Abstract:

One of the most significant problems in interventional cardiology is a correct drug-support after held procedure. First of all it is the prevention of stent thrombosis - application of anticoagulants and antiaggregants. The variety of these drugs on sale constantly grows - that leads to have clear ideas of their properties.

Article presents the review of clinical researches devoted to the recently appeared and early not used in Russia, drug Angioks (Bivalirudin), which has the same efficiency as well-known drugs, but is more safe.

References

1.     Maraganore J.M., Bourdon P., Jablonski J., Ramachandran K.L., Fenton J.W. 2nd. Design and characterization of hirulogs: a novel class of bivalent peptide inhibitors of thrombin. Biochemistry. 1990; 29(30): 7095-101.

2.     Bates S.M., Weitz J.I. Direct thrombin inhibitors for treatment of arterial thrombosis: potential differences between bivalirudin and hirudin. Am. J. Cardiol. 1998; 82(8B): 12P-18P. Review.

3.     Sciulli T.M., Mauro V.F. Pharmacology and clinical use of bivalirudin. Ann. Pharmacother. 2002; 36(6): 1028-41. Review.

4.     Topol E.J., Bonan R., Jewitt D., Sigwart U., Kakkar V.V., Rothman M., de Bono D., Ferguson J., Willerson J.T., Strony J., et al. Use of a direct antithrombin, hirulog, in place of heparin during coronary angioplasty. Circulation. 1993; 87(5): 1622-1629.

5.     Bates E.R. Bivalirudin: an anticoagulant option for percutaneous coronary intervention. Expert. Rev. Cardiovasc. Ther. 2004; 2(2): 153-62. Review.

6.     Bittl J.A., Strony J., Brinker J.A., Ahmed W.H., Meckel C.R., Chaitman B.R., Maraganore J., Deutsch E., Adelman B. 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): 764-9.

7.     Bittl J.A., Chaitman B.R., Feit F., Kimball W., Topol E.J. 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): 952-9.

8.     Lincoff A.M., KleimanN.S., Kottke-Marchant K., Maierson E.S., Maresh K., Wolski K.E., Topol E.J. 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): 847-53.

9.     Lincoff A.M., Bittl J.A., Harrington R.A., Feit F., Kleiman N.S., Jackman J.D., Sarembock I.J., Cohen D.J., Spriggs D., Ebrahimi R., Keren G., Carr J., Cohen E.A., Betriu A., Desmet W., Kereiakes D.J., Rutsch W., Wilcox R.G., de Feyter P.J., Vahanian A., Topol E.J. 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(7):853-63. Erratum in: JAMA. 2003; 289(13):1638.

10.   Gibson C.M., Morrow D.A., Murphy S.A., Palabrica T.M., Jennings L.K., Stone PH., Lui H.H., Bulle T., Lakkis N., Kovach R., Cohen D.J., Fish P,  McCabe C.H., Braunwald E. TIMI Study Group. 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-30trial. J. Am. Coll. Cardiol. 2006; 47(12): 2364-73.

11.   Pinto D.S., Stone G.W., Shi C., et al. on behalf of the ACUITY Investigators. Economic evaluation of bivalirudin with or without glycoprotein IIb/IIIa inhibition versus heparin with routine glycoprotein IIb/IIIa inhibition for early invasive management of acute coronary syndromes. J. Am. Coll. Cardiol. 2008; 25: 1758-1768.

12.   Kastrati A., Neumann F.J., Schulz S., Massberg S. et al. Abciximab and heparin versus bivalirudin for non-ST-elevation myocardial infarction. N. Engl. J. Med. 2011; 365: 21: 1980-1989.

13.   Stone G.W., Witzenbichler B., Guagliumi G., Peruga J.Z., Brodie B.R., Dudek D., Kornowski R., Hartmann F., Gersh B.J., Pocock S.J., Dangas G., Wong S.C., Kirtane A.J., Parise H., Mehran R. HORIZONS-AMI Trial Investigators. Bivalirudin during primary PCI in acute myocardial infarction. N. Engl. J. Med. 2008; 358(21): 2218-30.

