Impact of participation in randomized trials of reperfusion therapy on the time to reperfusion and hospital mortality in ST-segment elevation myocardial infarction: A single-centre cohort study

European Heart Journal. Acute Cardiovascular Care
Jean-Michel JuliardP Gabriel Steg

Abstract

There is uncertainty as to whether consenting and randomizing patients in randomized clinical trials (RCTs) in acute ST-segment elevation myocardial infarction (STEMI) delays reperfusion and increases mortality. The aim of this study was to determine whether participation of patients with STEMI in RCTs is associated with delay in implementation of reperfusion therapy and increased hospital mortality. A consecutive sample of 2523 patients, admitted within 6 hours of symptom onset without cardiogenic shock, was recruited from a single tertiary academic centre. They were categorized according to participation (n=392, 15.5%) or nonparticipation (n=2131, 84.5%) in RCTs of reperfusion therapy. Primary outcome was hospital mortality. Additional outcome was time from symptom onset to receipt of reperfusion therapy. Trial participants were more likely to receive fibrinolysis with a 37 min delay in comparison with patients not included in RCTs. Time from symptom onset to reperfusion (minutes) was longer for trial participants than nonparticipants (246 ± 85 vs 233 ± 93, p=0.01). Hospital mortality was 3.61% for nonparticipants. Expected mortality (based on risk modeling) for trial participants was 2.74% (p=0.014 vs nonparticipants). Obser...Continue Reading

References

Oct 29, 2003·Archives of Internal Medicine·Christopher B GrangerUNKNOWN Global Registry of Acute Coronary Events Investigators
Jan 11, 2007·Archives of Internal Medicine·Philippe Gabriel StegUNKNOWN GRACE Investigators
Sep 6, 2013·The New England Journal of Medicine·Daniel S MeneesHitinder S Gurm
Aug 27, 2014·JAMA : the Journal of the American Medical Association·Jacob A UdellStephen D Wiviott

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