title: Outcome of patients with acute coronary syndromes enrolled in clinical trials.
abstract: The objective of this study was to evaluate in-hospital and 1-year outcomes of patients with acute coronary syndrome (ACS) enrolled in clinical studies. Among patients included in the Canadian ACS Registries, patients enrolled in clinical studies (n = 883, 13.4%) were compared with patients who were not enrolled. Enrolled patients were younger, more likely to be smokers, had less diabetes, less hypertension, less previous myocardial infarction, and less previous percutaneous coronary intervention and coronary artery bypass grafting. Enrollment in clinical studies was higher in patients with ST-elevation and ST-depression ACS. Furthermore, patients enrolled had more coronary interventions (percutaneous coronary intervention and coronary artery bypass grafting) and received more evidence-based therapies such as aspirin and statins. Unadjusted event rates were significantly higher in patients not enrolled in clinical studies: in-hospital death 2.4 versus 1.1% (P = 0.02), and 1-year death 9.2 versus 6.1% (P = 0.003), and death or myocardial infarction 16.1 versus 13.8% (P = 0.09). After multivariable analysis, enrollment in clinical studies showed a trend towards decreased in-hospital and 1-year death. Patients with ACS in Canada who participate in clinical studies are more likely to receive evidence-based therapies and interventions throughout hospitalization. After multivariable analysis, enrollment in a clinical trial may also contribute to better in-hospital and 1-year outcome.
authors.affiliation: Terrence Donnelly Heart Centre, Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Canada. amit.segev@sheba.health.gov.il
authors.forename: Amit
authors.initials: A
authors.lastname: Segev
authors.forename: Paul
authors.initials: P
authors.lastname: Fefer
authors.forename: Bradley H
authors.initials: BH
authors.lastname: Strauss
authors.forename: Shlomi
authors.initials: S
authors.lastname: Matetzky
authors.forename: Mary
authors.initials: M
authors.lastname: Tan
authors.forename: Anatoly
authors.initials: A
authors.lastname: Langer
authors.forename: Shaun G
authors.initials: SG
authors.lastname: Goodman
mesh_terms: D054058:Acute Coronary Syndrome / Q000401:mortality / Q000628:therapy*; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000401:mortality / Q000706:statistics & numerical data; D002170:Canada / Q000453:epidemiology; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000401:mortality / Q000706:statistics & numerical data; D019317:Evidence-Based Medicine; D005260:Female; D006297:Health Services Accessibility; D017052:Hospital Mortality; D006801:Humans; D007297:Inpatients; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010043:Outcome and Process Assessment, Health Care; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents