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Both
rate control and rhythm control are reasonable goals in patients
with atrial fibrillation (AF), according to two new studies
that indicated they are at least equal in efficacy.
Results
of the AFFIRM (Atrial Fibrillation Follow-up Investigation
in Rhythm Management) and RACE (Rate Control vs. Electrical
Cardioversion for Persistent Atrial Fibrillation) trials were
discussed by their investigators during a news conference
here Monday. AFFIRM randomized patients to medical therapy
either to restore atrial rhythm or to control ventricular
heart rate, whereas RACE compared medical therapy to control
heart rate with electrocardioversion of rhythm.
Rate
control is considered by many physicians as a secondary strategy
for AF, said D. George Wyse, MD, PhD, of the Cardiac
Arrhythmia Clinic at the University of Calgary in Calgary,
Alberta, Canada.
Now,
with the AFFIRM trial, continued Dr. Wyse, We can say
that [rate control] is at least as good as rhythm control
and should be considered a primary strategy.
AFFIRM
randomized 4,060 elderly patients to medical management of
AF. The primary study endpoint, total mortality, was slightly
lower in the rate-control arm, although the trend was not
quite statistically significant, said Dr. Wyse. At an average
of 3.5 years of follow-up, there were 306 deaths in the rate-control
arm vs. 356 in the rhythm-control arm.
Outcomes
were approximately the same for the two groups in the secondary
endpoint, ischemic stroke, he added.
All
patients started the trial on anticoagulant therapy, which
could be discontinued in the rhythm control arms if patients
were thought to be in continuous sinus rhythm. Patients could
be crossed over to the alternate trial arm if necessary, although
Dr. Wyse noted that the analysis was done on an intent-to-treat
basis.
Dr.
Wyse said the trial results were pertinent to everyday practice
because patients enrolled were older than 65, unless they
had other risk factors. AF is prevalent among the elderly,
Dr. Wyse said, noting that it is found in 8 percent of people
over age 80.
Persistent
AF
The
difference between primary endpoints in the RACE study was
also small.
The
rate of death or severe cardiovascular incident was 17.2 percent
among the 256 patients in the rate-control trial arm vs. 22.6
percent among the 266 patients in the electrocardioversion
rhythm-control arm, said Harry J. Crijns, MD, of the Department
of Cardiology at University Hospital Maastricht in Maastricht,
the Netherlands.
Cardiovascular
mortality rates were 7.0 percent for the rate-control arm
and 6.7 percent for the rhythm-control arm; heart failure
rates were 3.5 percent and 4.5 percent, respectively; and
bleeding complication rates were 4.7 percent and 3.4 percent,
respectively.
Patients
with hypertension in particular did not do well with electrocardioversion
for rhythm control, Dr. Crijns said. The rate of mortality,
thromboembolism, or other severe complication was approximately
19 percent for rate-control therapy vs. approximately 31 percent
for rhythm control. Dr. Crijns speculated that some factor
in electroconversion might be especially thrombogenic in hypertensive
patients.
Rate
control is not inferior to rhythm control, and it appears
to be a very attractive alternative, especially for patients
with a high risk of AF recurrence, Dr. Crijns concluded,
adding that it is important to develop safer and more effective
antithrombotic drugs.
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