Background: Dual antiplatelet therapy with aspirin and a thienopyridine is used to prevent thrombotic complications of acute coronary syndrome (ACS) and percutaneous coronary interventions (PCI). Ticagrelor is an oral, reversible inhibitor of the adenosine diphosphate receptor P2Y12 with a faster onset and more potent platelet inhibition than clopidogrel. A study was needed to evaluate the efficacy and safety of generic ticagrelor in Egyptian patients.
Results: This multicenter study included 830 patients aged above 40 years and diagnosed with ACS, with or without ST segment elevation during the preceding 6 months. They received generic ticagrelor (Thrombolinta, Global Napi Pharmaceutical Company, Egypt) (180 mg loading dose, 90 mg twice daily thereafter), added to aspirin 75-100 mg daily. The mean age of our study population was 57.5 (8.3) years and 38.3% were females. Hypertension, diabetes mellitus, dyslipidemia and previous coronary revascularization were present in 70.7%, 59.2%, 80.7% and 31% of the patients, respectively, and 42.5% were current smokers. The qualifying event was unstable angina, non-ST segment elevation myocardial infarction and ST segment elevation myocardial infarction in 54%, 21.8% and 24.2% of the patients, respectively. At 6 months, the primary efficacy end point-a composite of cardiovascular death, myocardial infarction and stroke-occurred in 3.4% of patients, while the secondary efficacy endpoint-a composite of the primary efficacy endpoints with the addition of hospitalization for unstable angina and urgent revascularization-occurred in 15.3%. Cardiovascular death occurred in 1.2% of the patients, myocardial infarction in 0.8%, stroke in 1.3%, hospitalization for UA in 8.1% and urgent revascularization in 3.9%. TIMI major bleeding occurred in 1.2% of patients, intracranial hemorrhage in 0.2% and TIMI minor bleeding in 13.3%. No significant difference was found between patients who underwent PCI at baseline and those who were treated conservatively regarding the primary (14 patients in each group, P = 0.931) and secondary (62 vs. 65 patients, P = 0.946) efficacy endpoints.
Conclusions: In patients who had an ACS during the 6 months preceding enrollment, treatment with generic ticagrelor led to a low rate of cardiovascular death, myocardial infarction and stroke with a minor increase in the risk of major bleeding.
Keywords: Acute coronary syndrome; Antiplatelet therapy; Bleeding; Cardiovascular death.
© 2022. The Author(s).