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% (<0·2% per year). The numerical difference in mortality was comprised more of non-cardiovascular than cardiovascular death. Spontaneous myocardial infarction (6·2%, 95% CI 5·2–7·3 vs 2·6%, 2·0–3·4; hazard ratio [HR] 2·35, 95% CI 1·71–3·23; p<0·0001) and repeat revascularisation (18·3%, 16·7–20·0 vs 10·7%, 9·4–12·1; HR 1·78, 1·51–2·10; p<0·0001) were more common with PCI than with CABG. Differences in procedural myocardial infarction between strategies depended on the definition used. Overall, there was no difference in the risk of stroke between PCI (2·7%, 2·0–3·5) and CABG (3·1%, 2·4–3·9; HR 0·84, 0·59–1·21; p=0·36), but the risk was lower with PCI in the first year after randomisation (HR 0·37, 0·19–0·69).

Interpretation

Among patients with left main coronary artery disease and, largely, low or intermediate coronary anatomical complexity, there was no statistically significant difference in 5-year all-cause death between PCI and CABG, although a Bayesian approach suggested a difference probably exists (more likely than not <0·2% per year) favouring CABG. There were trade-offs in terms of the risk of myocardial infarction, stroke, and revascularisation. A heart team approach to communicate expected outcome differences might be useful to assist patients in reaching a treatment decision.

Funding

No external funding.

中文翻译：

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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治疗左主干冠状动脉疾病：个体患者数据荟萃分析

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，我们的目的是评估接受药物洗脱支架经皮冠状动脉介入治疗 (PCI) 与冠状动脉旁路移植术 (CABG) 治疗的患者的长期结局。

方法

在此个体患者数据荟萃分析中，我们使用搜索词“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*”搜索了 MEDLINE、Embase 和 Cochrane 数据库，以确定随机对照数据库建立至 2021 年 8 月 31 日期间以英文发表的试验 (RCT)，比较了对左主干冠状动脉疾病患者进行 PCI 与药物洗脱支架与 CABG 的治疗，这些患者对全因死亡率进行了至少 5 年的随访。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。次要终点是心血管死亡、自发性心肌梗死、手术性心肌梗死、中风和重复血运重建。我们采用了单阶段方法；使用 Kaplan-Meier 方法计算事件发生率，并使用 Cox 衰弱模型进行治疗组比较，试验为随机效应。在贝叶斯分析中，计算了 PCI 和 CABG 之间主要终点绝对风险差异大于 0·0%、至少 1·0%、2·5% 或 5·0% 的概率。

发现

我们的文献检索产生了 1599 个结果，其中符合我们纳入标准的 4 个 RCT（SYNTAX、PRECOMBAT、NOBLE 和 EXCEL）被纳入我们的荟萃分析中。4394 名中位 SYNTAX 评分为 25·0 (IQR 18·0–31·0) 的患者被随机分配接受 PCI (n=2197) 或 CABG (n=2197)。Kaplan-Meier 估计 PCI 组 5 年全因死亡率为 11·2% (95% CI 9·9–12·6)，CABG 组为 10·2% (9·0–11·6)（危险）比率 1·10，95% CI 0·91–1·32；p=0·33），导致绝对风险差异无统计学意义，为 0·9%（95% CI -0·9 至 2·8） ）。在贝叶斯分析中，PCI 组 5 年死亡率高于 CABG 组的概率为 85·7%；这种差异更有可能不少于 1·0%（每年 <0·2%）。死亡率的数字差异更多地包括非心血管死亡而不是心血管死亡。自发性心肌梗死（6·2%，95% CI 5·2–7·3 vs 2·6%，2·0–3·4；风险比 [HR] 2·35，95% CI 1·71–3 ·23；p<0·0001）和重复血运重建（18·3%、16·7–20·0 vs 10·7%、9·4–12·1；HR 1·78、1·51–2· 10；p<0·0001）在 PCI 中比 CABG 中更常见。不同策略之间的手术性心肌梗死的差异取决于所使用的定义。总体而言，PCI（2·7%、2·0–3·5）和 CABG（3·1%、2·4–3·9；HR 0·84、0·84）之间的卒中风险没有差异。 59–1·21；p=0·36），但随机分组后第一年 PCI 的风险较低（HR 0·37、0·19–0·69）。

解释

在患有左主干冠状动脉疾病且冠状动脉解剖复杂性很大程度上为低度或中度的患者中，PCI 和 CABG 之间的 5 年全因死亡没有统计学上的显着差异，尽管贝叶斯方法表明可能存在差异（更有可能）每年不<0·2%）有利于CABG。在心肌梗塞、中风和血运重建的风险方面存在权衡。心脏团队沟通预期结果差异的方法可能有助于帮助患者做出治疗决定。

资金

没有外部资金。