Improving clinical outcomes in coronary artery bypass graft surgery.

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.