapproved device or an unapproved indication for an approved device constituted 59.4% of all stent procedures. In addition, use of the non-FDA-approved adjunctive treatment regimen without warfarin Increased from 2.9% in the first 6-mo period of observation to 82.7% in the last 6 mo. The use of stents increased strikingly over a 36-mo period, from 6% to 46% of all procedures. The majority of implantations were performed either for an 'off-label' unapproved indication or with an unapproved device.

Original languageEnglish (US)
Pages (from-to)133-139
Number of pages7
JournalCatheterization and Cardiovascular Diagnosis
Volume40
Issue number2
DOIs
StatePublished - Feb 1997

Fingerprint

Cardiology
Stents
United States Food and Drug Administration
Equipment and Supplies
Warfarin
Patient Care
Observation
Delivery of Health Care

Keywords

  • interventional cardiology
  • intracoronary stents
  • percutaneous angioplasty

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Interventional cardiology and intracoronary stents - A changing practice : approved vs. nonapproved indications. / Holmes, David; Bell, Malcolm R.; Holmes III, David R.; Berger, Peter B.; Bresnahan, John F.; Hammes, LaVon N.; Grill, Diane E.; Garratt, Kirk N.

In: Catheterization and Cardiovascular Diagnosis, Vol. 40, No. 2, 02.1997, p. 133-139.

Research output: Contribution to journalArticle

Holmes, David ; Bell, Malcolm R. ; Holmes III, David R. ; Berger, Peter B. ; Bresnahan, John F. ; Hammes, LaVon N. ; Grill, Diane E. ; Garratt, Kirk N. / Interventional cardiology and intracoronary stents - A changing practice : approved vs. nonapproved indications. In: Catheterization and Cardiovascular Diagnosis. 1997 ; Vol. 40, No. 2. pp. 133-139.
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