Objectives

The aim of this study was to determine 1-year safety and efficacy after treatment with the COMBO and Orsiro stents.

Background

The COMBO stainless-steel stent has an anti-CD34⁺ antibody coating to capture endothelial progenitor cells, thereby promoting faster endothelialization. The Orsiro is an ultrathin-strut cobalt-chromium stent, covered by an extremely thin layer of amorphous silicon carbide to minimize ion leakage. Both devices elute sirolimus from biodegradable polymers.

Methods

For this analysis we included European patients from the COMBO collaboration, a patient-level pooling of 2 prospective all-comers registries of COMBO stent implantation (n = 2,775), and all patients randomized to the Orsiro stent (n = 1,169) from the Dutch BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) randomized trial. The main outcome of interest was 1-year target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization evaluated using propensity score–matched analysis.

Results

At baseline, COMBO patients were older and had more insulin-treated diabetes, renal insufficiency, and other comorbidities. However, Orsiro patients included more current smokers and more acute coronary syndrome presentations. Orsiro patients also received longer stents and had more complex target lesions. After propensity score–matched analysis (n = 862/arm), 1-year target lesion failure occurred in 4.1% of COMBO-treated and 2.7% of Orsiro-treated patients (hazard ratio: 1.55; 95% confidence interval: 0.92 to 2.62; p = 0.10). Definite stent thrombosis occurred in 0.5% of COMBO-treated and 0.5% of Orsiro-treated patients (p = 0.99).

Conclusions

A propensity score–matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences. Stent thrombosis risk was low and similar between the stents. (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population [BIO-RESORT], NCT01674803; MASCOT–Post Marketing Registry [MASCOT], NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE Reg], NCT01874002)

中文翻译：

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2种生物可吸收性聚合物涂层西罗莫司洗脱支架治疗所有患者的一年临床结果

目标

这项研究的目的是确定使用COMBO和Orsiro支架治疗后1年的安全性和有效性。

背景

COMBO不锈钢支架具有抗CD34 ⁺抗体涂层，可捕获内皮祖细胞，从而促进更快的内皮化。Orsiro是一种超薄撑杆式钴铬合金支架，上面覆盖着一层非常薄的非晶碳化硅，可最大程度地减少离子泄漏。两种设备均从可生物降解的聚合物中洗脱西罗莫司。

方法

在此分析中，我们纳入了来自COMBO合作的欧洲患者，对2个潜在的COMBO支架植入术的前瞻性登记者（n = 2775）进行了患者水平汇总，所有患者均从荷兰人随机分配到Orsiro支架（n = 1169） BIO-RESORT（所有人群中可生物降解的聚合物和耐用的聚合物洗脱药物支架的比较）随机试验。感兴趣的主要结果是使用倾向评分匹配分析评估的1年目标病灶衰竭，心源性死亡，目标血管心肌梗塞和临床驱动的目标病灶血运重建的综合结果。

结果

基线时，COMBO患者年龄较大，患有胰岛素治疗的糖尿病，肾功能不全和其他合并症更多。但是，Orsiro患者包括更多的当前吸烟者和更多的急性冠状动脉综合征表现。Orsiro患者还接受了更长的支架，并且靶标病变更加复杂。经过倾向评分匹配分析（n = 862 /组），在接受COMBO治疗的患者中有4.1％和在Orsiro治疗的患者中有1.7％发生了1年目标病变（危险比：1.55； 95％置信区间：0.92至2.62 ； p = 0.10）。在0.5％的COMBO治疗组和0.5％的Orsiro治疗患者中发生了明确的支架血栓形成（p = 0.99）。

结论

所有用COMBO或Orsiro支架治疗的参与者的倾向评分匹配比较均无统计学差异。支架之间的支架血栓形成风险较低且相似。（比较所有人群中可生物降解的聚合物和耐用的聚合物药物洗脱支架[BIO-RESORT]，NCT01674803； MASCOT-上市后注册中心[MASCOT]，NCT02183454；用于评估组合的长期安全性和性能的预期注册中心支架[REMEDEE Reg]，NCT01874002）