Journal of the American Heart Association · 2025
Safety and Efficacy of Cobalt Chromium Everolimus-Eluting Stents for Treatment of In-Stent Restenosis: An ILUMIEN IV Substudy.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
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, ILUMIEN IV Investigators
Аннотация
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% (P<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 mm2 versus 5.6±1.9 mm2; P<0.001), but minimum stent expansion was similar (78.8±18.0% versus 79.0±16.9%; P=0.87), as was 1-year target lesion failure (7.4% versus 4.7%; hazard ratio, 1.58 [95% CI, 0.95-2.61]; P=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.
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% (P<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 mm2 versus 5.6±1.9 mm2; P<0.001), but minimum stent expansion was similar (78.8±18.0% versus 79.0±16.9%; P=0.87), as was 1-year target lesion failure (7.4% versus 4.7%; hazard ratio, 1.58 [95% CI, 0.95-2.61]; P=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.