The bivalirudin paradox: High evidence, low use

Journal of Cardiovascular Medicine

Volumn 14, Issue 5, 2013, Pages 334-341

  De Servi, Stefano ^a   Mariani, Giuseppe ^a   Mariani, Matteo ^a   D'Urbano, Maurizio ^a  

^a Cardiovascular Department   (Italy)

Author keywords

Acute coronary syndrome; Bivalirudin; Percutaneous coronary intervention

Indexed keywords

ABCIXIMAB; CLOPIDOGREL; HEPARIN; HIRULOG; PRASUGREL; TICAGRELOR;

ACUTE CORONARY SYNDROME; ANGIOCARDIOGRAPHY; ANTICOAGULANT THERAPY; BLEEDING; BLOOD CLOT LYSIS; CARDIOLOGIST; CARDIOVASCULAR MAGNETIC RESONANCE; CARDIOVASCULAR MORTALITY; COST; DRUG USE; ENDOTHELIUM CELL; HEART INFARCTION; HIGH RISK PATIENT; HUMAN; MONOCYTE; MULTICENTER STUDY (TOPIC); NEUTROPHIL; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; PERCUTANEOUS CORONARY INTERVENTION; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK REDUCTION; SMOOTH MUSCLE FIBER; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; THROMBOCYTE ACTIVATION; THROMBOCYTE AGGREGATION; THROMBOCYTE COUNT;

ACUTE CORONARY SYNDROME; ANTITHROMBINS; CORONARY ARTERY BYPASS; DRUG UTILIZATION; EVIDENCE-BASED MEDICINE; HEMORRHAGE; HIRUDINS; HUMANS; MYOCARDIAL INFARCTION; PEPTIDE FRAGMENTS; PERCUTANEOUS CORONARY INTERVENTION; PHYSICIAN'S PRACTICE PATTERNS; RECOMBINANT PROTEINS; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84879504715     PISSN: 15582027     EISSN: 15582035     Source Type: Journal    
DOI: 10.2459/JCM.0b013e32835f1915     Document Type: Review

References (46)

