title: Evaluating the 'all-comers' design: a comparison of participants in two 'all-comers' PCI trials with non-participants.
abstract: OBJECTIVE
  We aimed to asses the generalizability of two 'all-comers' randomized clinical trials (AC-RCTs) in patients undergoing percutaneous coronary intervention (PCI).
  
  
  RESULTS
  Recently two large AC-RCT's comparing drug-eluting stents were performed in our institution (LEADERS and RESOLUTE-III). During the inclusion period of these trials 1242 consecutive PCI patients were treated of whom 579 (48%) were actually included. The most important reasons for non-participation were inability to provide informed consent (33.5%), refused to participate (19%), or patient met one of the other exclusion criteria (26.9%). Trial participants more frequently had stable angina (42.5 vs. 34.4%) and less frequently acute myocardial infarction as indication for PCI (31.4 vs. 42.4%) than non-participants. Hypertension (52.8 vs. 49.1%) and hypercholesterolaemia (56.3 vs. 49.1%) were seen more frequently in trial participants; heart failure was less common (2.1 vs. 4.4%). A significant difference in 30-day mortality was observed between AC-RCT participants and non-participants [0.7 vs. 4.5% events; adjusted hazard ratio (aHR) 0.18 and 95% confidence interval (CI) 0.06-0.52]. One-year mortality was also lower (3.1 vs. 6.9% events; aHR: 0.51 and 95% CI: 0.29-0.91, but 1-year mortality in 48 h survivors was similar (3.1 vs. 4.2% events; aHR: 0.74 and 95% CI: 0.41-1.34).
  
  
  CONCLUSIONS
  Applying the all-comers design did not result in inclusion of all consecutive patients, as only half of the target population was enrolled. It should be noted, however, that this design included more patients than observed in classical RCTs. AC-RCT participants and non-participants were different in terms of baseline characteristics and outcome.
authors.affiliation: Department of Cardiology, Erasmus MC, Thoraxcenter, 's Gravendijkwal 230, Rotterdam, The Netherlands.
authors.forename: Sanneke P M
authors.initials: SP
authors.lastname: de Boer
authors.forename: Mattie J
authors.initials: MJ
authors.lastname: Lenzen
authors.forename: Rohit M
authors.initials: RM
authors.lastname: Oemrawsingh
authors.forename: Cihan
authors.initials: C
authors.lastname: Simsek
authors.forename: Henricus J
authors.initials: HJ
authors.lastname: Duckers
authors.forename: Willem J
authors.initials: WJ
authors.lastname: van der Giessen
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Eric
authors.initials: E
authors.lastname: Boersma
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods* / Q000401:mortality; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods