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July 27, 2026Current Medical Research and Opinion0 citations

Real-world comparative safety and effectiveness of rivaroxaban versus warfarin in patients with non-valvular atrial fibrillation: a prospective cohort study

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NANawal AlsubaieZSZafar Ali ShahMIMuhammad Ilyas

Key Result

Rivaroxaban showed a non-significant trend toward reducing stroke or systemic embolism compared to warfarin (HR 0.63; 95% CI 0.36-1.10; p=0.09) in patients with NVAF.

Key Points

  • To compare the safety and efficacy of rivaroxaban versus warfarin in managing patients with non-valvular atrial fibrillation experiencing challenges with warfarin.
  • Prospective cohort study involving 892 patients with NVAF (rivaroxaban, n = 473; warfarin, n = 419)
  • Conducted at Kuwait Teaching Hospital, Peshawar, from January 2022 to December 2024
  • Followed patients for 12 months assessing composite stroke/systemic embolism and major bleeding.
  • 4.44% of rivaroxaban patients experienced the primary efficacy endpoint compared to 7.16% for warfarin (HR = 0.63, 95% CI = 0.36–1.10, p = 0.09)
  • Major bleeding rates were comparable at 6.77% for rivaroxaban and 6.92% for warfarin (p = 0.91)
  • Rivaroxaban showed significantly higher medication adherence at 91.4% compared to 69.3% for warfarin (p < 0.001).

Study Design

Type

Cohort (n=892)

Multicenter

No

Structured PICO

Does rivaroxaban improve efficacy and safety outcomes compared to warfarin in patients with non-valvular atrial fibrillation experiencing challenges in warfarin management?

P
Population
892 patients with non-valvular atrial fibrillation experiencing challenges in warfarin management, followed for 12 months.
E
Exposure
Rivaroxaban
C
Comparator
Warfarin
O
Outcome
Composite of stroke or systemic embolism (primary efficacy endpoint) and major bleeding according to International Society on Thrombosis and Haemostasis (ISTH) criteria (primary safety endpoint) at 12 months.composite

In a real-world cohort of NVAF patients, rivaroxaban demonstrated comparable efficacy and safety to warfarin, but with significantly higher medication adherence.

Main Result

Hazard Ratio: 0.63 (95% CI 0.36–1.1)

Absolute Event Rate: 4.44% vs 7.16%

p-value: p=0.09

Abstract

Background Direct oral anticoagulants (DOACs) provide several advantages over warfarin for stroke prevention in atrial fibrillation, particularly among patients with unstable or difficult-to-control international normalized ratio (INR) values.Objective To compare the safety and efficacy of rivaroxaban versus warfarin in patients with non-valvular atrial fibrillation (NVAF) experiencing challenges in warfarin management.Methods This prospective cohort study included 892 patients with NVAF (rivaroxaban, n = 473; warfarin, n = 419) treated at Kuwait Teaching Hospital, Peshawar, between January 2022 and December 2024, with a 12-month follow-up period. The primary efficacy endpoint was a composite of stroke or systemic embolism, while the primary safety endpoint was major bleeding according to International Society on Thrombosis and Haemostasis (ISTH) criteria. Secondary outcomes included thromboembolic events, bleeding complications, mortality, medication adherence, and treatment discontinuation. Cox proportional hazards regression with multivariable adjustment was applied.Results The primary efficacy endpoint occurred in 4.44% and 7.16% of rivaroxaban and warfarin patients, respectively (HR = 0.63, 95% CI = 0.36–1.10, p = 0.09), indicating a non-significant trend favoring Rivaroxaban. Major bleeding rates were comparable (6.77% vs. 6.92%, p = 0.91), with similar intracranial hemorrhage rates. Rivaroxaban showed significantly higher medication adherence (91.4% vs. 69.3%, p < 0.001), whereas treatment persistence and all-cause mortality were comparable between groups.Conclusions Rivaroxaban demonstrated comparable efficacy and safety to warfarin, with superior medication adherence and no requirement for INR monitoring. These findings suggest that rivaroxaban may represent a practical therapeutic option for patients with NVAF, particularly in healthcare settings with limited monitoring infrastructure.

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Cite This Study

Alsubaie et al. (2026) conducted a cohort in non-valvular atrial fibrillation (n=892). Rivaroxaban vs. Warfarin was evaluated on composite of stroke or systemic embolism (HR 0.63, 95% CI 0.36-1.10, p=0.09). Rivaroxaban showed a non-significant trend toward reducing stroke or systemic embolism compared to warfarin (HR 0.63; 95% CI 0.36-1.10; p=0.09) in patients with NVAF.

synapsesocial.com/papers/6a67008840bca442e0d4a3dbhttps://doi.org/10.1080/03007995.2026.2706317
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