Efficacy Endpoints Death at 6 months, heart attack at 6 months
Harm Endpoints Major bleeding events (brain bleeding or bleeding requiring transfusion)
Narrative There are four major trials that address this question, including just over 3000 subjects. Studies were of relatively high quality and the use of glycoprotein inhibitors in this situation represents a best-case-scenario: The subjects are low risk for bleeding, high risk for death or recurrent heart attack, and are undergoing invasive management. If the mechanism of action and conventional wisdom are to be believed glycoprotein inhibitors should be most helpful for high risk patients undergoing invasive procedures. The lack of benefit in this population, and an increase in harmful events, is remarkable.
Caveats There are only four trials, all industry sponsored. While neither death nor MI was affected, some may note that 'revascularizations' (repeat angioplasties) were reduced. However, at TheNNT.com we see this as neither a patient-oriented nor a clinically important endpoint. In these studies 'revascularization' was separate from 'MI' and death, which were both unaffected. This means that the condition that led to the repeat angioplasty did not result in death was not an MI, suggesting that the ‘need’ for the procedure was highly questionable. This is particularly true when one considers that only STEMI patients have been shown to benefit from angioplasty (see COURAGE trial and related data).
Author David Newman
Published/Updated October 23, 2009