| Background and Aim:Cardiovascular disease is the leading cause of death among Chinese residents.Despite the development of procedural techniques,medical devices,and medical therapy,cardiovascular deaths among Chinese residents are still on the rise in recent years.Prior studies have demonstrated that diabetes mellitus(DM),previous cardiovascular disease(CVD),and chronic obstructive pulmonary disease(COPD)are high-risk factors for coronary artery disease,and are closely related to the poor clinical prognosis.These above-mentioned high-risk factors could increase the risk of mortality in patients with complex coronary artery disease,which is also one of the main reasons for the high cardiovascular mortality of Chinese residents in recent years.Optimal medical therapy and coronary revascularization are the main treatment methods for coronary artery disease.The majority of previous studies have demonstrated that the effect of revascularization in patients with coronary artery disease is non-inferior or superior to medical therapy,especially in patients with high-risk complex coronary disease.For patients with high-risk complex coronary lesions,coronary revascularization is the main treatment modality recommended by current guidelines.Coronary revascularization strategies include percutaneous coronary intervention(PCI)and coronary artery bypass graft(CABG).However,there is still controversy over the choice of revascularization strategy(PCI or CABG)for patients with high-risk complex coronary lesions.Therefore,selecting an optimal revascularization strategy to reduce mortality in patients with high-risk complex coronary disease is of great significance for improving the long-term prognosis of such patients.Moreover,there are very limited randomized controlled studies directly comparing PCI or CABG in such patients,and the majority of the follow-up is ≤ 5 years.There is a lack of evidence from studies with long-term follow-up.The aim of the present study was to investigate the impact of high-risk factors such as DM,previous CVD,and COPD on 10-year all-cause mortality in patients with three-vessel disease and/or left main disease(3VD and/or LMCAD).The present study also explored whether the 10-year all-cause mortality was different between the two revascularization strategies in patients with 3VD and/or LMCAD,and may provide clinical insight for making optimal revascularization strategies for patients with high-risk factors such as DM,previous CVD,and COPD.Methods:The present study used the SYNTAX Extended Survival study(SYNTAXES)database,which enrolled 1800 patients with 3VD and/or LMCAD,who were randomly assigned to receive PCI(n= 903)or CABG(n= 897)in a 1:1 ratio and were followed up for 10 years.The primary endpoint of the study was 10-year all-cause mortality.The present study included the following 3 parts:1.Comparison of 10-year all-cause mortality after PCI or CABG in patients with complex coronary artery disease and DM.Patients were divided into diabetic group and non-diabetic group.In diabetic population,patients were divided into non-insulin drug treatment group and insulin treatment group according to whether they received insulin treatment.Time-to-event Kaplan-Meier estimates with the log-rank test were used to compare PCI and CABG in patients with and without diabetes,and to compare diabetes vs.no diabetes in PCI and CABG groups.Multivariable analyses were performed in the Cox proportional hazards regression model to evaluate whether pharmacologically treated or insulin-treated DM was an independent predictor of 10-year all-cause mortality.2.Comparison of 10-year all-cause mortality after PCI or CABG in patients with complex coronary artery disease and established CVD.In the present study,the cohort was stratified according to those with and without established CVD as reported by the investigator at the time of enrolment,and defined as≥1 prior myocardial infarction(MI),prior cerebrovascular disease,or established peripheral vascular disease(PVD)according to prior publications.The degree of established CVD was defined based on the extent of prior vascular disease with CVD-1defined as patients having only one of a previous myocardial infarction(MI),cerebrovascular disease,or PVD;CVD-2 patients having two of these three conditions and CVD-3 patients having all 3 of these diagnoses.Only a few patients had vascular disease in 3 territories,so they were combined with patients in the CVD-2 group.The Kaplan-Meier method was used to estimate cumulative event rates,with the log-rank test used to