14.   Mahaffey K.W., Lewis B.E., Wildermann N.M., Berkowitz S.D., Oliverio R.M., Turco M.A., Shalev Y., Ver Lee P., Traverse J.H., Rodriguez A.R., Ohman E.M., Harrington R.A., Califf R.M. ATBAT Investigators. The anticoagulant therapy with bivalirudin to assist in the performance of percutaneous coronary intervention in patients with heparin-induced thrombocytopenia (ATBAT) study: main results. J. Invasiv. Cardiol. 2003; 15(11): 611-6.

15.   Waksman R., Wolfram R.M., Torguson R.L., Okubagzi P., Xue Z., Suddath W.O., Satler L.F., Kent K.M. Switching from Enoxaparin to Bivalirudin in Patients with Acute Coronary Syndromes without ST-segment Elevation who Undergo Percutaneous Coronary Intervention. Results from SWITCH- a multicenter clinical trial. J. Invasiv. Cardiol. 2006; 18(8): 370-5.

16.   Andreas Koster, Bruce Spiess, Michael Jurmann, MD, Cornelius M. Dyke, Nicholas G. Smedira, MD, Sol Aronson and Michael A. Lincoff. Bivalirudin Provides Rapid, Effective, and Reliable Anticoagulation During Off-Pump Coronary Revascularization: Results of the «EVOLUTION OFF» Trial. Anesth Analg. 2006; 103(3): 540-4. 

Abstract:

The presented research on studying the efficiency and safety of various anticoagulants used in patients with acute coronary syndrome during percutaneous coronary interventions (PCI). High efficiency of a Bivalirudin is shown, in comparison with Unfractionated Heparin and Monofram on the amount of bleeding arising in the postoperative period and main adverse coronary events (MACE). 

References

1.     Bolezni serdca: Rukovodstvo dlja vrachej [Heart diseases: Manual for doctors]. (Pod red. R.G. Oganova, I.G. Fominoj) M. Litera. 2006; 1328 [In Russ].

2.     Rukovodstvo po kardiologii. Pod red. V.N. Kovalenko [Manual on cardiology edited by V.N.Kovalenko]. K. MORION. 2008; 1424 [In Russ] .

3.     Volozh O.I., Deev A.D., Kal'juste T.I. Prognosticheskoe znachenie nekotoryh faktorov dlja smertnosti trudosposobnogo vozrasta (prospektivnoe jepidemiologicheskoe issledovanie) [Prognostic value of some factors for estimation of mortality of able-bodied age (prospective epidemiologic study)]. Kardiologija. 1997; 9: 43-48 [In Russ].

4.     Oganov R.G. Pervichnaja profilaktika ishemicheskoj bolezni serdca [Primary prophylaxis of ischemic heart disease]. M. Medicina. 1990; 160 [In Russ].

5.     Paolo G. Camici, Sanjay Kumak Prosad, Omela E. Rimoldi. Stunning, Hybernating and Assesment of Myocardial Viability. Circulation, 2008; 117: 103-114.

6.     Aasa M., Dellborg M., Herlitz J. et al. Risk reduction for cardiac events after primary coronary intervention compared with thrombolysis for acute ST elevation myocardial infarction (five year results of the Swedish early decision reperfusion strategy [SWEDES] trial). Am. J. Cardiol. 2010; 106 (12): 1685-1691.

7.     2011 ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 - Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation, 2011; 123: e426-e579.

8.     The Direct Thrombin Inhibitor Trialists' Collaborative Group. Direct thrombin inhibitors in acute coronary syndromes: principal results of a meta-analysis based on individual patients' data. Lancet. 2002; 359: 294-302.

9.     Doyle B.J., Rihal C.S., Gastineau D.A., Holmes D.R. Jr. Bleeding, blood transfusion, and increased mortality after percutaneous coronary intervention: implications for contemporary practice. J Am. Coll. Cardiol. 2009; 53: 2019-2027.

10.   Kastrati A., Neumann F.J., Schulz S., Massberg S. et al. Abciximab and heparin versus bivalirudin for non-ST-elevation myocardial infarction. N. Engl. J.Med. 2011; 365(21): 1980-1989.

