A randomised study of dabigatran in elective percutaneous coronary intervention in stable coronary artery disease Patients

EuroIntervention

Volumn 8, Issue 9, 2013, Pages 1052-1060

  Vranckx, Pascal ^a,b   Verheugt, Freek W A ^a   De Maat, Moniek P ^c   Ulmans, Victor A W M ^d   Regar, Evelyn ^c   Smits, Peter ^e   Ten Berg, Jurrien M ^f   Lindeboom, Wietze ^b   Jones, Russel L ^g   Friedman, Jeffrey ^h   Reilly, Paul ^h   Leebeek, Frank W G ^c  

^a Department of Cardiac Intensive Care and Interventional Cardiology ^*  (Netherlands)

^b CARDIALYSIS   (Netherlands)

^c ERASMUS MEDICAL CENTER   (Netherlands)

^d Location Alkmaar   (Netherlands)

^e Maasstad Hospital Rotterdam   (Netherlands)

^f ST ANTONIUS HOSPITAL   (Netherlands)

^g BOEHRINGER INGELHEIM LTD   (United Kingdom)

^h BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

Angioplasty; Anticoagulation; Coronary artery disease; Thrombosis

Indexed keywords

ABCIXIMAB; ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; CLOPIDOGREL; DABIGATRAN; HEPARIN; PROTHROMBIN; THROMBIN;

ADULT; AGED; ANTICOAGULANT THERAPY; ARTICLE; BALLOON DILATATION; BLEEDING; BLOOD CLOTTING; CATHETER THROMBOSIS; CONTROLLED STUDY; CORONARY ARTERY DISEASE; CORONARY STENT; DRUG BLOOD LEVEL; DUAL ANTIPLATELET THERAPY; EXPLORATORY RESEARCH; FEMALE; HEART INFARCTION; HEMATOLOGICAL PARAMETERS; HUMAN; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PERCUTANEOUS CORONARY INTERVENTION; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; STENT THROMBOSIS; THROMBOSIS; VASCULAR ACCESS;

ADMINISTRATION, ORAL; AGED; ANTITHROMBINS; BENZIMIDAZOLES; BLOOD COAGULATION; CORONARY ARTERY DISEASE; CORONARY THROMBOSIS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MIDDLE AGED; PERCUTANEOUS CORONARY INTERVENTION; PYRIDINES; TREATMENT OUTCOME;

EID: 84873117738     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV8I9A162     Document Type: Article

References (23)

1. Prandoni P, Bilora F, Marchiori A, Bernardi E, Petrobelli F, Lensing AW, Prins PH, Girolami A. An association between atherosclerosis and venous thrombosis. N Engl J Med. 2003;348:1435-41. (Pubitemid 36407172)
2. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly P, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius D, Diener HC, Joyner CD, Wallentin L, and the RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
3. Sørensen HT, Horvath-Puho E, Pedersen L, Baron JA, Prandoni P. Venous thromboembolism and subsequent hospitalization due to acute arterial cardiovascular events: a 20-year cohort study. Lancet. 2007;370:1773-9. (Pubitemid 350137491)
4. Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W, for the Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005;26:804-47.
5. King SB III, Smith SC Jr, Hirshfeld JW Jr, Jacobs AK, Morrison DA, Williams DO, Feldman TE, Kern MJ, O'Neill WW, Schaff HV, Whitlow PL, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines: 2007 Writing Group to Review New Evidence and Update the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention, Writing on Behalf of the 2005 Writing Committee. Circulation. 2008;117:261-95.
6. Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007;357:2482-94.
7. Mann KG. Thrombin formation. Chest. 2003;124:4S-10S. (Pubitemid 37128430)
8. Ndrepepa G, Berger PB, Mehilli J, Seyfarth M, Neumann FJ, Schömig A, Kastrati A. Periprocedural bleeding and 1-year outcome after percutaneous coronary interventions appropriateness of including bleeding as a component of a quadruple end point. J Am Coll Cardiol. 2008;51:690-7. (Pubitemid 351221218)
9. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47:285-95. (Pubitemid 351508116)
10. Rao AK, Pratt C, Berke A, Jaffe A, Ockene I, Schreiber TL, Bell WR, Knatterud G, Robertson TL, Terrin ML. Thrombolysis in Myocardial Infarction (TIMI) Trial-phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol. 1988;11:1-11. (Pubitemid 18029027)
11. Thygesen K, Alpert JS, White HD Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Eur Heart J. 2007;28:2525-38.
12. Stevens LA, Coresh J, Greene T, Levey AS. Assessing kidney function - measured and estimated glomerular filtration rate. N Engl J Med. 2006;354:2473-83. (Pubitemid 43855050)
13. Wallentin L, Yusuf S, Ezekowitz MD, Alings M Flather M Franzosi MG, Pais P, Dans A, Eikelboom J, Oldgren J, Pogue J, Reilly PA, Yang S, Connolly SJ; RE-LY investigators. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet. 2010;376:975-83.
14. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly P, Wallentin L; Randomized Evaluation of Long-Term Anticoagulation Therapy Investigators. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
15. Ezekowitz MD, Reilly PA, Nehmiz G, Simmers TA, Nagarakanti R, Parcham-Azad K, Pedersen KE, Lionetti DA, Stangier J, Wallentin L. Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO Study). Am J Cardiol. 2007;100:1419-26. (Pubitemid 47576022)
16. Ezekowitz MD, Connolly SJ, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009;157:805-10.
17. Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361:2342-52.
18. Lincoff AM, Bittl JA, Harrington RA, Feit F, Kleiman NS, Jackman JD, Sarembock IJ, Cohen DJ, Spriggs D, Ebrahimi R, Keren G, Carr J, Cohen EA, Betriu A, Desmet W, Kereiakes DJ, Rutsch W, Wilcox RG, de Feyter PJ, Vahanian A, Topol EJ; REPLACE-2 Investigators. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA. 2003;289:853-63. (Pubitemid 37430344)
19. Stone GW, McLaurin BT, Cox DA, Bertrand ME, Lincoff AM, Moses JW, White HD, Pocock SJ, Ware JH, Feit F, Colombo A, Aylward PE, Cequier AR, Darius H, Desmet W, Ebrahimi R, Hamon M, Rasmussen LH, Rupprecht HJ, Hoekstra J, Mehran R, Ohman EM; ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355:2203-16. (Pubitemid 44791162)
20. Uchino K, Hernandez AV. Dabigatran association with higher risk of acute coronary events: meta-analysis of noninferiority randomized controlled trials. Arch Intern Med. 2012;172:397-402.
21. Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators, Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RG, Bassand JP, Wallentin L, Joyner C, Fox KA. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006;354:1464-76.
22. Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Kirtane AJ, Parise H, Mehran R; HORIZONS-AMI Trial Investigators. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008;358:2218-30. (Pubitemid 351724451)
23. Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008;372:1163-73.