A new study re-examining the validity of a major drug trial might have doctors rethinking how to treat heart attack survivors. Bolstered by the findings of a landmark clinical trial reported in 2015, the blood thinner ticagrelor has been increasingly prescribed by doctors to reduce the risk of heart attack in people with a history of heart problems. Now, researchers from France say those findings don’t apply to all patients who meet the original study’s criteria. That bias could prove critical for prescribers, who may witness more cases of serious bleeding and death among their patients than previously reported.
The 2015 drug study, known as the PEGASUS trial, screened heart attack survivors from around the globe. Those selected for the trial had to be at least 65 years old, or at least 50 with diabetes. Results showed that, when combined with aspirin, ticagrelor significantly decreased the risk of stroke or a second heart attack. It did, however, increase the risk of major bleeding. But less than 3% of patients were affected.
Applying those same criteria to heart attack survivors in France told a slightly different story. According to researchers unaffiliated with the PEGASUS trial, these patients showed more than four times the risk of serious bleeding as PEGASUS patients. In addition, the French sample was almost 7 years older on average and showed more than double the risk of death.
These findings suggest that, despite being a worldwide study, the PEGASUS trial is not representative of all heart attack survivors. One reason could be that these patients also suffer from non-heart problems not captured by the trial.
Future studies will continue to test ticagrelor’s suitability for general use, especially as the drug becomes more commercially available.