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Objectives: Previous studies of aprotinin use in thoracic aortic surgery, limited in size and design, reported minimal information regarding outcomes other than blood loss and transfusion. The evaluation of impact of aprotinin on surgical outcomes in a large sample is needed., Methods: Patients at Yale New Haven Hospital undergoing thoracic aortic surgery (aneurysm repair, dissections, penetrating ulcers, intramural hematomas) between 1995 and 2003 were considered for inclusion. Each patient receiving aprotinin was matched to a control per preoperative profile (age, gender, urgency of surgery, dissection/location of aortic disease). Data (surgical specifics, demographic variables, comorbidities, disease location-related variables, preoperative medications, intraoperative medications, surgical/operative data) were abstracted from the records of successfully matched aprotinin-treated patients and controls (n = 168). Comparison and determination of success of matching were performed using bivariate analyses. Outcome variables were compared using statistical tests for paired data. Supplementary unpaired and regression analyses were also performed., Results: Baseline demographics of groups were similar, although controls had reduced history of aortic disease, but greater intraoperative use of lysine analogs (P < .05). Aprotinin significantly reduced platelet transfusion (P < .05). Paired bivariate analyses showed a tendency toward reduced ventilation time, pulmonary complications, and permanent arrhythmias (P < .05) associated with aprotinin. Supplementary analyses were supportive only for pulmonary complications and permanent arrhythmias., Conclusions: The current evaluation substantiates previous reports that aprotinin may be safe to use and likely to improve some outcomes of thoracic aortic surgery. However, further studies for rare safety and efficacy end points are warranted.

Purpose: Medical decisions are often made based on personal experience or on limited clinical trial information. Results from systematic reviews of clinical trials, however, provide a more thorough understanding of available data and can foster evidence-based decision making. Data from a recent systematic review and meta-analysis of clinical outcomes after aprotinin treatment during coronary artery bypass graft (CABG) surgery have recently been published. This analysis was performed to further address concerns that aprotinin safety often outweighs the well-established transfusion reduction benefits., Summary: Data from placebo controlled, randomized, aprotinin trials published in MEDLINE, EMBASE, and PHARMLINE were analyzed. Relative risk (RR) and 95% confidence intervals (CI) were calculated for mortality, myocardial infarction, renal failure, stroke, atrial fibrillation, and blood transfusion. Fixed effect or random effect models were used. Homogeneity was tested across studies using chi(2) statistics and i-square (I(2)) values. Analysis of data from 35 placebo controlled trials (n = 3,887) confirms that aprotinin, when compared to placebo, reduces transfusion requirements (RR, 0.61; 95% CI, 0.58-0.66). Risks of mortality (RR, 0.96; 95% CI, 0.65-1.40), myocardial infarction (RR, 0.85; 95% CI, 0.63-1.14) and renal failure (RR, 1.01; 95% CI, 0.55-1.83) were neither increased nor decreased with aprotinin treatment. Aprotinin treatment was, however, associated with a reduced risk of stroke (RR, 0.53; 95% CI, 0.31-0.90) and a trend toward a reduced incidence of atrial fibrillation (RR, 0.90, 95% CI, 0.78-1.03)., Conclusion: Results from this systematic review and meta-analysis of randomized controlled trials in CABG surgery patients have shown that aprotinin was associated with a reduction in the need for blood transfusion, but was not associated with an increase in mortality, myocardial infarction, or renal failure risk. Evidence also suggests that aprotinin was associated with a reduced stroke risk and a trend toward a reduced incidence of atrial fibrillation.

Objective: Despite proven blood transfusion benefits, aprotinin may be underused in coronary artery bypass grafting. Reluctance to use aprotinin may stem from safety concerns. The current objective was to evaluate clinical outcomes (mortality, myocardial infarction, renal failure, stroke, atrial fibrillation) in patients undergoing coronary artery bypass grafting who receive aprotinin by performing a quantitative overview of published, randomized, controlled trials., Methods: MEDLINE, EMBASE, and PHARMLINE (1988-2001) and reference lists of relevant articles were searched for coronary artery bypass grafting studies. Criteria for data inclusion were as follows: (1) random allocation of study treatments, (2) placebo control, (3) enrollment only of patients undergoing coronary artery bypass grafting, (4) no combination with another experimental medication or device, and (5) prophylactic and continuous intraoperative use., Results: Data from 35 coronary artery bypass grafting trials (n = 3879) confirm that aprotinin reduces transfusion requirements (relative risk 0.61, 95% confidence interval 0.58-0.66) relative to placebo, with a 39% risk reduction. Aprotinin therapy was not associated with increased or decreased mortality (relative risk 0.96, 95% confidence interval 0.65-1.40), myocardial infarction (relative risk 0.85, 95% confidence interval 0.63-1.14), or renal failure (relative risk 1.01, 95% confidence interval 0.55-1.83) risk, but it was associated with a reduced risk of stroke (relative risk 0.53, 95% confidence interval 0.31-0.90) and a trend toward reduced atrial fibrillation (relative risk 0.90, 95% confidence interval 0.78-1.03)., Conclusions: Aprotinin reduces transfusion requirements. Concerns that aprotinin therapy is associated with increased mortality, myocardial infarction, or renal failure risk is not supported by data from published, randomized, placebo-controlled clinical trials. Evidence for a reduced risk of stroke and a tendency toward reduction of atrial fibrillation occurrence was observed in patients who received aprotinin.