Rivaroxaban and risk of myocardial infarction: Insights from a meta-analysis and trial sequential analysis of randomized clinical trials

Coronary Artery Disease

Volumn 24, Issue 8, 2013, Pages 628-635

  Chatterjee, Saurav ^a   Sharma, Abhishek ^b   Uchino, Ken ^c   Biondi Zoccai, Giuseppe ^e   Lichstein, Edgar ^b   Mukherjee, Debabrata ^d  

^a ST LUKE S ROOSEVELT HOSPITAL CENTER   (United States)

^b MAIMONIDES MEDICAL CENTER   (United States)

^c LERNER RESEARCH INSTITUTE   (United States)

^d TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER   (United States)

^e SAPIENZA UNIVERSITY OF ROME   (Italy)

Author keywords

meta analysis; myocardial infarction; rivaroxaban

Indexed keywords

ANTIVITAMIN K; ENOXAPARIN; FONDAPARINUX; HEPARIN; LOW MOLECULAR WEIGHT HEPARIN; PLACEBO; RIVAROXABAN; WARFARIN;

ACUTE CORONARY SYNDROME; ANTICOAGULATION; ARTICLE; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CINAHL; CONFIDENCE INTERVAL; DEEP VEIN THROMBOSIS; DISEASE ASSOCIATION; EMBASE; FOLLOW UP; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HUMAN; INTENTION TO TREAT ANALYSIS; INTERNATIONAL NORMALIZED RATIO; LUNG EMBOLISM; MEDLINE; META ANALYSIS; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REINFORCEMENT; SAMPLING ERROR; SEQUENTIAL ANALYSIS; STANDARD; TREATMENT DURATION; VALIDITY;

ANTICOAGULANTS; CHI-SQUARE DISTRIBUTION; HUMANS; MORPHOLINES; MYOCARDIAL INFARCTION; ODDS RATIO; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; RISK FACTORS; THIOPHENES; TIME FACTORS;

EID: 84888137135     PISSN: 09546928     EISSN: 14735830     Source Type: Journal    
DOI: 10.1097/MCA.0000000000000031     Document Type: Article

References (37)

