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Results from the new PLATO (PLATelet inhibition and patient Outcomes) trial, published in the British Medical Journal, revealed no increase in fatal or life-threatening bleeding associated with tricagrelor compared with clopidogrel.
Current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines recommend invasive treatment for patients with non-ST-segment elevation myocardial infarction (NSTEMI) who are at moderate-to-high risk for subsequent CV events. However, medical management, or non-invasive treatment plans, may be appropriate for some NSTEMI patients or those deemed unsuitable for an invasive strategy. Currently, 30–60% of NSTEMI patients in the Western world are managed medically.
“The PLATO study showed that ticagrelor led to fewer cardiovascular events and overall deaths, without an increase in overall major bleeding, versus clopidogrel in patients planned for non-invasive management,” said Stefan K. James, MD, PhD, Associate Professor, Uppsala Clinical Research Centre, Uppsala University, Sweden. “These data add to the body of evidence that ticagrelor is a valuable treatment option for a broad spectrum of ACS patients regardless of intended management strategy.”
The analysis included 5,216 ACS patients, who were expected to be on a background of aspirin therapy and for whom a non-invasive management strategy was planned. Patients intended for non-invasive management were more often older, female, and had increased CV risk factors compared to those intended for invasive management.
In patients intended for medical management, treatment with ticagrelor resulted in decreased rates of CV events and overall mortality compared with clopidogrel (12.0%/yr vs. 14.3%/yr, p=0.04 and 6.1%/yr vs. 8.2%/yr, p=0.01, respectively).
In this study, overall major and non-CABG major bleeding each did not differ between treatment groups, although in each case ticagrelor patients demonstrated numerically higher rates of bleeding than expected in this patient population (11.9% vs. 10.3%, p=0.08 and 4.0% vs. 3.1%, p=0.10, respectively). In addition, there was no difference in the frequency of fatal or life-threatening bleeding episodes between the two treatment arms (5.5% vs. 5.6%, p=0.91).