August 5, 2013 — AstraZeneca announced results from a new sub-analysis of the PLATO study that evaluated the incidence of stent thrombosis in patients with acute coronary syndrome (ACS). In the PLATO study, ACS patients who were treated with percutaneous coronary intervention (PCI) and who received drug-eluting or bare-metal stents demonstrated a lower risk of stent thrombosis with ticagrelor (Brilinta) tablets plus aspirin than with clopidogrel (Plavix) plus aspirin. This analysis suggests that the reduction of stent thrombosis seen with Brilinta in the PLATO study was consistent in non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI) patients, as well as stent types (drug-eluting or bare-metal stent). These data have been published in the online issue of Circulation.
“Stent thrombosis is a life-threatening complication that may occur after stent placement and is more frequent when platelet inhibition is inadequate,” said James Blasetto, M.D., vice president, U.S. Medical Affairs and Strategic Development. “This important sub-analysis suggests that the benefits of Brilinta in reducing stent thrombosis are consistent across a broad range of ACS patients, regardless of stent type or other characteristics.”
Specific data from this sub-analysis showed:
- Among the 18,624 patients hospitalized with ACS, 11,289 (60.6%) either had a previous stent implanted (n=1,404) or underwent stenting during the course of the trial (n=9,885).
- In the PLATO study, ticagrelor plus aspirin reduced stent thrombosis versus clopidogrel plus aspirin at one year: for adjucated “definite” 1.3% (n=71) versus 1.9% (n=106) (HR, 0.67 [95% confidence interval (CI), 0.50-0.91]; P=0.009).
- The reduction in definite stent thrombosis was evaluated among numerous factors including ACS type (NSTEMI or STEMI), diabetes, stent type, CYP2C19 genetic status, dose of clopidogrel pre-randomization, or use of GPIIb/IIIa inhibitors at randomization. This analysis showed no statistical interaction for the factors evaluated.
- The reduction in definite stent thrombosis with ticagrelor was also evaluated for late (> 30 days), sub-acute (24 hours – 30 days) and acute (< 24 hours) stent thrombosis.
- In the PLATO study overall, there was no significant difference in total major bleeding at 12 months (which includes fatal and life-threatening bleeding) for ticagrelor versus clopidogrel (11.6 vs. 11.2%). There was a somewhat greater risk of non–CABG-related major plus minor bleeding for ticagrelor versus clopidogrel (8.7 vs. 7.0%) and non–CABG-related major bleeding (4.5 vs. 3.8%), respectively. The PLATO trial did not show an advantage for ticagrelor compared with clopidogrel for CABG-related bleeding (total major 85.8 vs. 86.9% and fatal/life-threatening 48.1 vs. 47.9%, respectively).
Ticagrelor is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with ACS (unstable angina [UA], NSTEMI or STEMI). In PLATO, ticagrelor has been shown to reduce the rate of a combined endpoint of CV death, myocardial infarction (MI) or stroke compared to clopidogrel. In PLATO, the difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with PCI, ticagrelor reduces the rate of stent thrombosis.
Brilinta has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of ticagrelor. Patients are advised to avoid maintenance doses of aspirin above 100 mg daily.
For more information: www.brilinta.com