PCI加药物洗脱支架与CABG治疗左主干冠状动脉疾病的5年死亡率相差不大
2021-11-22   阅读:546   来源:柳叶刀

美国布列根和妇女医院和哈佛医学院Marc S Sabatine团队比较了左主干冠状动脉疾病经皮冠状动脉介入治疗加药物洗脱支架与冠状动脉旁路移植术的治疗效果。相关论文发表在2021年11月15日出版的《柳叶刀》杂志上。

左主干冠状动脉疾病患者的最佳血运重建策略尚不确定。该研究旨在评估使用药物洗脱支架的经皮冠状动脉介入治疗(PCI)与冠状动脉旁路移植术(CABG)的长期疗效。

在这项个体患者数据荟萃分析中,研究组使用关键词“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*”,在MEDLINE、Embase和Cochrane等大型数据库中检索从建库至2021年8月31日以英文发表的随机对照试验(RCT),这些试验均比较了对左主干冠状动脉疾病患者进行PCI和药物洗脱支架与CABG的效果,这些患者至少有5年的全因死亡率随访。

由两位作者来确定符合标准的研究。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、程序性心肌梗死、卒中和二次血运重建。研究组采用了一个阶段的方法;事件发生率采用Kaplan-Meier方法计算,治疗组比较采用Cox脆弱性模型,试验为随机效应。在贝叶斯分析中,计算PCI和CABG主要终点的绝对风险差异大于0.0%,且至少为1.0%、2.5%或5.0%的概率。

文献检索产生了1599个结果,其中四种RCTs-SYNTAX、PRECOMBAT、NOBLE和EXCEL符合纳入标准,并被纳入荟萃分析。4394名患者的中位SYNTAX评分为25.0分,将其随机分组,其中PCI组2197例,CABG组2197例。PCI组5年全因死亡的Kaplan-Meier估计值为11.2%,CABG组为10.2%,绝对风险差异无统计学意义。在贝叶斯分析中,PCI组的5年死亡率高于CABG组的概率为85.7%;这种差异很可能不低于1.0%。

死亡率的数字差异更多地由非心血管死亡构成。PCI组中自发性心肌梗死率为6.2%,显著高于CABG组的2.6%;再次血运重建率为18.3%,显著高于CABG组的10.7%。不同策略之间程序性心肌梗死的差异取决于所使用的定义。总体来说,PCI(2.7%)和CABG(3.1%)在卒中风险方面没有差异,但在随机分组后的第一年PCI组的风险较低。

研究结果表明,对于左主干冠状动脉疾病且大部分冠状动脉解剖结构复杂度较低或中等的患者,PCI和CABG之间的5年全因死亡率无统计学差异,尽管贝叶斯方法表明可能存在有利于CABG的差异。两种疗法在心肌梗死、中风和血运重建的风险方面存在权衡。

附:英文原文

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

Author: Marc S Sabatine, Brian A Bergmark, Sabina A Murphy, Patrick T OGara, Peter K Smith, Patrick W Serruys, A Pieter Kappetein, Seung-Jung Park, Duk-Woo Park, Evald H Christiansen, Niels R Holm, Per H Nielsen, Gregg W Stone, Joseph F Sabik, Eugene Braunwald

Issue&Volume: 2021-11-15

Abstract:

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.

DOI: 10.1016/S0140-6736(21)02334-5

编辑:小柯机器人

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