P3447Mortality and stroke prevention in atrial fibrillation; network meta-analysis of real world data

AbstractReal-world data are a well-recognized component within the drug lifecycle, and such data are generated from a range of sources and study designs, including claims databases, electronic health records, non-interventional studies (NIS) and registries. While this information can be of vital clinical importance, there may be challenges in understanding the relevance of the differing study designs, endpoints and populations. Here, we summarize the value of real-world evidence and considerations pertinent to their use in clinical research. Owing to the variety of analyses being conducted using real-world data, it is important for researchers and clinicians to have a clear understanding of the nature and origin of those data, and to ensure they are valid, reliable and robust in terms of extrapolating meaningful findings. There are crucial questions to address when evaluating real-world studies, and we introduce a checklist to meet these objectives. In addition to advice for appraising data quality and study designs, several updates will be covered from real-world studies of rivaroxaban for stroke prevention in patients with atrial fibrillation (AF): the nationwide Danish cohort study, U.S. Department of Defense Military Health System database, retrospective claim database study REAFFIRM and a pooled analysis from the global NIS XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation (XANTUS). Real-world studies consistently show that rivaroxaban is an effective treatment option with acceptable safety when used for stroke prevention in a large number of patients with AF across the globe.

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“Unreal world” or “real world” data in oral anticoagulant treatment of atrial fibrillation

Thrombosis and Haemostasis ◽

10.1160/th16-08-0658 ◽

2016 ◽

Vol 116 (10) ◽

pp. 587-589 ◽

Cited By ~ 41

Author(s):

Gregory Y. H. Lip ◽

Ben Freedman

Keyword(s):

Atrial Fibrillation ◽

Real World ◽

Oral Anticoagulant ◽

Review Process ◽

Anticoagulant Treatment ◽

Real World Data ◽

Oral Anticoagulant Treatment ◽

World Data

Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.

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Abstract TP519: The Effect of Different Oral Anticoagulants on Vascular Outcomes in Stroke With Atrial Fibrillation: A Real-world Data

Stroke ◽

10.1161/str.50.suppl_1.tp519 ◽

2019 ◽

Vol 50 (Suppl_1) ◽

Author(s):

Woo-Keun Seo ◽

Joon-Tae Kim ◽

Jong-Won Chung ◽

Tae-Jin Song ◽

Yong-Jae Kim ◽

...

Keyword(s):

Atrial Fibrillation ◽

Real World ◽

Oral Anticoagulants ◽

Real World Data ◽

World Data

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Edoxaban versus placebo, aspirin, or aspirin plus clopidogrel for stroke prevention in atrial fibrillation

Thrombosis and Haemostasis ◽

10.1160/th15-05-0383 ◽

2015 ◽

Vol 114 (08) ◽

pp. 403-409 ◽

Cited By ~ 8

Author(s):

Lars Rasmussen ◽

Torben Larsen ◽

Andrew Blann ◽

Flemming Skjøth ◽

Gregory Lip

Keyword(s):

Atrial Fibrillation ◽

Clinical Trial ◽

Real World ◽

Meta Analysis ◽

Oral Anticoagulants ◽

Published Data ◽

Real World Data ◽

Once Daily ◽

Increased Risk ◽

Reduced Risk

SummaryAs non-valvular atrial fibrillation (AF) brings a risk of stroke, oral anticoagulants (OAC) are recommended. In ‘real world’ clinical practice, many patients (who may be, or perceived to be, intolerant of OACs) are either untreated or are treated with anti-platelet agents. We hypothesised that edoxaban has a better net clinical benefit (NCB, balancing the reduction in stroke risk vs increased risk of haemorrhage) than no treatment or anti-platelet agents. We performed a network meta-analysis of published data from 24 studies of 203,394 AF patients to indirectly compare edoxaban with aspirin alone, aspirin plus clopidogrel, and placebo. Edoxaban 30 mg once daily significantly reduced the risk of all stroke, ischaemic stroke and mortality compared to placebo and aspirin. Compared to aspirin plus clopidogrel, there was a lower risk of intra-cranial haemorrhage (ICH). Edoxaban 60 mg once-daily had a reduced risk of any stroke and systemic embolism compared to placebo, aspirin, and aspirin plus clopidogrel. Mortality rates for both edoxaban doses were estimated to be lower compared to any anti-platelet, and significantly lower compared to placebo. With overall reduced risk of ischemic stroke and ICH, both edoxaban doses bring a NCB of mean (SD) 1.68 (0.15) saved events per 100 patients per year compared to anti-platelet drugs in a clinical trial population. The NCB was demonstrated to be lower, at 0.77 (0.12) events saved (p< 0.01) when modeled to data from a ‘real world’ cohort of AF patients. In conclusion, edoxaban is likely to provide even better protection from stroke and ICH than placebo, aspirin alone, or aspirin plus clopidogrel in both clinical trial populations and unselected community populations. Both edoxaban doses would also bring a positive NCB compared to anti-platelet drugs or placebo/non-treatment based on ‘real world’ data.Note: The review process for this paper was fully handled by Christian Weber, Editor in Chief.

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