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比较冠状动脉旁路移植术与药物洗脱支架置入术治疗左主干和/或三血管病变:SYNTAX 试验 3 年随访结果。

Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year follow-up of the SYNTAX trial.

机构信息

Department of Thoracic Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands.

出版信息

Eur Heart J. 2011 Sep;32(17):2125-34. doi: 10.1093/eurheartj/ehr213. Epub 2011 Jun 22.

Abstract

AIMS

Long-term randomized comparisons of percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in left main coronary (LM) disease and/or three-vessel disease (3VD) patients have been limited. This analysis compares 3-year outcomes in LM and/or 3VD patients treated with CABG or PCI with TAXUS Express stents.

METHODS AND RESULTS

SYNTAX is an 85-centre randomized clinical trial (n= 1800). Prospectively screened, consecutive LM and/or 3VD patients were randomized if amenable to equivalent revascularization using either technique; if not, they were entered into a registry. Patients in the randomized cohort will continue to be followed for 5 years. At 3 years, major adverse cardiac and cerebrovascular events [MACCE: death, stroke, myocardial infarction (MI), and repeat revascularization; CABG 20.2% vs. PCI 28.0%, P< 0.001], repeat revascularization (10.7 vs. 19.7%, P< 0.001), and MI (3.6 vs. 7.1%, P= 0.002) were elevated in the PCI arm. Rates of the composite safety endpoint (death/stroke/MI 12.0 vs. 14.1%, P= 0.21) and stroke alone (3.4 vs. 2.0%, P= 0.07) were not significantly different between treatment groups. Major adverse cardiac and cerebrovascular event rates were not significantly different between arms in the LM subgroup (22.3 vs. 26.8%, P= 0.20) but were higher with PCI in the 3VD subgroup (18.8 vs. 28.8%, P< 0.001).

CONCLUSIONS

At 3 years, MACCE was significantly higher in PCI- compared with CABG-treated patients. In patients with less complex disease (low SYNTAX scores for 3VD or low/intermediate terciles for LM patients), PCI is an acceptable revascularization, although longer follow-up is needed to evaluate these two revascularization strategies.

摘要

目的

经皮冠状动脉介入治疗(PCI)与冠状动脉旁路移植术(CABG)治疗左主干(LM)病变和/或三血管病变(3VD)患者的长期随机比较有限。本分析比较了接受 CABG 或 PCI 治疗并使用 TAXUS Express 支架的 LM 和/或 3VD 患者的 3 年结果。

方法和结果

SYNTAX 是一项 85 中心的随机临床试验(n=1800)。连续筛选出适合两种技术进行等效血运重建的 LM 和/或 3VD 患者,如果不适合,则将其纳入登记册。随机队列中的患者将继续随访 5 年。3 年时,主要不良心脑血管事件[MACCE:死亡、卒、心肌梗死(MI)和再次血运重建;CABG 为 20.2% vs. PCI 为 28.0%,P<0.001]、再次血运重建(10.7% vs. 19.7%,P<0.001)和 MI(3.6% vs. 7.1%,P=0.002)在 PCI 组中升高。治疗组之间复合安全终点(死亡/卒/MI 为 12.0% vs. 14.1%,P=0.21)和单独卒(3.4% vs. 2.0%,P=0.07)的发生率无显著差异。LM 亚组中,两组之间的 MACCE 发生率无显著差异(22.3% vs. 26.8%,P=0.20),但 3VD 亚组中 PCI 组更高(18.8% vs. 28.8%,P<0.001)。

结论

3 年时,与 CABG 治疗相比,PCI 治疗患者的 MACCE 显著更高。在疾病不太复杂的患者中(3VD 的 SYNTAX 评分较低或 LM 患者的评分较低/中三分之一),PCI 是一种可接受的血运重建方法,尽管需要更长时间的随访来评估这两种血运重建策略。

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