Appropriateness Of Treatment For Complex Coronary Artery Disease And Its Association With Clinical Outcomes

Three-vessel and left main coronary artery diseases (3VD/LM) are associated with more comorbidities and worse outcomes. Medical therapy and coronary revascularization procedures (coronary artery bypass grafting and percutaneous coronary intervneiton) are standard treatment strategies. Previous studies have shown that overuse and underuse of coronary revascularization existed in western countries.The prevelance of coronary artery disease is increasing in China. CABG and PCI are gaining popularity as well. But we have noticed that the national volume ratio of PCI versus CABG is 12-15:1, which is much higher than that of developed countries (3:1). Considering the lack of widely accepted tools for assessing the appropriateness of coronary revascularization in China, the paucity of standardized specialist physicians training system, and current compensation system that largely relies on workload and volume other than appropriateness and quality of care, critical concern has been raised regarding the appropriateness of treatment for 3VD/LM.The China Patient-Centered Evaluative Assessment of Cardiac Events-Prospective Study of 3-Vessel Disease (China PEACE-3VD) study is a multi-center, prospective, observational study that is conducted in 24 large teaching hospitals which have the capability to perform both CABG and PCI. China PEACE-3VD study has enrolled over 4000 patients who underwent elective coronary angiography and were diagnosed as 3VD/LM. We sought to use widely accepted guideline to assess the appropriateness of treatment, evaluate the association of treatment appropriateness and clinical outcomes, and identify some potential factors in the decision-making process that may worsen the appropriateness of treatment and clinical outcomes.The main results are as follows.Part 1:Assessing the appropritateness of treatment for 3VD/LMIntroduction:We sought to assess the appropriateness of treatment in a large multi-center prospective cohort of patients with 3VD/LM.Methods:We have consecutively enrolled patients who have underwent elective coronary angiography and were diagnosed as 3VD/LM in 24 large cardiac centers in China. We established the standardized appropriateness assessing criteria based on 2014 European Society of Cardiology and European Association of Cardio-Thoracic Surgery Guidelines on Myocardial Revascularization and evaluate the appropriateness of treatment with the criteria.Results:The appropriateness of treatment was 68% and 57.3%, respectively, in single-center pilot study and multi-center cohort. We identified certain variations among sites (23%-74.5), wards (50%-78%) and cardiologists (48%-82%). Procedure-related risk factors (SinoSCORE, chronic kidney disease, age) and complexity of coronary lesions (SYNTAX Score, LM) were independent risk factors for inappropriate treatment. There was no statistically significant correlation between treatment volumes of site, ward, or cardiologist and the appropriateness of treatment (Pearson correlation index:site:0.278, p=0.222; ward:0.455, p>0.05; cardiologist:0.216, p>0.05).Conclusions:The appropriateness of treatment for 3VD/LM was generally low in China, with significant variations among sites, wards and cardiologists. Great opportunity exists to improve the appropriateness of treatment.Part 2:The association of appropriateness of treatment for 3VD/LM and clinical outcomesIntroduction:We have identified that approximately 40% of all treatment for 3VD/LM were inappropriate. The aim of this study is to evaluate the association of treatment appropriateness and clinical outcomes.Methods:We consecutively invited patients who met the up-mentioned inclusion criteria to join into our prospective cohort, and followed up the patients for outcomes after discharge. We used COX model and propensity score matching (PSM) to evaluate the correlation of treatment under different indications and clinical outcomes.Results:Overall,3213 patients (medical therapy:485, CABG:1104, PCI:1199) were enrolled. After adjustment for risk factors using COX model, medical therapy was associated with increased rates of major adverse cardiac and cerebral-vascular events (MACCE) (14% vs 5.9%, Hazard Ratio (HR)= 2.004, p<0.001) and composite endpoint of all cause death, myocardial infarction (MI) and stroke (8.9% vs 3.1%, HR=1.918, p=0.001). We divided the patients who had underwent coronary revascularization into Group A (Class Ⅰ indication for CABG, Class Ⅰ or Ⅱa indication for PCI) and Group B (Class Ⅰ indication for CABG and Class Ⅲ indication for PCI). The MACCE (2.6% vs 5.7%, HR=2.563, p=0.008) of CABG in Group A was significantly lower than that of PCI, while the rates of death/MI/stroke showed no significant difference. However, both MACCE (3.8% vs 10%, HR=2.532, p=0.002) and rates of death/MI/stoke (2.5% vs 5.6%, HR=1.997) showed statistically significant differences between 2 groups. The results of comparative effectiveness research using PSMs were similar to regular COX models.Conclusions:Medical therapy is associated with worse outcomes for patients with 3VD/LM. The correlation of inappropriate revascularization and worse outcomes have been identified as well.Part 3:The appropriateness of treatment decision-making process for 3VD/LMIntroduction:Cardiologist, cardiac surgeon, patient and dependents may be involved in the treatment decision-making process. We sought to identify the key factors in this process that may influence the appropriateness of treatment and clinical outcomes.Methods:We chose the use of ad hoc PCI, surgeon’s consultation and patient’s refusal to physician’s recommendations as 3 potential factors, and retrospectively confirmed these factors for each patient according to medical chart. We used COX regression model and PSM to assess the association of each factor with treatment appropriateness and outcomes.Results:3213 patients were enrolled. The proportions of ad hoc PCI, surgeon’s consultation and patient’s refusal to physician’s recommendation were 49%,36.3% and 16.6%, respectively. As compared with staged coronary revascularization, ad hoc PCI was associated with worse appropriateness of treatment (57.9% vs 87.7%, p<0.01) and outcomes (MACCE:8.6%vs 4.9%, HR=0.543, p=0.002). The treatment appropriateness (56.6% vs 77.8%, p<0.01) in patients who have experienced surgeon’s consultation was better than those who haven’t. These patients had improved outcomes (MACCE:7.7% vs 6.3%, p=0.017). Patients who refused physicians recommendations had worse appropriateness of treatment (19.6% vs 74.2%, p<0.01) and outcomes (12.2% vs 6.2%, p<0.001).Conclusions:The use of ad hoc PCI, surgeon’s consultation, and patient’s refusal to physician’s recommendation were 3 key factors that influenced the appropriateness of treatment, as well as patient’s clinical outcomes.Part 4:Validation of Chinese Appropriate Use Criteria for Coronary RevascularizationIntroduction:The Chinese Appropriateness Use Criteria (Chinese AUC) has been built and published. We sought to validate the criteria using China PEACE-3VD single-center cohort.Methods:We have built up the standardized flowchart to assess the treatment appropriateness using Chinese AUC, and evaluated the accordance of treatment appropriateness that was identified by this flowchart and previously mentioned criteria on top of ESC/EACTS guideline.Results:Using this flowchart, we found that the treatment appropriateness was 65%, which was similar to 2014 ESC/EACTS guideline. We also identified significant variations among wards (50%-73.6%) and cardiologists (47.6%-81.8%). The accordance of appropriateness assessment between Chinese AUC and 2014 ESC/EACTS guideline was 96.4%.Conclusions:The Chinese AUC had high accordance to 2014 ESC/EACTS guideline, and can be used to assess the appropriateness of treatment for 3VD/LM in China.