1. Merlini PA, Bauer KA, Oltrona L, Ardissino D, Cattaneo M, Belli C, et al. Persistent activation of coagulation mechanism in unstable angina and myocardial infarction. Circulation 1994; 90:61-68.
2. Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK. Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 2001; 345:494-502.
3. Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, et al. Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001; 358:527-533.
4. Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002; 324:71-86.
5. Fox KA, Poole-Wilson PA, Henderson RA, Clayton TC, Chamberlain DA, Shaw TR, et al. Randomized Intervention Trial of unstable Angina Investigators. Interventional versus conservative treatment for patients with unstable angina or non-ST-elevation myocardial infarction: the British Heart Foundation RITA 3 randomised trial. Randomized Intervention Trial of unstable Angina. Lancet 2002; 360:743-751.
6. Kong DF, Califf RM, Miller DP, Moliterno DJ,White HD, Harrington RA, et al. Clinical outcomes of therapeutic agents that block the platelet glycoprotein IIb/IIIa integrin in ischemic heart disease. Circulation 1998; 98:2829-2835.
7. Steinhubl SR, Berger PB, Mann JT III, Fry ET, DeLago A,Wilmer C, Topol EJ. CREDO Investigators, Clopidogrel for the Reduction of Events During Observation. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 2002; 288:2411-2420.
8. Sabatine MS, Cannon CP, Gibson CM, Ló pez-Sendó n JL, Montalescot G, Theroux P, et al. CLARITY-TIMI 28 Investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med 2005; 352:1179-1189.
9. Hurlen M, Abdelnoor M, Smith P, Erikssen J, Arnesen H. Warfarin, aspirin, or both after myocardial infarction. N Engl J Med 2002; 347:969-974.
10. Brouwer MA, van den Bergh PJ, Aengevaeren WR, Veen G, Luijten HE, Hertzberger DP, et al. Aspirin plus coumarin versus aspirin alone in the prevention of reocclusion after fibrinolysis for acute myocardial infarction: results of the Antithrombotics in the Prevention of Reocclusion In Coronary Thrombolysis (APRICOT)-2 Trial. Circulation 2002; 106:659-665.
11. Coumadin Aspirin Reinfarction Study (CARS) Investigators. Randomised double-blind trial of fixed low-dose warfarin with aspirin after myocardial infarction. Coumadin Aspirin Reinfarction Study (CARS) Investigators. Lancet 1997; 350:389-396.
12. Fiore LD, Ezekowitz MD, Brophy MT, Lu D, Sacco J, Peduzzi P. Combination Hemotherapy and Mortality Prevention (CHAMP) Study Group. Department of Veterans Affairs Cooperative Studies Program Clinical Trial comparing combined warfarin and aspirin with aspirin alone in survivors of acute myocardial infarction: primary results of the CHAMP study. Circulation 2002; 105:557-563
13. 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.
14. Kubitza D, Becka M, Wensing G, Voith B, Zuehlsdorf M. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939-an oral, direct factor Xa inhibitor-after multiple dosing in healthy male subjects. Eur J Clin Pharmacol 2005; 61:873-880.
15. Kubitza D, Becka M, Roth A, Mueck W. Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects. Curr Med Res Opin 2008; 24:2757-2765.
16. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al. ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365:883-891.
17. Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, et al. ATLAS ACS 2 TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med 2012; 366:9-19.
18. Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, et al. RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008; 358:2765-2775.
19. Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, et al. RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet 2008; 372:31-39.
20. Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, et al. RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008; 358:2776-2786.
21. Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, et al. RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009; 373:1673-1680.
22. Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol 2008; 61:64-75.
23. Wetterslev J, Thorlund K, Brok J, Gluud C. Estimating required information size by quantifying diversity in random-effects model meta-analyses. BMC Med Res Methodol 2009; 9:86.
24. Brok J, Thorlund K, Gluud C, Wetterslev J. Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses. J Clin Epidemiol 2008; 61:763-769.
25. Lan KK, Hu M, Cappelieri J. Applying the law of the iterated logarithm to cumulative meta-analysis of a continuous endpoint. Statistica Sinica 2003; 13:1135-1145.
26. Mega JL, Braunwald E, Mohanavelu S, Burton P, Poulter R, Misselwitz F, et al. ATLAS ACS TIMI 46 Study Group. Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial. Lancet 2009; 374:29-38.
27. Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, et al. EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363:2499-2510.
28. Bü ller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, et al. EINSTEIN-PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366:1287-1297.
29. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med 2009; 6:e1000100.
30. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions. 2nd ed. Hoboken, NJ: Wiley; 2008.
31. Davis EM, Packard KA, Knezevich JT, Campbell JA. New and emerging anticoagulant therapy for atrial fibrillation and acute coronary syndrome. Pharmacotherapy 2011; 31:975-1016.
32. Doggrell SA. Is there evidence to support the use of direct factor Xa inhibitors in coronary artery disease? Rev Recent Clin Trials 2011; 6:147-157.
33. Squizzato A, Keller T, Romualdi E, Middeldorp S. Clopidogrel plus aspirin versus aspirin alone for preventing cardiovascular disease. Cochrane Database Syst Rev 2011; 1:CD005158.
34. Murphy SA, Gibson CM, Morrow DA, Van de Werf F, Menown IB, Goodman SG, et al. Efficacy and safety of the low-molecular weight heparin enoxaparin compared with unfractionated heparin across the acute coronary syndrome spectrum: a meta-analysis. Eur Heart J 2007; 28:2077-2086.
35. Rothberg MB, Celestin C, Fiore LD, Lawler E, Cook JR. Warfarin plus aspirin after myocardial infarction or the acute coronary syndrome: meta-analysis with estimates of risk and benefit. Ann Intern Med 2005; 143:241-250.
36. Alexander JH, Becker RC, Bhatt DL, Cools F, Crea F, Dellborg M, et al. APPRAISE Steering Committee and Investigators. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation 2009; 119:2877-2885.
37. Ageno W, Gallus AS,Wittkowsky A, Crowther M, Hylek EM, Palareti G. Oral anticoagulant therapy: antithrombotic therapy and prevention of thrombosis 9th ed. : American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141:e44S-e48S.