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Association of aspirin dose and vorapaxar safety and efficacy in patients with non-ST-segment elevation acute coronary syndrome (from the TRACER Trial).

Publication ,  Journal Article
Mahaffey, KW; Huang, Z; Wallentin, L; Storey, RF; Jennings, LK; Tricoci, P; White, HD; Armstrong, PW; Aylward, PE; Moliterno, DJ; Chen, E ...
Published in: Am J Cardiol
March 15, 2014

Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) trial compared vorapaxar and placebo in 12,944 high-risk patients with non-ST-segment elevation acute coronary syndrome. We explored aspirin (ASA) use and its association with outcomes. Kaplan-Meier event rates were compared in groups defined by ASA dose (low, medium, and high). Landmark analyses with covariate adjustment were performed for 0 to 30, 31 to 180, and 181 to 365 days. Of 12,515 participants, 7,523, 1,049, and 3,943 participants were treated with low-, medium-, and high-dose ASA at baseline, respectively. Participants enrolled in North America versus elsewhere were more often treated with a high dose at baseline (66% vs 19%) and discharge (60% vs 3%). Unadjusted cardiovascular death, myocardial infarction, stroke, hospitalization for ischemia, or urgent revascularization event rates tended to be higher with higher baseline ASA (18.45% low, 19.13% medium, and 20.27% high; p for trend = 0.15573). Unadjusted and adjusted hazard ratios (95% confidence intervals) for effect of vorapaxar on cardiovascular (unadjusted p for interaction = 0.065; adjusted p for interaction = 0.140) and bleeding (unadjusted p for interaction = 0.915; adjusted p for interaction = 0.954) outcomes were similar across groups. Landmark analyses showed similar safety and efficacy outcomes with vorapaxar and placebo by ASA dose at each time point except for 0 to 30 days, when vorapaxar tended to be worse for efficacy (hazard ratio 1.13, 95% confidence interval 0.89 to 1.44, p for interaction = 0.0157). In conclusion, most TRACER participants were treated with low-dose ASA, although a high dose was common in North America. High-dose participants tended to have higher rates of ischemic and bleeding outcomes. Although formal statistical testing did not reveal heterogeneity in vorapaxar's effect across dose subgroups, consistent trends support use of low-dose ASA with other antiplatelet therapies.

Duke Scholars

Published In

Am J Cardiol

DOI

EISSN

1879-1913

Publication Date

March 15, 2014

Volume

113

Issue

6

Start / End Page

936 / 944

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Receptors, Thrombin
  • Pyridines
  • Platelet Aggregation Inhibitors
  • Middle Aged
  • Male
  • Lactones
  • Humans
  • Follow-Up Studies
  • Female
 

Citation

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Mahaffey, K. W., Huang, Z., Wallentin, L., Storey, R. F., Jennings, L. K., Tricoci, P., … Harrington, R. A. (2014). Association of aspirin dose and vorapaxar safety and efficacy in patients with non-ST-segment elevation acute coronary syndrome (from the TRACER Trial). Am J Cardiol, 113(6), 936–944. https://doi.org/10.1016/j.amjcard.2013.11.052
Mahaffey, Kenneth W., Zhen Huang, Lars Wallentin, Robert F. Storey, Lisa K. Jennings, Pierluigi Tricoci, Harvey D. White, et al. “Association of aspirin dose and vorapaxar safety and efficacy in patients with non-ST-segment elevation acute coronary syndrome (from the TRACER Trial).Am J Cardiol 113, no. 6 (March 15, 2014): 936–44. https://doi.org/10.1016/j.amjcard.2013.11.052.
Mahaffey KW, Huang Z, Wallentin L, Storey RF, Jennings LK, Tricoci P, et al. Association of aspirin dose and vorapaxar safety and efficacy in patients with non-ST-segment elevation acute coronary syndrome (from the TRACER Trial). Am J Cardiol. 2014 Mar 15;113(6):936–44.
Mahaffey, Kenneth W., et al. “Association of aspirin dose and vorapaxar safety and efficacy in patients with non-ST-segment elevation acute coronary syndrome (from the TRACER Trial).Am J Cardiol, vol. 113, no. 6, Mar. 2014, pp. 936–44. Pubmed, doi:10.1016/j.amjcard.2013.11.052.
Mahaffey KW, Huang Z, Wallentin L, Storey RF, Jennings LK, Tricoci P, White HD, Armstrong PW, Aylward PE, Moliterno DJ, Van de Werf F, Chen E, Leonardi S, Rorick T, Held C, Strony J, Harrington RA. Association of aspirin dose and vorapaxar safety and efficacy in patients with non-ST-segment elevation acute coronary syndrome (from the TRACER Trial). Am J Cardiol. 2014 Mar 15;113(6):936–944.
Journal cover image

Published In

Am J Cardiol

DOI

EISSN

1879-1913

Publication Date

March 15, 2014

Volume

113

Issue

6

Start / End Page

936 / 944

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Receptors, Thrombin
  • Pyridines
  • Platelet Aggregation Inhibitors
  • Middle Aged
  • Male
  • Lactones
  • Humans
  • Follow-Up Studies
  • Female