This
3-year study is a randomized comparison of rate control and rhythm
control with endpoints of mortality and morbidity. Results of this
trial show rate control is not inferior to rhythm control. Patients
at high risk of atrial fibrillation recurrence, including hypertensive
patients may benefit from a rate control approach.
Rhythm control is often the preferred treatment in atrial fibrillation
patients. However, rhythm control requires electrical cardioversion,
particularly in patients with persistent atrial fibrillation. Cardioversions
frequently fail due to fibrillatory recurrence, which in turn makes
antiarrhythmic agents unavoidable. Furthermore, rhythm control comes
with risk of specific side effects, such as torsades de pointes.
The hypothesis of the Rate Control versus Electrical Cardioversion
for Persistent Atrial Fibrillation (RACE) study is that a rate control
approach is not inferior to rhythm control. The study included 522
patients enrolled in 35 centers throughout the Netherlands.
Patients in RACE had persistent atrial fibrillation or atrial flutter
for at least 24 hours but not longer than 1 year. They had undergone
1 or 2 electrical cardioversions in the previous 2 years.
The primary endpoint was the composite of cardiovascular death,
hospital admission for heart failure, pacemaker implantation, severe
bleeding, thrombo-embolic complications, or severe adverse effects
of therapy (for example, drug induced ventricular pro-arrhythmia
or syncope).
Investigators randomized patients (mean age 68 years, 63% male)
to rate or rhythm control and followed them for 36 months.
Rate control consisted of drugs such as beta-blockers, digitalis
and calcium antagonists. If symptoms remained intolerable, patients
underwent electrical cardioversion or atrio-ventricular node ablation.
Rhythm control consisted of electrical cardioversion and prophylactic
sotalol. In the case of early or late recurrence, investigators
followed a specific treatment algorithm incorporating repeat cardioversion
and other modalities.
Results showed that 17.2% of rate control patients reached the
primary endpoint, compared with 22.6% of rhythm control patients.
This was a risk difference of -5.4% in favor of rate control. Rate
control was non-inferior to rhythm control for patient with persistent
atrial fibrillation.
Primary Composite Endpoint
|
Rate control
|
Rhythm control
|
Endpoint
|
17.2%
|
22.6%
|
Risk
difference |
-5.4%
|
|
Components
of endpoint
|
|
|
Cardiovascular mortality
|
7.0%
|
6.7%
|
Heart failure
|
3.5%
|
4.5%
|
Thrombo-embolic complications
|
5.5%
|
7.5%
|
Bleeding
|
4.7%
|
3.4%
|
Adverse events
|
0.8%
|
4.5%
|
Pacemaker
|
1.2%
|
3.0%
|
About 7% of patients died in each group. The cause was sudden death
for about half the patients in each group. The second most common
reason for death in the rhythm control group was thrombo-embolic
complications. In rate control, patients died more frequently from
bleeding or heart failure.
The difference in the primary composite endpoint was mainly due
to a difference in non-fatal endpoints (10% and 15% of the rate
and rhythm control groups, respectively). There was a difference
in rate of severe adverse events and pacemaker implantation in favor
of rate control.
A subgroup analysis suggested hypertensive patients might do better
on rate control. However, this post-hoc hypothesis must be evaluated.
For now, results of RACE suggest that rate control is an attractive
alternative for patients at high risk of recurrence of atrial fibrillation.
|