11.   Kessler D.P., Kroch E., Hlatky M.A. et al. The effect of bivalirudin on costs and outcomes of treatment of ST-segment elevation myocardial infarction. Am. Heart. J. 2011; 162: 494-500.

12.   Linkins L.A., Warkentin T.E. Heparin-induced thrombocytopenia: real-world issues. Semin Thromb Hemost 2011; 37(6): 653-663.

13.   Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation. Eur. Hear. J. 2008; 29: 2909-2945.

14.   Budaj A., Eikelboom J.W., Mehta S.R. et al. Improving clinical outcomes by reducing bleeding in patients with non-ST-elevation acute coronary syndromes. Eur. Heart J. 2009; 30:655-661.

15.   Mehran R., Pocock S.J., Stone G.W. et al. Associations of major bleeding and myocardial infarction with the incidence and timing of mortality in patients presenting with non-ST-eleva- tion acute coronary syndromes: a risk model from the ACUITY trial. Eur Heart J. 2009; 30:1457-1466.

16.   Bittle J.A., Chaitman B.R., Feit F. et al. 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.

17.   Montalescot G., Baldit-Solier C., Chibedit D. et al. for the ARMADA investigators. ARMADA study: a randomized comparison of enoxaparin, dalteparin and unfractional heparin on markers off cell activation in patients with unstable angina. Am. J. Cardiol. 2003; 91: 925-930.

18.   Montalescot G., Collet G.P., Lison L. et al. Effects of various anticoagulant treatments on von Willebrand factor release in unstable angina. J. Am. Coll. Cardiol. 2000; 36:100-114.

19.   Kokov L.S., Lopotovsky P.Yu., Parkhomenko M.V., Larin A.G., Korobenin A.Yu. Experience with the Use of Angiox (Bivalirudin) in Acute Coronary Syndrome (ACS) Patients with Complications Caused by Percutaneous Coronary Intervention (PCI). International Journal of InterventionalCardioangiology, 2013; 34: 39-42.

20.   Manoukian S.V., 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.

21.   Stone G.W., Witzenbichler B., Guagliumi G. et al. 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 multicenter, randomized controlled trial. Lancet 2011; 377(9784): 2193-2204.

22.   Steg G., Stefan K. James, Atar D. et al. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012; 33:2569-2619. 

Abstract:

Aim: was to study the safety and efficacy of the use of the drug bivalirudin in patients with acute coronary syndrome (ACS) with ST-segment elevation.

Materials and methods: the study included 20 patients which were admitted to hospital with a diagnosis of ACS with ST-segment elevation. Among patients - 3 women and 17 men. The age of patients ranged from 31 to 79 years, mean 56±10,8 years. Myocardial infarction of bottom wall of left ventricular (LV) was diagnosed in 9 (45%) patients, front wall - 11(55%) patients. All patients in the emergency order underwent coronary angiography (CA) with further PCI. Multivessel coronary disease was found in 35% of patients, occlusion of a coronary artery - in 20% of cases, bifurcation lesion - 15% of patients, the left main coronary artery - in 30% of cases. Before performing the PCI, 14(70%) of patients were given clopidogrel (600 mg), 6 (30%) of patients - ticagrelor (180 mg) in combination with aspirin. Intraoperative, patients received bivalirudin («Angioks») under the scheme: 0.75 mg/kg intravenous bolus, further - intravenous infusion at a rate of 1.75 mg/kg/h during the whole period of endovascular intervention.

Three patients due to technical features during the operation underwent intracoronary thrombolytic therapy In 2 cases, situation required the installation of intra-aortic balloon counterpulsation. Results: 20 patients underwent implanting of 27 stents (mean 1,35). Immediate technical success of endovascular intervention was 100%. In the intensive care unit for 4 hours after surgery lasted bivalirudin infusion at a dose of 0.25 mg/kg/h, after the transfer to the Department of Cardiology continued therapy with enoxaparin within five days. After endovascular intervention patients were converted to standard doses of clopidogrel (75 mg daily) or ticagrelor (90 mg, 2 times a day), depending on drug, that patient was given during PCI and aspirin (100 mg); and patients receive adequate medical therapy of main disease according to standards of the disease. We presented clinical experience that shows safety of bivalirudin: in the group of patients was not observed any hemorrhagic complication during the time that patients were in a hospital.

