【文章】左主干冠状动脉疾病患者接受药物洗脱支架经皮冠状动脉介入治疗与冠状动脉旁路移植术后的长期结局：多中心IRIS-MAIN注册研究的前瞻性分析
完整摘要 · 中文译文
背景：使用药物洗脱支架的经皮冠状动脉介入治疗（PCI）已被广泛用于治疗左主干冠状动脉疾病患者；然而，在真实世界人群中，其与冠状动脉旁路移植术（CABG）的长期比较结局仍缺乏充分描述。我们旨在比较亚洲无保护左主干冠状动脉疾病患者接受PCI或CABG后的长期全因死亡率。 方法：我们分析了多中心IRIS-MAIN注册研究前瞻性收集的数据，该研究在韩国、印度、日本、印度尼西亚和马来西亚的46家医院开展。该注册研究纳入年龄18岁及以上、患无保护左主干冠状动脉疾病（定义为血管造影目测估计狭窄直径≥50%）、并接受PCI、CABG或单纯药物治疗的成人。主要结局为全因死亡率。我们采用目标试验模拟框架，比较药物洗脱支架PCI与单纯CABG之间长期全因死亡风险。我们使用倾向评分重叠加权来校正已测量的基线协变量。IRIS-MAIN注册研究已在ClinicalTrials.gov注册（NCT01341327）。 研究结果：2003年1月1日至2024年12月31日期间，IRIS-MAIN登记研究共纳入6900例患者，其中5379例（78.0%）通过药物洗脱支架经皮冠状动脉介入治疗（PCI）（3836例[71.3%]）或冠状动脉旁路移植术（CABG）（1543例[28.7%]）接受了冠状动脉血运重建，并被纳入分析。所有患者的中位随访时间为10.0年（IQR 5.0-16.7）。在重叠加权人群中，PCI与CABG之间的10年加权Kaplan-Meier全因死亡率未观察到统计学可检测的差异（24.0% vs 22.9%；重叠加权风险比1.00 [95% CI 0.87-1.14]；p=0.99）。该置信区间不能排除任一策略带来的死亡获益或危害。 解读：在这项针对左主干冠状动脉疾病患者的非随机登记分析中，PCI与CABG之间的全因死亡率未观察到统计学可检测的差异。对于被认为适合任一策略的患者，多学科心脏团队讨论可能有助于患者和临床医生权衡PCI与CABG之间选择的潜在利弊。这些结果为观察性研究，不能确立因果治疗效应或生存等效性。 资助：心血管研究基金会（韩国）。
完整摘要 · 英文原文
BACKGROUND: Percutaneous coronary intervention (PCI) with drug-eluting stents has been widely used to treat patients with left main coronary artery disease; however, long-term comparative outcomes versus coronary artery bypass grafting (CABG) in real-world populations remain poorly characterised. We aimed to compare long-term all-cause mortality after PCI or CABG in Asian patients with unprotected left main coronary artery disease. METHODS: We analysed prospectively collected data from the multicentre IRIS-MAIN registry, conducted at 46 hospitals in South Korea, India, Japan, Indonesia, and Malaysia. The registry enrolled adults aged 18 years or older with unprotected left main coronary artery disease (defined as a stenosis diameter of ≥50% as visually estimated on angiography), who had been treated with PCI, CABG, or medical therapy alone. The primary outcome was all-cause mortality. We used a target trial emulation framework to compare the long-term risk of all-cause mortality between PCI with drug-eluting stents and isolated CABG. We used propensity-score overlap weighting to adjust for measured baseline covariates. The IRIS-MAIN Registry study is registered with ClinicalTrials.gov (NCT01341327). FINDINGS: Between Jan 1, 2003, and Dec 31, 2024, 6900 patients were enrolled in the IRIS-MAIN registry, of whom 5379 (78·0%) underwent coronary revascularisation through either PCI with drug-eluting stents (3836 [71·3%]) or CABG (1543 [28·7%]) and were included in the analysis. The median duration of follow-up for all patients was 10·0 years (IQR 5·0-16·7). In the overlap-weighted population, no statistically detectable difference in 10-year weighted Kaplan-Meier rates of all-cause mortality was observed between PCI and CABG (24·0% vs 22·9%; overlap-weighted hazard ratio 1·00 [95% CI 0·87-1·14]; p=0·99). The confidence interval does not exclude a mortality benefit or harm with either strategy. INTERPRETATION: In this non-randomised registry analysis of patients with left main coronary artery disease, there was no statistically detectable difference in all-cause mortality between PCI and CABG. For patients considered suitable for either strategy, multidisciplinary Heart Team discussion might help patients and clinicians weigh potential trade-offs in the choice between PCI and CABG. These findings are observational and cannot establish causal treatment effects or equivalence in survival. FUNDING: The CardioVascular Research Foundation (South Korea).