Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.
JAMA Cardiol. 2017 Oct 1;2(10):1079-1088. doi: 10.1001/jamacardio.2017.2895.
In patients with left main coronary artery (LMCA) stenosis, coronary artery bypass grafting (CABG) has been the standard therapy for several decades. However, some studies suggest that percutaneous coronary intervention (PCI) with drug-eluting stents may be an acceptable alternative.
To compare the long-term safety of PCI with drug-eluting stent vs CABG in patients with LMCA stenosis.
PubMed, Scopus, EMBASE, Web of Knowledge, and ScienceDirect databases were searched from December 18, 2001, to February 1, 2017. Inclusion criteria were randomized clinical trial, patients with LMCA stenosis, PCI vs CABG, exclusive use of drug-eluting stents, and clinical follow-up of 3 or more years.
Trial-level hazard ratios (HRs) and 95% CIs were pooled by fixed-effect and random-effects models with inverse variance weighting. Time-to-event individual patient data for the primary end point were reconstructed. Sensitivity analyses according to drug-eluting stent generation and coronary artery disease complexity were performed.
The primary end point was a composite of all-cause death, myocardial infarction, or stroke at long-term follow-up. Secondary end points included repeat revascularization and a composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at long-term follow-up.
A total of 4 randomized clinical trials were pooled; 4394 patients were included in the analysis. Of these, 3371 (76.7%) were men; pooled mean age was 65.4 years. According to Grading of Recommendations, Assessment, Development and Evaluation, evidence quality with respect to the primary composite end point was high. Percutaneous coronary intervention and CABG were associated with a comparable risk of all-cause death, myocardial infarction, or stroke both by fixed-effect (HR, 1.06; 95% CI, 0.90-1.24; P = .48) and random-effects (HR, 1.06; 95% CI, 0.85-1.32; P = .60) analysis. Sensitivity analyses according to low to intermediate Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score (random-effects: HR, 1.02; 95% CI, 0.74-1.41; P = .89) and drug-eluting stent generation (first generation: HR, 0.90; 95% CI, 0.68-1.20; P = .49; second generation: HR, 1.19; 95% CI, 0.82-1.73; P = .36) were consistent. Kaplan-Meier curve reconstruction did not show significant variations over time between the techniques, with a 5-year incidence of all-cause death, myocardial infarction, or stroke of 18.3% (319 events) in patients treated with PCI and 16.9% (292 events) in patients treated with CABG. However, repeat revascularization after PCI was increased (HR, 1.70; 95% CI, 1.42-2.05; P < .001). Other individual secondary end points did not differ significantly between groups. Finally, pooled estimates of trials with LMCA stenosis tended overall to differ significantly from those of trials with multivessel coronary artery disease without left main LMCA stenosis.
Percutaneous coronary intervention and CABG show comparable safety in patients with LMCA stenosis and low to intermediate-complexity coronary artery disease. However, repeat revascularization is more common after PCI.
在左主干冠状动脉(LMCA)狭窄的患者中,冠状动脉旁路移植术(CABG)已经作为一种标准疗法存在了几十年。然而,一些研究表明,药物洗脱支架经皮冠状动脉介入治疗(PCI)可能是一种可接受的替代方法。
比较药物洗脱支架 PCI 与 LMCA 狭窄患者 CABG 的长期安全性。
从 2001 年 12 月 18 日至 2017 年 2 月 1 日,在 PubMed、Scopus、EMBASE、Web of Knowledge 和 ScienceDirect 数据库中进行了检索。纳入标准为随机临床试验、LMCA 狭窄患者、PCI 与 CABG、药物洗脱支架的单独使用以及 3 年以上的临床随访。
通过固定效应和随机效应模型,采用逆方差加权法对试验水平的风险比(HR)和 95%置信区间(CI)进行合并。通过重建主要终点的个体患者时间到事件数据进行敏感性分析。根据药物洗脱支架生成和冠状动脉疾病复杂性进行了敏感性分析。
主要终点是长期随访时全因死亡、心肌梗死或卒中的复合终点。次要终点包括长期随访时的再次血运重建和全因死亡、心肌梗死、卒中和再次血运重建的复合终点。
共纳入 4 项随机临床试验,共纳入 4394 例患者进行分析。其中,3371 例(76.7%)为男性,平均年龄 65.4 岁。根据推荐评估、制定与评估分级系统,主要复合终点的证据质量为高级别。固定效应分析(HR,1.06;95%CI,0.90-1.24;P=0.48)和随机效应分析(HR,1.06;95%CI,0.85-1.32;P=0.60)均显示 PCI 和 CABG 的全因死亡、心肌梗死或卒中风险相当。根据低至中等 SYNTAX 评分(随机效应:HR,1.02;95%CI,0.74-1.41;P=0.89)和药物洗脱支架生成(第一代:HR,0.90;95%CI,0.68-1.20;P=0.49;第二代:HR,1.19;95%CI,0.82-1.73;P=0.36)的敏感性分析结果一致。Kaplan-Meier 曲线重建未显示两种技术之间随时间的显著变化,PCI 治疗组 5 年全因死亡、心肌梗死或卒中的发生率为 18.3%(319 例事件),CABG 治疗组为 16.9%(292 例事件)。然而,PCI 后的再次血运重建增加(HR,1.70;95%CI,1.42-2.05;P<0.001)。其他次要终点在两组之间无显著差异。最后,LMCA 狭窄试验的汇总估计值与无左主干 LMCA 狭窄的多血管冠状动脉疾病试验的汇总估计值总体上存在显著差异。
在 LMCA 狭窄且冠状动脉疾病复杂程度低至中等的患者中,PCI 和 CABG 的安全性相当。然而,PCI 后再次血运重建更为常见。