Clinical Outcomes With Rivaroxaban in Patients Transitioned From Vitamin K Antagonist Therapy: A Subgroup Analysis of a Randomized Trial

Kenneth W Mahaffey; Daniel Wojdyla; Graeme J Hankey; Harvey D White; Christopher C Nessel; Jonathan P Piccini; Manesh R Patel; Scott D Berkowitz; Richard C Becker; Jonathan L Halperin; Daniel E Singer; Robert M Califf; Keith A A Fox; Günter Breithardt; Werner Hacke

doi:10.7326/0003-4819-158-12-201306180-00003

Clinical Outcomes With Rivaroxaban in Patients Transitioned From Vitamin K Antagonist Therapy: A Subgroup Analysis of a Randomized Trial

Kenneth W Mahaffey, Daniel Wojdyla, Graeme J Hankey, Harvey D White, Christopher C Nessel, Jonathan P Piccini, Manesh R Patel, Scott D Berkowitz, Richard C Becker, Jonathan L Halperin, Daniel E Singer, Robert M Califf, Keith A A Fox, Günter Breithardt, Werner Hacke

Research output: Contribution to journal › Article › peer-review

Abstract

Background: In ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), a large randomized, clinical trial, rivaroxaban was noninferior to warfarin in preventing stroke or systemic embolism in patients with atrial fibrillation.

Objective: To determine the efficacy and safety of rivaroxaban compared with warfarin among vitamin K antagonist (VKA)–naive and VKA-experienced patients.

Design: Prespecified subgroup analysis. (ClinicalTrials.gov: NCT00403767)

Setting: Global.

Patients: 14 264 persons with atrial fibrillation.

Measurements: Interaction of the relative treatment effect of rivaroxaban and warfarin on stroke or systemic embolism among VKA-naive and VKA-experienced patients.

Results: Overall, 7897 (55.4%) patients were VKA-experienced and 6367 (44.6%) were VKA-naive. The effect of rivaroxaban versus warfarin on stroke or systemic embolism was consistent: Rates per 100 patient-years of follow-up were 2.32 versus 2.87 for VKA-naive patients (hazard ratio [HR], 0.81 [95% CI, 0.64 to 1.03]) and 1.98 versus 2.09 for VKA-experienced patients (HR, 0.94 [CI, 0.75 to 1.18]; interaction P = 0.36). During the first 7 days, rivaroxaban was associated with more bleeding than warfarin (HR in VKA-naive patients, 5.83 [CI, 3.25 to 10.44], and in VKA-experienced patients, 6.66 [CI, 3.83 to 11.58]; interaction P = 0.53). After 30 days, rivaroxaban was associated with less bleeding than warfarin in VKA-naive patients (HR, 0.84 [CI, 0.74 to 0.95]) and similar bleeding in VKA-experienced patients (HR, 1.06 [CI, 0.96 to 1.17]; interaction P = 0.003).

Limitation: The trial was not designed to detect differences in these subgroups.

Conclusion: The efficacy of rivaroxaban in VKA-experienced and VKA-naive patients was similar to that of the overall trial. There were more bleeding events within 7 days of study drug initiation with rivaroxaban, but after 30 days, rivaroxaban was associated with less bleeding in VKA-naive patients and similar bleeding in VKA-experienced patients. This information may be useful to clinicians considering a transition to rivaroxaban for patients receiving VKA therapy.

Original language	English
Pages (from-to)	861-868
Number of pages	8
Journal	Annals of Internal Medicine
Volume	158
Issue number	12
DOIs	https://doi.org/10.7326/0003-4819-158-12-201306180-00003
Publication status	Published - 18 Jun 2013

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Mahaffey, K. W., Wojdyla, D., Hankey, G. J., White, H. D., Nessel, C. C., Piccini, J. P., Patel, M. R., Berkowitz, S. D., Becker, R. C., Halperin, J. L., Singer, D. E., Califf, R. M., Fox, K. A. A., Breithardt, G., & Hacke, W. (2013). Clinical Outcomes With Rivaroxaban in Patients Transitioned From Vitamin K Antagonist Therapy: A Subgroup Analysis of a Randomized Trial. Annals of Internal Medicine, 158(12), 861-868. https://doi.org/10.7326/0003-4819-158-12-201306180-00003

