Tactics of Endovascular Treatment of Patients with Coronary Heart Disease with Recurrent Coronary In-Stent Restenosis Using Second- and Third-Generation Stent Systems and Paclitaxel-Coated Balloon Catheters

Yuriy L. Shevchenko, D. Ermakov, Mikhail A. Maslennikov, Daniil S. Ul'bashev, Anastasiya Yu. Vakhrameyeva
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Abstract

INTRODUCTION: The binary in-stent restenosis (ISR) still remains the main factor limiting the effectiveness of percutaneous coronary intervention in the long-term period. Histologically, ISR is defined as neointimal hyperplasia leading to hemodynamically significant narrowing of the arterial lumen. Patients with coronary artery (CA) restenosis represent a particularly challenging group for endovascular treatment. AIM: To compare effectiveness and safety of the endovascular correction of coronary in-stent restenosis using second- and third-generation stent systems and balloon angioplasty with a drug-coated balloon catheter. MATERIALS AND METHODS: The study retrospectively included 62 patients with recurrent ISR after the previous endovascular correction. The patients underwent treatment with re-stenting in Saint George Clinic of Thoracic and Cardiovascular Surgery of the National Pirogov Medical Surgical Center in 2016–2023 with use of second- and third-generation drug-eluting stents — cobalt (cobalt alloy) systems with zotarolimus, cobalt-chromium stent systems with sirolimus and zotarolimus, platinum-chromium stent systems with everolimus with biodegradable drug coating. Balloon angioplasty was performed using paclitaxel-coated balloon catheters. The primary endpoint of the study was the target lesion failure (TLF) of CA. The secondary endpoint was major adverse cardiovascular events (MACE). RESULTS: The TLF rate was 15.6% vs. 13.3% and 28.1% vs. 46.7% in the groups with use of a drug-eluting stent and balloon angioplasty at 1- and 2-year follow-up, respectively (p = 0.30). MACE was recorded in 18.8% vs. 16.7% and 37.5% vs. 56.7% of cases in the groups with use of a drug-eluting stent and balloon angioplasty at 1- and 2-year follow-up, respectively (p = 0.25). The dispersion analysis of predictors of TFL risks identified three factors showing a reliable correlation with the probability for TFL by the second follow-up year in both groups: (1) recurrence of binary ISR (hazard ratio (HR) 2.21; 95% confidence interval (CI) 0.95–4.01; p = 0.03)) in 365 days after the third stage of the percutaneous coronary intervention; (2) length of coronary restenotic lesion (per every 10 mm) (HR 1.25; 95% CI 0.99–1.40; p = 0.002); (3) occlusive restenosis (HR 4.16; 95% CI 0.43–26.96; p = 0.04). CONCLUSIONS: The implantation of a second- and third-generation drug-eluting stent and balloon angioplasty with use of a drug-coated catheter are comparable in the effectiveness and safety in correcting the recurrent ISR, however, restenting is associated with a lower probability for developing TFL and adverse events.
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使用第二代和第三代支架系统及紫杉醇涂层球囊导管对复发性冠状动脉支架再狭窄的冠心病患者进行血管内治疗的策略
简介:二元支架内再狭窄(ISR)仍然是限制经皮冠状动脉介入治疗长期有效性的主要因素。组织学上,ISR 被定义为导致动脉管腔血流动力学显著狭窄的新内膜增生。冠状动脉(CA)再狭窄患者是对血管内治疗特别具有挑战性的群体。目的:比较使用第二代和第三代支架系统和使用药物涂层球囊导管进行球囊血管成形术对冠状动脉支架内再狭窄进行血管内矫治的有效性和安全性。材料与方法:该研究回顾性纳入了 62 例既往接受过血管内矫正术后复发的 ISR 患者。这些患者于2016-2023年在国立皮罗戈夫医疗外科中心胸腔和心血管外科圣乔治诊所接受了再支架治疗,使用的是第二代和第三代药物洗脱支架--钴(钴合金)系统与佐他洛利莫司、钴铬支架系统与西罗莫司和佐他洛利莫司、铂铬支架系统与依维莫司以及可降解药物涂层。使用涂有紫杉醇的球囊导管进行球囊血管成形术。研究的主要终点是CA靶病变失败(TLF)。次要终点是主要心血管不良事件(MACE)。结果:随访1年和2年时,使用药物洗脱支架组和球囊血管成形术组的TLF率分别为15.6%对13.3%和28.1%对46.7%(P = 0.30)。在随访1年和2年时,使用药物洗脱支架组和球囊血管成形术组分别有18.8%对16.7%和37.5%对56.7%的病例发生MACE(P = 0.25)。对 TFL 风险预测因素的离散度分析发现,有三个因素与两组患者在随访第二年发生 TFL 的概率有可靠的相关性:(1)二元 ISR 复发(危险比 (HR) 2.21;95% 置信区间 (CI) 0.95-4.01; p = 0.03));(2)冠状动脉再狭窄病变长度(每 10 mm)(HR 1.25; 95% CI 0.99-1.40; p = 0.002);(3)闭塞性再狭窄(HR 4.16; 95% CI 0.43-26.96; p = 0.04)。结论:植入第二代和第三代药物洗脱支架与使用药物涂层导管进行球囊血管成形术在纠正复发性 ISR 的有效性和安全性方面不相上下,但重新植入与较低的 TFL 发生概率和不良事件相关。
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