TY - JOUR
T1 - Evaluating the 'all-comers' design
T2 - A comparison of participants in two 'all-comers' PCI trials with non-participants
AU - De Boer, Sanneke P.M.
AU - Lenzen, Mattie J.
AU - Oemrawsingh, Rohit M.
AU - Simsek, Cihan
AU - Duckers, Henricus J.
AU - Van Der Giessen, Willem J.
AU - Serruys, Patrick W.
AU - Boersma, Eric
PY - 2011/9
Y1 - 2011/9
N2 - Aims We aimed to asses the generalizability of two 'all-comers' randomized clinical trials (AC-RCTs) in patients undergoing percutaneous coronary intervention (PCI). Methods and resultsRecently two large AC-RCTs 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) 0.060.52]. One-year mortality was also lower (3.1 vs. 6.9 events; aHR: 0.51 and 95 CI: 0.290.91, but 1-year mortality in 48 h survivors was similar (3.1 vs. 4.2 events; aHR: 0.74 and 95 CI: 0.411.34). Conclusion 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.
AB - Aims We aimed to asses the generalizability of two 'all-comers' randomized clinical trials (AC-RCTs) in patients undergoing percutaneous coronary intervention (PCI). Methods and resultsRecently two large AC-RCTs 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) 0.060.52]. One-year mortality was also lower (3.1 vs. 6.9 events; aHR: 0.51 and 95 CI: 0.290.91, but 1-year mortality in 48 h survivors was similar (3.1 vs. 4.2 events; aHR: 0.74 and 95 CI: 0.411.34). Conclusion 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.
KW - All-comers
KW - Percutaneous coronary intervention
KW - Randomized controlled trials
UR - https://www.scopus.com/pages/publications/80052506035
U2 - 10.1093/eurheartj/ehr126
DO - 10.1093/eurheartj/ehr126
M3 - Article
C2 - 21565848
AN - SCOPUS:80052506035
SN - 0195-668X
VL - 32
SP - 2161
EP - 2167
JO - European Heart Journal
JF - European Heart Journal
IS - 17
ER -