Comparison of primary percutaneous coronary intervention in real-world populations versus clinical trial populations

Am J Cardiol. 2010 Jun 15;105(12):1684-91. doi: 10.1016/j.amjcard.2010.01.344. Epub 2010 Apr 27.

Abstract

The efficacy of primary percutaneous coronary intervention (PPCI) has been documented in several randomized-controlled trials. We sought to examine the clinical outcome after PPCI of real-world patients eligible and ineligible for inclusion in a randomized trial (DANAMI-2) and to compare it to the outcome of the DANAMI-2 population. We did a population-based follow-up study comparing 1,320 consecutive real-world patients treated with PPCI from 2004 to 2006 to 686 patients treated with PPCI in the DANAMI-2 trial. By reviewing medical records we determined whether the real-world patients were eligible in the DANAMI-2 trial. The real-world population had a more adverse baseline risk profile. Cumulative incidences of the composite end point of all-cause mortality, reinfarction, and stroke after 1 year and 2 years were 17.8% and 22.0%, respectively, in the real-world population compared to 13.6% and 17.3% in the DANAMI-2 population. After adjustment for differences in baseline characteristics and treatment, differences persisted after 1 year (adjusted hazard ratio 1.8, 95% confidence interval 1.3 to 2.6) and 2 years (adjusted hazard ratio 1.7, 95% confidence interval 1.2 to 2.3). Results for the real-world patients eligible according to DANAMI-2 criteria were comparable to the results from the DANAMI-2 trial. In conclusion, real-world patients had a more adverse baseline prognostic profile and a poorer clinical outcome compared to the DANAMI-2 patients. However, clinical outcome in the real-world patients eligible in the DANAMI-2 trial was comparable to that for the DANAMI-2 patients after invasive and medical treatment.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / methods*
  • Denmark / epidemiology
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Myocardial Infarction / epidemiology
  • Myocardial Infarction / therapy*
  • Population Surveillance*
  • Recurrence
  • Registries
  • Retrospective Studies
  • Risk Factors
  • Time Factors
  • Treatment Outcome