The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Sorbonne Université, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France.
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
JACC Cardiovasc Interv. 2020 Jun 22;13(12):1417-1428. doi: 10.1016/j.jcin.2020.03.053.
The aim of this study was to evaluate the long-term impact of coronary artery calcification (CAC) on outcomes after percutaneous coronary intervention and the respective performance of first- and second-generation drug-eluting stents (DES).
Whether contemporary DES have improved the long-term prognosis after percutaneous coronary intervention in lesions with severe CAC is unknown.
Individual patient data were pooled from 18 randomized trials evaluating DES, categorized according to the presence of angiography core laboratory-confirmed moderate or severe CAC. Major endpoints were the patient-oriented composite endpoint (death, myocardial infarction [MI], or any revascularization) and the device-oriented composite endpoint of target lesion failure (cardiac death, target vessel MI, or ischemia-driven target lesion revascularization). Multivariate Cox proportional regression with study as a random effect was used to assess 5-year outcomes.
A total of 19,833 patients were included. Moderate or severe CAC was present in 1 or more target lesions in 6,211 patients (31.3%) and was associated with increased 5-year risk for the patient-oriented composite endpoint (adjusted hazard ratio [adjHR]: 1.12; 95% confidence interval [CI]: 1.05 to 1.20) and target lesion failure (adjHR: 1.21; 95% CI: 1.09 to 1.34), as well as death, MI, and ischemia-driven target lesion revascularization. In patients with CAC, use of second-generation DES compared with first-generation DES was associated with reductions in the 5-year risk for the patient-oriented composite endpoint (adjHR: 0.88; 95% CI: 0.78 to 1.00) and target lesion failure (adjHR: 0.73; 95% CI: 0.61 to 0.87), as well as death or MI, ischemia-driven target lesion revascularization, and stent thrombosis. The relative treatment effects of second-generation compared with first-generation DES were consistent in patients with and without moderate or severe CAC, although outcomes were consistently better with contemporary devices.
In this large-scale study, percutaneous coronary intervention of target lesion moderate or severe CAC was associated with adverse patient-oriented and device-oriented adverse outcomes at 5 years. These detrimental effects were mitigated with second-generation DES.
本研究旨在评估冠状动脉钙化（CAC）对经皮冠状动脉介入治疗后结局的长期影响，以及第一代和第二代药物洗脱支架（DES）的各自表现。
目前尚不清楚在严重 CAC 病变中，当代 DES 是否改善了经皮冠状动脉介入治疗的长期预后。
我们对 18 项评估 DES 的随机试验的个体患者数据进行了汇总，这些试验根据是否存在经血管造影核心实验室证实的中度或重度 CAC 进行分类。主要终点是患者导向的复合终点（死亡、心肌梗死[MI]或任何血运重建）和以器械为导向的靶病变失败复合终点（心源性死亡、靶血管 MI 或缺血驱动的靶病变血运重建）。使用多变量 Cox 比例风险回归模型，以研究为随机效应，评估 5 年结局。
共纳入 19833 例患者。1 个或多个靶病变中存在中度或重度 CAC 的患者有 6211 例（31.3%），与患者导向的复合终点 5 年风险增加相关（调整后的危险比[adjHR]：1.12；95%置信区间[CI]：1.05 至 1.20）和靶病变失败（adjHR：1.21；95%CI：1.09 至 1.34），以及死亡、MI 和缺血驱动的靶病变血运重建。在有 CAC 的患者中，与第一代 DES 相比，使用第二代 DES 与降低 5 年患者导向的复合终点风险相关（adjHR：0.88；95%CI：0.78 至 1.00）和靶病变失败风险（adjHR：0.73；95%CI：0.61 至 0.87），以及死亡或 MI、缺血驱动的靶病变血运重建和支架血栓形成。第二代 DES 与第一代 DES 相比的相对治疗效果在有或无中度或重度 CAC 的患者中是一致的，尽管使用当代器械的结局始终更好。
在这项大规模研究中，经皮冠状动脉介入治疗靶病变中度或重度 CAC 与 5 年内的不良患者导向和器械导向不良结局相关。第二代 DES 减轻了这些不利影响。
