Percutaneous coronary intervention with drug-eluting stents versus coronary artery bypass grafting in left main coronary artery disease: an individual patient data meta-analysis

Percutaneous coronary intervention with drug-eluting stents versus coronary artery bypass grafting in left main coronary artery disease: an individual patient data meta-analysis
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DOI:
10.1016/s0140-6736(21)02334-5
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发表时间:
2021-12-16
期刊:
影响因子:
168.9
通讯作者:
Braunwald, Eugene
Braunwald, Eugene
中科院分区:
医学1区
文献类型:
--
作者:
Sabatine, Marc S.;Bergmark, Brian A.;Braunwald, Eugene

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背景左主干冠状动脉疾病患者的最佳血运重建策略尚不确定。因此,我们的目的是评估长期的结果,经皮冠状动脉介入治疗(PCI)与药物洗脱支架与冠状动脉旁路移植术(CABG)治疗的患者。方法在这一个体患者数据荟萃分析,我们检索MEDLINE,Embase,和科克伦数据库使用的检索词“左主干”,“经皮冠状动脉介入治疗”或“支架”,和“冠状动脉旁路移植术 *”,以识别数据库建立至2021年8月31日期间以英文发表的随机对照试验(RCT),在至少随访5年的左主干冠状动脉疾病患者中比较PCI与药物洗脱支架联合CABG-导致死亡。两位作者(MSS和BAB)确定了符合标准的研究。主要终点是5年全因死亡率。次要终点为心血管死亡、自发性心肌梗死、手术性心肌梗死、卒中和重复血运重建。我们采用一阶段方法;使用Kaplan-Meier方法计算事件发生率,使用考克斯脆弱模型进行治疗组比较,试验作为随机效应。在贝叶斯分析中,PCI和CABG之间的主要终点的绝对风险差异的概率超过0. 0%,至少1. 0%,2. 5%,或5. 0%,calculated.Findings我们的文献检索产生了1599结果,其中四个随机对照试验,SYNTAX,PRECOMBAT,NOBLE,和EXCEL符合我们的纳入标准被列入我们的荟萃分析。4394例患者(中位SYNTAX评分为25.0(IQR 18.0-31.0))被随机分配接受PCI(n=2197)或CABG(n=2197)。PCI组5年全因死亡的Kaplan-Meier估计值为11.2%(95% CI 9.9-12.6),CABG组为10.2%(9.0-11.6)(风险比1.10,95% CI 0.91-1.32; p=0.33),导致0.9%(95% CI -0.9至2.8)的非统计学显著绝对风险差异。在贝叶斯分析中,PCI组5年死亡率高于CABG组的可能性为85.7%;该差异可能大于不低于1.0%(
Background The optimal revascularisation strategy for patients with left main coronary artery disease is uncertain. We therefore aimed to evaluate long-term outcomes for patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents versus coronary artery bypass grafting (CABG).Methods In this individual patient data meta-analysis, we searched MEDLINE, Embase, and the Cochrane database using the search terms "left main", "percutaneous coronary intervention" or "stent", and "coronary artery bypass graft*" to identify randomised controlled trials (RCTs) published in English between database inception and Aug 31, 2021, comparing PCI with drug-eluting stents with CABG in patients with left main coronary artery disease that had at least 5 years of patient follow-up for all-cause mortality. Two authors (MSS and BAB) identified studies meeting the criteria. The primary endpoint was 5-year all-cause mortality. Secondary endpoints were cardiovascular death, spontaneous myocardial infarction, procedural myocardial infarction, stroke, and repeat revascularisation. We used a one-stage approach; event rates were calculated by use of the Kaplan-Meier method and treatment group comparisons were made by use of a Cox frailty model, with trial as a random effect. In Bayesian analyses, the probabilities of absolute risk differences in the primary endpoint between PCI and CABG being more than 0.0%, and at least 1.0%, 2.5%, or 5.0%, were calculated.Findings Our literature search yielded 1599 results, of which four RCTs-SYNTAX, PRECOMBAT, NOBLE, and EXCEL-meeting our inclusion criteria were included in our meta-analysis. 4394 patients, with a median SYNTAX score of 25.0 (IQR 18.0-31.0), were randomly assigned to PCI (n=2197) or CABG (n=2197). The Kaplan-Meier estimate of 5-year all-cause death was 11.2% (95% CI 9.9-12.6) with PCI and 10.2% (9.0-11.6) with CABG (hazard ratio 1.10, 95% CI 0.91-1.32; p=0.33), resulting in a non-statistically significant absolute risk difference of 0.9% (95% CI -0.9 to 2.8). In Bayesian analyses, there was an 85.7% probability that death at 5 years was greater with PCI than with CABG; this difference was more likely than not less than 1.0% (