钴铬依维莫司洗脱支架治疗支架内再狭窄的安全性和有效性：ILUMIEN IV子研究
Safety and Efficacy of Cobalt Chromium Everolimus-Eluting Stents for Treatment of In-Stent Restenosis: An ILUMIEN IV Substudy.
作者信息
Ali Ziad A, Landmesser Ulf, Maehara Akiko, Shin Doosup, Sakai Koshiro, Matsumura Mitsuaki, Shlofmitz Richard A, Calligaris Giuseppe, Maksoud Aziz, Abdelwahed Youssef S, Canova Paolo, Gonzalo Nieves, Alfonso Fernando, Fall Khady N, Chehab Bassem, McGreevy Robert J, McNutt Robert W, Nie Hong, Wang Jin, Buccola Jana, Stone Gregg W
机构信息
St. Francis Hospital and Heart Center Roslyn NY USA.
Clinical Trials Center, Cardiovascular Research Foundation New York NY USA.
出版信息
J Am Heart Assoc. 2025 Jun 3;14(11):e039482. doi: 10.1161/JAHA.124.039482. Epub 2025 May 22.
BACKGROUND
The optimal management strategy for in-stent restenosis (ISR) remains unclear. We aimed to determine the safety and efficacy of percutaneous coronary intervention with XIENCE cobalt chromium everolimus-eluting stents (EES) for treatment of ISR.
METHODS
In the ILUMIEN IV (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in Percutaneous Coronary Intervention) trial, the 1-year outcomes of all randomized patients with a single diffuse or multifocal single-layer ISR lesion treated with EES were compared with a performance goal. The primary end point was target lesion failure, the composite of cardiac death, target vessel-myocardial infarction, or ischemia-driven target lesion revascularization. Outcomes in patients with a single EES-treated ISR and non-ISR lesion were also compared.
RESULTS
From May 2018 through December 2020, 247 patients with a single ISR lesion were treated with EES. Target lesion failure at 1 year occurred in 18 patients (7.4% [upper 1-sided 97.5% CI, 11.5%]), which was lower than the predefined performance goal of 20% (<0.001). Compared with non-ISR lesions treated with EES (n=2021), the postpercutaneous coronary intervention minimal stent area by optical coherence tomography was smaller in treated ISR lesions (5.0±1.8 mm versus 5.6±1.9 mm; <0.001), but minimum stent expansion was similar (78.8±18.0% versus 79.0±16.9%; =0.87), as was 1-year target lesion failure (7.4% versus 4.7%; hazard ratio, 1.58 [95% CI, 0.95-2.61]; =0.07).
CONCLUSIONS
XIENCE EES was safe and effective for treatment of single-layer ISR. Compared with non-ISR lesions, ISR lesions treated with EES had a smaller postpercutaneous coronary intervention minimal stent area although stent expansion and 1-year target lesion failure rates were not different.
REGISTRATION
URL: https://clinicaltrials.gov/; Unique identifier: NCT03507777.
背景
支架内再狭窄（ISR）的最佳管理策略仍不明确。我们旨在确定使用XIENCE钴铬依维莫司洗脱支架（EES）进行经皮冠状动脉介入治疗ISR的安全性和有效性。
方法
在ILUMIEN IV（光学相干断层扫描引导冠状动脉支架植入术与血管造影术比较：经皮冠状动脉介入治疗的多中心随机试验）试验中，将所有接受EES治疗的单个弥漫性或多灶性单层ISR病变的随机患者的1年结局与一个性能目标进行比较。主要终点是靶病变失败，即心源性死亡、靶血管心肌梗死或缺血驱动的靶病变血运重建的复合终点。还比较了接受单个EES治疗的ISR和非ISR病变患者的结局。
结果
从2018年5月至2020年12月，247例单个ISR病变患者接受了EES治疗。1年时发生靶病变失败的有18例患者（7.4%[单侧上限97.5%CI，11.5%]），低于预先定义的20%的性能目标（<0.001）。与接受EES治疗的非ISR病变（n = 2021）相比，经光学相干断层扫描测量，治疗后的ISR病变经皮冠状动脉介入治疗后的最小支架面积较小（5.0±1.8mm对5.6±1.9mm；<0.001），但最小支架扩张相似（78.8±18.0%对79.0±16.9%；P = 0.87），1年靶病变失败情况也相似（7.4%对4.7%；风险比，1.58[95%CI，0.95 - 2.61]；P = 0.07）。
结论
XIENCE EES治疗单层ISR安全有效。与非ISR病变相比，接受EES治疗的ISR病变经皮冠状动脉介入治疗后的最小支架面积较小，尽管支架扩张和1年靶病变失败率无差异。
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