Objective: To evaluate the 4-year clinical outcomes of patients following Firesorb bioresorbable scaffold (BRS) implantation. Methods: The study reported the 4-year follow-up results of the FUTURE I study. FUTURE I was a prospective, single-center, open-label, first-in-man study which evaluated the feasibility, preliminary safety, and efficacy of Firesorb stent in the treatment of coronary artery stenosis. A total of 45 patients with single de novo lesions in native coronary arteries ,who hospitalized in Fuwai Hospital from January to March 2016 were enrolled. After successfully stent implantation these patients were randomized in a 2∶1 ratio into cohort 1 (n=30) or cohort 2 (n=15). The patients in cohort 1 underwent angiographic, IVUS or OCT examination at 6 months and 2 years; and cohort 2 underwent angiographic, IVUS or OCT at 1 and 3 years. All patients underwent clinical follow-up at 1, 6 months and 1 year and annually thereafter up to 5 years. The primary endpoint was target lesion failure (TLF, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization). Secondary endpoints included patient-oriented composite endpoint (PoCE, defined as composite of all death, all miocardial infarction, or any revascularization). Results: A total of 45 patients were enrolled and implanted with Firesorb BRS, including 35 males (77.8%), and the age was (54.4±9.3) years. At 4 years, 10 patients in cohort 1 were reexamined by coronary angiography and OCT examination. Among them, 2 patients' stents were completely degraded and absorbed. Compared with the OCT images of the other 8 patients in cohort 2 at 3 years, the degree of stent degradation was increased, and no stent adherence was found. The 4-year clinical follow-up rate was 100%. In 4-year clinical following up, 2 patients suffered PoCE (4.4%): 1 patient underwent non-target vessel revascularization the day after index procedure and target vessel revascularization (Non-target lesion revascularization) at 2-year imaging follow-up; the other patient underwent target lesion revascularization during imaging follow-up at 4 years but not due to ischemic driven. There was no scaffold thrombosis or TLF events through 4 years. Conclusions: Four years after the implantation, complete degradation and absorption of the Firsorb stent are evidenced in some patients. Firesorb stent is feasible and effective in the treatment of patients with non-complex coronary lesions.
目的： 报道置入生物可吸收支架Firesorb的患者术后4年的随访结果。 方法： 本研究为FUTURE I研究的4年随访结果。FUTURE I研究是一项评估Firesorb支架治疗冠状动脉狭窄病变的可行性、初步安全性和有效性的前瞻性、单中心、非盲法的首次人体试验。2016年1至3月在阜外医院入选原发、原位、单支、单处冠状动脉狭窄病变患者45例。成功置入Firesorb支架后，以2∶1比例随机分为队列1（n=30）和队列2（n=15）。队列1患者在支架置入术后6个月、2年时进行冠状动脉造影、血管内超声（IVUS）、光学相干断层成像（OCT）检查，队列2患者在术后1、3年时进行上述检查。所有纳入患者在支架置入术后1、6个月及1、2、3、4、5年时进行临床随访。研究主要终点为术后1个月靶病变失败（TLF，包括心原性死亡、靶血管心肌梗死、缺血驱动的靶病变血运重建），次要终点包括患者相关临床复合终点（PoCE，包括全因死亡、所有的心肌梗死、所有的血运重建事件）。 结果： 本研究共纳入45例成功置入Firesorb支架患者，年龄为（54.4±9.3）岁，其中男性35例（77.8%）。随访4年时队列1中10例患者复查了冠状动脉造影及OCT检查，其中2例患者置入的支架已经完全降解吸收，其他8例患者与队列2中患者3年时的OCT图像比较，支架降解程度增加，未见任何支架贴壁不良。4年临床随访率为100%。45例患者中有2例发生了PoCE事件（4.4%），其中1例患者术后第1 天发生了非靶血管心肌梗死、非靶血管血运重建，并且于术后2年再次发生靶血管非靶病变血运重建；另1例患者于复查冠状动脉造影时进行了非缺血驱动的靶病变血运重建。4年随访期间无TLF、明确或可能的支架内血栓事件。 结论： 在置入Firsorb支架术后4年时部分患者可出现支架的完全降解吸收。Firesorb支架治疗简单冠状动脉病变安全、有效。.