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Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy.

Publication ,  Journal Article
Arbetter, DF; Jain, P; Yee, MK; Michalak, N; Hernandez, AF; Hull, RD; Goldhaber, SZ; Harrington, RA; Gold, A; Cohen, AT; Gibson, CM
Published in: Pharm Stat
November 2017

Competing risk methods are time-to-event analyses that account for fatal and/or nonfatal events that may potentially alter or prevent a subject from experiencing the primary endpoint. Competing risk methods may provide a more accurate and less biased estimate of the incidence of an outcome but are rarely applied in cardiology trials. APEX investigated the efficacy of extended-duration betrixaban versus standard-duration enoxaparin to prevent a composite of symptomatic deep-vein thrombosis (proximal or distal), nonfatal pulmonary embolism, or venous thromboembolism (VTE)-related death in acute medically ill patients (n = 7513). The aim of the current analysis was to determine the efficacy of betrixaban vs standard-duration enoxaparin accounting for non-VTE-related deaths using the Fine and Gray method for competing risks. The proportion of non-VTE-related death was similar in both the betrixaban (133, 3.6%) and enoxaparin (136, 3.7%) arms, P = .85. Both the traditional Kaplan-Meier method and the Fine and Gray method accounting for non-VTE-related death as a competing risk showed equal reduction of VTE events when comparing betrixaban to enoxaparin (HR/SHR = 0.65, 95% 0.42-0.99, P = 0.046). Due to the similar proportion of non-VTE-related deaths in both treatment arms and the use of a univariate model, the Fine and Gray method provided identical results to the traditional Cox model. Using the Fine and Gray method in addition to the traditional Cox proportional hazards method can indicate whether the presence of a competing risk, which is dependent of the outcome, altered the risk estimate.

Duke Scholars

Published In

Pharm Stat

DOI

EISSN

1539-1612

Publication Date

November 2017

Volume

16

Issue

6

Start / End Page

445 / 450

Location

England

Related Subject Headings

  • Venous Thrombosis
  • Venous Thromboembolism
  • Statistics & Probability
  • Risk Assessment
  • Risk
  • Research Design
  • Pyridines
  • Pulmonary Embolism
  • Proportional Hazards Models
  • Models, Statistical
 

Citation

APA
Chicago
ICMJE
MLA
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Arbetter, D. F., Jain, P., Yee, M. K., Michalak, N., Hernandez, A. F., Hull, R. D., … Gibson, C. M. (2017). Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy. Pharm Stat, 16(6), 445–450. https://doi.org/10.1002/pst.1823
Arbetter, Douglas F., Purva Jain, Megan K. Yee, Nathan Michalak, Adrian F. Hernandez, Russell D. Hull, Samuel Z. Goldhaber, et al. “Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy.Pharm Stat 16, no. 6 (November 2017): 445–50. https://doi.org/10.1002/pst.1823.
Arbetter DF, Jain P, Yee MK, Michalak N, Hernandez AF, Hull RD, et al. Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy. Pharm Stat. 2017 Nov;16(6):445–50.
Arbetter, Douglas F., et al. “Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy.Pharm Stat, vol. 16, no. 6, Nov. 2017, pp. 445–50. Pubmed, doi:10.1002/pst.1823.
Arbetter DF, Jain P, Yee MK, Michalak N, Hernandez AF, Hull RD, Goldhaber SZ, Harrington RA, Gold A, Cohen AT, Gibson CM. Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy. Pharm Stat. 2017 Nov;16(6):445–450.
Journal cover image

Published In

Pharm Stat

DOI

EISSN

1539-1612

Publication Date

November 2017

Volume

16

Issue

6

Start / End Page

445 / 450

Location

England

Related Subject Headings

  • Venous Thrombosis
  • Venous Thromboembolism
  • Statistics & Probability
  • Risk Assessment
  • Risk
  • Research Design
  • Pyridines
  • Pulmonary Embolism
  • Proportional Hazards Models
  • Models, Statistical