Jiang Jun, Li Changling, Chen Delong, Song Lei, Cui Zhanqian, Li Ping, Gan Lijun, Chen Yundai, Li Hui, Jia Shaobin, He Shenghu, Lu Wen, Gao Runlin, Wang Jianan
Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
State Key Laboratory of Transvascular Implantation Devices, Hangzhou, China.
BMC Med. 2025 Jul 9;23(1):419. doi: 10.1186/s12916-025-04254-0.
The first-generation bioresorbable scaffolds (BRS) have been associated with higher rates of device-related adverse outcomes in comparison to everolimus-eluting stents. We aimed to evaluate the efficacy and safety of the thinner-strut (100/125 μm) poly-L-lactic acid-based sirolimus-eluting Firesorb BRS in patients with de novo coronary lesions.
Patient-level data derived from 1205 patients in the FUTURE-II RCT (n = 215) and FUTURE-III registry (n = 990) were prospectively collected, pooled, and analyzed. The primary endpoint of 1-year target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization was also analyzed.
At 1-year follow-up, the cumulative rate of TLF was 1.67%, with an upper 95% confidence interval of 2.57%, significantly lower than the objective performance criterion goal of 6.6% (P < 0.001). The rate of single TLF components was 0.42% for cardiac death, 0.92% for target vessel myocardial infarction, and 0.42% for ischemia-driven target lesion revascularization. The cumulative rate of POCE at 1 year was 3.34%. No patient experienced definite or probable device thrombosis during 1-year follow-up.
This pooled, patient-level analysis indicates that the thinner strut Firesorb BRS exhibits promising 1-year efficacy and safety profiles with regard to TLF. However, our findings are only applicable to non-complex lesions; large-scale randomized clinical trials powered to assess clinical endpoints are necessary to evaluate the strategy of Firesorb BRS compared to drug-eluting stents.
ClinicalTrials.gov Identifier: NCT02890160 and NCT03660202.
与依维莫司洗脱支架相比，第一代生物可吸收支架（BRS）与更高的器械相关不良事件发生率相关。我们旨在评估更薄支架（100/125μm）的基于聚-L-乳酸的西罗莫司洗脱Firesorb BRS在初发冠状动脉病变患者中的疗效和安全性。
前瞻性收集、汇总并分析了来自FUTURE-II随机对照试验（RCT）（n = 215）和FUTURE-III注册研究（n = 990）中1205例患者的个体水平数据。1年靶病变失败（TLF）的主要终点定义为心源性死亡、靶血管心肌梗死或缺血驱动的靶病变血运重建的复合终点。还分析了全因死亡、任何心肌梗死或任何血运重建的以患者为导向的复合终点（POCE）。
在1年随访时，TLF的累积发生率为1.67%，95%置信区间上限为2.57%，显著低于6.6%的客观性能标准目标（P < 0.001）。单个TLF组分的发生率分别为：心源性死亡0.42%，靶血管心肌梗死0.92%，缺血驱动的靶病变血运重建0.42%。1年时POCE的累积发生率为3.34%。在1年随访期间，没有患者发生明确或可能的器械血栓形成。
这项汇总的个体水平分析表明，更薄支架的Firesorb BRS在TLF方面展现出有前景的1年疗效和安全性概况。然而，我们的研究结果仅适用于非复杂病变；需要开展大规模随机临床试验以评估临床终点，从而对比Firesorb BRS与药物洗脱支架的策略。
ClinicalTrials.gov标识符：NCT02890160和NCT03660202。
