Division of Cardiology, SS. Annunziata Hospital, Savigliano, Italy.
Division of Cardiology, Department of Internal Medicine, Città della Salute e della Scienza, University of Turin, Turin, Italy.
Catheter Cardiovasc Interv. 2020 Jul;96(1):1-9. doi: 10.1002/ccd.28667. Epub 2019 Dec 20.
To evaluate the independent clinical impact of stent structural features in a large cohort of patients undergoing unprotected left main (ULM) or coronary bifurcation percutaneous coronary intervention (PCI) with a range of very thin strut stents.
Clinical impact of structural features of contemporary stents remains to be defined.
All consecutive patients enrolled in the veRy thin stents for patients with left mAIn or bifurcatioN in real life (RAIN) registry were included. The following stent structural features were studied: antiproliferative drugs (everolimus vs. sirolimus vs. zotarolimus), strut material (platinum-chromium vs. cobalt-chromium), polymer (bioresorbable vs. durable), number of crowns (<8 vs. ≥8) and number of connectors (<3 vs. ≥3). For small diameter stents (≤2.5 mm), struct thickness (74 vs. 80/81 μm) was also tested. Target lesion failure (TLF), a composite of target lesion revascularization and stent thrombosis, was the primary endpoint. Multivariate analysis was performed with Cox regression models.
Out of 2,707 patients, 110 (4.1%) experienced a TLF event after 16 months (12-18). After adjustment for confounders, an increased number of connectors (adjusted hazard ratio [adj-HR] 0.62, 95% confidence interval (CI) 0.39-0.99, p = .04) reduced risk of TLF, driven by stents with ≥2.5 mm diameter (HR 0.54, 95% CI 0.32-0.93, p = .02). This independent relationship was lost for stents with diameter <2.5 mm, where only strut thickness appeared to impact. Conversely, no independent relationship of polymer type, number of crowns, and the specific limus-family eluted drug with outcomes was observed.
Among a range of contemporary very thin stent models, an increased number of connectors improved device-related outcomes in this investigated high-risk procedural setting.
在接受无保护左主干（ULM）或冠状动脉分叉经皮冠状动脉介入治疗（PCI）的大样本患者中，评估支架结构特征的独立临床影响，这些患者使用了一系列非常薄的支架。
目前仍需确定支架结构特征的临床影响。
纳入了 veRy thin stents for patients with left mAIn or bifurcatioN in real life（RAIN）登记研究中的所有连续患者。研究了以下支架结构特征：抗增殖药物（依维莫司、西罗莫司、佐他莫司）、支架材料（铂铬、钴铬）、聚合物（可生物吸收、耐用）、冠数（<8 个 vs. ≥8 个）和连接数（<3 个 vs. ≥3 个）。对于小直径支架（≤2.5mm），还测试了支架厚度（74μm 与 80/81μm）。主要终点是靶病变失败（TLF），即靶病变血运重建和支架血栓形成的复合终点。采用 Cox 回归模型进行多变量分析。
在 2707 例患者中，110 例（4.1%）在 16 个月（12-18 个月）后发生 TLF 事件。调整混杂因素后，连接数的增加（调整后的危险比 [adj-HR]0.62，95%置信区间 [CI]0.39-0.99，p =.04）降低了 TLF 的风险，这主要与直径≥2.5mm 的支架有关（HR0.54，95%CI0.32-0.93，p =.02）。对于直径<2.5mm 的支架，这种独立关系消失，只有支架厚度似乎有影响。相反，聚合物类型、冠数以及洗脱药物的特定 limus 家族与结果之间没有独立关系。
在一系列现代非常薄的支架模型中，在这种高风险的治疗环境中，连接数的增加改善了器械相关的结果。
