| ObjectiveWe sought to evaluate the predictive value of long-term prognosis in patients with acute coronary syndrome(ACS)undergoing percutaneous coronary intervention(PCI)based on risk stratification with the Optimal anti Platelet Therapy for Chinese patients with Coronary Artery Disease(OPT-CAD)risk-prediction model in the real world clinical practice and subsequently investigate the effectiveness and safety of ticagrelor versus clopidogrel in these patients with different ischemic risk stratified by the score.MethodsThis study was a post-hoc analysis of a single center,prospective,real world PCI registry.Between March 2016 and March 2019,ACS patients undergoing PCI in the General Hospital of Northern Theater Command were enrolled.The derivation of OPT-CAD score was based on a large-scale,multicenter,prospective registry study(NCT01735305)from 107 centers across China.The score,consisting of 10 simple and accessible risk factors,had a robust discrimination in patients with coronary artery disease(CAD)in predicting ischemic events at 1-year after discharge.In this study,we aimed to evaluate the value of predicting the ischemic events after completed the score calculation in the all patients.Subsequently,patients were divided into groups based on a prespecified threshold,low-risk(OPT-CAD score< 90 points)and intermediate-or high-risk(OPT-CAD score≥ 90 points)and types of P2Y12 inhibitors(ticagrelor or clopidogrel),respectively.The primary endpoints were ischemic events at 12-months,defined as the composite of cardiac death,myocardial infarction(MI),and/or stroke events.Secondary endpoints were 12-months all-cause mortality,cardiac death,MI,ischemic stroke events and Bleeding Academic Research Consortium(BARC)defined type 2,3,5 and 3,5 bleeding.Receiver operating characteristic curve(ROC)method was used to evaluate the predictive value of OPT-CAD score of 12-month ischemic events.Propensity score matching(PSM)was used to balance bias between the clopidogrel and ticagrelor groups in same ischemic risk stratification by OPT-CAD score.Results(1)A total of 22445 patients were included in this study.6102 patients were excluded,as a result of the OPT-CAD risk score incalculable,switching between ticagrelor and clopidogrel during hospitalization.Finally 16343 ACS patients were analyzed.The OPT-CAD score showed considerable predictive value to identify the ischemic events and all-cause mortality at 1-year after discharge with area under the curve(AUC)0.72(95%[Confidence interval,CI]: 0.71-0.73)and 0.79(95%CI: 0.78-0.79)for ischemic events and all-cause mortality,respectively.The optimal cut-off point to predict 12-months ischemic events was 95 with a sensitivity of 64% and specificity of 68%,which was similar to the OPT-CAD score prespecified threshold of 90.(2)The 16343 patients enrolled in the study were stratified according to the 90 points defined by OPT-CAD risk score,including 9841 patients(60%)in the low-risk group and 6502 patients(40%)in the intermediate-or high-risk group.Compared with low-risk patients,intermediate-or high-risk patients were older(66.09± 9.29 vs.57.33± 9.29,P< 0.001),had a higher proportion of female.Meanwhile,the intermediate-or high-risk group were more likely to have diabetes mellitus(DM)and stroke(P< 0.05).The proportions of patients with intermediate-or high-risk were less for trans-radial approach versus low risk during procedure.The utilization rates of clopidogrel,Angiotensin-converting enzyme inhibitor(ACEI)/ Angiotensin receptor blocker(ARB),β-blockers and proton pump inhibitor(PPI)were significantly higher in intermediate-or high-risk patients at discharge.The intermediate-or high-risk group was associated with higher 12-months ischemic events compared to the low risk group(4.09% vs.1.22%,P< 0.001).Comparing with the low-risk patients,the intermediate-or high-risk patients were associated with a higher rate of cardiac death(2.61% vs.0.50%,P< 0.001),MI(0.78% vs.0.35%,P< 0.001),stroke(0.85% vs.0.45%,P= 0.001),all-cause mortality(3.14% vs.0.83%,P< 0.001)and type BARC3,5 bleeding(2.35% vs.1.85%,P= 0.026).