Barcelona, Spain, 30 August: The presentation of the PLATO (A Study of Platelet Inhibition and Patient Outcomes), showed that ticagrelor (Brilinta®) reduced the rate of cardiovascular (CV) events (CV death, myocardial infarction or stroke) from 11.7% to 9.8% compared clopidogrel (Plavix®) XX% (p<0.001, RRR = 16%), without an increase in major bleeding. This efficacy endpoint was driven by a statistically significant reduction in both CV death and myocardial infarction (MI) with no difference in stroke. Ticagrelor is the first antiplatelet agent to demonstrate a reduction in CV death across all major acute coronary syndromes (ACS) patient types.
For every 1,000 patients admitted to the hospital because of an ACS event, use of ticagrelor instead ofclopidogrel, for up to one year, led to 14 fewer deaths, or 11 fewer MI's, or 8 fewer cases of stent thrombosis,without an increase in major bleeds. In the PLATO study, the reduction in risk of cardiovascular eventsappears early and the benefit over clopidogrel grows with time. Ticagrelor demonstrated a consistent benefitacross multiple secondary efficacy endpoints including CV death and total mortality; myocardial infarction; thecomposite of myocardial infarction, stroke, and total mortality; and a composite of cardiovascular death,myocardial infarction, stroke, transient ischemic attack, recurrent cardiac ischemia, severe recurrent cardiacischemia, and other arterial thrombotic events.
"Ticagrelor is the first antiplatelet therapy to achieve a significant reduction in CV mortality in ACS patientsversus clopidogrel and perhaps most importantly without an increase in major bleeding," commentedProfessor Lars Wallentin, co-chair of the PLATO Executive Committee. "PLATO has redefined what ispossible in the prevention of recurrent events in patients with acute coronary syndromes."
The PLATO study confirmed the clinical safety profile of previous ticagrelor studies by showing an efficacyadvantage without an increase in major bleeding. Across all the important patient subgroups (e.g. gender,weight, history of stroke/TIA) in PLATO, ticagrelor showed no difference versus clopidogrel in the incidence ofmajor bleeding. When minor bleeding was added, ticagelor showed a small increase in PLATO defined majorplus minor bleeding versus clopidogrel. At continuous ECG monitoring wile in hospital, but not at later followupin the outpatient setting, pauses in the heart rhythm were seen more frequent with ticagrelor. However suchpauses were not associated with any symptoms or clinical consequences for the patient. Transient symptomsof dyspnoea were reported more often by patients on ticarelor but only one in 100 ticagrelor treated patientsoverall stopped taking study medication due to dyspnoea.
PLATO was a head-to-head outcomes study of ticagrelor plus aspirin versus the active comparator,clopidogrel plus aspirin, and was designed to establish whether ticagrelor could achieve meaningfulcardiovascular endpoints in ACS patients. 18,624 patients at 893 sites in 43 countries across all continentswere sucessfully recruited. All patients were admitted to hospital because of acute coronary syndrome, onethird with ST-elevation myocardial infarction and two thrirds without ST-elevation. Shortly after admission tohospital, the patients started their long-term anti-platelet treatment with either ticagrelor (90 mg twice daily) orclopidogrel (75 mg daily) in a randomized, double-blind fashion for 6 - 12 months. The PLATO study was ledby the Executive Committee co-chairs, Professor Lars Wallentin, Sweden (Uppsala Clinical Research Center)and Professor Robert Harrington, USA (Duke Clinical Research Institute).
The PLATO study was sponsored by AstraZeneca which has developed and manufactures ticagrelor(Brilinta®). AstraZeneca is a major international healthcare business engaged in the research, development,manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services.
Source: European Society of Cardiology