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Am Heart J. 2016 Aug;178:55-64. doi: 10.1016/j.ahj.2016.03.017. Epub 2016 Apr 16.

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.

Author information

1
Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada. Electronic address: pkaul@ualberta.ca.
2
Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Durham, NC.
3
Duke Clinical Research Institute, Durham, NC.
4
Department of Medicine, Albany Stratton VA Medical Center and Albany Medical Center, Albany Medical College, Albany, NY.
5
Cardiovascular Clinical Research Center, Leon Charney Division of Cardiology, New York University School of Medicine, New York, NY.
6
University of Zagreb School of Medicine and University Hospital Centre Zagreb, Department of Medicine, Intensive Care Unit, Zagreb, Croatia.
7
Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada; Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Canada.
8
Eli Lilly and Company, Indianapolis, IN; Eli Lilly and Company, London, United Kingdom.
9
Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.
10
Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland, United Kingdom.
11
Centre for Chronic Disease Prevention and Public Health Foundation of India, New Delhi, India.

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.

PMID:
27502852
DOI:
10.1016/j.ahj.2016.03.017
[Indexed for MEDLINE]

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