爱施健紫杉醇药物洗脱球囊治疗冠状动脉支架内再狭窄的安全性和有效性
[Safety and efficacy of the Essential Pro paclitaxel drug-eluting balloon for the treatment of coronary in-stent restenosis].
作者信息
Padilla Lucio, Liberman Federico, Tello Jorge, Rosas Pablo, Spaletra Pablo, Pedernera Gustavo, Mascolo Pablo, Ordoñez Santiago, Santilli Pablo, Candiello Alfonsina, Cura Fernando, Belardi Jorge, Lamelas Pablo
机构信息
Servicio de Cardiología Intervencionista, Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina Servicio de Cardiología Intervencionista Instituto Cardiovascular de Buenos Aires Buenos Aires Argentina.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canadá Department of Health Research Methods, Evidence, and Impact McMaster University Hamilton Canadá.
出版信息
REC Interv Cardiol. 2024 Jul 12;6(3):166-171. doi: 10.24875/RECIC.M24000462. eCollection 2024 Jul-Sep.
INTRODUCTION AND OBJECTIVES
Drug-eluting balloons (DEB) are an established treatment option for in-stent restenosis (ISR). This study aimed to assess the safety and efficacy of a novel DEB in patients with ISR.
METHODS
This prospective, single-center study enrolled a consecutive cohort of patients diagnosed with ISR who underwent coronary angioplasty with a new second-generation paclitaxel-eluting balloon. The 3 main endpoints were myocardial infarction, target lesion revascularization, and target vessel revascularization. Baseline variables were collected, including patient and procedure characteristics. Follow-up data were collected through medical records or telephone contact.
RESULTS
The study included 160 consecutive patients with 206 treated lesions (mean age, 71.4 ± 14.9 years, 15.5% women) undergoing percutaneous coronary intervention with DEB for ISR. A total of 53.3% of patients had acute coronary syndrome. The average diameter of the treated vessel was 3.10 ± 0.7 mm. The DEB used had a mean diameter of 3.1 ± 0.6 mm and a mean length of 23.1 ± 6.8 mm. Predilatation was performed in 98% of the lesions, and a noncompliant balloon was used in 80%. Intracoronary imaging was used in 24% of cases. At the end of the procedure, 98.5% of patients had Thrombolysis in Myocardial Infarction flow grade 3, residual stenosis was > 30% in 3.4%, and dissection occurred in 1.4%. Bail-out stenting was required in 4.8% of patients. Mortality was nil during follow-up (maximum 768 days). The incidence of myocardial infarction, target lesion revascularization, and target vessel revascularization were 5.4% (95%CI, 0.69-10.1), 8.4% (95%CI, 0-17.8), and 14.2% (95%CI, 3.61-24.78), respectively.
CONCLUSIONS
In this cohort of patients with ISR treated with DEB, we observed a low rate of adverse events in both the short- and mid-term. These results support the safety and efficacy of this new generation of DEB for treating ISR.
引言与目的
药物洗脱球囊（DEB）是治疗支架内再狭窄（ISR）的一种既定治疗选择。本研究旨在评估一种新型DEB在ISR患者中的安全性和有效性。
方法
这项前瞻性单中心研究纳入了连续一组被诊断为ISR且接受了新型第二代紫杉醇洗脱球囊冠状动脉血管成形术的患者。3个主要终点为心肌梗死、靶病变血运重建和靶血管血运重建。收集了基线变量，包括患者和手术特征。通过病历或电话联系收集随访数据。
结果
该研究纳入了160例连续患者，共206处病变接受了DEB治疗ISR的经皮冠状动脉介入治疗（平均年龄71.4±14.9岁，女性占15.5%）。共有53.3%的患者患有急性冠状动脉综合征。治疗血管的平均直径为3.10±0.7毫米。所使用的DEB平均直径为3.1±0.6毫米，平均长度为23.1±6.8毫米。98%的病变进行了预扩张，80%使用了非顺应性球囊。24%的病例使用了冠状动脉内成像。手术结束时，98.5%的患者心肌梗死溶栓血流分级为3级，3.4%的患者残余狭窄>30%，1.4%的患者发生夹层。4.8%的患者需要补救性支架置入。随访期间（最长768天）无死亡病例。心肌梗死、靶病变血运重建和靶血管血运重建的发生率分别为5.4%（95%CI，0.69 - 10.1）、8.4%（95%CI，0 - 17.8）和14.2%（95%CI，3.61 - 24.78）。
结论
在这组接受DEB治疗的ISR患者中，我们观察到短期和中期不良事件发生率较低。这些结果支持了新一代DEB治疗ISR的安全性和有效性。
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