Direct thrombin inhibition with bivalirudin as an antithrombotic strategy in general and interventional cardiology

• ALBERS GW, DIENER HC, FRISON L et al.: Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. JAMA (2005) 293(6):690-698.
   PubMed Web of Science ®Google Scholar
• AHRENS I, PETER K, BODE C: Use of GP IIb/IIIa inhibitors in cardiovascular medicine. Expert Rev. Cardiovasc. Ther. (2003) 1(2):233-242.
   PubMedGoogle Scholar
• KIRTANE AJ, PIAZZA G, MURPHY SA et al.: Correlates of bleeding events among moderate- to high-risk patients undergoing percutaneous coronary intervention and treated with eptifibatide: observations from the PROTECT-TIMI-30 trial. J. Am. Coll. Cardiol. (2006) 47(12):2374-2379.
   PubMed Web of Science ®Google Scholar
• SADEGHI HM, STONE GW, GRINES CL et al.: Impact of renal insufficiency in patients undergoing primary angioplasty for acute myocardial infarction. Circulation (2003) 108(22):2769-2775.
   PubMed Web of Science ®Google Scholar
• HARVEY RP, DEGRYSE E, STEFANI L et al.: Cloning and expression of a cDNA coding for the anticoagulant hirudin from the bloodsucking leech, Hirudo medicinalis. Proc. Natl. Acad. Sci. USA (1986) 83(4):1084-1088.
   PubMed Web of Science ®Google Scholar
• MARAGANORE JM, BOURDON P, JABLONSKI J, RAMACHANDRAN KL, FENTON JW II: Design and characterization of hirulogs: a novel class of bivalent peptide inhibitors of thrombin. Biochemistry (1990) 29(30):7095-7101.
   PubMed Web of Science ®Google Scholar
• KELLY AB, MARAGANORE JM, BOURDON P, HANSON SR, HARKER LA: Antithrombotic effects of synthetic peptides targeting various functional domains of thrombin. Proc. Natl. Acad. Sci. USA (1992) 89(13):6040-6044.
   PubMed Web of Science ®Google Scholar
• BITTL JA, STRONY J, BRINKER JA et al.: Treatment with bivalirudin (Hirulog) as compared with heparin during coronary angioplasty for unstable or postinfarction angina. Hirulog Angioplasty Study Investigators. N. Engl. J. Med. (1995) 333(12):764-769.
   PubMed Web of Science ®Google Scholar
• PINA I: FDA panel votes against approval for bivalirudin. Circulation (1999) 99(10):1277.
   PubMed Web of Science ®Google Scholar
• BITTL JA, CHAITMAN BR, FEIT F, KIMBALL W, TOPOL EJ: Bivalirudin versus heparin during coronary angioplasty for unstable or postinfarction angina: Final report reanalysis of the Bivalirudin Angioplasty Study. Am. Heart J. (2001) 142(6):952-959.
   PubMed Web of Science ®Google Scholar
• WEITZ JI, LESLIE B, HUDOBA M: Thrombin binds to soluble fibrin degradation products where it is protected from inhibition by heparin–antithrombin but susceptible to inactivation by antithrombin-independent inhibitors. Circulation (1998) 97(6):544-552.
   PubMed Web of Science ®Google Scholar
• REED MD, BELL D: Clinical pharmacology of bivalirudin. Pharmacotherapy (2002) 22(6 Part 2):S105-S111.
   PubMedGoogle Scholar
• SCIULLI TM, MAURO VF: Pharmacology and clinical use of bivalirudin. Ann. Pharmacother. (2002) 36(6):1028-1041.
   PubMed Web of Science ®Google Scholar
• 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(7):853-863.
   PubMed Web of Science ®Google Scholar
• LUI HK: Dosage, pharmacological effects and clinical outcomes for bivalirudin in percutaneous coronary intervention. J. Invas. Cardiol. (2000) 12(Suppl. F):F41-F52.
   PubMed Web of Science ®Google Scholar
• TOPOL EJ, BONAN R, JEWITT D et al.: Use of a direct antithrombin, hirulog, in place of heparin during coronary angioplasty. Circulation (1993) 87(5):1622-1629.
   PubMed Web of Science ®Google Scholar
• ROBSON R, WHITE H, AYLWARD P, FRAMPTON C: Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose, and gender. Clin. Pharmacol. Ther. (2002) 71(6):433-439.
   PubMed Web of Science ®Google Scholar
• WHITE CM: Thrombin-directed inhibitors: pharmacology and clinical use. Am. Heart J. (2005)149(1 Suppl.):S54-S60.
   PubMed Web of Science ®Google Scholar
• THEROUX P, PEREZ-VILLA F, WATERS D et al.: Randomized double-blind comparison of two doses of Hirulog with heparin as adjunctive therapy to streptokinase to promote early patency of the infarct-related artery in acute myocardial infarction. Circulation (1995) 91(8):2132-2139.
   PubMed Web of Science ®Google Scholar
• WHITE HD, AYLWARD PE, FREY MJ et al.: Randomized, double-blind comparison of hirulog versus heparin in patients receiving streptokinase and aspirin for acute myocardial infarction (HERO). Hirulog Early Reperfusion/Occlusion (HERO) Trial Investigators. Circulation (1997) 96(7):2155-2161.
   PubMed Web of Science ®Google Scholar
• WHITE H: Thrombin-specific anticoagulation with bivalirudin versus heparin in patients receiving fibrinolytic therapy for acute myocardial infarction: the HERO-2 randomised trial. Lancet (2001) 358(9296):1855-1863.
   PubMed Web of Science ®Google Scholar
• STONE GW, MCLAURIN BT, COX DA et al.: Bivalirudin for patients with acute coronary syndromes. N. Engl. J. Med. (2006) 355(21):2203-2216.
