Aprotinin is an anti fibrinolytic drug that was originally released by Bayer Pharmaceuticals (trade name Trasylol) as a treatment for pancreatitis.
Although evidence suggested that it did not influence outcomes in patients with this potentially lethal condition, the drug remained available for use. In the late 1980s, investigators at the Hammersmith and Harefield Hospitals in London, discovered that Aprotinin was very successful at reducing bleeding after cardiac surgery. Dozens of further studies from all over the world of all sorts of heart operations suggested Aprotinin was indeed a wonder drug - it decreased bleeding and need for blood transfusions and in some cases protected the brain from damage, a known risk of heart surgery. Bleeding can be a problem after heart operations. Cardiac surgery (which is a relatively small specialty) consumes a massive 16% of all blood products (blood transfusion and plasma) donated/produced in the UK. Evidence also suggests that patients who bleed excessively after heart surgery and go back to the operating room for further control of bleeding, are twice as likely to die and the cost of their care doubles. Aprotinin is now manufactured as a generic drug and is cheaper than a bag of blood - one might assume therefore that a risk benefit analysis would massively favour the use of Aprotinin. In 2008, this study (BART) was published in the New England Journal of Medicine and everything changed. This one randomised study suggested an excess of deaths in patients who underwent complex cardiac surgery who had received aprotinin. Although aprotinin continued to be available, a number of caveats were placed with its use which unsurprisingly fell. When the term Aprotinin was searched in Google, the first entries were American Attorney firms. Associated with the fall in Aprotinin use has been a big increase in blood transfusion and blood product usage. Although cardiac surgeons accept that the drug is not indicated in every heart operation, they nonetheless felt that the decision to make Aprotinin hard to use was premature.
I was very pleased recently to hear that the European Medicines Agency have decided to lift the ban on the drug, which was present in many countries. This reversal is the second in recent months. Health Canada reviewed the comprehensive evidence and concluded that the benefits of Aprotinin outweighed the risks in patient undergoing coronary artery bypass surgery. This is significant as the BART study published in the New England of Medicine was Canadian.
Best thing since sliced bread? Probably not but pretty useful in the right circumstances. I am sure that the use of this drug will increase now and this will contribute to further improvements in safety of cardiac surgical procedures.