title: Health-related quality of life outcomes with prasugrel among medically managed non-ST-segment elevation acute coronary syndrome patients: Insights from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial.
abstract: BACKGROUND
  Few studies have assessed treatment effects on health-related quality of life (HRQoL) in patients with acute coronary syndrome (ACS) treated without revascularization. The TRILOGY ACS trial randomized patients with ACS to either prasugrel or clopidogrel therapy plus aspirin. Outcomes showed a complex pattern suggestive of late benefits with respect to repeat clinical events and benefits confined to patients who underwent angiography. Here, we examine the HRQoL correlates of these patterns.
  
  
  METHODS
  HRQoL was measured at baseline and 3, 12, and 24 months or end of study (EOS) in 7243 patients aged <75 years using the EuroQol 3-level, group 5-dimension index (EQ-5D). Linear mixed effects models for repeated measures were used to examine treatment differences in HRQoL overall, stratified by angiography status, and among patients who did and did not have non-fatal events.
  
  
  RESULTS
  No baseline differences in HRQoL were seen between patients randomized to prasugrel (n=3620) or clopidogrel (n=3623). At 24 months, remaining patients assigned to prasugrel (n=1450) vs. clopidogrel (n=1443) had higher EQ-5D index scores (86.4 vs. 84.9, P=.01). Mixed effects models found no difference in EQ-5D scores among prasugrel and clopidogrel patients overall across subgroups stratified by angiography status. However, among patients with non-fatal clinical events, patients on clopidogrel reported a larger decrement in HRQoL than patients on prasugrel (79.5±18.1 vs. 80.6±18.0; P=.02).
  
  
  CONCLUSIONS
  Overall, there was no difference in HRQoL outcomes among patients receiving prasugrel vs. clopidogrel. However, the differential effects of the treatments among patients with non-fatal events require further investigation.
authors: Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada. Electronic address: pkaul@ualberta.ca.
authors: Padma
authors: P
authors: Kaul
authors: Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Durham, NC.
authors: E Magnus
authors: EM
authors: Ohman
authors: Duke Clinical Research Institute, Durham, NC.
authors: J David
authors: JD
authors: Knight
authors: Duke Clinical Research Institute, Durham, NC.
authors: Kevin J
authors: KJ
authors: Anstrom
authors: Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Durham, NC.
authors: Matthew T
authors: MT
authors: Roe
authors: Department of Medicine, Albany Stratton VA Medical Center and Albany Medical Center, Albany Medical College, Albany, NY.
authors: William E
authors: WE
authors: Boden
authors: Cardiovascular Clinical Research Center, Leon Charney Division of Cardiology, New York University School of Medicine, New York, NY.
authors: Judith S
authors: JS
authors: Hochman
authors: University of Zagreb School of Medicine and University Hospital Centre Zagreb, Department of Medicine, Intensive Care Unit, Zagreb, Croatia.
authors: Vladimir
authors: V
authors: Gašparović
authors: Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada; Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Canada.
authors: Paul W
authors: PW
authors: Armstrong
authors: Eli Lilly and Company, Indianapolis, IN; Eli Lilly and Company, London, United Kingdom.
authors: Patrick
authors: P
authors: McCollam
authors: Eli Lilly and Company, Indianapolis, IN; Eli Lilly and Company, London, United Kingdom.
authors: Walid
authors: W
authors: Fakhouri
authors: Duke Clinical Research Institute, Durham, NC.
authors: Patricia
authors: P
authors: Cowper
authors: Duke Clinical Research Institute, Durham, NC.
authors: Linda
authors: L
authors: Davidson-Ray
authors: Duke Clinical Research Institute, Durham, NC.
authors: Nancy
authors: N
authors: Clapp-Channing
authors: Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.
authors: Harvey D
authors: HD
authors: White
authors: Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland, United Kingdom.
authors: Keith A A
authors: KA
authors: Fox
authors: Centre for Chronic Disease Prevention and Public Health Foundation of India, New Delhi, India.
authors: Dorairaj
authors: D
authors: Prabhakaran
authors: Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Durham, NC.
authors: Daniel B
authors: DB
authors: Mark
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000368:Aged; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006304:Health Status; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D000068799:Prasugrel Hydrochloride / Q000627:therapeutic use*; D011788:Quality of Life; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D000068799:Prasugrel Hydrochloride; D013988:Ticlopidine; D001241:Aspirin