Sirolimus-Eluting Balloon vs Repeat Drug-Eluting Stent or Balloon Angioplasty for Coronary In-Stent Restenosis.

The aim of the SELUTION4ISR (SELUTION SLR 014 In-stent Restenosis) trial was to assess the safety and effectiveness of a novel sirolimus drug-eluting balloon (DEB).

SELUTION4ISR（SELUTION SLR 014 支架内再狭窄）试验的目的是评估一种新型西罗莫司药物洗脱球囊（DEB）的安全性和有效性。

Methods

After successful lesion predilation, patients with ISR were randomly assigned to the SELUTION Sustained Limus Release (MedAlliance) DEB or a control strategy of usual care, including any approved DES or balloon angioplasty (BA) on the basis of operator selection prerandomization.

在成功进行病变预扩张后，ISR患者被随机分配到SELUTION持续释放药物球囊（MedAlliance）组或常规护理控制策略组，后者包括基于术者选择的任何已批准的药物洗脱支架（DES）或球囊血管成形术（BA）

Randomization to selected BA control treatment was limited to 20% of patients.

被随机分配到选定的BA对照治疗的患者比例限制在20%。

The primary outcome was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) assessed at 1 year in the per protocol group (all treated eligible patients with complete primary endpoint follow-up).

主要结果是目标病变失败（TLF）（心脏死亡、目标血管心肌梗死或临床驱动的目标病变血运重建），在按方案分析组中评估（所有接受治疗的符合条件的患者，具有完整的初级终点随访）。

Noninferiority was established if the upper limit of the 2-sided 95% credible interval was smaller than 10%.

如果双侧95%可信区间的上限小于10%，则确立非劣效性。

A sequential secondary hypothesis test was performed comparing DEB with DES in patients with single-layer ISR.

在单层ISR患者中进行了DEB与DES的序贯次要假设检验。

Results

From July 2020 to July 2024, 418 patients were randomly assigned to the DEB group (n = 210) or the control group (n = 208), with 390 patients per protocol (DEB, 197; control, 193 [154 DES; 39 BA]).

从2020年7月到2024年7月，418名患者被随机分配到DEB组（n=210）或对照组（n=208），按照方案有390名患者（DEB组197名；对照组193名[154名DES；39名BA]）。

TLF occurred in 32 (16.2%) of 197 patients in the DEB group and in 28 (14.5%) of 193 patients in the control group (difference: 1.7%; 95% credible interval: -5.5% to 8.9%; posterior probability of noninferiority: 98.80%).

在197名DEB组患者中，有32名（16.2%）发生了TLF事件，在193名对照组患者中，有28名（14.5%）发生了TLF事件（差异：1.7%；95% 置信区间：-5.5% 至 8.9%；非劣效性后验概率：98.80%）。

In the secondary hypothesis test, TLF occurred in 22 (14.2%) of 155 patients in the DEB group and in 9 (6.5%) of 138 patients in the DES control group (difference: 7.7%; 95% credible interval: 0.6%-14.6%, posterior probability for noninferiority: 76.07%).

在次要假设检验中，DEB组的155名患者中有22名（14.2%）发生了TLF事件，而DES对照组的138名患者中有9名（6.5%）发生了TLF事件（差异：7.7%；95% 置信区间：0.6% 至 14.6%，非劣效性的后验概率为76.07%）。

TLF according to operator selected control was higher for DEB compared with DES (15.3% vs 7.1%; difference: 8.1%; 95% credible interval: 1.4%-15.0%) and lower for DEB compared with BA (23.6% vs 43.6%; difference: 23.7%; 95% credible interval: -41.4% to -1.5%; Pforinteraction = 0.0026).

根据操作者选择的对照组，DEB的总生存高于DES（15.3%对比7.1%；差异：8.1%；95%置信区间：1.4%-15.0%）且低于BA（23.6%对比43.6%；差异：23.7%；95%置信区间：-41.4%至-1.5%；Pforinteraction = 0.0026）。

Conclusions

The sirolimus DEB was noninferior to a usual care control strategy including 80% repeat DES but not noninferior to DES for single-layer ISR for TLF at 12 months.

在12个月时，对于单层ISR的总生存，西罗莫司DEB不劣于包括80%重复DES的常规护理对照策略，但不劣于DES。

There was significant interaction on the basis of operator selection of DES vs BA.

基于操作者选择的药物洗脱支架（DES）与裸金属支架（BA）之间存在显著的相互作用。

(SELUTION SLR 014 In-stent Restenosis [SELUTION4ISR]; NCT04280029).

(SELUTION SLR 014 支架内再狭窄研究[SELUTION4ISR]; NCT04280029).