assess differences between groups.Multivariable analysis was performed to investigate whether established CVD was an independent predictor of 10-year all-cause mortality.3.Comparison of 10-year all-cause mortality after PCI or CABG in patients with complicated coronary artery disease and COPDPatients were stratified to COPD group and non-COPD group according to whether the patients were complicated with COPD.Time-to-event Kaplan-Meier estimates with log-rank test were used to compare COPD versus non-COPD in the PCI and CABG arm,respectively,and to compare PCI with CABG according to COPD.Multivariable analysis was performed to investigate whether COPD was an independent predictor of 10-year all-cause mortality.Results:1.Among patients with diabetes(n= 452),the risk of death at 5 years was numerically higher in the PCI-treated group compared with CABG [19.6% vs.13.3%,hazard ratio(HR): 1.53,95 % confidence interval(CI): 0.96,2.43,P = 0.075],while the CABG group had numerically higher all-cause mortality than PCI during the 5 to 10-year follow-up period(PCI vs.CABG: 20.8% vs.24.4 %,HR: 0.82,95% CI: 0.52,1.27,p= 0.366).There was no significant difference in 10-year all-cause mortality among diabetic patients treated with PCI or CABG,with an absolute treatment difference of 1.9% between groups(PCI vs.CABG: 36.4% vs.34.5%,difference: 1.9%,95% CI:-7.6%,11.1%,p= 0.551).In insulin-treated diabetic patients(n= 182),10-year all-cause mortality was numerically higher but not significant in the PCI group compared with the CABG group(47.9% vs.39.6%,difference: 8.2%,95% CI:-6.5%,22.5%,p= 0.227).After adjusting for baseline confounders,diabetes remained an independent risk factor for all-cause mortality at 10years(HR: 1.58,95% CI: 1.27,1.95,p< 0.001).2.Among patients with established CVD(n= 827),10-year all-cause mortality was numerically higher with PCI compared with CABG,but not statistically different(35.9%vs.27.2%;adjusted HR: 1.14;95% CI: 0.83-1.58,p= 0.412).CVD patients with only ≥ 2vascular beds involved(CVD-2)had a higher risk of all-cause mortality at 10 years compared with patients without CVD(adjusted HR: 2.99,95% CI: 2.11-4.23,p< 0.001).3.A significantly higher risk of all-cause mortality at 10 years was observed in the patients with COPD,compared with those without COPD(43.1% vs.24.9%;HR: 2.03;95% CI: 1.56-2.64;p< 0.001).Among patients with COPD(n= 154),the 10-year risk of all-cause mortality was numerically slightly higher but not significant in the PCI group than in the CABG group(43.9%vs.42.3%;HR: 1.04;95% CI: 0.64-1.69,p= 0.858).After adjustment for baseline confounders,COPD remained an independent predictor of all-cause mortality at 10 years in the CABG arm(adjusted HR: 2.10,95% CI: 1.19-3.69,p= 0.010),but was not an independent predictor in the PCI arm(adjusted HR: 1.19,95%CI: 0.69-2.06,p= 0.536).Conclusions:1.In patients with 3VD and/or LMCAD and DM,CABG did not reduce the 10-year risk of all-cause mortality compared with PCI,and there was no statistically significant difference in 10-year all-cause mortality between the two revascularization strategies.Ten-year all-cause mortality after CABG is numerically lower in diabetic patients treated with insulin than with PCI,and CABG may confer additional survival benefit in such patients,but further validation in larger sclae studies is needed.2.The presence of CVD involving more than one territory was associated with a significantly increased risk of 10-year all-cause mortality,which was non-significantly higher in complex CAD patients treated with PCI compared with CABG.Acceptable long-term outcomes were observed,suggesting that patients with established CVD should not be precluded from undergoing invasive angiography or revascularization.3.Compared to patients without COPD,patients with COPD had significantly increased the 10-year risk of all-cause mortality after revascularization in patients with complex coronary artery disease.There was no significant difference in 10-year all-cause mortality after CABG or PCI in patients with 3VD and/or LMCAD and COPD.Our findings suggest that patients with complex lesions and COPD should not be precluded from undergoing CABG.In summary,in patients with 3VD and/or LMCAD with high-risk factors such as DM,previous CVD,and COPD,there was no significant difference in 10-year all-cause mortality after PCI or CABG.Our study provides clinical evidence for making optimal revascularization strategies for such high-risk complex coronary artery disease patients. |
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