对比中美冠状动脉血运重建适宜性标准在中国人群中的适用性和科学性

Applicability and Scientificity: a Comparison of Chinese and American Appropriate Use Criteria for Coronary Revascularization in Chinese Patients

目的:旨在对比中美冠状动脉血运重建适宜性标准(以下分别简称“中国标准”、“美国标准”)在中国人群中的适用性和科学性。方法:连续入选4家大型心脏中心行择期冠状动脉造影中至少一支冠状动脉狭窄≥50%的稳定性冠心病患者。研究首先比较中美标准对入选患者的推荐结果。之后按中国标准推荐,将两种标准推荐不一致的患者划分为适宜组、不适宜组和可能适宜组,并根据实际接受的治疗将各组人群进一步划分为血运重建患者和药物治疗患者进行分析。主要结局指标为1年主要不良心脑血管事件(MACCE),包括全因死亡、非致死性心肌梗死、脑卒中、再次血运重建和再发心绞痛入院。结果:2016年8月至2017年8月连续入选6165例稳定性冠心病患者。根据中国标准,1.3%(80/6165)未得到推荐;根据美国标准,46.2%(2851/6165)未得到推荐;47.0%(2900/6165)中美标准推荐不一致,其中95.0%(2756/2900)术前未行负荷试验。在中美标准推荐不一致的2900例患者中,911例根据中国标准适宜血运重建,血运重建与1年MACCE无显著相关性(校正后HR=0.91,95%CI:0.53~1.57,P=0.74);504例根据中国标准不适宜血运重建,血运重建与1年MACCE无显著相关性(校正后HR=1.15,95%CI:0.33~3.97,P=0.82)。结论:与美国标准相比,中国标准临床场景覆盖率更高,适用性更好。在中美标准推荐不一致的患者中,遵循中国标准推荐进行决策与1年预后的改善无显著相关性,中国标准对“未行负荷试验”患者的推荐可能仍需进一步论证和优化。

Objectives:This study aimed to compare Chinese and American appropriateness use criteria(AUC)for coronary revascularization from the perspective of applicability and scientificity.Methods:We conducted a prospective cohort study among stable coronary artery disease(CAD)patients with coronary lesion stenosis≥50%within 4 large cardiac centers.First,this study compared the recommendations received from Chinese and American AUC in all patients.Then,patients with different recommendations were divided into appropriate,inappropriate and uncertain category according to Chinese AUC.Based on treatment received,these patients were further categorized as coronary revascularization group and medical therapy group across appropriateness categories.The primary outcome was major adverse cardiac and cerebrovascular events(MACCE)defined as a composite of death,myocardial infarction,stroke,repeated revascularization and ischemic symptom admitted to hospital.Results:6165 patients were consecutively enrolled from August 2016 to August 2017.Proportion of unmappable category was 1.3%(80/6165)and 46.2%(2851/6165)according to Chinese and American AUC respectively.Inconsistency ratio of recommendations from those two AUCs was 47.0%(2900/6165).Among patients with different recommendations,95.0%(2756/2900)did not undergo stress test before coronary angiography.In those receiving different recommendations and grouped into appropriate category according to Chinese AUC(n=2900),there was no significant correlation between revascularization and MACCEs within 1 year(adjusted HR=0.91,95%CI:0.53-1.57,P=0.74).In those grouped into inappropriate category,no significant association between revascularization and MACCEs was observed(adjusted HR=1.15,95%CI:0.33-3.97,P=0.82).Conclusions:Compared with the American AUC,Chinese AUC is more applicable in Chinese population.Among patients with different recommendations from Chinese and American AUC,treating patients according to Chinese AUC was not associated with lower MACCEs rates.Scenarios set for patients without stress tests results need to be further studied and optimized.