   PubMed Web of Science ®Google Scholar
• ANTMAN EM, BRAUNWALD E: A second look at bivalirudin. Am. Heart J. (2001) 142(6):929-931.
   PubMed Web of Science ®Google Scholar
• LINCOFF AM, KLEIMAN NS, KOTTKE-MARCHANT K et al.: Bivalirudin with planned or provisional abciximab versus low-dose heparin and abciximab during percutaneous coronary revascularization: results of the Comparison of Abciximab Complications with Hirulog for Ischemic Events Trial (CACHET). Am. Heart J. (2002) 143(5):847-853.
   PubMed Web of Science ®Google Scholar
• LINCOFF AM, BITTL JA, KLEIMAN NS et al.: Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial). Am. J. Cardiol. (2004) 93(9):1092-1096.
   PubMed Web of Science ®Google Scholar
• 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(6):696-703.
   PubMed Web of Science ®Google Scholar
• CHEW DP, LINCOFF AM, GURM H et al.: Bivalirudin versus heparin and glycoprotein IIb/IIIa inhibition among patients with renal impairment undergoing percutaneous coronary intervention (a subanalysis of the REPLACE-2 trial). Am. J. Cardiol. (2005) 95(5):581-585.
   PubMed Web of Science ®Google Scholar
• GURM HS, RAJAGOPAL V, SACHAR R et al.: Impact of diabetes mellitus on outcome of patients undergoing carotid artery stenting: insights from a single center registry. Catheter Cardiovasc. Interv. (2007) 69(4):541-545.
   PubMed Web of Science ®Google Scholar
• RAJAGOPAL V, LINCOFF AM, COHEN DJ et al.: Outcomes of patients with acute coronary syndromes who are treated with bivalirudin during percutaneous coronary intervention: an analysis from the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) trial. Am. Heart J. (2006) 152(1):149-154.
   PubMed Web of Science ®Google Scholar
• CHACKO M, LINCOFF AM, WOLSKI KE et al.: Ischemic and bleeding outcomes in women treated with bivalirudin during percutaneous coronary intervention: a subgroup analysis of the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial. Am. Heart J. (2006) 151(5):E1031-E1037.
   PubMedGoogle Scholar
• 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(9565):907-919.
   PubMed Web of Science ®Google Scholar
• SMITH SC Jr, FELDMAN TE, HIRSHFELD JW Jr et al.: 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 (ACC/AHA/SCAI Writing Committee to Update 2001 Guidelines for Percutaneous Coronary Intervention). Circulation (2006) 113(7):E166-E286.
   PubMedGoogle Scholar
• WAKSMAN R: ACUITY-PCI: one drug does not fit all. Lancet (2007) 369(9565):881-882.
   PubMed Web of Science ®Google Scholar
• AHRENS I, BODE C, PETER K: Inhibition of platelet activation and aggregation. Handb. Exp. Pharmacol. (2005) (170):443-462.
   PubMedGoogle Scholar
• Angiomax Prescribing Information, The Medicines Company, Parsippany, NJ, USA (6 December 2005).
   Google Scholar
• EIKELBOOM JW, MEHTA SR, ANAND SS et al.: Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation (2006) 114(8):774-782.
   PubMed Web of Science ®Google Scholar
• RAO SV, O'GRADY K, PIEPER KS et al.: A comparison of the clinical impact of bleeding measured by two different classifications among patients with acute coronary syndromes. J. Am. Coll. Cardiol. (2006) 47(4):809-816.
   PubMed Web of Science ®Google Scholar
• MANOUKIAN SV, FEIT F, MEHRAN R et al.: Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial. J. Am. Coll. Cardiol. (2007) 49(12):1362-1368.
   PubMed Web of Science ®Google Scholar
• CANNON CP: Evolving management of ST-segment elevation myocardial infarction: update on recent data. Am. J. Cardiol. (2006) 98(12A):Q10-Q21.
   PubMed Web of Science ®Google Scholar
• SAUCEDO JF, AUDE W, PACHECO R et al.: Inhibition of platelet aggregation with eptifibatide, bivalirudin, and heparin in patients undergoing percutaneous coronary intervention receiving clopidogrel pretreatment (The PharmacoDynamic Evaluation of Angiomax, Clopidogrel with or without INtegrilin [DEACON] study). Am. J. Cardiol. (2005) 95(12):1453-1456.
   PubMed Web of Science ®Google Scholar

Websites

• http://clinicaltrials.gov/ct/show/NCT00262600?order=1 Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate. RE-LY study, NCT00262600.
   Google Scholar
• http://clinicaltrials.gov/ct/show/NCT00433966?order=1 Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction. NCT00433966.
   Google Scholar
• http://clinicaltrials.gov/ct/show/NCT00262054?order=1 Un-Fractionated Heparin vs. Bivalirudin During PCI (ISAR-REACT-3). NCT00262054.
   Google Scholar
• http://clinicaltrials.gov/ct/show/NCT00373451?order=1 Periinterventional Abciximab + Heparin vs. Bivalirudin in Acute Coronary Syndrome (ISAR-REACT-4). NCT00373451
   Google Scholar
• http://www.emea.europa.eu/humandocs/Humans/EPAR/angiox/angiox.htm Angiox Product Information EMEA (07/03/2007 Angiox-H-C-562-II-07).
   Google Scholar
• http://clinicaltrials.gov/ct/show/NCT00433966?order=1 Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction. NCT00433966.
   Google Scholar