Gili Sebastiano, Galli Stefano, Teruzzi Giovanni, Santagostino Baldi Giulia, Ravagnani Paolo, Fabbiocchi Franco, Bartorelli Antonio, Montorsi Piero, Trabattoni Daniela
Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy.
Department of Biomedical and Clinical Sciences, "Luigi Sacco", University of Milan, Milan, Italy.
Front Cardiovasc Med. 2022 Feb 11;8:796604. doi: 10.3389/fcvm.2021.796604. eCollection 2021.
In recent years, the new third-generation ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES), characterized by some of the thinnest struts among commercially available devices (60-80 μm) and an amorphous silicon carbide coating, has been introduced for the treatment of coronary artery disease (CAD). The present study aimed to assess different clinical outcomes and safety of this drug-eluting stent in male and female patients in a real-world setting.
The present study is a retrospective analysis including all patients treated with BP-SES between January 2017 and December 2019 at a single high-volume center. Follow-up data, including stress test results and clinical setting, were collected during outpatient visits or by telephone contact. Patients symptomatic for angina or with a positive stress test were addressed to CT scan/coronary angiogram. The main study outcome was target lesion failure (TLF), defined as a composite of cardiovascular death, target vessel myocardial infarction, or target lesion revascularization.
Overall, 66 (15.9%) female and 349 (84.1%) male patients were included; women were older (median age 70 vs. 66, = 0.003) and with a lower body mass index (BMI) (25.0 vs. 26.1, = 0.010) compared to men, with no other relevant differences in baseline characteristics. Indication for percutaneous coronary intervention (PCI) was acute coronary syndrome in 86 (20.7%) of the cases, with no significant differences between male and female patients. A total of 558 lesions were treated with BP-SES stents, 90 in women and 468 in men (1.36 vs. 1.34 lesions per patient, = 0.83); cumulative stent length (33.6 vs. 38.4 mm, = 0.078), and mean stent diameter (2.92 vs. 3.0 mm, = 0.39) did not differ in women compared to men. Technical and clinical successes were achieved in all patients. Stent thrombosis (ST) occurred in 2 (0.5%) patients, both men. TLF occurred in 10 (2.9%) men and 2 (3.0%) women after a median follow-up of 402 days, without significant differences at log-rank analysis (2.34 events per 100 patient-years in men, 2.53 in women; = 0.80).
Ultrathin struts BP-SES showed to be a safe and effective option for the treatment of CAD in both women and men, with a very low ST rate and favorable long-term outcomes.
近年来，新型第三代超薄生物可吸收聚合物西罗莫司洗脱支架（BP-SES）已被用于治疗冠状动脉疾病（CAD），其特点是在市售器械中拥有一些最薄的支架小梁（60-80μm）以及非晶硅碳涂层。本研究旨在评估这种药物洗脱支架在真实世界环境中对男性和女性患者的不同临床结局及安全性。
本研究是一项回顾性分析，纳入了2017年1月至2019年12月期间在一个高容量单一中心接受BP-SES治疗的所有患者。随访数据，包括负荷试验结果和临床情况，通过门诊就诊或电话联系收集。有胸痛症状或负荷试验阳性的患者接受CT扫描/冠状动脉造影检查。主要研究结局是靶病变失败（TLF），定义为心血管死亡、靶血管心肌梗死或靶病变血运重建的复合终点。
总体而言，纳入了66例（15.9%）女性患者和349例（84.1%）男性患者；女性年龄更大（中位年龄70岁对66岁，P = 0.003），体重指数（BMI）更低（25.0对26.1，P = 0.010），与男性相比，基线特征无其他显著差异。经皮冠状动脉介入治疗（PCI）的指征在86例（20.7%）病例中为急性冠状动脉综合征，男性和女性患者之间无显著差异。共使用BP-SES支架治疗了558个病变，女性90个，男性468个（每位患者1.36个对1.34个病变，P = 0.83）；累积支架长度（33.6mm对38.4mm，P = 0.078）以及平均支架直径（2.92mm对3.0mm，P = 0.39）在女性与男性之间无差异。所有患者均取得技术和临床成功。支架血栓形成（ST）发生在2例（0.5%）患者中，均为男性。中位随访402天后，10例（2.9%）男性和2例（3.0%）女性发生TLF，对数秩分析无显著差异（男性每100患者年2.34次事件，女性为2.53次；P = 0.80）。
超薄支架小梁BP-SES对男性和女性CAD患者而言都是一种安全有效的治疗选择，ST发生率极低且长期结局良好。
