Objective: to assess the safety of ticagrelor in patients with ST-elevation myocardial infarction treated with fibrinolytic
therapy.
Methods: This unicenter, non randomized trial enrolled 200 patients (less than 75 years) diagnosed with STsegment
elevation myocardial infarction who received streptokinase from March to May 2018. One hundred
Patients received ticagrelor (180-mg loading dose followed with 90 mg twice daily) while other 100 patients received
clopidogrel (300-mg loading dose then 75 mg daily). Both P2Y12 inhibitors were administrated 2 hours
after streptokinase, all population were naïve for any P2Y12 inhibitors pretreatment.The primary end point was
thrombolysis in myocardial infarction (TIMI) major and minor bleedings through 60 days.
Results: At 60 days, TIMI major bleeding had occurred in 4 % of patients who received ticagrelor and in 3 % of patients
who recieved clopidogrel (Odds ratio =1.3472, 95 % CI =0.293 % to 6.18 %; P =0.7014 for safety). No rates of
fatal or intracranial bleeding occurred. Minor and minimal bleeding had occurred in 14 % of patients on ticagrelor
and in 11 % of patients on clopidogrel (Odds ratio =1.3171; 95 % CI =0.566 % to 3.06 %; P =0.5221 for safety). After
adjusting for subgroup of patients with high bleeding risk at baseline (HAS-BLED ≥3), Bleeding rates not increased
in ticagrelor group (Odd ratio=1.611; 95 % CI=0.52–4.9; NNT for harm=8.4; P=0.40). RRR of bleeding rates in the
clopidogrel group was only 1.25 %.
Conclusion: In patients younger than 75 years with ST-segment elevation myocardial infarction, delayed administration
of ticagrelor for 2 hours after fibrinolytic therapy was safe and non inferior to clopidogrel for TIMI major
and minor bleeding up to 60 days even in patients with high risk of bleeding (HAS-BLED score ≥3).