Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain.
Hospital Clínico San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
Eur Heart J. 2022 Mar 31;43(13):1320-1330. doi: 10.1093/eurheartj/ehab790.
Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes.
We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups.
In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome.
ClinicalTrials.gov: NCT03321032.
经皮血运重建后，糖尿病患者发生不良事件的风险较高，大多数现代药物洗脱支架之间的结局并无差异。Cre8 EVO 支架通过激光打孔从亲脂性载体中释放西罗莫司配方，在糖尿病中显示出临床获益。我们旨在比较糖尿病患者使用 Cre8 EVO 支架和 Resolute Onyx 支架（一种现代聚合物基佐他莫司洗脱支架）的效果。
我们在西班牙的 23 个地点进行了一项由研究者发起的、随机的、对照的、评估者盲法试验。合格的患者患有糖尿病且需要经皮冠状动脉介入治疗。共随机分配 1175 例患者（1:1）接受 Cre8 EVO 或 Resolute Onyx 支架。主要终点是靶病变失败，定义为 1 年随访时的心脏死亡、靶血管心肌梗死和临床指征靶病变血运重建的复合终点。该试验采用非劣效性设计，主要终点有 4%的边际。如果确认非劣效性，则计划进行优越性分析。共发生 106 例主要事件，Cre8 EVO 组 42 例（7.2%），Resolute Onyx 组 64 例（10.9%）[风险比（HR）：0.65，95%置信区间（CI）：0.44-0.96；P非劣效性<0.001；P优越性=0.030]。在次要终点中，Cre8 EVO 支架的靶血管失败率明显低于 Resolute Onyx 支架（7.5%比 11.1%，HR：0.67，95%CI：0.46-0.99；P=0.042）。两组之间的可能或确定的支架血栓形成和全因死亡无显著差异。
在糖尿病患者中，与 Resolute Onyx 支架相比，Cre8 EVO 支架在靶病变失败复合终点方面非劣效。1 年时的优越性探索性分析表明，Cre8 EVO 支架在相同结局方面可能优于 Resolute Onyx 支架。
ClinicalTrials.gov：NCT03321032。
