PCI of Native Coronary Artery vs Saphenous Vein Graft After Prior Bypass Surgery: A Multicenter, Randomized Trial.

However, this recommendation relies solely on observational data.

然而，这一推荐完全基于观察性数据。

This study compared clinical outcomes between a strategy of native vessel PCI with saphenous vein graft (SVG) PCI in post-CABG patients presenting with SVG failure.

本研究比较了在冠状动脉旁路移植术（CABG）后出现大隐静脉移植血管（SVG）失败的患者中，原生血管经皮冠状动脉介入治疗（PCI）与SVG PCI的临床结果。

Methods

The multicenter, randomized PROCTOR (Percutaneous Coronary Intervention of Native Coronary Artery versus Saphenous Vein Graft in Patients with Prior Coronary Artery Bypass Graft Surgery) trial included patients with significant SVG stenosis and a heart team-defined clinical indication for revascularization.

多中心、随机的 PROCTOR（原发性冠状动脉介入治疗与既往冠状动脉旁路移植术患者的大隐静脉移植血管介入治疗）试验包括了有显著SVG狭窄和心脏团队定义的血运重建临床指征的患者。

Patients were randomly assigned (1:1) to either a strategy of native vessel PCI or SVG PCI using an interactive web-based randomization platform.

患者被随机分配（1:1）到原生血管PCI策略或SVG PCI策略，使用交互式基于网络的随机化平台进行。

The trial was conducted across 14 centers in Europe.

该试验在欧洲的14个中心进行。

We report the occurrence of major adverse cardiac events at 1 year following the index PCI, defined as the composite of all-cause mortality, nonfatal target coronary territory myocardial infarction (MI), or clinically driven target coronary territory revascularization, analyzed on an intention-to-treatbasis.

我们在PCI术后1年报告了主要不良心脏事件的发生情况，定义为全因死亡、非致命性靶血管区域心肌梗死（MI）或临床驱动的靶血管区域血运重建的复合终点，按意向治疗分析。

The trial is registered with ClinicalTrials.gov (NCT03805048), and long-term follow-up is ongoing.

该试验已在ClinicalTrials.gov注册（NCT03805048），并正在进行长期随访。

Results

Between January 2019 and December 2023, 220 patients (mean age 73 ± 7 years; 84% men [185/220 patients]) were randomized to a strategy of native vessel PCI (n = 108) or SVG PCI (n = 112).

在2019年1月至2023年12月期间，共有220名患者（平均年龄73±7岁；84%为男性[185/220名患者]）被随机分配到原生血管PCI策略(n = 108)或SVG PCI策略(n = 112)。

At 1 year, major adverse cardiac events occurred in 37 patients (34%) in the native vessel PCI group and 21 patients (19%) in the SVG PCI group (HR: 2.14; 95% CI: 1.25-3.65; P = 0.006).

在1年时，原生血管PCI组有37名患者（34%）和SVG PCI组有21名患者（19%）发生了主要不良心脏事件（HR: 2.14; 95% 置信区间: 1.25-3.65; P = 0.006）。

There was no significant difference in all-cause mortality (HR: 1.59; 95% CI: 0.45-5.64; P = 0.472), whereas both nonfatal target coronary territory MI (HR: 2.12; 95% CI: 1.08-4.17; P = 0.029) and clinically driven target coronary territory revascularization (HR: 2.19; 95% CI: 1.02-4.72; P = 0.044) occurred more frequently in patients assigned to native vessel PCI.

在全因死亡率上没有显著差异（HR: 1.59; 95% 置信区间: 0.45-5.64; P = 0.472），然而，非致命性目标冠状动脉区域心肌梗死（HR: 2.12; 95% 置信区间: 1.08-4.17; P = 0.029）和临床驱动的目标冠状动脉区域血运重建（HR: 2.19; 95% 置信区间: 1.02-4.72; P = 0.044）在被分配到原生血管PCI的患者中发生得更频繁。

The incidenceof PCI-related MI was 13% in the native vessel PCI group and 1% in the SVG PCI group (HR: 14.85; 95% CI: 1.95-112.96; P = 0.009).

原生血管PCI组的PCI相关心肌梗死发生率为13%，而SVG PCI组的发生率为1%（HR: 14.85; 95% 置信区间: 1.95-112.96; P = 0.009）。

Conclusions

In the randomized PROCTOR trial, SVG PCI was associated with improved 1-year clinical outcomes compared with native vessel PCI, primarily driven by lower rates of PCI-related MI and clinically driven target coronary territory revascularization.

在随机化的PROCTOR试验中，SVG PCI与原生血管PCI相比，1年临床结果有所改善，主要得益于PCI相关心肌梗死和临床驱动的目标冠状动脉区域血运重建率降低。