Who is eligible for randomized trials? A comparison between the exclusion criteria defined by the ISCHEMIA trial and 3102 real-world patients with stable coronary artery disease undergoing stent implantation in a single cardiology center

Trials. 2015 Sep 15;16:411. doi: 10.1186/s13063-015-0934-4.


Background: Randomized controlled trials are the gold standard for evaluating therapy; however, controversy exists regarding the applicability of such results to daily practice, as patients are often pre-selected and may not reflect real-world clinical settings. We studied the eligibility criteria for 3102 "real-life" patients with stable coronary artery disease (SCAD) according to the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial exclusion criteria. The aim of our analysis was to estimate the percentage of real-life patients who would have met the exclusion criteria for the ISCHEMIA trial.

Methods: We analyzed 3102 patients with SCAD referred to the Silesian Center for Heart Disease who underwent both coronary angiography and stent implantation between January 2006 and December 2011. The patients were divided into two groups. Group A was composed of patients with SCAD who would have been excluded from the ongoing ISCHEMIA trial, whereas group B represented the remaining patients.

Results: A total of 1900 (61.3%) patients met at least one of the exclusion criteria. The most frequent exclusion criterion noted was revascularization within the previous 12 months (938 patients; 49.4%), followed by unacceptable level of angina symptoms (532 patients; 28 %), low ejection fraction (467 patients; 24.6%), and acute coronary syndrome within the previous 2 months (456 patients; 24%). Patients from our cohort who would have been excluded from the ISCHEMIA trial were older, had more comorbidities, and experienced worse long-term outcomes.

Conclusions: The ISCHEMIA trial exclusion criteria ruled out the majority of the patients with SCAD undergoing percutaneous coronary intervention in "real life". Our cohort of patients who would have been excluded from the ISCHEMIA trial had more comorbidities and experienced significantly worse long-term outcomes than patients who did not meet the ISCHEMIA trial exclusion criteria.

Trial registration: ClinicalTrials.gov NCT01471522.

Publication types

  • Observational Study

MeSH terms

  • Age Factors
  • Aged
  • Comorbidity
  • Coronary Angiography
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / physiopathology
  • Coronary Artery Disease / therapy*
  • Eligibility Determination*
  • Female
  • Health Status
  • Humans
  • Male
  • Middle Aged
  • Patient Selection*
  • Percutaneous Coronary Intervention / instrumentation*
  • Poland
  • Randomized Controlled Trials as Topic / methods*
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Stents*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01471522