Sirolimus-Eluting Balloon With Provisional Stenting Versus Systematic Drug-Eluting Stent Implantation to Treat De Novo Coronary Lesions: A Randomized, Open-Label, Noninferiority Trial.

An approach with minimal stenting deserves to be assessed in a randomized trial. We studied a novel sirolimus-eluting balloon (SEB) that elutes sirolimus over a 90-day period using a biodegradable polymer microreservoir technology.

一种最小化支架植入的方法值得在随机试验中进行评估。我们研究了一种新型的西罗莫司洗脱球囊（SEB），它利用可生物降解的聚合物微储存技术在90天内释放西罗莫司。

Methods

In a multicenter, open-label, randomized trial, we compared an SEB-based strategy with provisional DES with one of systematic DES for de novo lesions in coronary arteries between 2 and 5 mm in diameter.

在一项多中心、开放标签、随机试验中，我们比较了基于SEB策略与临时DES以及系统性DES对于直径在2至5毫米冠状动脉新发病变的治疗效果。

Subjects were randomized 1:1 before percutaneous coronary intervention.

在经皮冠状动脉介入治疗前，受试者按1:1的比例进行随机分配。

The primary end point was target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization.

主要终点是靶血管失败，这是心脏死亡、靶血管相关心肌梗死和临床驱动的靶血管血运重建的复合终点。

It was tested for noninferiority at 1 year with the use of an absolute margin equal to 50% of the combined event rate at a significance level of 0.025.

在1年时，使用等于联合事件率50%的绝对边界值进行了非劣效性测试，显著性水平为0.025。

The primary analysis population included all randomized subjects with completed or attempted percutaneous revascularization, analyzed according to the intention-to-treatprinciple.

主要分析人群包括所有随机受试者，无论是否完成或尝试过经皮血运重建，均按照意向治疗原则进行分析。

A sensitivity analysis was performed on the per-protocol population.

对符合方案人群进行了敏感性分析。

Results

Between August 27, 2021, and July 29, 2024, 3323 participants were randomized and treated in 62 sites.

2021年8月27日至2024年7月29日期间，3323名参与者在62个研究地点被随机分组并接受治疗。

Among 1661 participants in the SEB strategy group, bailout stenting was performed in 343 (20.7%).

在SEB策略组的1661名参与者中，有343人（占20.7%）进行了救援性支架植入术。

Target vessel failure occurred over 365 days in 88 (5.3%) and 73 (4.4%) participants in the SEB and the systematic DES strategy groups, respectively (risk difference, 0.91% [95% CI -0.55% to 2.38%]; 1-sided P=0.02 for noninferiority with a 2.44% noninferiority margin).

在365天内，SEB策略组和系统性DES策略组分别有88名（5.3%）和73名（4.4%）参与者发生了靶血管失败（风险差异，0.91% [95% 置信区间 -0.55% 至 2.38%]；单侧P=0.02，非劣效性边际为2.44%）。

Clinically driven target vessel revascularization occurred more frequently in the SEB strategy group (3.3% versus 2.1%; risk difference, 1.22% [95% CI, 0.11%-2.33%).

在SEB策略组中，临床上驱动的靶血管血运重建发生得更频繁（3.3%对比2.1%；风险差异，1.22% [95% 置信区间, 0.11%-2.33%]）。

Safety events, including lesion thrombosis, were low and similar in both groups.

包括病变血栓形成在内的安全事件发生率低，且两组相似。

Although the results of the per-protocol population (3194 participants, 96%) did not confirm noninferiority (upper boundary of the 95% CI, 2.63; P=0.04), they were similar to the intention-to-treatresults in both magnitude and direction.

尽管按方案人群的结果（3194名参与者，96%）没有确认非劣效性（95%置信区间上限，2.63；P=0.04），但其在大小和方向上与意向治疗结果相似。

Conclusions

At 1 year, in the primary intention-to-treatanalysis population, a strategy of percutaneous coronary intervention with SEB and provisional DES was noninferior to the systematic use of DES for the primary end point of target vessel failure.

在主要意向治疗分析人群中，1年时，采用经皮冠状动脉介入治疗（PCI）联合SEB和临时使用DES的策略对于靶血管失败的主要终点事件，与系统性使用DES相比，显示出非劣效性。

The per-protocol population sensitivity analysis did not confirm noninferiority.

按方案人群敏感性分析未确认非劣效性。

Clinically driven target vessel revascularization occurred more frequently in the SEB strategy group.

在SEB策略组中，临床驱动的目标血管血运重建发生得更频繁。

At 5 years, target vessel failure will be tested again for noninferiority and for superiority if noninferiority is achieved.

在5年时，将再次测试目标血管失败以证明非劣效性，并且如果达到非劣效性，则测试优越性。

registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04859985.

网址: https://www.clinicaltrials.gov; 唯一标识符: NCT04859985。