Recombinant nematode anticoagulant protein c2 in non-ST segment elevation acute coronary syndrome and beyond

Future Cardiology

Volumn 3, Issue 4, 2007, Pages 365-375

  Fluture, Adrian ^a   Giugliano, Gregory R ^b   Giugliano, Robert P ^c  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Cardiac Catheterization Laboratory and Cardiology Research   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

Acute coronary syndrome; Anticoagulant; Myocardial infarction; Thrombosis; Tissue factor

Indexed keywords

ABCIXIMAB; ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT; BLOOD CLOTTING FACTOR 10A; BLOOD CLOTTING FACTOR 10A INHIBITOR; BLOOD CLOTTING FACTOR 7A; CLOPIDOGREL; ENOXAPARIN; EPTIFIBATIDE; FIBRINOGEN RECEPTOR ANTAGONIST; FONDAPARINUX; HEPARIN; HIRULOG; LOW MOLECULAR WEIGHT HEPARIN; PLACEBO; RECOMBINANT NEMATODE ANTICOAGULANT PROTEIN C2; THROMBIN INHIBITOR; THROMBOPLASTIN; TIROFIBAN; UNCLASSIFIED DRUG;

ACUTE CORONARY SYNDROME; ANAPHYLAXIS; ANGIOCARDIOGRAPHY; ARTICLE; BLEEDING; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CORONARY ARTERY BYPASS GRAFT; DEEP VEIN THROMBOSIS; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REGIMEN; DRUG FATALITY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG MEGADOSE; DRUG POTENTIATION; ESOPHAGITIS; ESOPHAGUS HEMORRHAGE; HEART MUSCLE ISCHEMIA; HUMAN; MONOTHERAPY; NONHUMAN; PERCUTANEOUS CORONARY INTERVENTION; PHARMACODYNAMICS; PRIORITY JOURNAL; RECURRENT DISEASE; SINGLE DRUG DOSE; ST SEGMENT ELEVATION; STROKE; THROMBOSIS;

EID: 34447319081     PISSN: 14796678     EISSN: 17448298     Source Type: Journal    
DOI: 10.2217/14796678.3.4.365     Document Type: Article

References (52)

