What question did this study set out to answer?

To evaluate the safety and efficacy of the oral factor Xa inhibitor apixaban compared to the vitamin K antagonist phenprocoumon in patients with atrial fibrillation undergoing maintenance haemodialysis.

September 1, 2018BMJ OpenOpen Access

Design and rationale of a randomised controlled trial comparing apixaban to phenprocoumon in patients with atrial fibrillation on chronic haemodialysis: the AXADIA-AFNET 8 study

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Atrial fibrillation on chronic haemodialysis (n=222). Intervention: Apixaban vs. Dose-adjusted vitamin K antagonist therapy (phenprocoumon). Primary outcome: Major or clinically relevant, non-major bleedings or death of any cause.

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Key result

The AXADIA-AFNET 8 trial is an ongoing randomized study designed to evaluate apixaban versus vitamin K antagonists in 222 patients with atrial fibrillation on chronic hemodialysis.

Why the study?

Does apixaban reduce major bleeding or death compared to vitamin K antagonists in patients with atrial fibrillation on chronic haemodialysis?

Population

222 patients with atrial fibrillation (AF) requiring maintenance haemodialysis

Comparison

Apixaban 2.5 mg twice daily vs Dose-adjusted vitamin K antagonist therapy

Design

Other, 1:1 design, open-labelled

Follow-up

minimum of 6 months up to a maximum of 24 months

Authors

HRHolger ReineckeInterventional Cardiology SJSabine JürgensmeyerAtrial Fibrillation NETwork CEChristiane EngelbertzUniversity Hospital Münster

Discussion

Member takes

Implication

The AXADIA-AFNET 8 trial is designed to provide randomized data on the safety and efficacy of apixaban versus vitamin K antagonists in patients with atrial fibrillation on chronic hemodialysis.

Key Points

To evaluate the safety and efficacy of the oral factor Xa inhibitor apixaban compared to the vitamin K antagonist phenprocoumon in patients with atrial fibrillation undergoing maintenance haemodialysis.
Phase IIIb open-label randomized controlled trial (AXADIA-AFNET 8, NCT02933697) designed to enroll 222 patients with atrial fibrillation on maintenance haemodialysis across Germany.
Participants are randomized 1:1 to receive apixaban 2.5 mg twice daily or dose-adjusted phenprocoumon targeting an international normalised ratio of 2.0 to 3.0.
Patients are followed for a minimum of 6 months up to 24 months to assess the primary composite endpoint of major or clinically relevant non-major bleeding, or all-cause mortality.
The report establishes the protocol and rationale for evaluating factor Xa inhibition versus vitamin K antagonism in end-stage kidney disease; trial enrollment commenced in June 2017 with quantitative event rates pending.
Secondary efficacy outcomes focus on cumulative incidences of stroke, cardiovascular death, and systemic thromboembolic events between the two oral anticoagulation regimens.

Study Design

Type

RCT (n=222)

Blinding

Open-label

Randomization

1:1

Multicenter

Yes

Structured PICO

Does apixaban reduce major bleeding or death compared to vitamin K antagonists in patients with atrial fibrillation on chronic haemodialysis?

Population

222 patients with atrial fibrillation requiring maintenance hemodialysis, randomized to apixaban or vitamin K antagonist, followed for 6 to 24 months.

Intervention

Apixaban 2.5 mg twice daily

Comparator

Dose-adjusted vitamin K antagonist therapy (phenprocoumon, target international normalised ratio 2.0-3.0)

Outcome

Major or clinically relevant, non-major bleedings or death of any causecomposite

The AXADIA-AFNET 8 trial is designed to provide randomized data on the safety and efficacy of apixaban versus vitamin K antagonists in patients with atrial fibrillation on chronic hemodialysis.

