生物可吸收血管支架治疗冠状动脉支架内再狭窄的长期临床结果：意大利多中心经验。
Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis: A Multicenter Italian Experience.
机构信息
From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
出版信息
Circ Cardiovasc Interv. 2016 Apr;9(4):e003148. doi: 10.1161/CIRCINTERVENTIONS.115.003148.
BACKGROUND
Treatment of in-stent restenosis (ISR) is still challenging. In this setting, the use of bioresorbable vascular scaffold (BVS) seems attractive because it allows drug delivery combined with transient vessel scaffolding. We aimed to investigate the long-term results after BVS use in ISR lesions.
METHODS AND RESULTS
A prospective analysis was performed on all patients who underwent percutaneous coronary intervention with BVS implantation for ISR at 7 Italian Centers. Primary end point was the device-oriented composite end point (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) at the longest follow-up available. From April 2012 to June 2014, 116 patients (127 lesions) underwent percutaneous coronary intervention for ISR with BVS implantation. Among the ISR lesions, the majority were drug-eluting stent ISR (78, 61.6%), de novo ISR (92, 72.4%), and diffuse ISR (81, 63.8%). Procedural success was achieved for all (100%) patients. No in-hospital death, myocardial infarction, or revascularization occurred. At 15 months of follow-up, the incidence of the device-oriented composite end point estimated with the Kaplan-Meier method was 9.1%. No significant differences were reported between drug-eluting stent and bare-metal stent ISR groups in terms of device-oriented composite end point (10.9% versus 6.4%; hazard ratio, 1.7; 95% confidence interval, 0.5-6.5; P=0.425) and its singular components (cardiac death: 2.8% versus 2.0%, hazard ratio, 1.3; 95% confidence interval, 0.1-14.1, P=0.843; target vessel myocardial infarction: 1.5% versus 0%, P=0.421; ischemia-driven target lesion revascularization: 9.6% versus 4.4%, hazard ratio, 2.3; 95% confidence interval, 0.5-10.8, P=0.309).
CONCLUSIONS
Our registry suggests that the use of BVS implantation for the treatment of complex drug-eluting stent and bare-metal stent ISR lesions might be associated with acceptable long-term clinical outcomes.
背景
治疗支架内再狭窄（ISR）仍然具有挑战性。在这种情况下，使用生物可吸收血管支架（BVS）似乎很有吸引力，因为它可以结合药物输送和临时血管支架。我们旨在研究 BVS 在 ISR 病变中的长期结果。
方法和结果
对 7 家意大利中心接受 BVS 植入治疗 ISR 的所有患者进行前瞻性分析。主要终点是最长随访时间的器械定向复合终点（心脏死亡、靶血管心肌梗死和缺血驱动的靶病变血运重建）。2012 年 4 月至 2014 年 6 月，116 例患者（127 处病变）因 ISR 接受 BVS 植入经皮冠状动脉介入治疗。在 ISR 病变中，大多数为药物洗脱支架 ISR（78 例，61.6%）、新发 ISR（92 例，72.4%）和弥漫性 ISR（81 例，63.8%）。所有患者均达到了手术成功（100%）。无住院期间死亡、心肌梗死或血运重建。在 15 个月的随访中，Kaplan-Meier 方法估计的器械定向复合终点发生率为 9.1%。在药物洗脱支架和裸金属支架 ISR 组之间，器械定向复合终点（10.9%对 6.4%；危险比，1.7；95%置信区间，0.5-6.5；P=0.425）及其单一成分（心脏死亡：2.8%对 2.0%，危险比，1.3；95%置信区间，0.1-14.1，P=0.843；靶血管心肌梗死：1.5%对 0%，P=0.421；缺血驱动的靶病变血运重建：9.6%对 4.4%，危险比，2.3；95%置信区间，0.5-10.8，P=0.309）均无显著差异。
结论
我们的注册研究表明，BVS 植入治疗复杂药物洗脱支架和裸金属支架 ISR 病变可能与可接受的长期临床结果相关。
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