Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation

New England Journal of Medicine

Volumn 377, Issue 16, 2017, Pages 1513-1524

  Cannon, Christopher P ^a   Bhatt, Deepak L ^a   Oldgren, Jonas ^c   Lip, Gregory Y H ^d   Ellis, Stephen G ^g   Kimura, Takeshi ^h   Maeng, Michael ⁱ   Merkely, Bela ^j   Zeymer, Uwe ^k   Gropper, Savion ^l   Nordaby, Matias ^l   Kleine, Eva ^l   Harper, Ruth ^e   Manassie, Jenny ^e   Januzzi, James L ^a,b   Ten Berg, Jurrien M ⁿ   Steg, P Gabriel ^f,o   Hohnloser, Stefan H ^m  

^a HARVARD MEDICAL SCHOOL   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c UPPSALA UNIVERSITY   (Sweden)

^d UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^e BOEHRINGER INGELHEIM LTD   (United Kingdom)

^f IMPERIAL COLLEGE LONDON   (United Kingdom)

^g LERNER RESEARCH INSTITUTE   (United States)

^h KYOTO UNIVERSITY   (Japan)

ⁱ AARHUS UNIVERSITY HOSPITAL   (Denmark)

^j Heart and Vascular Centre   (Hungary)

^k KLINIKUM LUDWIGSHAFEN   (Germany)

^l Boehringer Ingelheim   (United Kingdom)

^m GOETHE UNIVERSITY   (Germany)

ⁿ ST ANTONIUS HOSPITAL   (Netherlands)

^o UNIVERSITÉ PARIS DESCARTES   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; DABIGATRAN ETEXILATE; TICAGRELOR; WARFARIN; ADENOSINE; ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT; DABIGATRAN; PURINERGIC P2Y RECEPTOR ANTAGONIST; TICLOPIDINE;

ACUTE CORONARY SYNDROME; AGED; ARTICLE; ATRIAL FIBRILLATION; BLEEDING; BRAIN HEMORRHAGE; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DEATH; DRUG EFFICACY; DRUG FATALITY; DRUG WITHDRAWAL; DUAL ANTIPLATELET THERAPY; EMBOLISM; FEMALE; HEART INFARCTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PAROXYSMAL ATRIAL FIBRILLATION; PERCUTANEOUS CORONARY INTERVENTION; PERMANENT ATRIAL FIBRILLATION; PERSISTENT ATRIAL FIBRILLATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; CLINICAL TRIAL; COMBINATION DRUG THERAPY; HEMORRHAGE; INCIDENCE; MIDDLE AGED; RISK;

ADENOSINE; AGED; ANTICOAGULANTS; ASPIRIN; ATRIAL FIBRILLATION; DABIGATRAN; DRUG THERAPY, COMBINATION; FEMALE; HEMORRHAGE; HUMANS; INCIDENCE; MALE; MIDDLE AGED; PERCUTANEOUS CORONARY INTERVENTION; PLATELET AGGREGATION INHIBITORS; PURINERGIC P2Y RECEPTOR ANTAGONISTS; RISK; TICLOPIDINE; WARFARIN;

EID: 85031670044     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1708454     Document Type: Article

References (29)

