CLINICAL
NEWS
American College of Cardiology Extended Learning
known duration, anticoagulate with warfarin
for at least 3 weeks prior to and 4 weeks after
cardioversion.
• With AF or atrial flutter for > 48 hours or unknown duration requiring immediate cardioversion, anticoagulate as soon as possible and
continue for at least 4 weeks.
• With AF or atrial flutter for < 48 hours and
high stroke risk, IV heparin or LMWH or factor Xa or direct thrombin inhibitor is recommended before or immediately after cardioversion, followed by long-term anticoagulation.
• Following cardioversion of AF, long-term
anticoagulation should be based on thromboembolic risk.
The third bullet point is new. It’s given a level
of evidence C, meaning expert opinion, but Dr.
Prystowsky asked what if the patient has had AF
or atrial flutter less than 4 hours: do you still need
to anticoagulate first? In the past, he said, many
clinicians would have said no to this. “It becomes
a problem for clinicians and, I hate to say it, it
become a medico-legal problem, too,” he said. “I
could understand if they said greater than 24 but
less than 48 hours, but I don’t know of any data
to suggest that if a patient has had AF for 4 hours,
you’re putting someone at high risk of you don’t
anticoagulated them first.”
Considering the new guidelines, Dr. Prystowsky
said the committee did a wonderful job of getting
everyone up-to-date. “Clearly, in the anticoagulation
area there are changes and they are going to affect
clinical practice.”
He added, “I say this as a person who spent years
writing guidelines: they are guidelines—not the tablets from the mountain. As a clinician, and it is stated
in the (guidelines) preface, you need to incorporate
them into patient care the best way you can.” ■
REFERENCES
1. Anderson JL, Halperin JL, Albert NM, et al.
J Am Coll Cardiol. 2013;61(18):1935-44.
2. January CT, Wann L, Alpert JS, et al. J Am Coll Cardiol.
2014;64:e1-e76.
3. Wyse DG, Waldo AL, DiMarco JP, et al.
N Engl J Med. 2002;347:1825-33.
4. Ionescu-Ittu R, Abrahamowicz M, Jackevicius CA, et al.
Arch Intern Med. 2012;172:997-1004.
5. Prystowsky EN, Padanilam BJ. J Am Coll Cardiol.
2013;62:540-2.
Take-aways
• Treatment of AF involves three major strategies,
but the bottom line is stroke prevention.
• In the most recent iteration of AF treatment
guidelines, there are changes that are going to
affect clinical practice, especially in the area of
anticoagulation.
• Clinicians should do more to identify
asymptomatic AF and evaluate new strategies
to fulfill the first commandment of therapy for
patients with AF: preserve the brain.
24
CardioSource WorldNews
PCSK9: New Kid in Town
FDA approval now puts reimbursement in the spotlight
T
here is a new option for patients at high
risk from high cholesterol. What we don’t
know, yet, is whether these new drugs
(another is in the wings) represent a true breakthrough—or whether we can even afford them.
On July 21, 2015, the European Commission
approved Amgen’s PCSK9 inhibitor, evolocumab,
for the treatment of patients with uncontrolled cholesterol who require additional intensive LDL-C reduction. That makes Repatha (as it’s called) the first
PCSK9 inhibitor to be approved by any regulatory
agency in the world. A few days later, alirocumab
(Praluent), from Regeneron Pharmaceuticals Inc.
and Sanofi SA, was approved by the U.S. Food and
Drug Administration. (The FDA press release is
here: 1.usa.gov/1EdYLiD )
The FDA approved alirocumab for use in addition to diet and maximally-tolerated statin therapy
in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks
or strokes, who require additional lowering of LDL
cholesterol.
A little more than a month later, as this issue
of CardioSource WorldNews was being finalized,
the FDA agreed with their European counterparts:
evolocumab injection was approved as an adjunct
to diet and maximally-tolerated statin therapy for
the treatment of adults with heterozygous familial
hypercholesterolemia or clinical atherosclerotic
cardiovascular disease, who require additional
lowering of LDL-C; and as an adjunct to diet and
other LDL-lowering therapies for the treatment of
patients with homozygous familial hypercholesterolemia, who require add