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Aprotinin during coronary-artery bypass grafting and risk of death
Sebastian Schneeweiss1, John D Seeger, Joan Landon
1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA. schneeweiss@post.harvard.edu
Insights
Aprotinin (Trasylol) use during coronary-artery bypass grafting (CABG) surgery is linked to increased patient mortality compared to aminocaproic acid. This finding persists across multiple analyses, suggesting a potential safety concern with aprotinin.
Area of Science:
- Cardiovascular Surgery
- Pharmacology
- Clinical Outcomes Research
Background:
- Aprotinin (Trasylol) is administered to reduce bleeding during coronary-artery bypass grafting (CABG).
- Emerging data indicate a potential association between aprotinin use and increased mortality rates.
Purpose of the Study:
- To compare the in-hospital mortality rates associated with aprotinin versus aminocaproic acid in patients undergoing CABG.
- To investigate the safety profile of aprotinin in the context of cardiac surgery.
Main Methods:
- Retrospective analysis of electronic administrative records from the Premier Perspective Comparative Database.
- Inclusion of patients who received either aprotinin (33,517) or aminocaproic acid (44,682) on the day of CABG.
- Utilized multivariable logistic regression, propensity-score matching, and instrumental-variable analysis to control for confounding factors.
Main Results:
- Aprotinin recipients had a higher mortality rate (4.5%) compared to aminocaproic acid recipients (2.5%).
- Adjusted analyses revealed a significantly higher risk of death associated with aprotinin use (relative risk, 1.64; 95% CI, 1.50 to 1.78).
- Propensity-score matched and instrumental-variable analyses corroborated the increased mortality risk with aprotinin.
Conclusions:
- Patients receiving aprotinin during CABG surgery experienced higher mortality than those receiving aminocaproic acid.
- The observed mortality difference was not explained by patient or surgeon characteristics.
- The findings suggest a potential safety concern with aprotinin use in CABG patients, independent of confounding variables.
Background:
Aprotinin (Trasylol) is used to mitigate bleeding during coronary-artery bypass grafting (CABG). Accumulating evidence suggests that this practice increases mortality.
Methods:
Using electronic administrative records of the Premier Perspective Comparative Database, we studied hospitalized patients with operating-room charges for the use of aprotinin (33,517 patients) or aminocaproic acid (44,682 patients) on the day CABG was performed. We tabulated the numbers of patients with a hospital-discharge status of death and performed three types of analyses: a multivariable logistic-regression analysis (primary analysis); propensity-score matching in the highly selected subcohort of patients who received full amounts of the study drug, who underwent CABG by surgeons who performed 50 or more CABG surgeries during the study period, and for whom information on 10 additional covariates was available because the surgery occurred on hospital day 3 or later; and an instrumental-variable analysis of data from patients whose surgeons showed a strong preference for one of the two study drugs.
Results:
In all, 1512 of the 33,517 aprotinin recipients (4.5%) and 1101 of the 44,682 aminocaproic acid recipients (2.5%) died. After adjustment for 41 characteristics of patients and hospitals, the estimated risk of death was 64% higher in the aprotinin group than in the aminocaproic acid group (relative risk, 1.64; 95% confidence interval [CI], 1.50 to 1.78). In the first 7 days after surgery, the adjusted relative risk of in-hospital death in the aprotinin group was 1.78 (95% CI, 1.56 to 2.02). The relative risk in a propensity-score-matched analysis was 1.32 (95% CI, 1.08 to 1.63). In the instrumental-variable analysis, the use of aprotinin was found to be associated with an excess risk of death of 1.59 per 100 patients (95% CI, 0.14 to 3.04). Postoperative revascularization and dialysis were more frequent among recipients of aprotinin than among recipients of aminocaproic acid.
Conclusions:
Patients who received aprotinin alone on the day of CABG surgery had a higher mortality than patients who received aminocaproic acid alone. Characteristics of neither the patients nor the surgeons explain the difference, which persisted through several approaches to control confounding.
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