The Safety Of Ticagrelor For Long Term Antiplatelet Therapy In Patients Undergoing Percutaneous Coronary Intervention

ObjectiveAs the publication of PLATO study,ticagrelor which has significant clinical benefits has been recommended as the preferred antiplatelet drug for acute coronary syndrome by European and American guidelines. The safety of ticagrelor for long term antiplatelet therapy in Chinese patients is unknown. We evaluate the bleeding risk of ticagrelor in Chinese patients undergoing percutaneous coronary intervention(PCI)with acute coronary syndrome(ACS)at 1 year. We evaluate the influence factors of bleeding. We also assess the other adverse effect, such as the rate of dyspnea and discontinuation rate in a real world population. MethodsFrom January to June 2014, a total of 342 ACS patients in Beijing An Zhen Hospital have been successfully completed PCI,accepted ticagrelor and aspirin for 1 year were selected. We recorded subtypes,age,sex,weight,hemoglobin,creatinine,creatinine clearance rate,history of hypertension、diabetes mellitus、gastrointestinal bleeding 、 stroke, combination medication(Glycoprotein IIb/IIIa inhibitor 、proton-pump inhibitor) and so on. All patients received aspirin(100mg qd)and ticagrelor(90mg bid) for 1 year.We defined the primary safety endpoint is the rate of non-CABG related major or minor bleeding which used in PLATO trial. The secondary endpoints are the rate of non-CABG major bleeding、the intracranial hemorrhage rate、dyspnea rate,discontinuation rate. We compared the clinical factors between bleeding group and non-bleeding group by univariate analysis and Logistic regression analysis. Results1. The incidence of non-CABG related major or minor bleeding is 13.5% and the non-CABG related major bleeding is 5.5%;the incidence of intracranial bleeding is 1.5% and the fatal intracranial bleeding is 0.8%. The rate of dyspnea is 14.5%, and the discontinuation rate of ticagrelor at 1 year is 13.1%. 2.Compare to non-bleeding group, the bleeding group has more STEMI、older age、lower creatinine clearance rate 、 lower proportion of combination with proton-pump inhibitor and higher proportion of CRUSADE Score ≥31(P<0.05). 3. The multifactor Logistic regression analysis showed that CRUSADE Score>31(OR=3.354,95%CI 1.046-10.751,P=0.042)and proton-pump inhibitor(OR=0.403,95%CI 0.180-0.902,P=0.027)were the main influence factors of bleeding. ConclusionsThe incidence of non-CABG related major or minor bleeding is 13.5%.Increasing of Age and CRUSADE Score>31 were the risk factors of PLATO defined non-CABG related bleeding in ACS patients with ticagrelor,and proton-pump inhibitor were the protective factor.