title: Do randomized clinical trial selection criteria reflect levels of risk as observed in a general population of acute myocardial infarction survivors? The PEGASUS trial in the light of the FAST-MI 2005 registry.
abstract: BACKGROUND
  Few clinical trials have focused on populations with a history of distant myocardial infarction (MI). The PEGASUS trial assessed the impact of dual antiplatelet therapy in such patients, selected by enrichment criteria of high cardiovascular risk. Whether the PEGASUS population reflects the risk of a broader post-MI population is questionable. We analyzed whether 4-year mortality of a routine-practice population would differ according to the inclusion and exclusion criteria used in PEGASUS.
  
  
  METHODS
  FAST-MI is a nationwide French registry recruiting acute MI patients in November 2005; 2490 patients alive and without recurrent MI at one year were classified into three groups: Group 1 ("PEGASUS-like" population; n=1395; 56%), Group 2 (population having ≥1 exclusion criterion for the trial; n=677; 27%), and group 3 (population meeting neither the PEGASUS inclusion nor exclusion criteria; n=418, 17%).
  
  
  RESULTS
  Group 1 patients were older than Group 3 patients, with higher GRACE scores, more comorbidity, and less STEMI, but were younger than the PEGASUS trial population. Enrichment criteria successfully defined a population at higher risk: 4-year survival 83% in Group 1, 97% in Group 2, and 68% in Group 3 (P<0.001). Among risk-enrichment criteria, age alone was highly discriminant: in PEGASUS-like patients, survival was 78% in those ≥65 versus 94% in those <65years.
  
  
  CONCLUSIONS
  Enrichment criteria used in PEGAGUS succeed in defining a population at increased risk in patients with prior MI, age being the most discriminant factor. The trial population, however, was notably younger and more masculine than the corresponding real-life population in France. Clinicaltrials.govnumber:NCT00673036.
authors: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou (HEGP), Department of Cardiology, Paris, Université Paris-Descartes, Paris, France. Electronic address: etienne.puymirat@egp.aphp.fr.
authors: Etienne
authors: E
authors: Puymirat
authors: University Hospital Jean Minjoz, Department of Cardiology, Besançon, France.
authors: François
authors: F
authors: Schiele
authors: Laboratoire de Physiopathologie et Pharmacologie Cardiométaboliques, INSERM UMR866, Université de Bourgogne-Franche Comté, Dijon, France.
authors: Marianne
authors: M
authors: Zeller
authors: Emile Müller Hospital, Department of Cardiology, Mulhouse, France.
authors: Laurent
authors: L
authors: Jacquemin
authors: University Hospital, Department of Cardiology, Montpellier, France.
authors: Florence
authors: F
authors: Leclercq
authors: Vichy General Hospital, Department of Cardiology, Vichy, France.
authors: Xavier
authors: X
authors: Marcaggi
authors: Toulouse Rangueil University Hospital, Department of Cardiology, Toulouse, France, UMR1027, INSERM, Toulouse, France.
authors: Jean
authors: J
authors: Ferrières
authors: AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), Paris, France, Université Pierre et Marie Curie (UPMC-Paris 06), France.
authors: Tabassome
authors: T
authors: Simon
authors: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou (HEGP), Department of Cardiology, Paris, Université Paris-Descartes, Paris, France.
authors: Nicolas
authors: N
authors: Danchin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D005602:France / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000453:epidemiology*; D018579:Patient Selection; D011159:Population Surveillance / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012042:Registries; D012307:Risk Factors; D017741:Survivors
keywords: Acute myocardial infarction; Antiplatelet therapy; Coronary artery disease; Reperfusion therapy; ST-elevation myocardial infarction