1. Levine GN, Bates ER, Bittl JA, et al. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: an update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention, 2011 ACCF/AHA guideline for coronary artery bypass graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/ STS guideline for the diagnosis and management of patients with stable ischemic heart disease, 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction, 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes, and 2014 ACC/AHA guideline on periop-erative cardiovascular evaluation and management of patients undergoing noncar-diac surgery. Circulation 2016;134(10): e123-e155.
2. Steg PG, Bhatt DL. Viewpoint: a proposal for a simple algorithm for managing oral anticoagulation and antiplatelet therapy in patients with non-valvular atrial fibrillation and coronary stents. Eur Heart J Acute Cardiovasc Care 2017; 6:93-7.
3. Lip GY, Windecker S, Huber K, et al. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS). Eur Heart J 2014;35:3155-79.
4. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation 2014;130:2071-104.
5. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation 2011;124:2574-609.
6. Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014;35: 2541-619.
7. De Caterina R, Husted S, Wallentin L, et al. Vitamin K antagonists in heart disease: current status and perspectives (Section III) — position paper of the ESC Working Group on Thrombosis–Task Force on Anticoagulants in Heart Disease. Thromb Haemost 2013;110:1087-107.
8. Vardi M, Debidda M, Bhatt DL, Mauri L, Cannon CP. Evolving antithrombotic strategies in patients with atrial fibrillation undergoing percutaneous coronary intervention: results from a survey among US cardiologists. Clin Cardiol 2014;37:103-7.
9. Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J 2016;37: 2893-962.
10. Andrade JG, Deyell MW, Khoo C, Lee M, Humphries K, Cairns JA. Risk of bleeding on triple antithrombotic therapy after percutaneous coronary intervention/stenting: a systematic review and meta-analysis. Can J Cardiol 2013;29:204-12.
11. Lamberts M, Olesen JB, Ruwald MH, et al. Bleeding after initiation of multiple antithrombotic drugs, including triple therapy, in atrial fibrillation patients following myocardial infarction and coronary intervention: a nationwide cohort study. Circulation 2012;126:1185-93.
12. Lemesle G, Ducrocq G, Elbez Y, et al. Vitamin K antagonists with or without long-term antiplatelet therapy in outpatients with stable coronary artery disease and atrial fibrillation: association with ischemic and bleeding events. Clin Cardiol 2017 July 10 (Epub ahead of print).
13. Depta JP, Cannon CP, Fonarow GC, Zhao X, Peacock WF, Bhatt DL. Patient characteristics associated with the choice of triple antithrombotic therapy in acute coronary syndromes. Am J Cardiol 2009; 104:1171-8.
14. Dewilde WJ, Janssen PW, Verheugt FW, et al. Triple therapy for atrial fibrillation and percutaneous coronary intervention: a contemporary review. J Am Coll Cardiol 2014;64:1270-80.
15. Lamberts M, Gislason GH, Olesen JB, et al. Oral anticoagulation and antiplatelets in atrial fibrillation patients after myocardial infarction and coronary intervention. J Am Coll Cardiol 2013;62:981-9.
16. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51.
17. Dans AL, Connolly SJ, Wallentin L, et al. Concomitant use of antiplatelet therapy with dabigatran or warfarin in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Circulation 2013;127:634-40.
18. Dewilde WJ, Oirbans T, Verheugt FW, et al. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. Lancet 2013; 381:1107-15.
19. Fiedler KA, Maeng M, Mehilli J, et al. Duration of triple therapy in patients requiring oral anticoagulation after drug-eluting stent implantation: the ISAR-TRIPLE Trial. J Am Coll Cardiol 2015;65: 1619-29.
20. Gibson CM, Mehran R, Bode C, et al. Prevention of bleeding in patients with atrial fibrillation undergoing PCI. N Engl J Med 2016;375:2423-34.
21. Gibson CM, Pinto DS, Chi G, et al. Recurrent hospitalization among patients with atrial fibrillation undergoing intra-coronary stenting treated with 2 treatment strategies of rivaroxaban or a dose-adjusted oral vitamin K antagonist treatment strategy. Circulation 2017;135: 323-33.
22. Bhatt DL. O PIONEERs! The beginning of the end of full-dose triple therapy with warfarin? Circulation 2017;135:334-7.
23. Cannon CP, Gropper S, Bhatt DL, et al. Design and rationale of the RE-DUAL PCI trial: a prospective, randomized, phase 3b study comparing the safety and efficacy of dual antithrombotic therapy with dabigatran etexilate versus warfarin triple therapy in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention with stenting. Clin Cardiol 2016;39:555-64.
24. Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005;3:692-4.
25. Jackson K, Gersh BJ, Stockbridge N, et al. Antithrombotic drug development for atrial fibrillation: proceedings, Washington, DC, July 25-27, 2005. Am Heart J 2008;155:829-40.
26. Rosendaal FR, Cannegieter SC, van der Meer FJM, Briët E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 1993;3: 236-9.
27. Faxon DP, Eikelboom JW, Berger PB, et al. Consensus document: antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting: a North-American perspective. Thromb Haemost 2011;106:572-84.
28. Angiolillo DJ, Goodman SG, Bhatt DL, et al. Antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention: a North American perspective — 2016 update. Circ Cardiovasc Interv 2016;9(11): e004395 .
29. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365:883-91.