1. Antman EM, Anbe DT, Armstrong PW et al.: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of patients with acute myocardial infarction). J. Am. Coll. Cardiol. 44(3), E1-E211 (2004).
2. Braunwald E, Antman EM, Beasley JW et al.: ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction - summary article:a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients With Unstable Angina). J. Am. Coll. Cardiol. 40(7), 1366-1374 (2002).
3. Gelfand EV, Cannon CP: Acute Coronary Syndromes. In: Hemostasis and Thrombosis. Colman R (Ed.). Lippincott Williams & Wilkins, Philadelphia, USA 1387-1404 (2006).
4. Ferguson JJ, Califf RM, Antman EM et al.: Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial. JAMA 292(1), 45-54 (2004).
5. Kastrati A, Mehilli J, Neumann FJ et al.: Abciximab in patients with acute coronary syndromes undergoing percutaneous coronary intervention after clopidogrel pretreatment: the ISAR-REACT 2 randomized trial. JAMA 295(13), 1531-1538 (2006).
6. Cannon CP, Weintraub WS, Demopoulos LA et al.: Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban. N. Engl. J. Med. 344(25), 1879-1887 (2001).
7. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17, 187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Lancet 2(8607), 349-360 (1988).
8. Antithrombotic Trialists' Collaboration: Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. Br. Med. J. 324(7329), 71-86 (2002).
9. Risk of myocardial infarction and death during treatment with low dose aspirin and intravenous heparin in men with unstable coronary artery disease. The RISC Group. Lancet 336(8719), 827-830 (1990).
10. Theroux P, Ouimet H, McCans J et al.: Aspirin, heparin, or both to treat acute unstable angina. N. Fngl. J. Med. 319(17), 1105-1111 (1988).
11. Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK: Effect of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N. Engl. J. Med. 345(7), 494-502 (2001).
12. Mehta SR, Yusuf S, Peters RJ et al.: Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 358(9281), 527-533 (2001).
13. Steinhubl SR, Berger PB, Mann JT 3rd et al.: Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 288(19), 2411-2420 (2002).
14. Oler A, Whooley MA, Oler J, Grady D: Adding heparin to aspirin reduces the incidence of myocardial infarction and death in patients with unstable angina. A meta-analysis. JAMA 276(10), 811-815 (1996).
15. Antman EM, McCabe CH, Gurfinkel EP et al.: Enoxaparin prevents death and cardiac ischemic events in unstable angina/non-Q-wave myocardial infarction. Results of the thrombolysis in myocardial infarction (TIMI) 11B trial. Circulation 100(15), 1593-1601 (1999).
16. Cohen M, Demers C, Gurfinkel EP et al.: A comparison of low-molecular-weight heparin with unfractionated heparin for unstable coronary artery disease. Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events Study Group. N. Engl. J. Med. 337(7), 447-452 (1997).
17. Blazing MA, de Lemos JA, White HD et al.: Safety and efficacy of enoxaparin vs unfractionated heparin in patients with non-ST-segment elevation acute coronary syndromes who receive tirofiban and aspirin: a randomized controlled trial. JAMA 292(1), 55-64 (2004).
18. Topol EJ, Ferguson JJ, Weisman HF et al.: Long-term protection from myocardial ischemic events in a randomized trial of brief integrin β3 blockade with percutaneous coronary intervention. EPIC Investigator Group. Evaluation of Platelet IIb/IIIa Inhibition for Prevention of Ischemic Complication. JAMA 278(6), 479-484(1997).
19. Inhibition of the platelet glycoprotein IIb/IIIa receptor with tirofiban in unstable angina and non-Q-wave myocardial infarction. Platelet Receptor Inhibition in Ischemic Syndrome Management in Patients Limited by Unstable Signs and Symptoms (PRISM-PLUS) Study Investigators. N. Engl. J. Med. 338(21), 1488-1497 (1998).
20. Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. The PURSUIT Trial Investigators. Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy. N. Engl. J. Med. 339(7), 436-443 (1998).
21. Boersma E, Harrington RA, Moliterno DJ et al.: Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: a meta-analysis of all major randomised clinical trials. Lancet 359(9302), 189-198 (2002).
22. 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 289(7), 853-863 (2003).
23. Stone GW, McLaurin BT, Cox DA et al.: Bivalirudin for patients with acute coronary syndromes. N. Engl. J. Med. 355(21), 2203-2216 (2006).
24. Gibson CM, Morrow DA, Murphy SA et al.: A randomized trial to evaluate the relative protection against post-percutaneous coronary intervention microvascular dysfunction, ischemia, and inflammation among antiplatelet and antithrombotic agents: the PROTECT-TIMI-30 trial. J. Am. Coll. Cardiol. 47(12), 2364-2373 (2006).
25. Weitz JI, Bates SM: New anticoagulants. J. Thromb. Haemost. 3(8), 1843-1853 (2005).
26. Yusuf S, Mehta SR, Chrolavicius S et al.: Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N. Engl. J. Med. 354(13), 1464-1476 (2006).
27. Morrow DA, Murphy SA, McCabe CH, Mackman N, Wong HC, Antman EM: Potent inhibition of thrombin with a monoclonal antibody against tissue factor (Sunol-cH36): results of the PROXIMATE-TIMI 27 trial. Eur. Heart J. 26(7), 682-688 (2005).
28. Lee AY, Vlasuk GP: Recombinant nematode anticoagulant protein c2 and other inhibitors targeting blood coagulation factor VIIa/tissue factor. J. Intern. Med. 254(4), 313-321 (2003).
