Comparison of primary percutaneous coronary intervention in real-world populations versus clinical trial populations.
The efficacy of primary percutaneous coronary intervention (PPCI) has been documented in several randomized-controlled trials. We sought to examine the clinical outcome after PPCI of real-world patients eligible and ineligible for inclusion in a randomized trial (DANAMI-2) and to compare it to the outcome of the DANAMI-2 population. We did a population-based follow-up study comparing 1,320 consecutive real-world patients treated with PPCI from 2004 to 2006 to 686 patients treated with PPCI in the DANAMI-2 trial. By reviewing medical records we determined whether the real-world patients were eligible in the DANAMI-2 trial. The real-world population had a more adverse baseline risk profile. Cumulative incidences of the composite end point of all-cause mortality, reinfarction, and stroke after 1 year and 2 years were 17.8% and 22.0%, respectively, in the real-world population compared to 13.6% and 17.3% in the DANAMI-2 population. After adjustment for differences in baseline characteristics and treatment, differences persisted after 1 year (adjusted hazard ratio 1.8, 95% confidence interval 1.3 to 2.6) and 2 years (adjusted hazard ratio 1.7, 95% confidence interval 1.2 to 2.3). Results for the real-world patients eligible according to DANAMI-2 criteria were comparable to the results from the DANAMI-2 trial. In conclusion, real-world patients had a more adverse baseline prognostic profile and a poorer clinical outcome compared to the DANAMI-2 patients. However, clinical outcome in the real-world patients eligible in the DANAMI-2 trial was comparable to that for the DANAMI-2 patients after invasive and medical treatment.
Jakobsen
Lars
L
Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark. larsj@dadlnet.dk
Niemann
Troels
T
Pedersen
Niels T
NT
Nielsen
Torsten T
TT
Johnsen
Søren P
SP
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D003718:Denmark / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000628:therapy*; D011159:Population Surveillance; D012008:Recurrence; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome