CardioSource WorldNews | Page 29

Messages from the DAPT Study
What Do You Need to Know?

R

oxana Mehran, MD, professor of medicine
and director of interventional cardiovascular research and clinical trials at Mount
Sinai School of Medicine, New York,
NY, puts the problem this way: “This
is a daily question: When can I stop
dual antiplatelet therapy [DAPT]
safely after I’ve put in a stent?”
It’s been more than a decade
since the FDA approval of the first
drug-eluting stents (DES): sirolimuseluting in 2003 and paclitaxel-eluting
in 2004. Original recommendations
for patients receiving first-generation
DES advised 3 to 6 months of DAPT
with aspirin plus a thienopyridine.
After a warning of late risk in 2004
and alarming additional evidence in
2006, it appeared that the reduction
in restenosis associated with DES
was achieved at the cost of late—and
potentially fatal—stent thrombosis.
In 2011, the ACC/American Heart
Association (AHA) guidelines for
percutaneous coronary intervention
recommended a minimum DAPT
duration of at least 12 months after
DES, irrespective of clinical presentation.1 Yet, with evidence suggesting
that DES use is associated with a late

tracted and possibly indefinite clopidogrel therapy.
increased risk of catastrophic stent thrombosis at a
B:7.875 in
Indeed, at the 2014 Cardiovascular Research
rate significantly higher than with bare-metal stents
T:7.5 in
Technologies annual meeting, investigators from
(BMS), it was speculated that DES may require proS:7 in

Add Corlanor ® to maximally tolerated doses of beta-blockers and help give
appropriate patients with heart rate ≥ 70 bpm and stable, symptomatic chronic HF...

MORE HOME. LESS HOSPITAL.

Learn how you can DO MORE with Corlanor® to reduce the risk
of hospitalization for worsening heart failure (HF)
1

“This is a daily
question: When
can I stop dual
antiplatelet
therapy [DAPT]
safely after I’ve
put in a stent?”

CorlanorHCP.com
Indication
Corlanor® (ivabradine) is indicated to reduce the risk of hospitalization
for worsening heart failure in patients with stable, symptomatic
chronic heart failure with left ventricular ejection fraction ≤ 35%, who
are in sinus rhythm with resting heart rate ≥ 70 beats per minute and
either are on maximally tolerated doses of beta-blockers or have a
contraindication to beta-blocker use.

Important Safety Information
Contraindications: Corlanor® is contraindicated in patients with
acute decompensated heart failure, blood pressure < 90/50 mmHg,
sick sinus syndrome, sinoatrial block, 3rd degree atrioventricular
block (unless a functioning demand pacemaker is present), a resting
heart rate < 60 bpm prior to treatment, severe hepatic impairment,
pacemaker dependence (heart rate maintained exclusively by the
pacemaker), and concomitant use of strong cytochrome P450 3A4
(CYP3A4) inhibitors.
Fetal Toxicity: Corlanor® may cause fetal toxicity when administered
to a pregnant woman based on embryo-fetal toxicity and cardiac
teratogenic effects observed in animal studies. Advise females to use
effective contraception when taking Corlanor®.
Atrial Fibrillation: Corlanor® increases the risk of atrial fibrillation.
The rate of atrial fibrillation in patients treated with Corlanor®
compared to placebo was 5% vs. 3.9% per patient-year, respectively.
Regularly monitor cardiac rhythm. Discontinue Corlanor® if atrial
fibrillation develops.

—Roxanna Mehran, MD

ACC.org/CSWN

© 2015 Amgen Inc. All rights reserved. Not for reproduction. USA-998-115485 11-15

Bradycardia and Conduction Disturbances: Bradycardia, sinus
arrest and heart block have occurred with Corlanor®. The rate of
bradycardia in patients treated with Corlanor® compared to placebo
was 6% (2.7% symptomatic; 3.4% asymptomatic) vs. 1.3% per
patient-year, respectively. Risk factors for bradycardia include sinus
node dysfunction, conduction defects, ventricular dyssynchrony, and
use of other negative chronotropes. Concurrent use of verapamil or
diltiazem also increases Corlanor® exposure, contributes to heart rate
lowering, and should be avoided. Avoid use of Corlanor® in patients
with 2nd degree atrioventricular block unless a functioning demand
pacemaker is present.
Adverse Reactions: The most common adverse drug reactions reported
at least 1% more frequently with Corlanor® than placebo and that
occurred in more than 1% of patients treated with Corlanor® were
bradycardia (10% vs. 2.2%), hypertension or increased blood pressure
(8.9% vs. 7.8%), atrial fibrillation (8.3% vs. 6.6%), and luminous
phenomena (phosphenes) or visual brightness (2.8% vs. 0.5%).
Please see Brief Summary of full Prescribing Information
on adjacent page.
BPM = beats per minute; HF = heart failure.
Reference: 1. Corlanor® (ivabradine) Prescribing Information, Amgen.