Clinical Study Of Dual-antiplatelet Treatment For 18 Months In Patients With Acute Coronary Syndrome After Coronary Intervention

Background With China's rapid economic development,the disease burden may have changed in the country. Coronary atherosclerotic heart disease(CHD) has become one of the main causes of death. The number of patients with acute coronary syndrome(ACS)is increasing rapidly. Dual-antiplatelet treatment(DAPT),defined as the combination of a platelet P2Y12 inhibitor and aspirin,such as clopidogrel plus aspirin, is the standard to prevent myocardial ischemia events. According to recent studies, the foreign guidelines recommend that ticagrelor is recommended, in the absence of contraindications, for all patients at moderate-to-high risk of ischaemic events, regardless of initial treatment strategy and including those pretreated with clopidogrel. The optimal duration of DAPT remains unclear. Through observing the efficiency and safety of ticagrelor treatment for 18 months in patients with acute coronary syndrome after percutaneous coronary intervention, the present study expects to to provide more evidence for clinical treatment with ticagrelor.Objective To observe the efficiency and safety of ticagrelor treatment for 18 months in patients with ACS after percutaneous coronary intervention.Methods 300 patients with acute coronary syndrome who were hospitalized in cardiovascular department of the first Affiliated Hospital of Zhengzhou University undergoing percutaneous coronary intervention were enrolled in this study. They would receive aspirin 100 mg daily and ticagrelor in a loading dose of 180 mg, followed by a dose of 90 mg twice daily for 12 months. Depending on the following up of 12 months, 208 patients who were free of major adverse cardiovascular and cerebrovascular events(MACCE) or major bleeding events in 12 months were eligible in this study. Patients were randomized in control group(n=104) and observation group(n=104), in each group patients received aspirin 100 mg daily without ticagrelor and aspirin 100 mg daily plus ticagrelor 90 mg twice daily continued. The MACCE and bleeding events were observed during 6 months after randomization. Statistical analyses were carried out using SPSS 21.0 software.Results 1. There were no statistically differences between DAPT for 18 months groups and DAPT for 12 months groups in basic clinical data(age, the proportion of male, BMI, hypertension and etal. P>0.05) 2. At 18 months, the MACCE had occurred in 4.81% of patients receiving DAPT for 18 months as compared with 8.65% of those receiving DAPT for 12 months(hazard ratio, 0.54; 95% confidence interval [CI], 0.18 to 1.61; P=0.26>0.05). No significant difference in the rates of death from any cause, stent thrombosis and stroke was found between two groups. 3. No significant difference in the rates of bleeding events was found between DAPT for 18 months groups and DAPT for 12 months groups(6.73% vs. 3.85%;HR 1.78, 95%CI 0.52-6.09, P=0.36>0.05), as well as major bleeding alone(1.92% vs. 0.96%,P>0.05)or minor bleeding alone(4.81% vs. 2.88%,P=0.72>0.05).Conclusions 1. The use of DAPT for 18 months was not significantly more effective than aspirin monotherapy in reducing the rate of MACCE.2. The use of DAPT for 18 months was not significantly more dangerous than aspirin monotherapy in incresing the rate of bleeding events. 3. In patients who had ACS and were treated with ticagrelor for DAPT after PCI,there was no apparent benefit with extension of DAPT for 18 months.