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• W2086436794 abstract "Bivalirudin is a short-acting direct thrombin inhibitor that is increasingly used for anticoagulation during cardiac surgery in patients with heparin-induced thrombocytopenia (HIT).1Koster A. Dyke C.M. Aldea G. et al.Bivalirudin during cardiopulmonary bypass in patients with previous or acute heparin-induced thrombocytopenia and heparin antibodies: results of the CHOOSE-ON trial.Ann Thorac Surg. 2007; 83: 572-577Abstract Full Text Full Text PDF PubMed Scopus (167) Google Scholar During cardiopulmonary bypass (CPB) with heparin anticoagulation, aprotinin reduces hemostatic activation, inflammatory response, perioperative blood loss, and transfusion requirements. The current investigation was performed to assess the effects of aprotinin when bivalirudin is used for anticoagulation during CPB.See related articles on pages 487, 495, and 573. See related articles on pages 487, 495, and 573. After approval by the German Ministry for Drug Safety and the local ethics committee and informed consent was obtained, 14 patients scheduled for first-time elective coronary artery bypass grafting (CABG) were enrolled in this prospective single-center investigation. Patients were randomized to 2 groups with 7 patients each: 1 group with bivalirudin anticoagulation only and 1 group with bivalirudin and aprotinin. All patients had normal renal function, a left ventricular ejection fraction of more than 30%, and antiplatelet therapy discontinued 5 days before surgery. Bivalirudin dosing and CPB management were performed as described before using closed CPB systems without cardiotomy suction.2Koster A. Yeter R. Buz S. et al.Assessment of hemostatic activation during cardiopulmonary bypass for coronary artery bypass grafting with bivalirudin: results of a pilot study.J Thorac Cardiovasc Surg. 2005; 129: 1391-1394Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar Aprotinin was given according to a high-dose protocol with 2 × 106 kallikrein inhibiting units (KIU) as patient bolus, 2 × 106 KIU in the CPB priming solution, and continuous infusion of 0.5 × 106 KIU during CPB. Packed red blood cell concentrates were transfused when the hemoglobin level was less than 8 g/dL. The transfusion of fresh-frozen plasma and platelets was based on the physicians' decision. Samples for measurement of bivalirudin concentrations were obtained after the bolus was given and at intervals of 15 minutes during CPB, at intervals of 5 minutes until 1 hour after CPB, and at intervals of 15 minutes during the following hour. Bivalirudin concentrations were analyzed with high-performance liquid chromatography. Samples for assessment of markers of hemostatic activation (fibrinopeptide A and prothrombin fragment 1+2) and inflammation (interleukin 6 and myeloperoxidase) were obtained 5 minutes after the bivalirudin bolus was given (before initiation of CPB) and after termination of the bivalirudin infusion, shortly before termination of CPB. Samples were analyzed with standard enzyme-linked immune assays. Statistical analysis was performed using the Student t, Wilcoxon rank-sum, and paired Wilcoxon signed-rank tests. There were no differences regarding patients' demographic data, duration of CPB, or surgery (Table 1). The clinical course of all patients was uneventful. In control patients treated only with bivalirudin, there was a moderate increase in markers of hemostatic activation and inflammatory response during CPB. The administration of high-dose aprotinin did not influence bivalirudin pharmacokinetics, hemostatic activation, and inflammatory response, but there was a significant reduction of perioperative blood loss and a marked trend toward lower transfusion requirements (Table 1; Figure 1).Table 1Clinical and laboratory dataBivalirudin (n = 7)Bivalirudin + aprotinin (n = 7)PBaseline characteristics Age63.0 ± 7.061.7 ± 9.1.70 Gender, male %85.785.71.0 Weight (kg)88.7 ± 15.089.0 ± 14.9.85CPB + surgery Time on CPB (min)86.4 ± 21.493.0 ± 28.2.57 Duration of surgery (min)213.9 ± 38.4214.7 ± 54.8.85Blood loss + transfusions Mean blood loss 2 h postsurgery (mL)454 ± 30496 ± 37.002 Mean blood loss 12 h postsurgery (mL)959 ± 472274 ± 53.002 Any transfusions (%)71.442.9.59 PRBC (%)57.128.6.59 Mean no. of units in patients with PRBC3.3 ± 2.62 ± 0.62Inflammation + hemostatic activation MPO (pM) pre-CPB66.8 ± 136.769.4 ± 153.0.65 MPO (pM) post-CPB63.5 ± 88.476.7 ± 133.95 Pre vs post-CPB P value (within group).56.237 IL6 (pg/mL) pre-CPB13.0 ± 4.715.9 ± 11.4.85 IL6 (pg/mL) post-CPB72.1 ± 49.483.6 ± 42.1.57 Pre vs post-CPB P value (within group).018.028 FPA (ng/mL) pre-CPB20.6 ± 19.614.2 ± 8.1.85 FPA (ng/mL) post-CPB26.0 ± 16.632.6 ± 19.6.41 Pre vs post-CPB P value (within group).091.063 PF 1+2 (pM) pre-CPB476 ± 264222 ± 54.025 PF 1+2 (pM) post-CPB512 ± 251418 ± 211.37 Pre vs post-CPB P value (within group).128.043CPB, Cardiopulmonary bypass; PRBC, packed red blood cell concentrates; MPO, myeloperoxidase; IL, interleukin; FPA, fibrinopeptide A; PF 1+2, prothrombin fragment 1+2. Open table in a new tab CPB, Cardiopulmonary bypass; PRBC, packed red blood