The results of the phase IV ATLANTIC study, which indicates that the profile of Ticagrelor ( Brilinta, Brilique ) is comparable whether administered in a pre-hospital or in-hospital setting to ST segment elevation myocardial infarction ( STEMI ) patients.
The data were presented during the European Society of Cardiology congress in Barcelona. Results of the ATLANTIC study were also published in the New England Journal of Medicine ( NEJM ).
ATLANTIC was designed to evaluate pre-hospital administration versus in-hospital administration of Ticagrelor in terms of pre-percutaneous coronary intervention ( PCI ) procedural effectiveness, bleeding at 24 hours and 30 days and the pre-specified composite endpoint of death, myocardial infarction, stroke, urgent revascularisation and definite acute stent thrombosis at 30 days.
Research has shown that the effectiveness of PCI may be impacted by delays caused when transferring patients with acute STEMI to the catheterisation lab in hospital, and that STEMI patients have a high risk of persistent and total coronary occlusion, resulting in a higher risk of short-term mortality.
There was no statistically significant difference between the pre-hospital or in-hospital study arms in the co-primary endpoints of pre-PCI procedural effectiveness; percentage of patients not achieving ST segment elevation resolution greater than or equal to 70% before PCI ( odds ratio, OR=0.93;95% CI 0.69, 1.25; p=0.632 ), and percentage of patients not reaching thrombolysis in myocardial infarction ( TIMI ) flow grade 3 in the infarct-related artery at initial angiography ( OR=0.97; 95% CI 0.75, 1.25; p=0.821 ).
The ATLANTIC study was not powered to look at clinical outcomes, however there was no difference between the two arms in terms of composite endpoint.
The pre-hospital administration of Ticagrelor has indicated a risk reduction of post-PCI stent thrombosis ( a secondary endpoint ) both at 24 hours ( 0% versus 0.8%; nominal p = 0.0078 ) and 30 days ( 0.2% versus 1.2%; nominal p=0.023 ).
The study results also showed that there was no difference in bleeding events between the pre-hospital and in-hospital study arms, the primary safety endpoint of the study.
Rates of bleeding events that were not related to coronary-artery bypass grafting were low during the first 48 hours after the initial dose, and from 48 hours through to 30 days, and the rates did not differ significantly between the two study groups, indicating that earlier, pre-hospital administration of Ticagrelor in patients with acute STEMI can be undertaken without increased bleeding risk.
ATLANTIC is a key trial building on the results of the pivotal PLATO study, which demonstrated that treatment with Ticagrelor plus Acetylsalicylic acid ( Aspirin ) for 12 months was associated with a 21% relative risk reduction ( RRR ) in cardiovascular death ( 4% vs. 5.1%; 1.1% ARR; P=0.001 ) and a 16% RRR in myocardial infarction compared to Clopidogrel ( Plavix ) plus Acetylsalicylic acid at 12 months ( 5.8% vs. 6.9%; 1.1% ARR; P less than 0.005 ).
Ticagrelor is an oral antiplatelet treatment for acute coronary syndromes ( ACS ). Ticagrelor is a direct-acting P2Y12 receptor antagonist in a new chemical class called cyclopentyltriazolopyrimidines ( CPTPs ). ( Xagena )
Source: AstraZeneca, 2014