Serruys Patrick W, Ormiston John A, Onuma Yoshinobu, Regar Evelyn, Gonzalo Nieves, Garcia-Garcia Hector M, Nieman Koen, Bruining Nico, Dorange Cécile, Miquel-Hébert Karine, Veldhof Susan, Webster Mark, Thuesen Leif, Dudek Dariusz
Thorax Center, Erasmus Medical Center, Rotterdam, Netherlands.
Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.
Drug-eluting metallic coronary stents predispose to late stent thrombosis, prevent late lumen vessel enlargement, hinder surgical revascularisation, and impair imaging with multislice CT. We assessed the safety of the bioabsorbable everolimus-eluting stent (BVS).
30 patients with a single de-novo coronary artery lesion were followed up for 2 years clinically and with multiple imaging methods: multislice CT, angiography, intravascular ultrasound, derived morphology parameters (virtual histology, palpography, and echogenicity), and optical coherence tomography (OCT).
Clinical data were obtained from 29 of 30 patients. At 2 years, the device was safe with no cardiac deaths, ischaemia-driven target lesion revascularisations, or stent thromboses recorded, and only one myocardial infarction (non-Q wave). 18-month multislice CT (assessed in 25 patients) showed a mean diameter stenosis of 19% (SD 9). At 2-year angiography, the in-stent late loss of 0.48 mm (SD 0.28) and the diameter stenosis of 27% (11) did not differ from the findings at 6 months. The luminal area enlargement on OCT and intravascular ultrasound between 6 months and 2 years was due to a decrease in plaque size without change in vessel size. At 2 years, 34.5% of strut locations presented no discernible features by OCT, confirming decreases in echogenicity and in radiofrequency backscattering; the remaining apparent struts were fully apposed. Additionally, vasomotion occurred at the stented site and adjacent coronary artery in response to vasoactive agents.
At 2 years after implantation the stent was bioabsorbed, had vasomotion restored and restenosis prevented, and was clinically safe, suggesting freedom from late thrombosis. Late luminal enlargement due to plaque reduction without vessel remodelling needs confirmation.
药物洗脱金属冠状动脉支架易引发晚期支架血栓形成，阻碍晚期管腔血管扩张，妨碍外科血管重建，并影响多层螺旋CT成像。我们评估了生物可吸收依维莫司洗脱支架（BVS）的安全性。
对30例新发单支冠状动脉病变患者进行了为期2年的临床随访，并采用多种成像方法：多层螺旋CT、血管造影、血管内超声、衍生形态学参数（虚拟组织学、触诊成像和回声性）以及光学相干断层扫描（OCT）。
30例患者中有29例获得了临床数据。在2年时，该装置是安全的，未记录到心脏死亡、缺血驱动的靶病变血管重建或支架血栓形成，仅发生1例心肌梗死（非Q波）。18个月时的多层螺旋CT（对25例患者进行评估）显示平均直径狭窄为19%（标准差9）。在2年血管造影时，支架内晚期管腔丢失0.48 mm（标准差0.28），直径狭窄27%（11），与6个月时的结果无差异。在6个月至2年期间，OCT和血管内超声显示管腔面积增大是由于斑块大小减小，而血管大小无变化。在2年时，34.5%的支架支柱部位经OCT检查无明显特征，证实回声性和射频后向散射降低；其余可见的支柱完全贴合。此外，对血管活性药物的反应显示，支架置入部位及相邻冠状动脉发生了血管运动。
植入后2年，该支架已被生物吸收，血管运动得以恢复，再狭窄得到预防，且临床安全，提示无晚期血栓形成。由斑块缩小而非血管重塑导致的晚期管腔扩大有待证实。
