用于治疗冠状动脉支架内再狭窄的生物可吸收药物洗脱血管支架：一项双中心注册研究。
Bioabsorbable drug-eluting vascular scaffold for the treatment of coronary in-stent restenosis: A two center registry.
作者信息
Moscarella Elisabetta, Varricchio Attilio, Stabile Eugenio, Franzone Anna, Granata Francesco, Rapacciuolo Antonio, Galasso Gennaro, Capozzolo Claudia, Cirillo Plinio, Monda Vittorio, Monterforte Ida, Borgia Francesco, Piro Orlando, Bonzani Giulio, Trimarco Bruno, Esposito Giovanni
机构信息
Division of Cardiology, Seconda Università degli studi di Napoli, AO Dei cColli, PO Monaldi.
Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italia.
出版信息
Cardiovasc Revasc Med. 2015 Oct-Nov;16(7):401-5. doi: 10.1016/j.carrev.2015.07.008. Epub 2015 Aug 10.
BACKGROUND/PURPOSE: Coronary in-stent restenosis (ISR) is a clinical problem for which a satisfactory solution has not been found yet. Bioabsorbable drug eluting vascular scaffolds (BVSs) provide transient vessel scaffolding combined with prolonged drug delivery capability. The aim of this study was to investigate the safety of BVS for the treatment of coronary ISR.
METHODS/MATERIALS: Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months.
RESULTS
A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6±15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%).
CONCLUSIONS
Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial.
背景/目的：冠状动脉支架内再狭窄（ISR）是一个尚未找到满意解决方案的临床问题。可生物吸收的药物洗脱血管支架（BVS）提供了短暂的血管支架支撑并具有延长的药物递送能力。本研究的目的是调查BVS治疗冠状动脉ISR的安全性。
方法/材料：在2013年1月至2013年6月期间，27例因冠状动脉ISR出现稳定或不稳定型心绞痛的患者（31处病变）被纳入一项单臂、前瞻性、开放标签的注册研究。主要终点是12个月时靶血管重建（TVR）的发生情况。次要终点是12个月时死亡、心肌梗死和TVR的复合情况。
结果
70%的病变呈现弥漫性ISR模式；平均病变长度为34.6±15。BVS成功植入所有患者，住院期间无主要不良心血管事件（MACE）。随访12个月时，MACE发生率为18.5%。1例患者因非心脏原因死亡，1例患者因可能的支架血栓形成死亡，3例患者（11.1%）需要进行TVR。
结论
我们的数据表明，BVS治疗长段弥漫性冠状动脉ISR是安全且技术上可行的。这些数据可被视为随机临床试验的假设生成依据。
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