Kočka Viktor, Toušek Petr, Kozel Martin, Buono Andrea, Hajšl Martin, Lisa Libor, Buděšínský Tomáš, Malý Martin, Widimský Petr
Cardiocenter, Third Faculty of Medicine, Charles University and University Hospital Kralovské Vinohrady, Šrobárova 50, Prague 10, 100 34, Czech Republic.
Department of Cardiology, Niguarda Ca' Granda Hospital, Milan, Italy.
J Transl Med. 2020 Jan 30;18(1):33. doi: 10.1186/s12967-020-02230-1.
Bioresorbable scaffold (BRS) Absorb™ clinical use has been stopped due to higher rate of device thrombosis. Scaffold struts persist longer than 2 years in the vessel wall. Second generation devices are being developed. This study evaluates long-term invasive imaging in STEMI patients.
PRAGUE-19 study is an academic study enrolling consecutive STEMI patients with intention to implant Absorb™ BRS. A total of 83 STEMI patients between December 2012 and March 2014 fulfilled entry criteria. Coronary angiography and optical coherence tomography at 5 year follow-up was performed in 25 patients.
Primary combined clinical endpoint (death, myocardial infarction or target vessel revascularization) occurred in 12.6% during the five-year follow-up with overall mortality 6.3%. Definite scaffold thrombosis occurred in 2 patients in the early phase after BRS implantation. Quantitative coronary angiography after 5 years demonstrated low late lumen loss of 0.11 ± 0.35 mm with binary restenosis rate of 0%. Optical coherence tomography demonstrated complete resorption of scaffold struts and mean lumen diameter of 3.25 ± 0.30 and 3.22 ± 0.49 (P = 0.73) at baseline and after 5 years, respectively. Three patients developed small coronary artery aneurysm in the treated segment.
Invasive imaging results 5 years after BRS implantation in STEMI showed complete resorption of scaffold struts and stable lumen vessel diameter. Trial registration ISRCTN43696201 (retrospectivelly registred, June 7th, 2019). https://www.isrctn.com/ISRCTN43696201.
可生物吸收支架（BRS）Absorb™因器械血栓形成率较高已停止临床使用。支架支柱在血管壁内持续存在超过2年。第二代器械正在研发中。本研究评估ST段抬高型心肌梗死（STEMI）患者的长期侵入性成像。
PRAGUE - 19研究是一项学术研究，纳入连续的拟植入Absorb™ BRS的STEMI患者。2012年12月至2014年3月期间共有83例STEMI患者符合入选标准。25例患者在5年随访时进行了冠状动脉造影和光学相干断层扫描。
在五年随访期间，主要联合临床终点（死亡、心肌梗死或靶血管血运重建）发生率为12.6%，总死亡率为6.3%。2例患者在BRS植入后的早期发生了明确的支架血栓形成。5年后的定量冠状动脉造影显示晚期管腔丢失较低，为0.11±0.35 mm，二元再狭窄率为0%。光学相干断层扫描显示支架支柱完全吸收，基线时平均管腔直径为3.25±0.30，5年后为3.22±0.49（P = 0.73）。3例患者在治疗节段出现小冠状动脉瘤。
STEMI患者植入BRS 5年后的侵入性成像结果显示支架支柱完全吸收且管腔血管直径稳定。试验注册号ISRCTN43696201（回顾性注册，2019年6月7日）。https://www.isrctn.com/ISRCTN43696201 。