@article{cbe4cecc71894c32adcd4b005856a2d5,

title = "Clinical Outcomes With Rivaroxaban in Patients Transitioned From Vitamin K Antagonist Therapy: A Subgroup Analysis of a Randomized Trial",

abstract = "Background: In ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), a large randomized, clinical trial, rivaroxaban was noninferior to warfarin in preventing stroke or systemic embolism in patients with atrial fibrillation.Objective: To determine the efficacy and safety of rivaroxaban compared with warfarin among vitamin K antagonist (VKA)–naive and VKA-experienced patients.Design: Prespecified subgroup analysis. (ClinicalTrials.gov: NCT00403767)Setting: Global.Patients: 14 264 persons with atrial fibrillation.Measurements: Interaction of the relative treatment effect of rivaroxaban and warfarin on stroke or systemic embolism among VKA-naive and VKA-experienced patients.Results: Overall, 7897 (55.4%) patients were VKA-experienced and 6367 (44.6%) were VKA-naive. The effect of rivaroxaban versus warfarin on stroke or systemic embolism was consistent: Rates per 100 patient-years of follow-up were 2.32 versus 2.87 for VKA-naive patients (hazard ratio [HR], 0.81 [95% CI, 0.64 to 1.03]) and 1.98 versus 2.09 for VKA-experienced patients (HR, 0.94 [CI, 0.75 to 1.18]; interaction P = 0.36). During the first 7 days, rivaroxaban was associated with more bleeding than warfarin (HR in VKA-naive patients, 5.83 [CI, 3.25 to 10.44], and in VKA-experienced patients, 6.66 [CI, 3.83 to 11.58]; interaction P = 0.53). After 30 days, rivaroxaban was associated with less bleeding than warfarin in VKA-naive patients (HR, 0.84 [CI, 0.74 to 0.95]) and similar bleeding in VKA-experienced patients (HR, 1.06 [CI, 0.96 to 1.17]; interaction P = 0.003).Limitation: The trial was not designed to detect differences in these subgroups.Conclusion: The efficacy of rivaroxaban in VKA-experienced and VKA-naive patients was similar to that of the overall trial. There were more bleeding events within 7 days of study drug initiation with rivaroxaban, but after 30 days, rivaroxaban was associated with less bleeding in VKA-naive patients and similar bleeding in VKA-experienced patients. This information may be useful to clinicians considering a transition to rivaroxaban for patients receiving VKA therapy.",

author = "Mahaffey, {Kenneth W} and Daniel Wojdyla and Hankey, {Graeme J} and White, {Harvey D} and Nessel, {Christopher C} and Piccini, {Jonathan P} and Patel, {Manesh R} and Berkowitz, {Scott D} and Becker, {Richard C} and Halperin, {Jonathan L} and Singer, {Daniel E} and Califf, {Robert M} and Fox, {Keith A A} and G{\"u}nter Breithardt and Werner Hacke",

year = "2013",

month = jun,

day = "18",

doi = "10.7326/0003-4819-158-12-201306180-00003",

language = "English",

volume = "158",

pages = "861--868",

journal = "Annals of Internal Medicine",

issn = "0003-4819",

publisher = "American College of Physicians",

number = "12",

}

Mahaffey, KW, Wojdyla, D, Hankey, GJ, White, HD, Nessel, CC, Piccini, JP, Patel, MR, Berkowitz, SD, Becker, RC, Halperin, JL, Singer, DE, Califf, RM, Fox, KAA, Breithardt, G & Hacke, W 2013, 'Clinical Outcomes With Rivaroxaban in Patients Transitioned From Vitamin K Antagonist Therapy: A Subgroup Analysis of a Randomized Trial', Annals of Internal Medicine, vol. 158, no. 12, pp. 861-868. https://doi.org/10.7326/0003-4819-158-12-201306180-00003

TY - JOUR

T1 - Clinical Outcomes With Rivaroxaban in Patients Transitioned From Vitamin K Antagonist Therapy

