Choosing wisely: The impact of patient selection on efficacy and safety outcomes in the EINSTEIN-DVT/PE and AMPLIFY trials.
- Beyer-Westendorf J Thrombosis Research Unit, Center for Vascular Medicine and Department of Medicine III, University Hospital "Carl Gustav Carus" Dresden, Germany. Electronic address: jan.beyer@uniklinikum-dresden.de.
- Lensing AW Bayer HealthCare Pharmaceuticals, Wuppertal, Germany.
- Arya R King's Thrombosis Centre, Department of Haematological Medicine, King's College Hospital, London, UK.
- Bounameaux H University Hospitals of Geneva and Faculty of Medicine, Geneva, Switzerland.
- Cohen AT Department of Haematology, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
- Wells PS Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
- Middeldorp S Department of Vascular Medicine, Academic Medical Center, Amsterdam, Netherlands.
- Verhamme P Vascular Medicine and Haemostasis, University of Leuven, Belgium.
- Hughes R Academic Directorate of Respiratory Medicine, Sheffield Teaching Hospitals, Sheffield, UK.
- Kucher N Clinic for Angiology, Cardiovascular Center, University Hospital Bern, Switzerland.
- Pap AF Bayer HealthCare Pharmaceuticals, Wuppertal, Germany.
- Trajanovic M Bayer HealthCare Pharmaceuticals Inc., Parsippany, NJ, USA.
- Prins MH Maastricht University Medical Center, Maastricht, Netherlands.
- Prandoni P Department of Cardiovascular sciences, Vascular Medicine Unit, University of Padua, Italy.
- Weitz JI Thrombosis & Atherosclerosis Research Institute and McMaster University, Hamilton, Ontario, Canada.
- 2016-11-26
Published in:
- Thrombosis research. - 2017
anticoagulation
apixaban
rivaroxaban
venous thromboembolism
Adult
Aged
Cohort Studies
Factor Xa Inhibitors
Female
Hemorrhage
Humans
Male
Middle Aged
Patient Selection
Pyrazoles
Pyridones
Rivaroxaban
Treatment Outcome
Venous Thromboembolism
English
BACKGROUND
The results of the EINSTEIN-DVT/PE and AMPLIFY trials, which compared rivaroxaban and apixaban with conventional anticoagulation therapy for acute venous thromboembolism (VTE), respectively, are often compared. However, the trials differed in duration of therapy (3-12 and 6months, respectively) and in patient selection (few exclusion criteria and more stringent exclusion criteria, respectively).
METHODS
To determine the effect of these methodological differences on outcomes, the patients enrolled in EINSTEIN-DVT/PE were divided into 2 cohorts; the 5253 patients that matched the exclusion criteria for AMPLIFY and were treated for at least 6months (cohort 1) and the 2368 patients who would have been ineligible for AMPLIFY (cohort 2).
RESULTS
Compared with patients in cohort 2, those in cohort 1 were older and more often male and there were more with unprovoked VTE, prior VTE, cancer and known thrombophilia. In cohort 1, rivaroxaban would have significantly reduced recurrent VTE (relative risk [RR], 0.64; 95% confidence interval [CI], 0.43-0.95) and major bleeding (RR, 0.50; 95% CI, 0.30-0.82) compared with conventional therapy, whereas the two treatments would have had similar effects on recurrent VTE (RR, 1.08; 95% CI, 0.65-1.79) and major bleeding (RR, 1.03; 95% CI, 0.48-2.18) in cohort 2.
CONCLUSIONS
This analysis illustrates the influence of patient selection and treatments duration on outcome results and highlights the limitations of cross-trial comparisons.
The results of the EINSTEIN-DVT/PE and AMPLIFY trials, which compared rivaroxaban and apixaban with conventional anticoagulation therapy for acute venous thromboembolism (VTE), respectively, are often compared. However, the trials differed in duration of therapy (3-12 and 6months, respectively) and in patient selection (few exclusion criteria and more stringent exclusion criteria, respectively).
METHODS
To determine the effect of these methodological differences on outcomes, the patients enrolled in EINSTEIN-DVT/PE were divided into 2 cohorts; the 5253 patients that matched the exclusion criteria for AMPLIFY and were treated for at least 6months (cohort 1) and the 2368 patients who would have been ineligible for AMPLIFY (cohort 2).
RESULTS
Compared with patients in cohort 2, those in cohort 1 were older and more often male and there were more with unprovoked VTE, prior VTE, cancer and known thrombophilia. In cohort 1, rivaroxaban would have significantly reduced recurrent VTE (relative risk [RR], 0.64; 95% confidence interval [CI], 0.43-0.95) and major bleeding (RR, 0.50; 95% CI, 0.30-0.82) compared with conventional therapy, whereas the two treatments would have had similar effects on recurrent VTE (RR, 1.08; 95% CI, 0.65-1.79) and major bleeding (RR, 1.03; 95% CI, 0.48-2.18) in cohort 2.
CONCLUSIONS
This analysis illustrates the influence of patient selection and treatments duration on outcome results and highlights the limitations of cross-trial comparisons.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1016/j.thromres.2016.11.014
- PMID 27886530
- Persistent URL
- https://sonar.ch/global/documents/155601
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