The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital, New York, USA.
Department of Clinical and Experimental Cardiology, Amsterdam UMC, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.
Cardiovasc Drugs Ther. 2021 Apr;35(2):309-320. doi: 10.1007/s10557-020-07087-6. Epub 2021 Jan 30.
The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype.
The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST).
We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01-2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91-6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients.
Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.
COMBO 可生物降解聚合物西罗莫司洗脱支架包含内皮祖细胞捕获（EPC）技术，可实现快速内皮化，这可能在急性冠状动脉综合征（ACS）中具有优势。我们旨在通过 ACS 状态和 ACS 亚型分析 COMBO 支架的性能。
COMBO 合作研究（n=3614）是来自 MASCOT 和 REMEDEE 注册研究的患者水平合并数据集。我们根据 ACS 状态和 ST 段抬高型心肌梗死（STEMI）或非 ST 段抬高型心肌梗死（NSTEMI）与不稳定型心绞痛（UA）患者的 ACS 亚型评估了结局。主要终点是 1 年靶病变失败（TLF），包括心脏死亡、靶血管心肌梗死或临床驱动的靶病变血运重建的复合终点。次要结局包括支架血栓形成（ST）。
我们比较了 1965 例（54%）ACS 和 1649 例（46.0%）非 ACS 患者。ACS 表现包括 40%（n=789）STEMI、31%（n=600）NSTEMI 和 29%（n=576）UA 患者。ACS 患者 1 年 TLF 的风险更高（4.5%比 3.3%，HR 1.51，95%CI 1.01-2.25，p=0.045），但确定/可能的 ST 无显著差异（1.1%比 0.5%，HR 2.40，95%CI 0.91-6.31，p=0.08）。STEMI、NSTEMI 和 UA 患者的 1 年 TLF 相似（4.8%比 4.8%比 3.7%，p=0.60），但 STEMI 患者的确定/可能 ST 更高（1.9%比 0.5%比 0.7%，p=0.03）。调整后的结局在 MI 与 UA 患者之间无差异。
尽管采用了新型 EPC 捕获技术，但 COMBO 支架 PCI 与 ACS 患者 1 年 TLF 风险增加相关，而非 ACS 患者，支架血栓形成无显著差异。ACS 亚型之间 1 年 TLF 无差异。
