Subscribe to RSS
DOI: 10.1055/s-0029-1186067
© Georg Thieme Verlag KG Stuttgart · New York
Aprotinin-Associated Risks in Off-Pump Coronary Artery Bypass Grafting[*]
Publication History
received January 31, 2009
Publication Date:
14 December 2009 (online)
Abstract
Background: Little data is available regarding the safety of using the serine protease inhibitor aprotinin in off-pump cardiac surgery. We retrospectively assessed the risks of administering the drug to adult patients undergoing off-pump coronary artery bypass grafting (OPCABG). Methods: Aprotinin was administered as a bolus of 1 or 2 million kallikrein inhibiting units to 391 patients following median sternotomy; 370 control patients underwent surgery during the same time period without receiving aprotinin. No other antifibrinolytic agents were administered. Results: Preoperative characteristics, length of ICU and hospital stay were similar between the mostly medium-risk aprotinin and the control patients. Postoperative cardiac, renal, neurological, and respiratory complications and hospital mortality occurred with comparable frequencies in both groups. Levels of myocardial enzymes during the first 72 h after surgery also did not differ significantly. Conclusion: Use of aprotinin in OPCABG was not associated with a higher incidence of hospital mortality, cardiovascular, renal, or other complications. Given the good safety profile in this large patient population we suggest that aprotinin could still be a valid antifibrinolytic treatment option in OPCABG.
Key words
antifibrinolytic treatment - aprotinin - complications - off‐pump coronary artery bypass grafting - safety
1 Presented in part at the 36th Annual Meeting of the German Society for Thoracic and Cardiovascular Surgery, Hamburg, February 11–14, 2007.
References
- 1 Sedrakyan A, Treasure T, Elefteriades J A. Effect of aprotinin on clinical outcomes in coronary artery bypass graft surgery: a systematic review and meta-analysis of randomized clinical trials. J Thorac Cardiovasc Surg. 2004; 128 442-448
- 2 Henry D A, Carless P A, Moxey A J et al. Anti-fibrinolytic use for minimizing perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2007; (4) CD001886 DOI: 10.1002/14651858.CD001886.pub2
- 3 Englberger L, Markart P, Eckstein F S, Immer F F, Berdat P A, Carrel T P. Aprotinin reduces blood loss in off-pump coronary artery bypass (OPCAB) surgery. Eur J Cardiothorac Surg. 2002; 22 545-551
- 4 Vanek T, Jares M, Fajt R et al. Fibrinolytic inhibitors in off-pump coronary surgery: a prospective, randomized, double-blind TAP study (tranexamic acid, aprotinin, placebo). Eur J Cardiothorac Surg. 2005; 28 563-568
- 5 Poston R S, White C, Gu J et al. Aprotinin shows both hemostatic and antithrombotic effects during off-pump coronary artery bypass grafting. Ann Thorac Surg. 2006; 81 104-111
- 6 Bittner H B, Lange M, Lemke J, Rastan A, Mohr F W. The impact of aprotinin on blood loss and blood transfusion in off-pump coronary artery bypass grafting. Ann Thorac Surg. 2008; 85 1662-1668
- 7 Mangano D T, Tudor J C, Dietzel C. The risk associated with aprotinin in cardiac surgery. New Eng J Med. 2006; 354 353-365
- 8 Mangano D T, Miao Y, Vuylsteke A et al. Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery. JAMA. 2007; 297 471-479
- 9 Ferraris V A, Bridges C R, Anderson R P. Aprotinin in cardiac surgery. N Engl J Med. 2006; 354 1953-1954
- 10 Sedrakyan A, Atkins D, Treasure T. The risk of aprotinin: a conflict of evidence. Lancet. 2006; 367 1376-1377
- 11 Royston D, Chhatwani A. Safety aspects of aprotinin therapy in cardiac surgery patients. Expert Opin Drug Saf. 2006; 5 539-552
- 12 Mouton R, Finch D, Davies I, Binks A, Zacharowski K. Effect of aprotinin on renal dysfunction in patients undergoing on-pump and off-pump cardiac surgery: a retrospective observational study. Lancet. 2008; 371 475-482
- 13 Pagano D, Howell N J, Freemantle N et al. Bleeding in cardiac surgery: the use of aprotinin does not affect survival. J Thorac Cardiovasc Surg. 2008; 135 495-502
- 14 Fergusson D A, Hébert P C, Mazer C D et al. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. New Engl J Med. 2008; 358 2319-2331
- 15 Dietrich W, Ebell A, Busley R, Boulesteix A-L. Aprotinin and anaphylaxis: analysis of 12403 exposures to aprotinin in cardiac surgery. Ann Thorac Surg. 2007; 84 1144-1150
- 16 Levey A S, Greene T, Kusek J W, Beck G L. MDRD Study Group . A simplified equation to predict glomerular filtration rate from serum creatinine. J Am Soc Nephrol. 2000; 11 A0828
- 17 Alderman E L, Levy J H, Rich J B et al. Analyses of coronary graft patency after aprotinin use: results from the International Multicenter Aprotinin Graft Patency Experience (IMAGE) trial. J Thorac Cardiovasc Surg. 1998; 116 716-730
- 18 Poston R S, Gu J, White C et al. Perioperative management of aspirin resistance after off-pump coronary artery bypass grafting: possible role for aprotinin. Transfusion. 2008; 48 39S-46S
- 19 Sear J W. Kidney dysfunction in the postoperative period. Br J Anaesth. 2005; 95 20-32
- 20 Chertow G M, Lazarus J M, Christiansen C L et al. Preoperative renal risk stratification. Circulation. 1997; 95 878-884
- 21 Godet G, Fléron M-H, Vicaut E et al. Risk factors for acute postoperative renal failure in thoracic or thoracoabdominal aortic surgery: a prospective study. Anesth Analg. 1997; 85 1227-1232
- 22 Conlon P J, Stafford-Smith M, White W D et al. Acute renal failure following cardiac surgery. Nephrol Dial Transplant. 1999; 14 1158-1162
- 23 O'Connor C J, Brown D V, Avramov M, Barnes S, O'Connor H N, Tuman K J. The impact of renal dysfunction on aprotinin pharmacokinetics during cardiopulmonary bypass. Anesth Analg. 1999; 89 1101-1107
- 24 Sedrakyan A, Wu A W, Parashar A, Bass E B, Treasure T. Off-pump surgery is associated with reduced occurrence of stroke and other morbidity as compared with traditional coronary artery bypass grafting. A meta-analysis of systematically reviewed trials. Stroke. 2006; 37 2759-2769
1 Presented in part at the 36th Annual Meeting of the German Society for Thoracic and Cardiovascular Surgery, Hamburg, February 11–14, 2007.
Dr. MD, PhD Hartmuth B. Bittner
Heart Center Leipzig
Struempellstr. 39
04289 Leipzig
Germany
Phone: + 493418651422
Fax: + 493418651452
Email: heartbeatgermany@aol.com