29. Buddai SK, Toulokhonova L, Bergum PW, Vlasuk GP, Krishnaswamy S: Nematode anticoagulant protein c2 reveals a site on factor Xa that is important for macromolecular substrate binding to human prothrombinase. J. Biol. Chem. 277(29), 26689-26698 (2002).
30. Bergum PW, Cruikshank A, Maki SL, Kelly CR, Ruf W, Vlasuk GP: Role of zymogen and activated factor X as scaffolds for the inhibition of the blood coagulation factor VIIa-tissue factor complex by recombinant nematode anticoagulant protein c2. J. Biol. Chem. 276(13), 10063-10071 (2001).
31. Giugliano RP, Wiviott SD, Stone PH et al.: Recombinant nematode anticoagulant protein c2 (rNAPc2) in patients with non-ST-elevation acute coronary syndrome - The ANTHEM (Anticoagulation with rNAPc2 To Help Eliminate MACE) - TIMI 32 trial. J. Am. Coll. Cardiol. 59, 2398-2407 (2007).
32. Schneider DJ, Whitaker DA, Sobel BE: Efficiency in clinical research: assessment in vitro of potential anti-thrombotic drug interactions. Coron. Artery Dis. 15(3), 177-181 (2004).
33. Coughlin SR, Camerer E: Participation in inflammation. J. Clin. Invest. 111(1), 25-27 (2003).
34. Riewald M, Ruf W: Mechanistic coupling of protease signaling and initiation of coagulation by tissue factor. Proc. Natl. Acad. Sci. USA 98(14), 7742-7747 (2001).
35. Geisbert TW, Hensley LE, Jahrling PB et al.: Treatment of Ebola virus infection with a recombinant inhibitor of factor VIIa/tissue factor: a study in rhesus monkeys. Lancet 362(9400), 1953-1958 (2003).
36. Hembrough TA, Swartz GM, Papathanassiu A et al.: Tissue factor/ factor VIIa inhibitors block angiogenesis and tumor growth through a nonhemostatic mechanism. Cancer Res. 63(11), 2997-3000 (2003).
37. Vlasuk GP, Bradbury A, Lopez-Kinninger L. et al.: Pharmacokinetics and anticoagulant properties of the factor VIIa-tissue factor inhibitor recombinant nematode anticoagulant protein c2 following subcutaneous administration in man. Dependence on the stoichiometric binding to circulatuig factor X. Thromb. Haemost. 90(5), 803-812 (2003).
38. de Pont AC, Bakhtiari K, Hutten BA et al.: Endotoxaemia induces resistance to activated protein C in healthy humans. Br. J. Haematol. 134(2), 213-219 (2006).
39. de Pont AC, Moons AH, de Jonge E et al.: Recombinant nematode anticoagulant protein c2, an inhibitor of tissue, factor/factor VIIa, attenuates coagulation and the interleukin-10 response in human endotoxemia. J. Thromb. Haemost. 2(1), 65-70 (2004).
40. Moons AH, Peters RJ, Bijsterveld NR et al.: Recombinant nematode anticoagulant protein c2, an inhibitor of the tissue factor/factor VIIa complex, in patients undergoing elective coronary angioplasty. J. Am. Coll. Cardiol. 41(12), 2147-2153 (2003).
41. Friederich PW, Levi M, Bauer KA et al.: Ability of recombinant factor VIIa to generate thrombin during inhibition of tissue factor in human subject. Circulation 103(21), 2555-2559 (2001).
42. Lee A, Agnelli G, Buller H et al.: Dose-response study of recombinant factor VIIa/tissue factor inhibitor recombinant nematode anticoagulant protein c2 in prevention of post-operative venous thromboembolism in patients undergoing total knee replacement. Circulation 104(1), 74-78 (2001).
43. Narula, T, Southard MC, Gibson CM et al.: Outcomes in patients with NSTE-ACS Undergoing PCI on a novel tissue factor/factor VIIa, inhibitor (rNAPc2) with full, half dose or no heparin in the ANTHEM-TIMI 32 trial. Am. J. Cardiol. 98(8), 196M (2006).
44. Fluture A, Giugliano GR, Southard MC et al.: Angiographic outcomes in patients with non-STE ACS undergoing PCI using adjunctive recombinant nematode anticoagulant protein c2 versus placebo: an ANTHEM-TIMI 32 angiographic core lab analysis. Am. J. Cardiol. 98(8), 198M (2006).
45. O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM: Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 295(3), 293-298 (2006).
46. Steffel J, Luscher TF, Tanner FC: Tissue factor in cardiovascular diseases: molecular mechanisms and clinical implications. Circulation 113(5), 722-731 (2006).
47. Stouffer GA, Pathak A, Whinna HC, Ohman EM: Effect of multielement intravascular ultrasound on the anticoagulant potency of enoxaparin. Am. J. Cardiol. 93(11), 1453-1454 (2004).
48. Madan M, Radhakrishnan S, Reis M et al.: Comparison of enoxaparin versus heparin during elective percutaneous coronary intervention performed with either eptifibatide or tirofiban (the ACTION Trial). Am. J. Cardiol. 95(11), 1295-1301 (2005).
49. Buller CE, Pate GE, Armstrong PW et al.: Catheter thrombosis during primary percutaneous coronary intervention for acute ST elevation myocardial infarction despite subcutaneous low-molecular-weight heparin, acetylsalicylic acid, clopidogrel and abciximab pretreatment. Can. J. Cardiol. 22(6), 511-515 (2006).
50. Frishman WH, Cheng-Lai A, Nawarskas J: Antithrombotic therapy. In: Current cardiovascular drugs (4th Edition). Frishman WH (Ed.). Current Medicine LLC, PA, USA 98-151 (2005).
51. Griffin JH: Blood coagulation. The thrombin paradox. Nature 378(6555), 337-338 (1995).
52. Vlasuk GR, Rote WE: Inhibition of factor VIIa/tissue factor with nematode anticoagulant protein c2: from unique mechanism to a promising new clinical anticoagulant. Trends Cardiovasc. Med. 12(8), 325-331 (2002).