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March 1, 2019BMJ Open78 citationsOpen Access

Risk factors for thromboembolic and bleeding events in anticoagulated patients with atrial fibrillation: the prospective, multicentre observational PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF)

MRMiklós RohlaTWThomas W. WeissLPLadislav Pecen

Key Result

Each single point decrease on a modifiable bleeding risk scale was associated with a 30% lower risk for major bleeding (OR 0.70; 95% CI 0.64-0.76) and a 28% lower rate of thromboembolic events.

Study Design

Type

Observational (n=8,466)

Multicenter

Yes

Structured PICO

What are the risk factors for thromboembolic and bleeding events in anticoagulated patients with atrial fibrillation?

P
Population
8,466 anticoagulated patients with atrial fibrillation (mean age 72, 40% female) treated with VKA or NOACs across 7 European countries, followed for 1 year.
E
Exposure
Assessment of modifiable risk factors for bleeding and thromboembolism
O
Outcome
Thromboembolic events (ischaemic stroke, systemic embolism) and major bleeding (gastrointestinal bleeding, intracerebral haemorrhage and other life-threatening bleeding) at 1-year follow-upcomposite

Addressing modifiable bleeding risk factors in anticoagulated AF patients is associated with significant reductions in both major bleeding and thromboembolic events.

Main Result

Odds Ratio: 0.7 (95% CI 0.64–0.76)

p-value: p=<0.01

Abstract

Objectives We identified factors associated with thromboembolic and bleeding events in two contemporary cohorts of anticoagulated patients with atrial fibrillation (AF), treated with either vitamin K antagonists (VKA) or non-VKA oral anticoagulants (NOACs). Design Prospective, multicentre observational study. Setting 461 centres in seven European countries. Participants 5310 patients receiving a VKA (PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF), derivation cohort) and 3156 patients receiving a NOAC (PREFER in AF Prolongation, validation cohort) for stroke prevention in AF. Outcome measures Risk factors for thromboembolic events (ischaemic stroke, systemic embolism) and major bleeding (gastrointestinal bleeding, intracerebral haemorrhage and other life-threatening bleeding). Results The mean age of patients enrolled in the PREFER in AF registry was 72±10 years, 40% were female and the mean CHA 2 DS 2 -VASc Score was 3.5±1.7. The incidence of thromboembolic and major bleeding events was 2.34% (95% CI 1.93% to 2.74%) and 2.84% (95% CI 2.41% to 3.33%) after 1-year of follow-up, respectively. Abnormal liver function, prior stroke or transient ischaemic attack, labile international normalised ratio (INR), concomitant therapy with antiplatelet or non-steroidal anti-inflammatory drugs, heart failure and older age (≥75 years) were independently associated with both thromboembolic and major bleeding events. With the exception of unstable INR values, these risk factors were validated in patients treated with NOACs (PREFER in AF Prolongation Study, 72±9 years, 40% female, CHA 2 DS 2 -VASc 3.3±1.6). For each single point decrease on a modifiable bleeding risk scale we observed a 30% lower risk for major bleeding events (OR 0.70, 95% CI 0.64 to 0.76, p<0.01) and a 28% lower rate of thromboembolic events (OR 0.72, 95% CI 0.66 to 0.82, p<0.01). Conclusion Attending to modifiable risk factors is an important treatment target in anticoagulated AF patients to reduce thromboembolic and bleeding events. Initiation of anticoagulation in those at risk of stroke should not be prevented by elevated bleeding risk scores.

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Cite This Study

Rohla et al. (2019) conducted an observational in Atrial fibrillation (n=8,466). Single point decrease on a modifiable bleeding risk scale was evaluated on Major bleeding events (OR 0.70, 95% CI 0.64 to 0.76, p=<0.01). Each single point decrease on a modifiable bleeding risk scale was associated with a 30% lower risk for major bleeding (OR 0.70; 95% CI 0.64-0.76) and a 28% lower rate of thromboembolic events.

synapsesocial.com/papers/6a61c344437918011ec91d09https://doi.org/10.1136/bmjopen-2018-022478
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