1. Liaw PCY, Becker DL, Stafford AR, et al. Molecular basis for the susceptibility of fibrin-bound thrombin to inactivation by heparin cofactor II in the presence of dermatan sulphate but not heparin. J Biol Chem 2001; 276:20959-20965.
2. Xiao Z, Theroux P. Platelet activation with unfractionated heparin at therapeutic concentrations and comparisons with a low-molecular-weight heparin and with a direct thrombin inhibitor. Circulation 1998; 97:251-256. (Pubitemid 28067310)
3. Lewis B. Thrombocytopenia and outcome in invasive cardiology. J Invas Cardiol 2002; 14 (Suppl B):38B-47B. (Pubitemid 34304132)
4. Robson R, White H, Aylward P, Frampton C. Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose and gender. Clin Pharmacol Ther 2002; 71:433-439. (Pubitemid 34701350)
5. Weitz JI, Crowther M. Direct thrombin inhibitors. Thromb Res 2002; 106:V275-V284. (Pubitemid 35279149)
6. Kleiman NS, Klem J, Fernandes LS, et al. Pharmacodynamic profile of the direct thrombin antagonist bivalirudin given in combination with the glycoprotein IIb/IIIa antagonist eptifibatide.AmHeart J 2002; 143:585-593. (Pubitemid 34454690)
7. Becker RC. Understanding the dynamics of thrombin in cardiovascular disease: pathobiology and biochemistry for the clinician. Am Heart J 2005; 149:S2-S8. (Pubitemid 40017965)
8. Vu TK, Hung DT, Wheaton VI, et al. Molecular cloning of a functional thrombin receptor reveals a novel proteolytic mechanism of receptor activation. Cell 1991; 64:1057-1068. (Pubitemid 121001193)
9. Andersen H, Greenberg DL, Fujikawa K, et al. Protease-activated receptor-1 is the primary mediator of thrombin-stimulated platelet procoagulant activity. Proc Natl Acad Sci USA 1999; 96:11189-11193. (Pubitemid 29487356)
10. Mirabet M, Garcia-Dorado D, Ruiz-Meana M, Barrabes JA, Soler-Soler J. Thrombin increases cardiomyocyte acute cell death after ischemia and reperfusion. J Mol Cell Cardiol 2005; 39:277-283. (Pubitemid 40995017)
11. Santilli F, Davi G. Thrombin as a common downstream target blocking both platelet and monocyte activation. Thromb Haemost 2009; 101:220-221.
12. Busch G, Steppich B, Sibbing D, et al. Bivalirudin reduces platelet and monocyte acvtivation after elective percutaneous coronary intervention. Thromb Haemost 2009; 101:340-344.
13. Keating FK, Dauerman HL, Whitaker DA, Sobel BE, Schneider DJ. Increased expression of platelet P-selectin and formation of plateletleukocyte aggregates in blood from patients treated with unfractionated heparin plus eptafibatide compared with bivalirudin. Thrombosis Res 2006; 118:361-369. (Pubitemid 44067197)
14. Lincoff AM, Bittl JA, Harrington RA, et al. 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; 289:853-863. (Pubitemid 37430344)
15. Kastrati A, Neumann FJ, Mehilli J, et al. Bivalirudin versus unfractionated heparin during percutaneous coronary intervention. N Engl J Med 2008; 359:688-696.
16. Lincoff AM, Kleiman NS, Kereiakes DJ, et al. Long-term efficacy of bivalirudin and provisional glycoprotein IIb/IIIa blockade vs heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary revascularization: REPLACE-2 randomized trial. JAMA 2004; 292:696- 703. (Pubitemid 39062523)
17. Parodi G, Migliorini A, Valentiu R, et al. Comparison of bivalirudin and unfractionated heparin plus protamine in patients with coronary heart disease undergoing percutaneous coronary intervention (from the Antithrombotic Regimens and Outcome ARNO trial). Am J Cardiol 2010; 105:1053-1059.
18. Levin GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guidelines for percutaneous coronary interventions: 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. J Am Coll Cardiol 2011; 58:2550-2583.
19. Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med 2008; 358:2218-2230. (Pubitemid 351724451)
20. Stone GW, Witzenbichler B, Guagliumi G, et al., for the HORIZONS-AMI trial investigators. Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial. Lancet 2011; 377:2193- 2204.
21. Wohrle J, Merkle N, Kunze M, et al. Effect of bivalirudin compared with unfractionated heparin plus abciximab on infarct size and myocardial recovery after primary percutaneous coronary intervention: the HORIZONS-AMI CMRI substudy. Cathet Cardiovasc Interv 2012; 79:1083-1089.
22. Suh JW, Mehran R, Claessen BE, et al. Impact of in-hospital major bleeding on late clinical outcomes after primary percutaneous coronary intervention in acute myocardial infarction. The HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) Trial. J Am Coll Cardiol 2011; 58:1750-1756.
23. Verheugt FWA, Steinhubl SR, Hamon M, et al. Incidence, prognostic impact, and influence of antithrombotic therapy on access and nonaccess site bleeding in percutaneous coronary intervention. JACC Cardiovasc Interv 2011; 4:191-197.
24. Pinto DS, Ogbonnaya A, Sherman SA, Tung P, Normand ST. Bivalirudin therapy is associated with improved clinical and economic outcomes in STelevation myocardial infarction patients undergoing percutaneous coronary intervention: Results from an observational database. Circ Cardiovasc Qual Outcomes 2012; 5:52-61.
25. Stone GW, McLaurin BT, Cox DA, et al. Bivalirudin for patients with acute coronary syndrome. N Engl J Med 2006; 355:2203-2216. (Pubitemid 44791162)
