"Off-label" stent therapy 2-year comparison of drug-eluting versus bare-metal stents

J Am Coll Cardiol. 2008 Feb 12;51(6):607-14. doi: 10.1016/j.jacc.2007.08.064.

Abstract

Objective: The aim was to compare 2-year outcomes with the routine use of drug-eluting stents (DES) (>75% "off-label") with a comparable group treated with bare-metal stents (BMS).

Background: Safety concerns >1 year from implantation have been raised about DES used "off-label." There are limited data comparing DES and BMS in "off-label" patients.

Methods: Clinical outcomes (nonfatal myocardial infarction [MI], all-cause mortality) were assessed in 1,164 consecutive patients who received BMS in the year before introduction of DES at Wake Forest University Baptist Medical Center and 1,285 consecutive patients who received DES after it became our routine choice. "On-label" stent use was defined as treatment for a single de novo lesion <30 mm, without recent MI or other major illnesses.

Results: At 2 years, the hazard ratio for DES compared with BMS for nonfatal MI or death was 0.77 (95% confidence interval [CI] 0.62 to 0.95), for all-cause mortality 0.71 (0.54 to 0.92), and stent thrombosis (ST) 0.97 (0.49 to 1.91). "On-label" stent procedures were associated with lower risk of MI, death, and ST than "off-label" stent procedures. For "off-label" stent procedures, the hazard ratio for DES compared with BMS for nonfatal MI or death was 0.78 (95% CI 0.62 to 0.98), all-cause mortality 0.72 (0.54 to 0.94), and ST 0.91 (0.46 to 1.80). The hazard of nonfatal MI or death was similar or lower for DES than BMS in high-risk subgroups, including renal failure and recent MI.

Conclusions: The routine clinical use of drug-eluting stents for "off-label" indications was associated with lower nonfatal MI and death at 2 years than in a comparable group of patients treated with BMS.

Publication types

  • Clinical Trial
  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angioplasty, Balloon, Coronary* / instrumentation
  • Anticoagulants / administration & dosage
  • Anticoagulants / adverse effects
  • Blood Vessel Prosthesis Implantation*
  • Coronary Restenosis / prevention & control*
  • Coronary Restenosis / surgery
  • Coronary Thrombosis / epidemiology
  • Coronary Thrombosis / etiology
  • Drug-Eluting Stents* / adverse effects
  • Female
  • Heparin / administration & dosage
  • Heparin / adverse effects
  • Hirudins / administration & dosage
  • Hirudins / adverse effects
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Male
  • Middle Aged
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy*
  • Paclitaxel / administration & dosage
  • Peptide Fragments / administration & dosage
  • Peptide Fragments / adverse effects
  • Proportional Hazards Models
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Risk Factors
  • Secondary Prevention
  • Sirolimus / administration & dosage
  • Treatment Outcome*

Substances

  • Anticoagulants
  • Hirudins
  • Immunosuppressive Agents
  • Peptide Fragments
  • Recombinant Proteins
  • Heparin
  • Paclitaxel
  • bivalirudin
  • Sirolimus