Author(s) |
(a) Planning and Steering Committees of the AFFIRM Study for the NHLBI AFFIRM Investigators
(b) Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators |
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Title(s) |
(a)Atrial fibrillation follow-up investigation of rhythm management - the AFFIRM study design
(b) A comparison of rate control and rhythm control in patients with atrial fibrillation |
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Reference(s) |
(a) Am J Cardiol 1997;79:1198-202
(b) N Engl J Med 2002;347:1825–33 |
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Disease |
Atrial fibrillation
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Purpose |
To compare the effects of antiarrhythmic therapy vs heart rate control therapy in patients with atrial fibrillation on overall mortality. |
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Study design |
Randomised, open, parallel-group
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Follow-up |
Mean 3.5 years
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Patients |
4060 patients (2033 rhythm control, 2027 heart rate control), aged 69.7 ± 9.0 years, with episodes of atrial fibrillation in the last 6 months and at least 1 documented episode within 6 weeks (later changed to 12 weeks) of enrolment. All patients must were at high risk of stroke (≥ 65 years of age, or < 65 years with at least 1 other risk factor)
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Treatment regimen |
Step I: restricted choice (according to history) of ≥ 1 antiarrhythmic from a specified group, including amiodarone and sotalol, or heart rate control with ≥ 1 drug from a group including beta-blockers, digoxin, diltiazem and verapamil
Step II: protocol-specified innovative therapy (ablation of an atrial focus; atrial pacing alone; atrial pacing and antiarrhythmic drugs; surgical maze or atrial isolation procedures) after failure or intolerance in step I
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Concomitant therapy |
Initial antithrombotic therapy (warfarin for at least 12 weeks, then ASA), atrioventricular nodal blocking drugs. Cardioversion as required
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Results |
There was no significant difference in overall mortality between the rhythm-control group and the heart rate-control group (26.7% vs 25.9%; p = 0.08). Only a small number of patients were given nonpharmalogical (step II) therapies, which were considered not applicable to elderly patients with atrial fibrillation |
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Comments |
A substudy evaluating the efficacy of antiarrhythmic drugs used in the rhythm-control group has been published in J Am Coll Cardiol 2003;42:20–9. Data on stroke rates have been published in Arch Intern Med 2005;165:1185–91 |
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