PURPOSE: Aprotinin has been shown to diminish the need for blood transfusions during coronary artery bypass graft operations. However, several independent studies published in early 2006 attempted to validate the FDA’s 1993 concerns regarding renal toxicity. We examined the clinical and fiscal impact of these studies on the utilization of Aprotinin in elective coronary revascularization cases.
METHODS: We studied 1372 patients undergoing elective, first-time coronary revascularization, divided into two groups. The groups consisted of those cases (703) performed twenty-eight months prior to the publication of a major article questioning the safety of Aprotinin, and those performed during the ensuing twenty-eight months(669). These data included all patient demographics including the use of anti-thrombotic drugs before surgery, the duration of cardiopulmonary bypass and all other pertinent operative details. Transfusions, postoperative mediastinal shed blood, and adverse events were examined, as well as hospital costs.
RESULTS: All Demographic variables were similar between the treatment groups. Aprotinin utilization decreased significantly (44.6% vs 3.8%, p< 0.05) and Amicar usage significantly increased (22% vs 80.4%. p< 0.05) in the two intervals. All other clinical outcomes remained essentially equal, including the percentage of patients receiving pRBC transfusions(36% vs 38%, n.s.), mediastinal shed blood(986ml vs 1039ml, n.s.), postoperative renal dysfunction(0.7% vs 0.6%, n.s.), and all other adverse events. Cost was significantly ($2,973) decreased in the latter study group.
CONCLUSION: Safe, effective, and far less expensive alternatives to Aprotinin do not significantly increase allogeneic blood use or the volume of mediastinal shed blood.
CLINICAL IMPLICATIONS: Cost savings can be achieved in perioperative cardiac care without negatively impacting clinical outcomes.
DISCLOSURE: Daniel Watson, No Financial Disclosure Information; No Product/Research Disclosure Information