(3)The 9841 patients were included in the low-risk group,55 patients were excluded,as a result of missing information of P2Y12 inhibitors.Finally 9786 patients were analyzed,including 3464 ticagrelor group(35%)and 6322 clopidogrel group(65%).Compared with clopidogrel group,ticagrelor group were younger(55.40± 9.17 vs.58.40± 9.16,P< 0.001),had a higher proportion of male.Meanwhile,ticagrelor group were more likely to have previous MI and were associated with fewer hypertension and stroke(P< 0.05).The proportions of patients with ticagrelor group were more with left main coronary artery(LM),more stents were implanted versus clopidogrel group(P< 0.05).The utilization rate of ACEI/ARB was significantly higher and the utilization rates of statins and PPI were lower in ticagrelor group at discharge(P< 0.05).Before PSM,there was no significant difference between ticagrelor group and clopidogrel group in the incidence of 12-months ischemic events(1.04% vs.1.25%,P= 0.356).Meanwhile,there was no significant difference between the two cohorts in the incidence of all-cause mortality(0.69% vs.0.79%,P= 0.592).However,ticagrelor group were associated with higher risk of type BARC2,3,5 and BARC3,5 bleeding events(4.13% vs.2.85%,P< 0.001;2.22% vs.1.61%,P= 0.031).After PSM,there was also no significant difference in the incidence of 12-months ischemic events between the two cohorts(0.96% vs.1.22%,P= 0.329).Meanwhile,there was also no significant difference between ticagrelor group and clopidogrel group in the incidence of all-cause mortality(0.64% vs.0.77%,P= 0.545).And ticagrelor group was also associated with higher risk of type BARC2,3,5 bleeding events(4.11% vs.3.02%,P= 0.020).(4)The 6502 patients were included in the intermediate-or high-risk group,91 patients were excluded,as a result of missing information of P2Y12 inhibitors.Finally 6411 patients were analyzed,including 1832 ticagrelor group(29%)and 4579 clopidogrel group(71%).Compared with clopidogrel group,ticagrelor group were younger(62.06± 8.15 vs.67.67± 9.23,P< 0.001),had a higher proportion of male.Meanwhile,ticagrelor group were associated with fewer hypertension,anemia and stroke(P< 0.05).The proportions of patients with ticagrelor group were more stents were implanted as well as higher total length of stent values versus clopidogrel group(P< 0.05).The utilization rate of β-blockers was significantly higher in ticagrelor group at discharge(P< 0.05).Before PSM,ticagrelor group were associated with lower risk of 12-months ischemic events(2.73% vs.3.89%,P= 0.024)and all-cause morality(1.75% vs.2.86%,P= 0.011)compared to clopidogrel group.However,there were no significant difference in the incidence of cardiac death,MI,stroke,type BARC2,3,5 and BARC 3,5 bleeding events between ticagrelor group and clopidogrel group(P> 0.05).After PSM,ticagrelor group was also associated with lower risk of 12-months ischemic events compared to clopidogrel group(2.26% vs.3.60%,P= 0.023).Comparing with clopidogrel group,ticagrelor group was associated with a lower rate of all-cause morality(1.34% vs.2.38%,P= 0.028).And there were also no significant difference in the incidence of cardiac death,MI,stroke,type BARC2,3,5 and BARC3,5 bleeding events between the two groups(P> 0.05).ConclusionsThe OPT-CAD risk-prediction model had a considerable value to predict risk in ACS patients undergoing PCI.In low-risk patients defined by this score,ticagrelor was associated with significant increase in bleeding risk without reducing the risk of ischemic events and all-cause mortality compared with clopidogrel.Nevertheless,the benefit of ticagrelor,in comparison with clopidogrel,may be related to reduce ischemic events and all-cause mortality without increasing risk of bleeding in patients with intermediate-or high-risk.The management strategy based on OPT-CAD risk-prediction model for guiding P2Y12 inhibitor treatment might be reasonable and effective.Meanwhile,the usability needs further evaluation by well-designed randomized trials. |
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