Objective: To evaluate the current clinical application of domestic tirofiban in patients with acute coronary syndrome (ACS) and to explore its safety profile focused on the common causes and correlation factors for the hemorrhagic events.
Methods: The patients diagnosed as ST-elevation myocardial infarction (STEMI) and medium to high risk non-ST-elevation myocardial infarction (NSTEMI)/unstable angina(UA) in 15 hospitals from September 2009 to December 2011 and given domestic tirofiban, were enrolled in this study. The following data were carefully collected: demographic data, comorbidities, concomitant medications, laboratory data, interventional treatment, application of tirofiban, hemorrhagic events and major adverse cardiac events(MACE) in hospital and at day 30 after discharge.
Results: (1) A total of 927 patients were enrolled in the study. The domestic tirofiban was given to 241 subjects (26.0%) before the intervention, 567 subjects (61.2%) during the intervention and 89 subjects (9.6%) after the intervention. The standardized application was performed in 737 subjects (79.5%) with the loading dose of 10 µg/kg and the maintenance dose of 0.15 µg·kg(-1)·min(-1). In all the subjects, the average maintenance time was (30.4 ± 14.2) hours with the average dose of (339.3 ± 182.9)ml. (2)During hospitalization, major bleeding happened in 4 cases (0.4%) and major adverse cardiac events (MACE) in 37 cases (4.0%). (3)At day 30 after discharge, 1 cases (0.1%) was reported with major bleeding and 9 cases (1.0%) with MACE. (3)The least MACE was showed in the preoperative tirofiban group (2.5%) and followed by the intraoperative group (4.1%) and the postoperative group (9.0%). Compared with the non-standardized application group, MACE was significantly decreased in the standardized application group (2.44% vs 10.00%, P < 0.05).
Conclusions: The standardized application of the domestic tirofiban could decrease the incidence of MACE. Taken into account the combination therapy of clopidogrel and aspirin in the vast majority of patients, the domestic tirofiban exhibits a good safety profile with a relatively lower incidence of bleeding than the similar clinical studies.