| Authors |
| Roy D, Talajic M, Nattel S, et al. |
| Title |
| Rhythm Control versus Rate Control for Atrial Fibrillation and Heart Failure |
| References |
| N Engl J Med 2008;358:2667-77. |
| Background |
| Heart failure (HF) patients with atrial fibrillation (AF) have been under-represented in previous rate vs. rhythm control trials. The literature suggests that heart failure patients with AF have a worse prognosis than those who maintain sinus rhythm. |
| Purpose |
| To determine if rhythm control will have a beneficial impact on CV death, as compared to rate control, for patients with AF and HF (LVEF ≤ 35%, NYHA class II-IV). |
| Design |
- Randomized, multicenter, unblinded trial
- 1376 patients, ≥ 18 years with documented LVEF ≤ 35% (by nuclear imaging, echo or cardiac angiography) and a history of both:
- atrial fibrillation = one episode lasting ≥ 6 hours or cardioversion within the last 6 months or an episode lasting ≥ 10 minutes in the last 6 months and previous electrical conversion
- Heart failure = NYHA class II-IV symptoms in the last 6 months, asymptomatic with either HF hospitalization in the last 6 months or LVEF ≤ 25%.
- For all patients, recommendations for ACE inhibitor or ARB therapy; maximum tolerated doses of beta-blockers; anticoagulation. Recommendations for implantable defibrillator and ventricular-resynchronization as per guidelines.
|
| Exclusion Criteria |
- persistent AF >12 months, AF or HF with reversible etiology, use of antiarrhythmic drugs for other arrhythmias, 2° and 3° AV block, HF decompensation within 48 hrs of randomization, previous AV nodal ablation, long-QT syndrome, planned cardiac transplant, dialysis patients
|
| Follow-Up |
| Mean of 37 months. |
| Treatment Regimen |
- Rhythm Control arm: Initial therapy with amiodarone and either sotalol or dofetilide if required. Electrical cardioversion was performed within 6 wks of randomization if patients did not convert to sinus rhythm after antiarrhythmic drug therapy; if needed, a second cardioversion was performed within three months and for subsequent AF recurrences. Pacemakers were recommended if bradycardia prevented use of antiarrhythmics.
- Rate Control arm: Titrated beta-blocker with digitalis to achieve target resting heart rate <80 bpm and 6 minute walk test HR <110 bpm. AV nodal ablation and pacemaker therapy were recommended if rate control was not achieved with drugs.
|
| Results |
Primary Endpoints Death from cardiovascular causes: 27% (rhythm-control) vs. 25% (rate-control); unadjusted hazard ratio 1.06 (0.86-1.30), p=0.59.
Secondary Endpoints (see study for complete list) | Rhythm Control | Rate Control | Hazard Ratio | p | | All cause mortality | | 32% | 33% | 0.97 (0.80-1.17) | 0.73 | | Stroke |
|---|
| 3% | 4% | 0.74 (0.40-1.35) | 0.32 | | Worsening HF (hospitalization required, IV diuretics, change in treatment strategy) |
|---|
| 28% | 31% | 0.87 (0.72-1.06) | 0.17 | | Composite of death from CV causes, stroke, worsening HF |
|---|
| 43% | 46% | 0.90 (0.77-1.06) | 0.20 | - increased hospitalization in the rhythm-control group (64%) than in the rate-control group (59%), p=0.06
- increased hospitalization for AF in the rhythm-control group (14%) than in the rate-control group (9%), p=0.001
- increased hospitalization for bradyarrhythmias in the rhythm-control group (6%) than in the rate-control group (3%), p=0.02
|
| Summary |
| Rhythm-control strategy does not reduce mortality rates from cardiovascular causes for patients with atrial fibrillation and heart failure as compared to rate-control. |