Division of Cardiology, University Hospitals Geneva, Geneva, Switzerland.
Department of Cardiology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
Heart. 2022 Jul 27;108(16):1310-1318. doi: 10.1136/heartjnl-2021-320116.
The primary objective was to assess the performance of a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer in an all comer population. The secondary objective was to detail differences in contemporary percutaneous coronary intervention (PCI) practice worldwide.
e-Ultimaster was an all-comer, prospective, global registry (NCT02188355) with independent event adjudication enrolling patients undergoing PCI with the study stent. The primary outcome measure was target lesion failure (TLF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularisation. Data were stratified according to 4 geographical regions.
A total of 37 198 patients were enrolled (Europe 69.2%, Asia 17.8%, Africa/Middle East 6.6% and South America/Mexico 6.5%) and 1-year follow-up was available for 35 389 patients (95.1%). One-year TLF occurred in 3.2% of the patients, ranging from 2% (Africa/Middle East) to 4.1% (South America/Mexico). In patients with acute coronary syndrome, potent P2Y inhibitors were prescribed in 48% of patients at discharge, while at 1 year 72% were on any dual antiplatelet therapy. Lipid-lowering treatment was administered in 80.9% and 75.5% of patients at discharge and 1 year, respectively. Regional differences in the profile of the treated patients as well as in PCI practice were reported.
In this investigation with worldwide representation, contemporary PCI using a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer was associated with low 1-year TLF across clinical presentations and continents. Suboptimal adherence to current recommendations around antiplatelet and lipid lowering treatments was detected.
本研究的主要目的是评估新一代带有可降解外膜的薄壁西罗莫司洗脱冠状动脉支架在所有患者人群中的表现。次要目的是详细介绍全球经皮冠状动脉介入治疗（PCI）实践中的差异。
e-Ultimaster 是一项在所有患者中进行的前瞻性全球注册研究（NCT02188355），由独立的事件裁决机构进行，招募接受研究支架 PCI 的患者。主要终点是 1 年时的靶病变失败（TLF），定义为心脏死亡、靶血管心肌梗死和临床驱动的靶病变血运重建的复合终点。数据按 4 个地理区域进行分层。
共纳入 37198 例患者（欧洲 69.2%，亚洲 17.8%，非洲/中东地区 6.6%，南美/墨西哥 6.5%），35389 例患者（95.1%）可获得 1 年随访。1 年时 TLF 发生率为 3.2%，范围为 2%（非洲/中东地区）至 4.1%（南美/墨西哥）。在急性冠状动脉综合征患者中，出院时 48%的患者使用了强效 P2Y12 抑制剂，而 1 年后，72%的患者接受了任何双联抗血小板治疗。出院时和 1 年后，分别有 80.9%和 75.5%的患者接受降脂治疗。报告了不同地区患者治疗情况和 PCI 实践的差异。
在这项具有全球代表性的研究中，新一代带有可降解外膜的薄壁西罗莫司洗脱冠状动脉支架的当代 PCI 与各种临床表现和大陆的 1 年 TLF 发生率低相关。检测到抗血小板和降脂治疗的当前推荐方案的依从性欠佳。
