Menozzi Alberto, Campo Gianluca Calogero, Guiducci Vincenzo, Dall'Ara Gianni, Santarelli Andrea, Sbarzaglia Paolo, Balducelli Marco, Magnavacchi Paolo, Sgura Fabio, Losi Luciano, Vignali Luigi, Casella Gianni, Steffanon Luigi, Tarantino Fabio, Saia Francesco
U.O. Cardiologia, Azienda Ospedaliero-Universitaria di Parma.
U.O. Cardiologia, Azienda Ospedaliera Universitaria di Ferrara.
G Ital Cardiol (Rome). 2017 Feb;18(2 Suppl 1):9S-18S. doi: 10.1714/2657.27243.
The bioresorbable vascular scaffold (BRS) technology constitutes the new revolution of the coronary artery disease interventional treatment. Currently, three distinct types of BRSs are available but only one, the Absorb BVS, was on the market in 2013 when the Regional Commission for Medical Devices and the Cardiology and Cardiac Surgery Commission of the Emilia-Romagna Region drew up a technical and scientific essay to provide guidance for the introduction of BRS in public and affiliated health facilities. Five preferential indications were given for use: long coronary lesions (>28 mm), ostial lesions (left main stem excluded), complete revascularization in patients aged <50 years, diffuse disease (>40 mm) or involving the mid/distal left anterior descending (LAD) branch in patients <70 years, spontaneous coronary artery dissection.
This survey analyzed data from all the catheterization laboratories in the Emilia-Romagna Region, merged in a unified database.
In a 3-year study period, 546 BRS were implanted in 328 patients, corresponding to 1.5% of the drug-eluting stents (DES) used, with a trend towards a progressive increase over time. Initial indications were followed in 200/328 (61.0%) patients (about one third fitting more indications), mainly for treatment of long lesions in vessels >2.5 mm (67%), young patients (31.5%) and mid/distal LAD (28%). In 22.6% of cases the clinical scenario was a ST-segment elevation myocardial infarction, in 39.3% a non-ST-segment elevation acute coronary syndrome. Intracoronary imaging was infrequently used (intravascular ultrasound in 24.7% of cases). In 85 patients (25.9%) a hybrid procedure (BVS/DES) was performed.
BRS use has resulted lower than expected, with discrete variability among centers, but according to the initial indications of the Emilia-Romagna Region in the majority of cases. The underuse might have been due to operators' caution in their initial experience. However, the increasing trend may reveal a greater confidence in the implantation technique and the whole amount of safety and efficacy data.
生物可吸收血管支架（BRS）技术构成了冠状动脉疾病介入治疗的新革命。目前有三种不同类型的BRS，但在2013年区域医疗器械委员会以及艾米利亚 - 罗马涅地区心脏病学和心脏外科学委员会起草一篇技术和科学论文为公共及附属医疗机构引入BRS提供指导时，只有一种，即Absorb BVS在市场上。给出了五个优先使用指征：长冠状动脉病变（>28毫米）、开口病变（不包括左主干）、年龄<50岁患者的完全血运重建、弥漫性疾病（>40毫米）或<70岁患者累及左前降支（LAD）中/远端分支、自发性冠状动脉夹层。
本调查分析了艾米利亚 - 罗马涅地区所有导管实验室的数据，并合并到一个统一数据库中。
在为期3年的研究期间，328例患者植入了546个BRS，占使用的药物洗脱支架（DES）的1.5%，且随着时间推移有逐渐增加的趋势。200/328（61.0%）例患者遵循了初始指征（约三分之一符合更多指征），主要用于治疗直径>2.5毫米血管的长病变（67%）、年轻患者（31.5%）和LAD中/远端病变（28%）。22.6%的病例临床情况为ST段抬高型心肌梗死，39.3%为非ST段抬高型急性冠状动脉综合征。冠状动脉内成像很少使用（血管内超声在24.7%的病例中使用）。85例患者（25.9%）进行了混合手术（BVS/DES）。
BRS的使用低于预期，各中心之间存在一定差异，但在大多数情况下符合艾米利亚 - 罗马涅地区的初始指征。使用不足可能是由于操作人员在初期经验中较为谨慎。然而，增加的趋势可能表明对植入技术以及整个安全性和有效性数据更有信心。
