Abluminus DES+ sirolimus-eluting stent versus everolimus-eluting stent in patients with diabetes and coronary artery disease (ABILITY Diabetes Global): results from a multicentre, randomised controlled trial.

The Abluminus DES+ is a thin-strut cobalt-chromium sirolimus-eluting stent (SES) with abluminal and balloon-surface coating intended to enhance drug delivery to the vessel wall.

Abluminus DES+ 是一种薄支架钴铬合金西罗莫司洗脱支架（SES），具有外表面和球囊表面涂层，旨在增强药物向血管壁的传递。

We aimed to compare the efficacy and safety of the Abluminus DES+ SES versus the XIENCE durable-polymer everolimus-eluting stent (EES) in patients with diabetes undergoing PCI.

我们旨在比较Abluminus药物洗脱支架+西罗莫司洗脱支架（SES）与XIENCE持久聚合物依维莫司洗脱支架（EES）在接受经皮冠状动脉介入治疗（PCI）的糖尿病患者中的疗效和安全性。

Methods

ABILITY Diabetes Global was a multicentre, prospective, open-label, randomised controlled trialconducted at 74 sites in 16 countries.

ABILITY Diabetes Global是一项在16个国家的74个地点进行的多中心、前瞻性、开放标签、随机对照试验。

Adults (aged ≥18 years) with type 1 or type 2 diabetes undergoing PCI for at least one de novo coronary lesion due to chronic coronary syndrome or non-ST-elevation acute coronary syndrome were eligible.

年龄≥18岁的1型或2型糖尿病患者，因慢性冠状动脉综合征或非ST段抬高型急性冠状动脉综合征，至少有一个新发冠状动脉病变接受经皮冠状动脉介入治疗（PCI）者符合入选条件。

Patients were randomly assigned (1:1) to the Abluminus DES+ SES or the XIENCE EES.

患者按1:1的比例随机分配到Abluminus药物洗脱支架（DES）+生物可降解聚合物涂层支架（SES）组或XIENCE Everolimus药物洗脱支架（EES）组。

Randomisation was stratified by site using a secure web-based system with concealed allocation and randomly varying block sizes (4, 6, and 8).

随机分组是通过使用安全的基于网络的系统进行的，该系统具有隐藏的分配和随机变化的块大小（4、6和8）。

Operators were unmasked to allocation; staff performing clinical follow-up and the independent clinical events committee were masked.

操作者未被屏蔽分配；执行临床随访和独立临床事件委员会的工作人员被屏蔽。

For the Abluminus DES+ SES, a balloon inflation time of at least 45 s was recommended to facilitate drug transfer; dual antiplatelet therapy was prescribed to all patients according to clinical guidelines and local practice.

对于Abluminus DES+SES，建议至少45秒的球囊充气时间以促进药物转移；根据临床指南和当地实践，所有患者均被开具了双联抗血小板治疗。

The primary hypothesis of the study was the non-inferiority of the Abluminus DES+ SES compared with the XIENCE EES for the two coprimary endpoints at 12 months (in the per-protocol population): ischaemia-driven target-lesion revascularisation (2·8% non-inferiority margin) and target-lesion failure (3·0% margin), defined as a composite of cardiovascular death, target-vessel myocardial infarction, or ischaemia-driven target-lesion revascularisation.

该研究的主要假设是Abluminus DES+SES与XIENCE EES在12个月时的两个共同主要终点的非劣效性（在符合方案的人群中）：缺血驱动的目标病变血运重建（2.8%的非劣效性边界）和目标病变失败（3.0%的边界），后者被定义为心血管死亡、目标血管心肌梗死或缺血驱动的目标病变血运重建的复合终点。

Time-to-event analyses were conducted with Kaplan-Meier estimates and Cox proportional hazards models.

事件时间分析采用Kaplan-Meier估计和Cox比例风险模型进行。

This trial is registered with ClinicalTrials.gov (NCT04236609) and is complete.

该试验已在ClinicalTrials.gov注册（NCT04236609），且已完成。

Results

Between June 12, 2020, and Sept 9, 2022, 3032 patients were randomly assigned to the Abluminus DES+ SES (n=1514) or XIENCE EES (n=1518). 2931 (96·7%) of 3032 patients completed follow-up to death or 24-month follow-up.

2020年6月12日至2022年9月9日期间，3032名患者被随机分配至Abluminus DES+SES组（n=1514）或XIENCE EES组（n=1518）。3032名患者中有2931名（96.7%）完成了至死亡或24个月的随访。

Median age was 68·0 years (IQR 60-74). 879 (29·0%) of 3032 patients were female and 2153 (71·0%) were male.

