major bleeding,” compared to clopidogrel, according to
a recent European “joint consensus statement” on the
management of antithrombotic therapy in AF patients
presenting with ACS and/or undergoing percutaneous
coronary or valve interventions.8
As for the NOACs, they are considered a preferred
alternative to warfarin for AF stroke prophylaxis based
on recent clinical trials showing better similar or better
ischemic outcomes and a decreased risk of bleeding. However, the consensus appears to be that more
data are needed to determine how they’ll perform in
patients with both AF and CAD.
The 2014 U.S. AF guidelines summarized the situation succinctly: “The novel oral OACs have not been
evaluated in the context of AF and ACS and thus no
recommendation for their use can be made.”
Going one step further, they make a class I recommendation for anticoagulation with warfarin (unless
contraindicated) for patients with ACS and AF.
The ongoing PIONEER AF-PCI trial will evaluate
the safety of two different rivaroxaban treatment
strategies and one VKA treatment strategy utilizing
various combinations of dual antiplatelet therapy
or low-dose aspirin or clopidogrel (or prasugrel or
ticagrelor) in 2,100 patients with AF who undergo
PCI with stent placement.
The much larger RE-DUAL PCI trial will evaluate
dabigatran (110 mg or 150 mg bid) plus clopidogrel or
ticagrelor versus the triple antithrombotic therapy regi-
men with warfarin plus clopidogrel or ticagrelor plus
aspirin. The trial will enroll 8,500 AF patients who
have undergone PCI with stent implantation at 700
sites in more than 40 countries worldwide.
Dr. Cannon, lead investigator of the study, told
CSWN, said this large scale multinational trial
should help better determine ways to safely reduce
bleeding risk. Besides evaluating dual therapy approach with two dabigatran doses, they will also be
incorporating efforts to reduce bleeding risk into the
control arm by shortening the duration of dual antiplatelet therapy to 1 month post bare-metal stenting
(relatively standard now) and pushing duration of
therapy down to just 3 months post drug-eluting
stent placement. Also they will be dropping one
of the two antiplatelets (dropping aspirin, not the
P2Y12 inhibitor). Dr. Cannon said, “These strategies
came after much discussion with the Steering Committee – and in full recognition that there are about
40 different possible combinations of agents, doses,
and durations that might be tried. We have three
promising approaches that we aim to test and hope
that it can be useful information on how to manage
this very tricky clinical scenario.” ■
See this month’s cover story for additional
updates on dual antiplatelet therapy from
AHA 2014 Scientific Sessions.
REFERENCES
1. Kolber M, Sharif N, Marceau R, Szafran O. Can Fam Physician .2013;59:55-61.
2. ASPIRIN® 81mg for Emergency Use during Heart
Attacks: Approved in Canada (press release). http://
www.newswire.ca/en/story/1431994/aspirin-81mg-foremergency-use-during-heart-attacks-approved-in-canada.
Accessed on October 28, 2014.
3. Kenaan M, Seth M, Aronow HD, et al. J Am Coll Cardiol.
2013;62:2083-9.
4. Weitz JI. 2015. Philadelphia: Elsevier, pp. 1819.
5. Hamon M, Lemesle G, Tricot O, et al. J Am Coll Cardiol.
2014;64:1430-6.
6. Dauerman HL. J Am Coll Cardiol. 2014;64:1437-40.
7. Steinberg BA, Kim S, Piccini JP, et al. J Am Coll Cardiol.
2013;128:721-8.
8. Lip GY, Windecker S, Huber K, et al. Eur Heart J. 2014
Aug 25. [Epub ahead of print]
9. Dewilde WJ, Janssen PE, Verheugt FW, et al. J Am Coll
Cardiol. 2014;64:1270-80.
10. Fuster V, Ryden LE, Cannom DS, et al. J Am Coll Cardiol.
2011;57:101-98.
11. January CT, Wann LS, Alpert JS, et al J Am Coll Cardiol.
2014 March 28. [Epub ahead of print]
12. Amsterdam EA, Wenger NK, Brindis RG, et al. J Am Coll
Cardiol. 2014 Sep 18. [Epub ahead of print]
13. Alexander JH, Lopes RD, Thomas L, et al. Eur Heart J.
2014;35:224-32.
14. Dans Al. Connolly SJ, Wallentin L, et al. Circulation.
2013;127:634-40.
15. Hernandez I, Baik SH, Piñera A, Zhang Y. JAMA Intern
Med. 2014 Nov 3. [Epub ahead of print]
16. Redberg RF. JAMA Intern Med. 2014 Nov 3. [Epub
ahead of print]
17. Dewilde WJ, Oirbans T, Verheugt FW, et al. Lancet.
2013;381:1107-15.
“What Gets Measured, Gets Managed”
Based on an increasing awareness of the adverse
consequences of bleeding that appear to extend
beyond the actual bleeding event itself, recent
American and European atrial fibrillation (AF)
guidelines strongly emphasize the importance of
carefully balancing the benefits of pharmacologic
stroke prophylaxis with bleeding risk.
The new U.S. guidelines show a preference for
the CHA2DS2-VASc score for nonvalvular AF over
the older CHADS2 score, noting that the CHA2DS2VASc has a broader score range (from 0 to 9) and
includes more risk factors (female sex, 65 to 74
years of age, and vascular disease). It has also been
shown to better distinguish stroke risk than the
CHADS2 scale and offers superior discrimination for
who should receive anticoagulation therapy.
This desire to better define those at low risk, and
t