26. Stone GW, White HD, Ohman EM, et al. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial. Lancet 2007; 369:907-919. (Pubitemid 46400858)
27. Lincoff AM, Steinhubl SR, Manoukian SV, et al. Influence of timing of clopidogrel treatment on the efficacy and safety of bivalirudin in patients with non-ST-segment elevation acute coronary syndromes undergoing percutaneous coronary intervention: an analysis of the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. JACC Cardiovasc Interv 2008; 1:639-648.
28. Pocock SJ, Mehran R, Clayton TC, et al. Prognostic modelling of individual patient risk and mortality impact of ischemic and hemorrhagic complications: assessment from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. Circulation 2010; 121:43-51.
29. Lopes RD, Alexander KP, Manoukian SV, et al. Advanced age, antithrombotic strategy, and bleeding in non-ST-segment elevation acute coronary syndromes: results from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial. J Am Coll Cardiol 2009; 53:1021-1030.
30. Goto K, Lansky AJ, Fahy M, et al. Predictors of outcomes in medically treated patients with acute coronary syndromes after angiographic triage: an Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) substudy. Circulation 2010; 121:853-862.
31. Kastrati A, Neumann F, Schultz S, et al., for the ISAR-REACT 4 Investigators. Abciximab and Heparin versus bivalirudin for non-ST Elevation Myocardial Infarction. N Engl J Med 2011; 365:1980- 1989.
32. Sibbing D, Bernlochner I, Schulz S, et al. Prognostic value of high onclopidogrel treatment platelet reactivity in bivalirudin versus abciximab treated non-ST-segment elevation myocardial infarction patients. ISARREACT-4 (Intracoronary Stenting and Antithrombotic Regimen: rapid Early Action for Coronary treatment-4) platelet substudy. J Am Coll Cardiol 2012; 60:369-377.
33. Wiviott SD, Braunwald E, McCabe Ch, et al., on behalf of TRITON Investigators. Prasugrel versus Clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007; 357:2001-2015. (Pubitemid 350106708)
34. Wallentin L, Becker RC, Budaj A, et al., on behalf of PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009; 361:1-13.
35. Kadakia MB, Desai NR, Alexander KP, et al. Use of anticoagulant agents and risk of bleeding among patients admitted with myocardial infarction: a report from the NCDR ACTION Registry -GWTG (National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry - Get With the Guidelines). JACC Cardiovasc Interv 2010; 3:1166-1177.
36. Radovanovic D, Nallamothu BK, Seifert B, et al. for the AMIS Plus Investigators. Temporal trends in treatment of ST-elevation myocardial infarction among men and women in Switzerland between 1997 and 2011. Eur Heart J Acute Cardiovasc Care 2012; 3:183- 191.
37. SchwenkglenksM, Toward TJ, Plent S, Szucs TD, Blackman DJ, Baumbach A. Cost-effectiveness of bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitor in the treatment of acute ST-segment elevation myocardial infarction. Heart 2012; 98:544-551.
38. Baumbach A, Johnson TW, Oriolo V, et al. Prasugrel and bivalirudin for primary angioplasty: early results on stent thrombosis and bleeding. Int J Cardiol 2011; 153:222-224.
39. Wu E, Ortiz JT, Tejedor P, et al. Infarct size by contrast enhanced cardiac magnetic resonance is a stronger predictor of outcome than left ventricular ejection fraction or end-systolic volume index: prospective cohort study. Heart 2008; 94:730-736. (Pubitemid 351744690)
40. Musumeci G, Rossini R, Lettieri C, et al. Prognostic implication of early and long-term bleeding events in patients on one-year dual antiplatelet therapy following drug-eluting stent implantation. Catheter Cardiovasc Interv 2012; 80:395-405.
41. Rossini R, Capodanno D, Lettieri C, et al. Prevalence, predictors, and longterm prognosis of premature discontinuation of oral antiplatelet therapy after drug-eluting stent implantation. Am J Cardiol 2011; 107:186- 194.
42. Wright RS, Anderson JL, Adams CD, et al. 2011ACCF/AHA focused updated of the guidelines for the management of patients with unstable angina/Non ST-Elevation Myocardial Infarction (updating the 2007 guidelines): a report of the American College of Cardiology Foundation/ American heart Association task force on practice guidelines developed in collaboration with the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2011; 57:1920-1959.
43. Hamm CW, Bassand JP, Agewall S, et al. ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J 2011; 32:2999- 3054.
44. Kushner FG, Hand M, SmithSC Jr, et al. 2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (Updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (Updating the 2005 Guideline and 2007 Focused Update): a Report of the American College of Cardiology Foundation/American Heart Association Task Forceon PracticeGuidelines. JAmCollCardiol2009;54:2205-2241.
45. Wijns W, Kolh P, Danchin N, et al. 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 (ECTS). Eur Heart J 2010; 31:2501-2555.
46. Stone GW. Bivalirudin in acute myocardial infarction: NICE guidance. Heart 2012; 98:435-437.