cell concentrates; MPO, myeloperoxidase; IL, interleukin; FPA, fibrinopeptide A; PF 1+2, prothrombin fragment 1+2. The elimination of bivalirudin is mainly achieved by proteolytic cleavage. Because aprotinin is a proteinase inhibitor, concerns may be raised that high concentrations of this agent may prolong bivalirudin half-life and thereby increase the risk of hemorrhage. In a previous pilot investigation using a different protocol for bivalirudin and a half-dose aprotinin regimen, no impact of aprotinin on bivalirudin pharmacokinetics, blood loss, and transfusion requirements was noted.3Koster A. Spiess B.D. Chew D.P. et al.Effectiveness of bivalirudin as a replacement for heparin during cardiopulmonary bypass in patients undergoing coronary artery bypass grafting.Am J Cardiol. 2004; 93: 356-359Abstract Full Text Full Text PDF PubMed Scopus (100) Google Scholar Our current data show that a high-dose aprotinin protocol does not affect the pharmacology of bivalirudin. Moreover, the administration of aprotinin does not attenuate the moderate hemostatic activation and inflammatory response observed during bivalirudin anticoagulation of CPB. However, even in this small number of patients, the administration of aprotinin according to the high-dose protocol resulted in a highly significant decrease in perioperative blood loss and a marked trend toward a reduction of transfusions. Aprotinin is one of the most effective drugs to reduce perioperative blood loss and transfusion requirements in patients undergoing CPB procedures with heparin anticoagulation. Recent studies associated the use of aprotinin with increased myocardial infarction, renal failure, and 5-year mortality when given during CPB with heparin anticoagulation and protamine reversal in patients undergoing elective CABG.4Mangano D.T. Tudor I.C. Dietzel C. Multicenter Study of Perioperative Research GroupIschemia Research and Education Foundation. The risk associated with aprotinin in cardiac surgery.N Engl J Med. 2006; 354: 353-365Crossref PubMed Scopus (930) Google Scholar, 5Mangano D.T. Miao Y. Vuylsteke A. et al.Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery.JAMA. 2007; 297: 471-479Crossref PubMed Scopus (326) Google Scholar These results may promote the more cautious use of aprotinin, particularly in low-risk patients undergoing CABG. However, although the current investigation was not powered to assess patient outcomes in this regard, the observed reduction of blood loss and transfusions in our patients undergoing on-pump CABG with bivalirudin anticoagulation remains impressive. The effects of drugs influencing the hemostatic system observed in patients without HIT cannot automatically be translated to patients with HIT. Nevertheless, in view of the current data, we believe that in the high-risk population of patients with HIT, high-dose aprotinin may be considered as an adjunctive agent during CPB anticoagulation with bivalirudin. This applies particularly to complex procedures with a high risk of increased perioperative bleeding. Aprotinin: Twenty-five years of claim and counterclaimThe Journal of Thoracic and Cardiovascular SurgeryVol. 135Issue 3PreviewThe coagulopathy after blood–foreign surface interaction in the cardiopulmonary bypass circuit is part of the “postperfusion syndrome,” which historically has accounted for as many deaths as has cardiac insufficiency. Cardiopulmonary bypass induces platelet dysfunction, thrombin production, and plasmin release.1 These changes provide the basis for postoperative hemorrhage, cardiac tamponade, and the need for surgical re-entry or excessive blood transfusion. Antiplatelet therapy in patients with coronary artery disease further compounded these effects. Full-Text PDF Bleeding in cardiac surgery: The use of aprotinin does not affect survivalThe Journal of Thoracic and Cardiovascular SurgeryVol. 135Issue 3PreviewThe antifibrinolytic drug aprotinin has been the most widely used agent to reduce bleeding and its complications in cardiac surgery. Several randomized trials and meta-analyses have demonstrated it to be effective and safe. However, 2 recent reports from a single database have implicated the use of aprotinin as a risk for postoperative complications and reduced long-term survival. Full-Text PDF Aprotinin confers neuroprotection by reducing excitotoxic cell deathThe Journal of Thoracic and Cardiovascular SurgeryVol. 135Issue 3PreviewAprotinin is used in cardiac surgery for its anti-inflammatory and hemostatic benefits. Recent reports describe the neuroprotective effects of other serine protease inhibitors via reduced excitotoxic cell death, a common pathway causing cytotoxic edema induced in various neuropathologic conditions. The purpose of this study was to investigate whether aprotinin directly protects against glutamatergic excitotoxicity in cell cultures. Full-Text PDF" @default.
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• W2086436794 title "High-dose aprotinin effectively reduces blood loss during on-pump coronary artery bypass grafting with bivalirudin anticoagulation" @default.
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