CardioSource WorldNews December 2014 - Page 49

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