What is the clinical evidence from this study?

Study design: RCT. Population: Persistent atrial fibrillation (n=161). Intervention: Amiodarone vs. Placebo. Primary outcome: Maintenance of sinus rhythm at 8 weeks following DC cardioversion (Difference -35%, 95% CI -48 to -18, p=<0.001).

January 1, 2004European Heart Journal

A randomized placebo-controlled trial of pre-treatment and short- or long-term maintenance therapy with amiodarone supporting DC cardioversion for persistent atrial fibrillation

Q: What are the key findings of this study?

Amiodarone therapy maintained sinus rhythm at 8 weeks post-cardioversion in 51% of patients compared to 16% on placebo (P<0.001).

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Key result

Amiodarone therapy maintained sinus rhythm at 8 weeks post-cardioversion in 51% of patients compared to 16% on placebo (P<0.001).

Why the study?

Does amiodarone pre-treatment and maintenance therapy improve the restoration and maintenance of sinus rhythm in patients with persistent atrial fibrillation undergoing DC cardioversion?

Study Design

Type

RCT (n=161)

Blinding

Double-blind

Structured PICO

Does amiodarone pre-treatment and maintenance therapy improve the restoration and maintenance of sinus rhythm in patients with persistent atrial fibrillation undergoing DC cardioversion?

Population

161 subjects with persistent atrial fibrillation (AF) undergoing DC cardioversion (DCCV)

Intervention

Amiodarone 400mg BD for 2 weeks prior to DCCV, then either 200mg daily for 8 weeks followed by placebo for 44 weeks (short-term amiodarone, n=62) or 200mg daily for 52 weeks (long-term amiodarone, n=61)

Comparator

Placebo (n=38)

Outcome

Restoration and maintenance of sinus rhythm (SR) at 8 weeks and 1 yearsurrogate

Main Result

Effect estimate: Difference -35% (95% CI -48 to -18)

Absolute Event Rate: 51% vs 16%

p-value: p=<0.001

Amiodarone pre-treatment and 8-week maintenance therapy significantly improves the maintenance of sinus rhythm following DC cardioversion for persistent AF compared to placebo, while avoiding the higher rate of serious adverse effects seen with 1-year maintenance therapy.

Discussion

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Implication

Supports short-term amiodarone around cardioversion for persistent AF; confirms efficacy versus placebo without long-term adverse effects.

Cite This Study

Kevin S. Channer (2004) conducted an RCT in Persistent atrial fibrillation (n=161). Amiodarone vs. Placebo was evaluated on Maintenance of sinus rhythm at 8 weeks following DC cardioversion (Difference -35%, 95% CI -48 to -18, p=<0.001). Amiodarone therapy maintained sinus rhythm at 8 weeks post-cardioversion in 51% of patients compared to 16% on placebo (P<0.001).

synapsesocial.com/papers/6a0a58bb97b2cd6568591766 https://doi.org/10.1016/j.ehj.2003.10.020

Topics

Persistent AF management Atrial fibrillation Anticoagulation in AF AF ablation outcomes

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Implication

Supports short-term amiodarone around cardioversion for persistent AF; confirms efficacy versus placebo without long-term adverse effects.

A randomized placebo-controlled trial of pre-treatment and short- or long-term maintenance therapy with amiodarone supporting DC cardioversion for persistent atrial fibrillation

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Topics

A randomized placebo-controlled trial of pre-treatment and short- or long-term maintenance therapy with amiodarone supporting DC cardioversion for persistent atrial fibrillation

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Also Consider

Topics

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