References

1.     Bolezni serdca: Rukovodstvo dlja vrachej [Cardiac diseases: guide-book for doctors]. (pod red. R.G. Oganova, I.G. Fominoj) M.: Litera. 2006; 1328 [In Russ].

2.     Byrne C.E., Fitzgerald A., Cannon C.P., Fitzgerald D. J., Shields D. C. Elevated white cell count in acute coronary syndromes: relationship to variants in inflammatory and thrombotic genes Text. BMC Med. Genet. 2004; 5: 13.

3.     Nacional'nye klinicheskie rekomendacii [National clinical recommendations] (pod red. R.G. Oganova, M.N. Mamedova) M.: MEDI-Jekspo, 2009; 390 [In Russ].

4.     Dovgalevskij P.Ja. Ostryj koronarnyj sindrom: patogenez, klinicheskaja kartina, aspekty lechenija. Chto my znaem i chto nado delat'? [Acute coronary syndrome: pathogenesis, clinical picture, aspects of treatment. What we know and what to do?] Serdce. 2002; 1(1): 1315 [In Russ].

5.     Keeley E.C., Boura J.A., Grines C.L. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomized trials. Lancet. 2003; 361: 13-20.

6.     Steg G., Stefan K. James, Atar D. et al. ESC Guidelines for the management of acute myocardial infarction in patients with ST-segment elevation. Eur. Heart J. 2012; 33: 2569-2619.

7.     Wright R.S., Anderson J.L., Adams C.D. et al. 2011 ACCF/AHA focused update of the guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction (updating the 2007 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J. Am. Coll. Cardiol. 2011; 57: 1920-59.

8.     Averkov O.V. Teoreticheskoe obosnovanie i prakticheskie aspekty ispol'zovanija bivalirudina pri chrezkozhnyh vnutrikoronarnyh vmeshatel'stvah u bol'nyh s ostrym koronarnym sindromom [Theoretical basis and practical aspects of the use of bivalirudin during PCI in patients with acute coronary syndrome.]. Rossijskij kardiologicheskij zhurnal. 2012; 3 (95): 102-112 [In Russ].

9.     Mehran R., Pocock S.J., Stone G.W. et al. Associations of major bleeding and myocardial infarction with the incidence and timing of mortality in patients presenting with non-ST-elevation acute coronary syndromes: a risk model from the ACUITY trial. Eur. Heart J. 2009; 30: 655-661.

10.   Bittle J.A., Chaitman B.R., Feit F. et al. 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.

11.   Nicolas W. Shammas. Bivalirudin: Pharmacology and Clinical Applications. Cardiovascular Drug Reviews. 2005; 23( 4): 345-360.

12.   Kelton J.G., Warkentin T.E. Heparin-induced thrombocytopenia: a historical perspective. Blood. 2008; 112 (7): 2607-16.

13.   Montalescot G., Collet G.P, Lison L. et al. Effects of various anticoagulant treatments on von Willebrand factor release in unstable angina. J. Am. Coll. Cardiol. 2000; 36: 100-114.

14.   Stone G.W., Witzenbichler B., Guagliumi G. et al. for the HORIZONS-AMI Trial Investigators. Bivalirudin during primary PCI in acute myocardial infarction. N. Engl. J. Med. 2008 May 22; 358 (21): 2218-30.

15.   Stone G.W., Witzenbichler B., Guagliumi G. et al. Heparin plus a glycoprotein 11 b/111 a inhibitors versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-years results from a multicenter, randomized controlled trial. Lancet. 2011; 377 (9784): 2193-2204.

16.   Guidelines on myocardial revascularization, Eur. Heart J. 2010; doi 10.1093/eurheartj/ehj277.

17.   Kushner F.G., Hand M., Smith S.C., et al. 2009 Focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guidline 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 Assotiation Task Force on practice guidelines. J. Am. Coll. Cardiol. 2009; 54: 2205-2241.