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Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial.

Breithardt G, Baumgartner H, Berkowitz SD, Hellkamp AS, Piccini JP, Stevens SR, Lokhnygina Y, Patel MR, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Fox KA, Califf RM, ROCKET AF Steering Committee & Investigato - Eur. Heart J. (2014)

Bottom Line: However, rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD (19.8% rivaroxaban vs. 16.8% warfarin; HR 1.25, 95% CI 1.05-1.49) vs. those without (14.2% rivaroxaban vs. 14.1% warfarin; HR 1.01, 95% CI 0.94-1.10; interaction P = 0.034), even when controlling for risk factors and potential confounders.In intracranial haemorrhage, there was no interaction between patients with and without SVD where the overall rate was lower among those randomized to rivaroxaban.Efficacy of rivaroxaban vs. warfarin was similar in patients with and without SVD; however, the observed risk of bleeding was higher with rivaroxaban in patients with SVD but was the same among those without SVD.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiovascular Medicine, Division of Electrophysiology, University Hospital Münster, Von-Esmarch-Strasse 117, Münster D-48149, Germany g.breithardt@uni-muenster.de.

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Unadjusted primary combined outcome parameters of stroke or systemic embolism in patients with and without significant valvular disease (SVD) randomized to either rivaroxaban or warfarin.
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EHU305F2: Unadjusted primary combined outcome parameters of stroke or systemic embolism in patients with and without significant valvular disease (SVD) randomized to either rivaroxaban or warfarin.

Mentions: The rate of stroke or systemic embolism in patients treated with rivaroxaban compared with warfarin was consistent among patients with SVD (2.01% rivaroxaban vs. 2.43% warfarin; HR 0.83, 95% CI 0.55–1.27) and without SVD (1.96% rivaroxaban vs. 2.22% warfarin; HR 0.89, 95% CI 0.75–1.07; interaction P = 0.76) (Figure 2 and Table 5). However, the rates of major and non-major clinically relevant bleeding in patients with SVD were higher among those treated with rivaroxaban compared with warfarin (19.8% rivaroxaban vs. 16.8% warfarin; HR 1.25, 95% CI 1.05–1.49), whereas there was no difference among those without SVD (14.2 vs. 14.1%; HR 1.01, 95% CI 0.94–1.10; interaction P = 0.034). There was no difference in HRs whether heart failure was included in the safety model or not (Supplementary material online), and there was also no difference in the new use of any antiplatelet drugs or the duration of aspirin use during follow-up (Supplementary material online). Median time in therapeutic range of INR values (TTR) was not significantly different in warfarin patients with and without SVD (60.8 vs. 57.4). The rate of intracranial haemorrhage was lower with rivaroxaban than with warfarin among those without SVD but was about the same among those with SVD. This difference in interaction of SVD and treatment did not achieve statistical significance (P = 0.084), however.Table 5


Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial.

Breithardt G, Baumgartner H, Berkowitz SD, Hellkamp AS, Piccini JP, Stevens SR, Lokhnygina Y, Patel MR, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Fox KA, Califf RM, ROCKET AF Steering Committee & Investigato - Eur. Heart J. (2014)

Unadjusted primary combined outcome parameters of stroke or systemic embolism in patients with and without significant valvular disease (SVD) randomized to either rivaroxaban or warfarin.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4265383&req=5

EHU305F2: Unadjusted primary combined outcome parameters of stroke or systemic embolism in patients with and without significant valvular disease (SVD) randomized to either rivaroxaban or warfarin.
Mentions: The rate of stroke or systemic embolism in patients treated with rivaroxaban compared with warfarin was consistent among patients with SVD (2.01% rivaroxaban vs. 2.43% warfarin; HR 0.83, 95% CI 0.55–1.27) and without SVD (1.96% rivaroxaban vs. 2.22% warfarin; HR 0.89, 95% CI 0.75–1.07; interaction P = 0.76) (Figure 2 and Table 5). However, the rates of major and non-major clinically relevant bleeding in patients with SVD were higher among those treated with rivaroxaban compared with warfarin (19.8% rivaroxaban vs. 16.8% warfarin; HR 1.25, 95% CI 1.05–1.49), whereas there was no difference among those without SVD (14.2 vs. 14.1%; HR 1.01, 95% CI 0.94–1.10; interaction P = 0.034). There was no difference in HRs whether heart failure was included in the safety model or not (Supplementary material online), and there was also no difference in the new use of any antiplatelet drugs or the duration of aspirin use during follow-up (Supplementary material online). Median time in therapeutic range of INR values (TTR) was not significantly different in warfarin patients with and without SVD (60.8 vs. 57.4). The rate of intracranial haemorrhage was lower with rivaroxaban than with warfarin among those without SVD but was about the same among those with SVD. This difference in interaction of SVD and treatment did not achieve statistical significance (P = 0.084), however.Table 5

Bottom Line: However, rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD (19.8% rivaroxaban vs. 16.8% warfarin; HR 1.25, 95% CI 1.05-1.49) vs. those without (14.2% rivaroxaban vs. 14.1% warfarin; HR 1.01, 95% CI 0.94-1.10; interaction P = 0.034), even when controlling for risk factors and potential confounders.In intracranial haemorrhage, there was no interaction between patients with and without SVD where the overall rate was lower among those randomized to rivaroxaban.Efficacy of rivaroxaban vs. warfarin was similar in patients with and without SVD; however, the observed risk of bleeding was higher with rivaroxaban in patients with SVD but was the same among those without SVD.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiovascular Medicine, Division of Electrophysiology, University Hospital Münster, Von-Esmarch-Strasse 117, Münster D-48149, Germany g.breithardt@uni-muenster.de.

Show MeSH
Related in: MedlinePlus