Assessing the Association of Appropriateness of Coronary Revascularization and 1-Year Clinical Outcomes for Patients with Stable Coronary Artery Disease in China
Introduction
Coronary artery disease (CAD) remains a leading cause of morbidity and mortality worldwide. Over the past few decades, coronary revascularization, including percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), has been widely used to manage stable CAD. However, randomized controlled trials have shown that while revascularization can relieve symptoms, it does not necessarily improve survival in patients with stable CAD. This has raised concerns about the appropriateness of revascularization, especially given the potential complications and costs associated with these procedures.
To address these concerns, appropriate use criteria (AUC) for coronary revascularization have been developed in various regions, including the United States, Europe, Japan, and China. These criteria aim to optimize clinical decision-making by integrating evidence, guidelines, and clinician experience. In China, the rapid increase in revascularization procedures and the disproportionate use of PCI over CABG have highlighted the need for improved appropriateness in clinical practice. The Chinese AUC for coronary revascularization was released in 2016, tailored to the specific needs and clinical scenarios of the Chinese population.
This study aimed to evaluate the association between the appropriateness of coronary revascularization based on the Chinese AUC and 1-year clinical outcomes in patients with stable CAD. The findings provide valuable insights into the effectiveness of the Chinese AUC in guiding clinical practice and improving patient outcomes.
Methods
This was a prospective, multi-center cohort study conducted in four tertiary cardiac centers in Beijing, China. The study enrolled patients with stable CAD and at least one coronary lesion stenosis of 50% or greater, as determined by elective coronary angiography. Patients with prior CABG or those without corresponding indications in the Chinese AUC were excluded.
Patients were classified into three groups based on the Chinese AUC recommendations: appropriate indications, uncertain indications, and inappropriate indications. Within each group, patients were further divided into the coronary revascularization group or the medical therapy group, depending on the treatment they received.
Data on clinical characteristics, including Canadian Cardiovascular Society (CCS) class, stress test results, and left ventricular ejection fraction (LVEF), were collected. Follow-up was conducted at 1 year, with outcomes assessed through telephone or mail contact. The primary outcome was a composite of major adverse cardiovascular and cerebrovascular events (MACCEs), including all-cause death, non-fatal myocardial infarction, stroke, repeat revascularization, and ischemic symptoms requiring hospital admission.
Statistical analysis was performed using Cox proportional hazards models to examine the associations between treatment appropriateness and clinical outcomes. Propensity score matching was also used to adjust for potential confounding variables.
Results
A total of 6,085 patients were enrolled in the study, with 1,617 (26.6%) classified as having appropriate indications, 2,658 (43.7%) as uncertain indications, and 1,810 (29.7%) as inappropriate indications. Among patients with appropriate indications, 1,252 underwent coronary revascularization, while 365 received medical therapy. In the uncertain indication group, 1,966 patients underwent revascularization, and 692 received medical therapy. In the inappropriate indication group, 762 patients underwent revascularization, and 1,048 received medical therapy.
Appropriate Indications
In patients with appropriate indications, coronary revascularization was associated with a significantly lower risk of 1-year MACCEs compared to medical therapy (9.7% vs. 15.9%, adjusted hazard ratio [HR]: 0.62; 95% confidence interval [CI]: 0.45–0.86; P = 0.004). Revascularization also reduced the risk of repeat revascularization (3.0% vs. 7.9%, adjusted HR: 0.36; 95% CI: 0.22–0.59; P < 0.001) and ischemic symptoms requiring hospital admission (5.9% vs. 10.7%, adjusted HR: 0.51; 95% CI: 0.34–0.77; P = 0.001).
Uncertain Indications
For patients with uncertain indications, there was no significant difference in 1-year MACCEs between the revascularization and medical therapy groups (7.1% vs. 7.5%, adjusted HR: 0.81; 95% CI: 0.52–1.25; P = 0.338). Similarly, no significant differences were observed in secondary outcomes, including death, myocardial infarction, stroke, repeat revascularization, or ischemic symptoms requiring hospital admission.
Inappropriate Indications
In the inappropriate indication group, coronary revascularization did not provide a significant benefit in 1-year MACCEs compared to medical therapy (4.2% vs. 5.3%, adjusted HR: 0.80; 95% CI: 0.51–1.23; P = 0.308). There were also no significant differences in secondary outcomes between the two groups.
Subgroup Analysis
A subgroup analysis of patients without stress test results showed that coronary revascularization was still associated with a lower risk of 1-year MACCEs in patients with appropriate indications (9.9% vs. 15.7%, adjusted HR: 0.63; 95% CI: 0.45–0.88; P = 0.006). This finding supports the effectiveness of the Chinese AUC in guiding decision-making even in the absence of stress test results.
Discussion
This study provides the first validation of the Chinese AUC for coronary revascularization, demonstrating that adherence to these criteria is associated with improved 1-year outcomes in patients with stable CAD. Specifically, coronary revascularization was found to significantly reduce the risk of MACCEs in patients with appropriate indications, while no significant benefit was observed in patients with uncertain or inappropriate indications.
The findings are consistent with previous studies validating the US AUC, which also showed that revascularization was associated with better outcomes in patients with appropriate indications but not in those with uncertain or inappropriate indications. This highlights the importance of using AUC to guide clinical decision-making and optimize the use of revascularization procedures.
One notable difference between the Chinese AUC and the US AUC is the inclusion of a “stress test not performed” category in the Chinese criteria. This reflects the reality that stress testing is not widely used in China due to limited resources and potential risks. The study’s subgroup analysis of patients without stress test results supports the effectiveness of the Chinese AUC in these scenarios, as revascularization was still associated with improved outcomes in patients with appropriate indications.
The study also revealed that only 26.6% of patients had appropriate indications for revascularization, compared to higher rates in other regions. This may be attributed to differences in clinical practice, such as the lower prevalence of severe angina symptoms and the limited use of stress testing in China. These findings underscore the need for improved preoperative assessment and adherence to AUC in clinical practice.
Limitations
Several limitations should be considered when interpreting the results of this study. First, the study was observational, and patients were not randomized to treatment groups. Although statistical methods were used to adjust for confounding variables, residual bias may still exist. Second, the study did not assess the impact of revascularization on quality of life or symptomatic relief, which are important outcomes for patients with stable CAD. Finally, the use of CCS classification, which is subjective and physician-driven, may have introduced some variability in the data.
Conclusion
This study demonstrates that the Chinese AUC for coronary revascularization is a valuable tool for guiding clinical decision-making in patients with stable CAD. Coronary revascularization was associated with significantly lower risks of 1-year MACCEs in patients with appropriate indications, while no benefit was observed in patients with uncertain or inappropriate indications. These findings support the use of the Chinese AUC to optimize the appropriateness of revascularization procedures and improve patient outcomes.
doi.org/10.1097/CM9.0000000000000592
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