Newly published data from the PLATO trial showed that acute coronary syndrome patients, who were intended to follow a non-invasive treatment plan, had fewer cardiovascular events and fewer deaths without an increase in fatal or life threatening bleeding when taking ticagrelor tablets (Brilinta) compared to those taking clopidogrel.
These data are now available online in the British Medical Journal.
Current AHA/ACC guidelines recommend invasive treatment for patients with non ST-elevation myocardial infarction (NSTEMI) who are at moderate-to-high risk for subsequent cardiovascular events. Invasive procedures, which identify and treat blocked arteries of the heart, include coronary angiography, percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG) surgery. In contrast, medical management may be appropriate for some NSTEMI patients or those deemed unsuitable for an invasive strategy on the basis of co-morbidities or other clinical features (e.g. higher age). 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, associate professor, Uppsala Clinical Research Center, Uppsala University, Sweden. “These data add to the body of evidence that ticagrelor is a valuable treatment option for a broad spectrum of acute coronary syndrome patients regardless of intended management strategy.”
The analysis included 5,216 acute coronary syndrome patients, 28% of the total 18,624 randomised patients in PLATO (n=2,601 for ticagrelor and n=2,615 for clopidogrel), 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 cardiovascular risk factors such as diabetes, previous heart attack, stroke, or peripheral artery disease, compared to those intended for invasive management.
In these patients intended for medical management, treatment with ticagrelor resulted in decreased rates of cardiovascular events (composite of cardiovascular death, myocardial infarction, and stroke) and overall mortality compared with clopidogrel (12.0%/year vs. 14.3%/year, hazard ratio 0.85, 95% CI 0.73–1.00, p=0.04 and 6.1%/year vs. 8.2%/year, hazard ratio 0.75, 95% CI 0.61–0.93, p=0.01, respectively). These findings were consistent with the overall PLATO results.
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 as expected in this patient population (11.9% vs. 10.3%, hazard ratio 1.17, 95% CI 0.98–1.39, p=0.08 and 4% vs. 3.1%, hazard ratio 1.30, 95% CI 0.95–1.77, p=0.10, respectively). In addition, consistent with the overall PLATO results, there was no difference in the frequency of fatal/life-threatening bleeding episodes between the two treatment arms (5.5% vs. 5.6%, hazard ratio 0.99, 95% CI 0.77–1.26; p=0.91).