ArticlePharmacoepidemiology and drug safety2020
Rivaroxaban was found to be noninferior to warfarin in routine clinical care: A retrospective noninferiority cohort replication study.
Article in Pharmacoepidemiology and drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 10 citations in OpenAlex.
- Concordance between target trial emulation and randomised controlled trials: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2026Pooled it
- Use of sensitivity analyses to assess uncontrolled confounding from unmeasured variables in observational, active comparator pharmacoepidemiologic studies: a systematic review.American journal of epidemiology · 2025Pooled it
- Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials: A Systematic Review.JAMA network open · 2023Pooled it
- Resident Participation in Operative Fixation of Distal Radius Fractures: A Comparison of Outcomes.Journal of hand surgery global online · 2026Article
- Progression-free survival outcomes of PARP inhibitors in ovarian cancer: an exploratory analysis of treatment heterogeneity based on organ vulnerability.Frontiers in oncology · 2026Article
- Review of Recent Pharmacoepidemiologic Post-Market Safety Studies Through the Lens of the Estimand Framework.Therapeutic innovation & regulatory science · 2025Review
- Methodologies for the Emulation of Biomarker-Guided Trials Using Observational Data: A Systematic Review.Journal of personalized medicine · 2025Review
- Making causal inferences from transactional data: A narrative review of opportunities and challenges when implementing the target trial framework.The Journal of international medical research · 2024Review
- Implementation of the trial emulation approach in medical research: a scoping review.BMC medical research methodology · 2023Article
- Rivaroxaban was found to be noninferior to warfarin in routine clinical care: A retrospective noninferiority cohort replication study.Pharmacoepidemiology and drug safety · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo compare the effectiveness and safety of a drug in daily practice with the outcomes of a target non-inferiority trial by rigorously mimickingin an observational study the trial's design features.
methodsThis cohort study was conducted using the British Clinical Practice Research Datalink (CPRD) to emulate the 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) trial. Patients with atrial fibrillation who were newly prescribed (>=12 months of no use) either rivaroxaban or warfarinfrom October 2008 to December 2017 were included. Non-inferiority of rivaroxaban to warfarin in the prevention of stroke or systemic embolism was assessed in different analysis populations (intention-to-treat [ITT], per-protocol [PP], and as-treated populations) using a hazardratio (HR) of 1.46 as the non-inferiority margin. Major bleeding (safety outcome) was also assessed and compared to that of the target trial. All outcomes were analyzed using Cox-proportional hazard analyses.
resultsWe included 25,473 incident users of rivaroxaban (n=4,008) or warfarin(n=21,465). Similar to the trial, non-inferiority in the primary out come was demonstrated in all three analysis populations: HR=1.04 (95%CI 0.84 to 1.30) (ITT), HR=0.98 (95%CI 0.70 to 1.38) (PP), and HR=1.11 (95%CI 0.86 to 1.42) (as-treated). Risk of major bleeding was also similar to the target trial.
conclusionThe results of this study provide supportive evidence to the effectiveness of rivaroxaban and adds knowledge on the usefulness of emulating a non-inferiority trial to assess drug effectiveness.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.