Cite This Study

Reinecke et al. (2018) conducted an RCT in Atrial fibrillation on chronic haemodialysis (n=222). Apixaban vs. Dose-adjusted vitamin K antagonist therapy (phenprocoumon) was evaluated on Major or clinically relevant, non-major bleedings or death of any cause. The AXADIA-AFNET 8 trial is an ongoing randomized study designed to evaluate apixaban versus vitamin K antagonists in 222 patients with atrial fibrillation on chronic hemodialysis.

synapsesocial.com/papers/6a9557996f34f99aa233169c https://doi.org/10.1136/bmjopen-2018-022690

Topics

Atrial fibrillation Persistent AF management Anticoagulation in AF

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September 1, 2018BMJ OpenOpen Access

Design and rationale of a randomised controlled trial comparing apixaban to phenprocoumon in patients with atrial fibrillation on chronic haemodialysis: the AXADIA-AFNET 8 study

View Full Paper

Ask AI

Bookmark

Key result

The AXADIA-AFNET 8 trial is an ongoing randomized study designed to evaluate apixaban versus vitamin K antagonists in 222 patients with atrial fibrillation on chronic hemodialysis.

Why the study?

Does apixaban reduce major bleeding or death compared to vitamin K antagonists in patients with atrial fibrillation on chronic haemodialysis?

Population

222 patients with atrial fibrillation (AF) requiring maintenance haemodialysis

Comparison

Apixaban 2.5 mg twice daily vs Dose-adjusted vitamin K antagonist therapy

Design

Other, 1:1 design, open-labelled

Follow-up

minimum of 6 months up to a maximum of 24 months

Authors

HRHolger ReineckeInterventional Cardiology SJSabine JürgensmeyerAtrial Fibrillation NETwork CEChristiane EngelbertzUniversity Hospital Münster

Discussion

Member takes

Implication

The AXADIA-AFNET 8 trial is designed to provide randomized data on the safety and efficacy of apixaban versus vitamin K antagonists in patients with atrial fibrillation on chronic hemodialysis.

Key Points

To evaluate the safety and efficacy of the oral factor Xa inhibitor apixaban compared to the vitamin K antagonist phenprocoumon in patients with atrial fibrillation undergoing maintenance haemodialysis.
Phase IIIb open-label randomized controlled trial (AXADIA-AFNET 8, NCT02933697) designed to enroll 222 patients with atrial fibrillation on maintenance haemodialysis across Germany.
Participants are randomized 1:1 to receive apixaban 2.5 mg twice daily or dose-adjusted phenprocoumon targeting an international normalised ratio of 2.0 to 3.0.
Patients are followed for a minimum of 6 months up to 24 months to assess the primary composite endpoint of major or clinically relevant non-major bleeding, or all-cause mortality.
The report establishes the protocol and rationale for evaluating factor Xa inhibition versus vitamin K antagonism in end-stage kidney disease; trial enrollment commenced in June 2017 with quantitative event rates pending.
Secondary efficacy outcomes focus on cumulative incidences of stroke, cardiovascular death, and systemic thromboembolic events between the two oral anticoagulation regimens.

Study Design

Type

RCT (n=222)

Blinding

Open-label

Randomization

1:1

Multicenter

Yes

Structured PICO

Does apixaban reduce major bleeding or death compared to vitamin K antagonists in patients with atrial fibrillation on chronic haemodialysis?

Population

222 patients with atrial fibrillation requiring maintenance hemodialysis, randomized to apixaban or vitamin K antagonist, followed for 6 to 24 months.

Intervention

Apixaban 2.5 mg twice daily

Comparator

Dose-adjusted vitamin K antagonist therapy (phenprocoumon, target international normalised ratio 2.0-3.0)

Outcome

Major or clinically relevant, non-major bleedings or death of any causecomposite

The AXADIA-AFNET 8 trial is designed to provide randomized data on the safety and efficacy of apixaban versus vitamin K antagonists in patients with atrial fibrillation on chronic hemodialysis.

Cite This Study

synapsesocial.com/papers/6a9557996f34f99aa233169c https://doi.org/10.1136/bmjopen-2018-022690

Also Consider

Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context:

Topics

Atrial fibrillation Persistent AF management Anticoagulation in AF

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