Deferral of percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation (PRO-TAVI): an investigator-initiated, multicentre, open-label, non-inferiority, randomised controlled trial.

We aimed to assess whether deferral of percutaneous coronary intervention (PCI) is non-inferior to routine PCI before TAVI in patients with coronary artery disease.

我们旨在评估在TAVI术前，延迟进行经皮冠状动脉介入治疗（PCI）是否不劣于常规PCI，在冠状动脉疾病患者中的效果。

Methods

In this investigator-initiated, open-label, randomised controlled trial, done at 12 hospitals in the Netherlands, TAVI patients with coronary artery disease were randomly assigned in a 1:1 ratio to deferral of PCI or PCI before TAVI.

在这项由研究者发起的、开放标签的、随机对照试验中，荷兰的12家医院对冠状动脉疾病患者进行了TAVI治疗，并按照1:1的比例随机分配到PCI延期组或PCI在TAVI前进行组。

Randomisation was done by use of a web-based system with random block sizes of 2 and 4, and stratification by presence of coronary artery disease involving proximal left anterior descending artery.

随机分组是通过使用一个基于网络的系统完成的，该系统采用2和4的随机分块大小，并根据是否存在涉及近端左前降支的冠状动脉疾病进行分层。

The primary endpoint was a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding at 1 year.

主要终点是1年内全因死亡、心肌梗死、中风和主要出血事件的复合终点。

Non-inferiority testing was done in the intention-to-treatpopulation against the prespecified margin of 11 percentage points.

在预设的11个百分点的非劣效性边界内，对意向治疗人群进行了非劣效性测试。

The study is registered with ClinicalTrials.gov (NCT05078619) and long-term follow-up is ongoing.

该研究已在ClinicalTrials.gov上注册（NCT05078619），长期随访正在进行中。

Results

Between Oct 7, 2021, and Nov 19, 2024, 466 patients were enrolled: 233 were assigned to deferral of PCI and 233 to PCI before TAVI.

从2021年10月7日到2024年11月19日，共有466名患者被纳入研究：233名被分配到PCI延期组，另外233名被分配到TAVI前进行PCI组。

Median age was 81 years (IQR 78-84), and 166 (36%) of 466 patients were female.

中位年龄为81岁（四分位数间距78-84），466名患者中有166名（36%）为女性。

The primary endpoint occurred in 56 (24%) of 233 patients in the deferral group as compared with 60 (26%) of 233 patients in the PCI group (rate difference -1·7% [95% CI -9·5 to 6·2]; hazard ratio0·89 [95% CI 0·62-1·28]; p=0·0008 for non-inferiority; p=0·68 for superiority).

在延迟组的233名患者中，主要终点事件发生在56名（24%）患者中，而在PCI组的233名患者中，主要终点事件发生在60名（26%）患者中（率差-1.7% [95% 置信区间 -9.5至6.2]；风险比0.89 [95% 置信区间 0.62-1.28]；非劣效性检验的p值为0.0008；优效性检验的p值为0.68）。

interpretation

In patients with coronary artery disease undergoing TAVI, deferral of PCI was non-inferior to PCI before TAVI for the 1-year composite of all-cause mortality, myocardial infarction, stroke, and major bleeding.

在接受经导管主动脉瓣置换术（TAVI）的冠状动脉疾病患者中，延迟行经皮冠状动脉介入治疗（PCI）与TAVI前进行PCI在1年内的全因死亡、心肌梗死、中风和主要出血的复合终点上非劣效。

These findings suggest that an initial conservative strategy can be appropriate in selected patients, although patient-tailored treatment decisions remain essential.

这些发现表明，在选定的患者中，初始保守策略可能是适当的，尽管患者个体化的治疗决策仍然是必要的。

funding

ZonMw.

ZonMw.