Pharmacy & Therapeutics - February 2008 - (Page 106)

Antifibrinolytic Therapy in Cardiothoracic Surgery mens of antifibrinolytic agents. Nonetheless, a retrospective database analysis may offer certain advantages over lengthy and expensive randomized, controlled trials, such as quickly providing insight into controversial medical practice issues, generating large heterogeneous or homogeneous samples for analysis, and presenting the capability of tracking patients longitudinally, if necessary. Table 7 Postoperative Stroke in Cardiothoracic Surgery (CTS) and Coronary Artery Bypass Graft (CABG) Patients Receiving Aprotinin or Aminocaproic Acid Stroke, Secondary: ICD-9-CM Diagnotic Code 433.x1, 434.x1, 997.02 All CTS Patients Aminocaproic acid vs. controls (150 of 9,751 vs. 244 of 46,123) All CTS Patients Aprotinin vs. controls (147 of 6,855 vs. 244 of 46,123) All CTS Patients Aprotinin vs. aminocaproic acid (147 of 6,855 vs. 150 of 9,751) CABG Only Aminocaproic acid vs. controls (98 of 7,064 vs. 57 of 6,879) CABG Only Aprotinin vs. controls (57 of 3,066 vs. 57 of 6,879) CABG Only Aprotinin vs. aminocaproic acid (57 of 3,066 vs. 98 of 7,064) Odds Ratio 2.866 95% Confidence Limits 2.336 3.518 P Value P < 0.0001 CONCLUSION Indicators for evidence-based criteria P < 0.0001 4.123 3.345 5.083 continue to evolve in terms of the use and choice of antifibrinolytic therapy in cardiothoracic surgery and in terms of how to deterP = 0.0006 1.506 1.191 1.905 mine which patients should be considered at high or low risk. New publications concerning aprotinin’s safety, comparative effectiveness, P = 0.0012 1.722 1.240 2.392 and potential drug interactions are steadily appearing. Although administrative data sets and drug-specific registries can test the P < 0.0001 2.177 1.502 3.155 robustness of certain findings, they generally provide weak and sometimes conflicting results in addressing vital clinical questions. P = 0.1331 1.290 0.925 1.798 Even so, however, they provide an inexpensive and multifactorial review mechanism to quickly test evolving clinical experience. In ICD = International Classification of Diseases. our opinion, randomized, controlled clinical implications of aprotinin use: The Retrospective Evaluation of safety trials, as well as cost-effectiveness studies to guide Aprotinin in CardioThoracic Surgery (REACTS). J Thorac Cardioclinicians on appropriate and efficient choices in cardiac vasc Surg 2007;133:1547–1552. surgery patients, are still necessary in this area. 10. Sedrakyan A, Treasure T, Elefteriades JA. Effect of aprotinin on Although the marketing of aprotinin has been recently susclinical outcomes in coronar y arter y bypass graft surger y: pended by Bayer, there is a reasonable expectation that it will A systematic review and meta-analysis of randomized clinical trials. J Thorac Cardiovasc Surg 2004;128:442–448. re-emerge under registry requirements or with restricted indi11. Serna DL, Thourani VH, Puskas JD. Antifibrinolytic agents in cations. The results and recommendations of this study, therecardiac surgery: Current controversies. Semin Thorac Cardiovasc fore, are considered relevant for future decision making. Surg 2005;17:52–58. REFERENCES 1. Mannucci PM, Levi M. Prevention and treatment of major blood loss. N Engl Med J 2007;356(22):2301–2311. 2. Armstrong D. Serious risks are found in heart drug. The New York Times, January 26, 2006. 3. Barclay L. Aprotinin use may increase risk for end organ damage in cardiac surgery. Medscape Medical News. Available at: www. medscape.com/viewarticle/522313. Accessed February 14, 2006. 4. Drazen JM. Research replication (Editorial). N Engl J Med 2006; 355(21):2252–2253. 5. Grady D. Doctors urge ending use of heart surgery drug. The New York Times, January 26, 2006. 6. Kristeller JL, Stahl RE, Roslund BP, Roke-Thomas M. Aprotinin use in cardiac surgery patients at low risk for requiring blood transfusion. Pharmacotherapy 2007;27(7):988–994. 7. 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. 8. Kincaid EH, Ashburn DA, Hoyle JR, et al. Does the combination of aprotinin and angiotensin-converting enzyme inhibitor cause renal failure after cardiac surgery? Ann Thorac Surg 2005;80: 1388–1393. 9. Coleman CI, Rigali VT, Hammond J, et al. Evaluating the safety 12. Mangano DT, Tudor JC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006;354(4):353–356. 13. Karkouti K, Beattie WS, Dattilo KM, et al. A propensity score case–control comparison of aprotinin and tranexamic acid in high-transfusion-risk cardiac surgery. Transfusion 2006;46:327– 338. 14. Hiatt WR. Observational studies of drug safety: Aprotinin and the absence of transparency (Editorial). N Engl J Med 2006;355(21): 2171–2173. 15. Ferguson TB. Aprotinin: Are there lessons learned? (Editorial). JAMA 2007;297(5):527–529. 16. Mangano DT, Miao Y, Vuylsteke A. et al. Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery. JAMA 2007;297(5):471–479. 17. Safety trials in Trasylol’s future, but design could prove challenging. The Pink Sheet, September 17, 2007, pp. 8–9. 18. Early communication about an ongoing safety review aprotinin injection. Available at: www.fda.gov/cder/drug/early_comm/ aprotinin.htm. Accessed November 31, 2007. 19. Bloom M. Aprotinin (Trasylol) marketing halted over suspected mortality risk. Available at: www.medpagetoday.com/Surgery/ GeneralSurgery/dh/7239. Accessed November 6, 2007. 20. Van der Linden PJ, Hardy JF, Trenchant A, De Hert SG. Cardiac surgery with cardiopulmonary bypass: Does aprotinin affect outcome? Br J Anaesth 2007;99(5):646–652. 21. Kleinbaum DG, Kupper LL, Muller KE, Nizam A. Applied Regression Analysis and Multivariable Methods, 3rd ed. Pacific Grove, CA: Duxbury Press, 1998. I 106 P&T® • February 2008 • Vol. 33 No. 2 http://www.medscape.com/viewarticle/522313 http://www.medscape.com/viewarticle/522313 http://www.fda.gov/cder/drug/early_comm/aprotinin.htm http://www.fda.gov/cder/drug/early_comm/aprotinin.htm http://www.medpagetoday.com/Surgery/GeneralSurgery/dh/7239 http://www.medpagetoday.com/Surgery/GeneralSurgery/dh/7239

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Pharmacy & Therapeutics - February 2008 Contents Editorial Medication Errors Prescription: Washington The Language of (Forgive Us) Change, As P&T Enters the Digital Age New Drugs/Drug News/New Medical Devices Drug Forecast Use and Outcomes of Antifibrinolytic Therapy in Patients Undergoing Cardiothoracic Surgery at 20 Academic Medical Centers in the United States Evaluation of the Management of Acute Venous Thromboembolism and Its Outcomes: One Institution's Experience American Society of Hematology, 49th Annual Meeting Pharmaceutical Approval Update

Pharmacy & Therapeutics - February 2008

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