title: 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.
abstract: 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01471522.
authors.affiliation: Medical University of Silesia, School of Medicine with the Division of Dentistry, 3rd Department of Cardiology, Silesian Center for Heart Diseases, Marii Skłodowskiej-Curie Street 9, 41-800, Zabrze, Poland. jaroswasilewski@gmail.com.
authors.forename: Jarosław
authors.initials: J
authors.lastname: Wasilewski
authors.affiliation: Medical University of Silesia, School of Medicine with the Division of Dentistry, 3rd Department of Cardiology, Silesian Center for Heart Diseases, Marii Skłodowskiej-Curie Street 9, 41-800, Zabrze, Poland. scchs@sum.edu.pl.
authors.forename: Lech
authors.initials: L
authors.lastname: Poloński
authors.affiliation: Medical University of Silesia, School of Medicine with the Division of Dentistry, 3rd Department of Cardiology, Silesian Center for Heart Diseases, Marii Skłodowskiej-Curie Street 9, 41-800, Zabrze, Poland. alekstonhemo@sccs.pl.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Lekston
authors.affiliation: Medical University of Silesia, School of Medicine with the Division of Dentistry, 3rd Department of Cardiology, Silesian Center for Heart Diseases, Marii Skłodowskiej-Curie Street 9, 41-800, Zabrze, Poland. tadeuszosa@wp.pl.
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Osadnik
authors.affiliation: Medical University of Silesia, School of Medicine with the Division of Dentistry, 3rd Department of Cardiology, Silesian Center for Heart Diseases, Marii Skłodowskiej-Curie Street 9, 41-800, Zabrze, Poland. r.regula@gmail.com.
authors.forename: Rafał
authors.initials: R
authors.lastname: Reguła
authors.affiliation: Medical University of Silesia, School of Medicine with the Division of Dentistry, 3rd Department of Cardiology, Silesian Center for Heart Diseases, Marii Skłodowskiej-Curie Street 9, 41-800, Zabrze, Poland. kamil_bujak@o2.pl.
authors.forename: Kamil
authors.initials: K
authors.lastname: Bujak
authors.affiliation: Medical University of Silesia, School of Medicine with the Division of Dentistry, 3rd Department of Cardiology, Silesian Center for Heart Diseases, Marii Skłodowskiej-Curie Street 9, 41-800, Zabrze, Poland. ania_kurek@o2.pl.
authors.forename: Anna
authors.initials: A
authors.lastname: Kurek
mesh_terms: D000367:Age Factors; D000368:Aged; D015897:Comorbidity; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D004608:Eligibility Determination; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D011044:Poland; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D016896:Treatment Outcome