Pharmacy & Therapeutics - February 2008 - (Page 105)

Antifibrinolytic Therapy in Cardiothoracic Surgery recorded among the controls. These findings led us to speculate whether this event was being accurately captured in the database. DISCUSSION Although comparisons of the efficacy of aprotinin and AA in patients undergoing CABG suggested that aprotinin might be superior in reducing blood transfusions, this was not true for the larger group of CTS patients. Adverse events, including acute renal failure and new-onset hemodialysis, as well as mortality, were significantly higher with aprotinin use relative to AA. The odds for morbidity or mortality were often two to three times greater with aprotinin. Data for postoperative stroke did suggest an increased risk within the aprotinin-treated CTS patients compared with the AA-treated patients but not within the CABG patient subgroup. The additional efficacy of aprotinin in the CABG patients suggested by this data should be weighed against the significant additional risk for adverse events associated with aprotinin in the CABG population. AA appears to be the safer agent for preventing bleeding within the larger CTS patient population, but high-quality published comparative clinical trial evidence is lacking to validate this choice. As a result of the growing evidence for using antifibrinolytic agents in CTS, hospitals might benefit by evaluating current patterns of use and by formulating institution-specific curtailments of aprotinin for patients at increased risk for bleeding during CTS procedures. Table 5 Hemodialysis in Cardiothoracic Surgery (CTS) and Coronary Artery Bypass Graft (CABG) Patients Receiving Aprotinin or Aminocaproic Acid Hemodialysis, Secondary: P ICD-9-CM Procedure Code 39.95 Value All CTS Patients Aminocaproic acid vs. controls (271 of 9,751 vs. 1,212 of 46,123) All CTS Patients Aprotinin vs. controls (442 of 6,855 vs. 1,212 of 46,123) All CTS Patients Aprotinin vs. aminocaproic acid (442 of 6,855 vs. 271 of 9,751) CABG Only Aminocaproic acid vs. controls (169 of 7,064 vs. 227 of 6,879) CABG Only Aprotinin vs. controls (222 of 3,066 vs. 227 of 6,879) CABG Only Aprotinin vs. aminocaproic acid (222 of 3,066 vs. 169 of 7,064) P = 0.1142 Odds 95% Confidence Ratio Limits 1.119 0.973 1.287 P < 0.0001 3.034 2.691 3.420 P < 0.0001 2.709 2.296 3.196 P = 0.0008 0.693 0.560 0.858 P < 0.0001 2.378 1.935 2.921 P < 0.0001 3.406 2.734 4.244 ICD = International Classification of Diseases. Table 6 Hospital Mortality Rates for Cardiothoracic Surgery (CTS) and Coronary Artery Bypass Graft (CABG) Patients Receiving Aprotinin or Aminocaproic Acid In-Hospital Mortality All CTS Patients Aminocaproic acid vs. controls (250 of 9,751 vs. 1,793 of 46,123) All CTS Patients Aprotinin vs. controls (357 of 6,855 vs. 1,793 of 46,123) All CTS Patients Aprotinin vs. aminocaproic acid (357 of 6,855 vs. 250 of 9,751) CABG Only Aminocaproic acid vs. controls (145 of 7,064 vs. 192 of 6,879) CABG Only Aprotinin vs. controls (156 of 3,066 vs. 192 of 6,879) CABG Only Aprotinin vs. aminocaproic acid (156 of 3,066 vs. 145 of 7,064) P Value Odds Ratio 95% Confidence Limits STUDY LIMITATIONS P = 0.0041 0.801 0.689 0.932 We acknowledge some limitations of the study. For instance, UHC’s Clinical Data Base P = 0.0003 1.271 1.116 1.448 contains information on inpatients only. We could not track outpatient or emergency department treatments or mortality rates outP < 0.0001 1.633 1.366 1.953 side the hospital. Our study was naturalistic (observational). Patients were not randomly assigned to treatP = 0.0206 0.766 0.612 0.960 ment arms, and they were not case-matched. This might have created certain biases in the observed results. P = 0.0005 1.496 1.192 1.878 Specific details (e.g., patient coronary anatomy, lesion characteristics, physical assessment, extent of previous myocardial damage, P < 0.0001 1.969 1.547 2.507 other confounding factors), were unknown. Large group sizes often contribute to statistical differences; caution must be exercised ICD = International Classification of Diseases. when interpreting the overall clinical impact of specific therapies. Problems with inadequate or inaccurate coding plague all timing of secondary complications, with specific attribution to database studies. We were unable to determine the temporal drug therapy. Finally, we could not capture the dosing regi- Vol. 33 No. 2 • February 2008 • P&T® 105

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - February 2008

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

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.