Aprotinin: No Justification for Current Use

Abstract

Objective:

To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of aprotinin.

Data Identification:

A literature search using Grateful Med from 1991 to 1994 and the search term “aprotinin” was performed.

Study Selection:

Open and controlled trials were reviewed.

Data Extraction:

Studies evaluating aprotinin for use in primary and repeat coronary artery bypass graft (CABG) surgery were evaluated and results of the effects of aprotinin on decreasing transfusion requirements as well as adverse effects were summarized.

Data Synthesis:

Many European studies have shown that aprotinin reduces blood loss and transfusion requirements during CABG. More recently, two studies in the US and one in Canada have been published that confirm the effects of aprotinin on blood loss, but raise questions concerning its safety. Combined data indicate that aprotinin is associated with an increased incidence of renal failure, and there are trends toward increases in myocardial infarction, graft occlusion, and mortality. There is no question that aprotinin reduces blood loss during CABG. How much it will save depends on surgical skill and the use of other blood conservation techniques. There are many theoretical benefits to patients from this reduction in blood loss. Whether the benefits of aprotinin administration exceed the risks associated with its use has not been adequately assessed, and further multicenter trials are currently in progress. Whether the cost of aprotinin is counterbalanced by a reduction in transfusion requirements will vary, depending on the cost and amount of blood products used at the specific institution, but this type of analysis does not account for the cost of adverse effects of aprotinin or transfusions, and no pharmacoeconomic evaluations have been published.

Conclusions:

Until studies can demonstrate a positive benefit/risk ratio in terms of patient outcome, aprotinin should not be added to the formulary or used in patients undergoing CABG.