中位年龄为68.0岁（四分位数间距60-74）。3032名患者中，879名（29.0%）为女性，2153名（71.0%）为男性。

At 12 months, in the per-protocol analysis, the Abluminus DES+ SES did not meet the criteria for non-inferiority for ischaemia-driven target-lesion revascularisation compared with XIENCE EES (67 of 1421 patients [Kaplan-Meier estimate 4·8%, 95% CI 3·9-6·2] vs 30 of 1446 [2·1%, 95% CI 1·6-3·2]; absolute risk difference 2·7%, 95% CI 1·3-4·1; pnon-inferiority=0·44) and target lesion failure (137 [9·7%, 8·4-11·5] vs 89 [6·2%, 5·3-7·8]; 3·5%, 1·5-5·5; pnon-inferiority=0·68).

在12个月的按方案分析中，Abluminus DES+SES在缺血驱动的目标病变血运重建方面与XIENCE EES相比，未达到非劣效性标准（1421名患者中有67名患者发生目标病变血运重建，Kaplan-Meier估计值为4.8%，95%置信区间为3.9-6.2，而1446名患者中有30名患者发生目标病变血运重建，95%置信区间为1.6-3.2；绝对风险差异为2.7%，95%置信区间为1.3-4.1；非劣效性p值为0.44），在目标病变失败方面也未达到非劣效性标准（1421名患者中有137名患者发生目标病变失败，估计值为9.7%，95%置信区间为8.4-11.5，而1446名患者中有89名患者发生目标病变失败，估计值为6.2%，95%置信区间为5.3-7.8；绝对风险差异为3.5%，95%置信区间为1.5-5.5；非劣效性p值为0.68）。

For both endpoints, the lower bound of the 95% CI for the absolute risk difference excluded zero.

对于这两个终点，绝对风险差异的95%置信区间的下限排除了零。

Target-vessel myocardial infarction occurred more frequently in the Abluminus DES+ SES group (73 of 1421 patients [Kaplan-Meier estimate 5·2%, 95% CI 4·1-6·5] vs 44 of 1446 patients [3·1%, 2·4-4·3]) but there were no significant differences in cardiovascular death (41 of 1421 patients [2·9%, 2·1-3·9] vs 30 of 1446 patients [2·1%, 1·5-3·0]) and all-cause death (52 of 1421 patients [3·7%, 2·8-4·8] vs 48 of 1446 patients [3·3%, 2·5-4·4]).

靶血管心肌梗死在Abluminus DES+SES组中更频繁发生（1421名患者中有73例[卡普兰-迈尔估计值为5.2%，95%置信区间4.1-6.5]，而1446名患者中有44例[3.1%，2.4-4.3]），但在心血管死亡（1421名患者中有41例[2.9%，2.1-3.9]，而1446名患者中有30例[2.1%，1.5-3.0]）和全因死亡（1421名患者中有52例[3.7%，2.8-4.8]，而1446名患者中有48例[3.3%，2.5-4.4]）方面没有显著差异。

Results were consistent at 24 months in the intention-to-treatanalysis, however no significant differences were observed between the two groups in landmark analyses between 12 and 24 months.

在意向治疗分析中，24个月的结果是一致的，然而，在12至24个月的里程碑分析中，两组之间没有观察到显著差异。

interpretation

In patients with diabetes undergoing PCI, the Abluminus DES+ SES was not non-inferior to the XIENCE EES, resulting in higher rates of ischaemia-driven target-lesion revascularisation and target lesion failure at 12-month follow-up.

在进行经皮冠状动脉介入治疗（PCI）的糖尿病患者中，Abluminus DES+SES与XIENCE EES相比，并未显示出非劣效性，导致在12个月随访时，缺血驱动的目标病变血运重建和目标病变失败率较高。

Event rates between 12 and 24 months were similar between groups.

在12至24个月之间，两组的事件发生率相似。

These findings highlight the persistent challenge of optimising outcomes in patients with diabetes and underscore the need for continued innovation in stent design and adjunctive pharmacotherapy to reduce residual ischaemic risk in this population.

这些发现突显了在糖尿病患者中优化治疗结果的持续挑战，并强调了在支架设计和辅助药物治疗方面持续创新的必要性，以减少这一人群的残余缺血风险。

funding

Concept Medical.

概念医学。