Stephanie Müller, Luise Tittl, Vicky Speed, Lara Roberts, Jignesh Patel, Raj K Patel, Roopen Arya, Nils Kucher, David Spirk, Kurtulus Sahin, Jan Beyer-Westendorf
| Original language | English |
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| Article number | e12829 |
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| Number of pages | 10 |
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| Journal | Research and practice in thrombosis and haemostasis |
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| Volume | 6 |
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| Issue number | 7 |
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| Early online date | 30 Oct 2022 |
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| DOIs | |
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| Accepted/In press | 2 Oct 2022 |
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| E-pub ahead of print | 30 Oct 2022 |
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| Published | Oct 2022 |
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Funding Information:
The authors thank the statistical team at ClinStat GmbH, Institut für klinische Forschung und Statistik, Max-Planck-Str. 22a, 50858 Köln for their support in analyzing the data. Open Access funding enabled and organized by Projekt DEAL.
Funding Information:
The FIRST, SWIVTER, and DRESDEN NOAC registries were all investigator‐initiated studies, supported by grants from Bayer AG. Furthermore, the pooled analysis reported here was additionally supported by a grant from Bayer AG.
Publisher Copyright:
© 2022 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis (ISTH).
Pooled Analysis of Rivaroxaban_MULLER_2022_GOLD VoR (CC BY-NC-ND)
Muller_Tittl_Speed_Roberts_Patel_Patel_Arya_Kucher_Spirk_Sahin_Beyer_Wesrendorf._Pooled_analysis_of_rivaroxaban_for_acute_VTE_in_FIRST_SWIVTER_and_DRESDEN._RPTH_2022_.pdf, 1.1 MB, application/pdf
Uploaded date:02 Nov 2022
Version:Final published version
Licence:CC BY-NC-ND
Background
The direct factor Xa inhibitor rivaroxaban is approved for the treatment of venous thromboembolism (VTE), based on the results of large phase III trials.
Objectives
To confirm rivaroxaban's effectiveness and safety in routine clinical care of patients with VTE.
Methods
Data were obtained from prospective, noninterventional registries: the FIRST registry (United Kingdom), DRESDEN NOAC registry (Germany), and SWIVTER (Switzerland). Baseline characteristics of these registries and effectiveness and safety outcome rates for the FIRST and DRESDEN NOAC registries were compared.
Results
A total of 1841 rivaroxaban-treated patients with acute VTE (57.9% male, 76.6% deep vein thrombosis [DVT]; 23.4% pulmonary embolism ± DVT; median age, 61 years) were included: 1217 from the FIRST registry, 418 from the DRESDEN NOAC registry, and 206 from SWIVTER. Median time between VTE diagnosis and initiation of rivaroxaban was 1.4 ± 1.81 days (25th–75th percentile 1–1; range, 0–15 days). On-treatment outcome rates for the FIRST and DRESDEN NOAC registries were 0.74 per 100 patient-years (95% confidence interval [CI], 0.35–1.54) versus 0.96 per 100 patient-years (95% CI, 0.46–2.01) for VTE recurrence; 1.16 per 100 patient years (95% CI, 0.64–2.09) versus 2.51 per 100 patient-years (95% CI, 1.58–3.98) for ISTH major bleeding and 1.69 per 100 patient-years (95% CI, 1.21–2.35) versus 1.73 per 100 patient-years (95% CI, 1.27–2.36) for all-cause mortality (intention-to-treat analysis), respectively.
Conclusion
Overall treatment outcomes were consistent with the results of the phase III rivaroxaban trials in VTE treatment, indicating that the use of rivaroxaban offers acceptable treatment results also in routine care. However, we observed significant differences in patient characteristics and management patterns across Switzerland, the United Kingdom, and Germany, limiting direct comparisons of unadjusted outcome event rates between registries.