Effects Of Prolonged Dual Antiplatelet Therapy (>12 Months) On The Progonosis Of Patients With Acute Coronary Syndrome

Objectives:To evaluate the effect of dual antiplatelet therapy on the prognosis of patients with acute coronary syndrome(ACS)in China in the real world over 12 months,and to evaluate the applicability of DAPT score to the decision of antiplatelet therapy in ACS patients.Materials and methods:Optimal antiPlatelet Therapy for Chinese patients with Coronary Artery Disease(OPT-CAD,NCT01735305)study is a real world,prospective,large-scale,multi-center,clinical registration research.In this study,patients with acute coronary syndrome were selected from OPD-CAD study.The patients were followed up for 3months,6 months,9 months,12 months and 24 months respectively,and the follow-up included drug treatment and adverse events.Grouping scheme:(1)Patients who were adhered to DAPT for 3,6 and 9 months follow-up were assigned to two groups.Patients who were treated with DAPT for more than 12 months were DAPT group,and the patients who received DAPT treatment for less than 12 months were SAPT group.(2)The DAPT scores of all patients with ACS were calculated.Patients who extended DAPT treatment for more than 12months were divided into DAPT score>2 group and DAPT score<2 group.For patients with DAPT score equal or greater than 2,they were divided into dual antiplatelet therapy groups(DAPT)and single antiplatelet therapy group(SAPT).(3)Patients who come from shenyang military region general hospital in OPD-CAD were divided into traditional Chinese medicine treatment group and routine drug treatment group,according to whether the patients after discharge on antiplatelet drug therapy based on combined application of traditional Chinese medicine therapy.The primary endpoint was major adverse cardiovascular and cerebrovascular events(MACCE)of two groups patients in 12 to 24 months.The MACCE was a composite endpoints that include cardiac death,myocardial infarction and stroke.The secondary endpoint include the following:all-cause death in 12 to 24 months;cardiac death,myocardial infarction and stroke in 12 to 24 months;Bleeding Academic Research Consortium(BARC)defined bleeding in 12 to 24 months;MACCE events in 12 to 24 months of subgroups,including age,sex,body mass index(BMI),blood pressure,high cholesterol,diabetes,previous myocardial infarction,previous history of stroke,always PCI treatment,kidney function,smoking history,whether PCI treatment;According to the combination of Traditional Chinese medicine treatment group after discharge,the MACCE event and BARC hemorrhage of 24 months were observed.Results:1.Baseline data:In 12 months,there were 4771 patients in DAPT group and 1543 patients in SAPT group.Patients taking DAPT for more than 12 months were 75.6%.In baseline data,patients with SAPT group were significantly more likely to have PCI treatment(P<0.0001),prior history of stroke(P<0.0001)and hypertension history(P=0.05)than patients in DAPT group.The patients in DAPT group were significantly more than those in SAPT group in smoking(P=0.01)and ACEI drugs(P=0.04).2.The primary endpoint:The incidence of MACCE in DAPT group and SAPT group in 12 to24 months was 1.55%and 2.33%respectively.The incidence of MACCE in DAPT group was significantly lower than that in SAPT group(P=0.047).3.The secondary endpoint:(1)DAPT group compared to SAPT group,in 12-24 months the incidence of all-cause mortality(0.65%vs1.17%,P=0.044),cardiac death rate(0.40%vs0.91%,P=0.017),the incidence of stroke(0.59%vs1.17%,P=0.021)were significantly decreased.The incidence of myocardial infarction(0.65%vs0.58%,P=0.754)in the two groups there was no statistically significant difference.(2)There was no statistically significant difference between DAPT group and SAPT group in 12-24 months of bleeding(2.85%vs2.85%,P=0.968)and barc3-5 bleeding(0.25%vs0.32%,P=0.645).(3)The subgroup analysis,age?60 years patients,the incidence rate of MACCE in SAPT group was significantly higher than that of group DAPT(HR 0.62,95%CI 0.39-0.98,P=0.04).In male patients,the incidence of MACCE in group SAPT was significantly higher than that in group DAPT(HR 0.57,95%CI 0.37-0.90,P=0.01).In the BMI?28kg/m~2 patients,the incidence rate of MACCE SAPT group was significantly higher than that of DAPT group(HR0.39,95%CI,0.16-0.92,P=0.03).In smoking patients,the incidence of MACCE in group SAPT was significantly higher than that in group DAPT(HR 0.53,95%CI 0.31-0.90,P=0.02).The incidence of MACCE was 12-24 months in the other subgroups,and there was no significant difference between the DAPT group and the SAPT group.(4)DAPT score of 5307 patients was calculated.In patients with prolonged DAPT treatment,the MACCE incidence of DAPT score?2 groups and DAPT score<2 group was not statistically significant in 12 to 24 months(1.60%vs1.49%,P=0.786).Two groups of 12 to24 months for all-cause death rate(0.63%vs0.53%,P=0.668),the incidence of myocardial infarction(0.80vs%0.57%,P=0.376),the incidence of cardiac death(0.46%vs0.31%,P=0.439),the incidence of stroke(0.46%vs0.70%,P=0.317)and the incidence of bleeding(2.69%vs3.20%,P=0.344)were no statistically significant difference.In patients with a DAPT score?2,the incidence of MACCE(1.60%vs1.89%,P=0.667),all-cause death(0.63%vs0.34%,P=0.422),myocardial infarction(0.80%vs0.86%,P=0.916),cardiac death(0.46%vs0.34%,P=0.702),stroke(0.46%vs0.86%,P=0.271)and bleeding(2.69%vs3.09%,P=0.650)had no significant statistical difference between DAPT group and SAPT group in 12 to24 months.(5)In the study of OPD-CAD,591 consecutive patients with coronary heart disease were recruited from cardiovascular department of General Hospital of Shenyang Military.There were 203 cases in the Chinese medicine group,388 in the routine treatment group and 34.3%in the patients with TCM treatment.The incidence of MACCE(9.0%vs11.8%,P=0.27),for all-cause death(1.6%vs2.0%,P=0.71),myocardial infarction(3.9%vs2.9%,P=0.58),cardiac death(1.6%vs1.5%,P=0.96),stroke(7.4%vs4.6%,P=0.16)and bleeding(13.9%vs13.8%,P=0.98)were no statistically significant difference between Traditional Chinese medicine group and routine treatment group in 24 months.In the traditional Chinese medicine group,the application proportion of sanqi and danshen was the highest,46.8%and 41.9%respectively.Conclusions:DAPT treatment extended for more than 12 months can significantly reduce the incidence of major ischemic events between 12 and 24 months in ACS patients,and did not increase the risk of bleeding for 12 to 24 months.However,for patients with high risk of atherosclerosis,prolonged DAPT treatment may lead to a decrease in ischemic risk.For patients with DAPT score?2,prolonged DAPT treatment did not reduce the incidence of major ischemic events in 12 to 24 months,but did not increase the risk of bleeding in 12 to 24 months.The applicability of DAPT score in the treatment of ACS patients in China for prolonging DAPT treatment remains to be further confirmed.The 34.3%of the Chinese ACS patients after discharge on the basis of conventional treatment combined application of traditional Chinese medicine treatment,the combined application of traditional Chinese medicine treatment did not reduce the risk of ischemic events in patients with 24 months,but also did not increase the risk of bleeding in 24 months.