T2 - A Subgroup Analysis of a Randomized Trial

AU - Mahaffey, Kenneth W

AU - Wojdyla, Daniel

AU - Hankey, Graeme J

AU - White, Harvey D

AU - Nessel, Christopher C

AU - Piccini, Jonathan P

AU - Patel, Manesh R

AU - Berkowitz, Scott D

AU - Becker, Richard C

AU - Halperin, Jonathan L

AU - Singer, Daniel E

AU - Califf, Robert M

AU - Fox, Keith A A

AU - Breithardt, Günter

AU - Hacke, Werner

PY - 2013/6/18

Y1 - 2013/6/18

N2 - Background: In ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), a large randomized, clinical trial, rivaroxaban was noninferior to warfarin in preventing stroke or systemic embolism in patients with atrial fibrillation.Objective: To determine the efficacy and safety of rivaroxaban compared with warfarin among vitamin K antagonist (VKA)–naive and VKA-experienced patients.Design: Prespecified subgroup analysis. (ClinicalTrials.gov: NCT00403767)Setting: Global.Patients: 14 264 persons with atrial fibrillation.Measurements: Interaction of the relative treatment effect of rivaroxaban and warfarin on stroke or systemic embolism among VKA-naive and VKA-experienced patients.Results: Overall, 7897 (55.4%) patients were VKA-experienced and 6367 (44.6%) were VKA-naive. The effect of rivaroxaban versus warfarin on stroke or systemic embolism was consistent: Rates per 100 patient-years of follow-up were 2.32 versus 2.87 for VKA-naive patients (hazard ratio [HR], 0.81 [95% CI, 0.64 to 1.03]) and 1.98 versus 2.09 for VKA-experienced patients (HR, 0.94 [CI, 0.75 to 1.18]; interaction P = 0.36). During the first 7 days, rivaroxaban was associated with more bleeding than warfarin (HR in VKA-naive patients, 5.83 [CI, 3.25 to 10.44], and in VKA-experienced patients, 6.66 [CI, 3.83 to 11.58]; interaction P = 0.53). After 30 days, rivaroxaban was associated with less bleeding than warfarin in VKA-naive patients (HR, 0.84 [CI, 0.74 to 0.95]) and similar bleeding in VKA-experienced patients (HR, 1.06 [CI, 0.96 to 1.17]; interaction P = 0.003).Limitation: The trial was not designed to detect differences in these subgroups.Conclusion: The efficacy of rivaroxaban in VKA-experienced and VKA-naive patients was similar to that of the overall trial. There were more bleeding events within 7 days of study drug initiation with rivaroxaban, but after 30 days, rivaroxaban was associated with less bleeding in VKA-naive patients and similar bleeding in VKA-experienced patients. This information may be useful to clinicians considering a transition to rivaroxaban for patients receiving VKA therapy.

AB - Background: In ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), a large randomized, clinical trial, rivaroxaban was noninferior to warfarin in preventing stroke or systemic embolism in patients with atrial fibrillation.Objective: To determine the efficacy and safety of rivaroxaban compared with warfarin among vitamin K antagonist (VKA)–naive and VKA-experienced patients.Design: Prespecified subgroup analysis. (ClinicalTrials.gov: NCT00403767)Setting: Global.Patients: 14 264 persons with atrial fibrillation.Measurements: Interaction of the relative treatment effect of rivaroxaban and warfarin on stroke or systemic embolism among VKA-naive and VKA-experienced patients.Results: Overall, 7897 (55.4%) patients were VKA-experienced and 6367 (44.6%) were VKA-naive. The effect of rivaroxaban versus warfarin on stroke or systemic embolism was consistent: Rates per 100 patient-years of follow-up were 2.32 versus 2.87 for VKA-naive patients (hazard ratio [HR], 0.81 [95% CI, 0.64 to 1.03]) and 1.98 versus 2.09 for VKA-experienced patients (HR, 0.94 [CI, 0.75 to 1.18]; interaction P = 0.36). During the first 7 days, rivaroxaban was associated with more bleeding than warfarin (HR in VKA-naive patients, 5.83 [CI, 3.25 to 10.44], and in VKA-experienced patients, 6.66 [CI, 3.83 to 11.58]; interaction P = 0.53). After 30 days, rivaroxaban was associated with less bleeding than warfarin in VKA-naive patients (HR, 0.84 [CI, 0.74 to 0.95]) and similar bleeding in VKA-experienced patients (HR, 1.06 [CI, 0.96 to 1.17]; interaction P = 0.003).Limitation: The trial was not designed to detect differences in these subgroups.Conclusion: The efficacy of rivaroxaban in VKA-experienced and VKA-naive patients was similar to that of the overall trial. There were more bleeding events within 7 days of study drug initiation with rivaroxaban, but after 30 days, rivaroxaban was associated with less bleeding in VKA-naive patients and similar bleeding in VKA-experienced patients. This information may be useful to clinicians considering a transition to rivaroxaban for patients receiving VKA therapy.

U2 - 10.7326/0003-4819-158-12-201306180-00003

DO - 10.7326/0003-4819-158-12-201306180-00003

M3 - Article

C2 - 23778903

VL - 158

SP - 861

EP - 868

JO - Annals of Internal Medicine

JF - Annals of Internal Medicine

SN - 0003-4819

IS - 12

ER -

Clinical Outcomes With Rivaroxaban in Patients Transitioned From Vitamin K Antagonist Therapy: A Subgroup Analysis of a Randomized Trial

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