超薄生物可吸收聚合物西罗莫司洗脱支架与薄型持久聚合物依维莫司洗脱支架在冠状动脉血运重建中的比较：随机 BIOFLOW V 试验 3 年结果。
Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial.
机构信息
Piedmont Heart Institute, Atlanta, Georgia.
Catharina Hospital, Eindhoven, the Netherlands.
出版信息
JACC Cardiovasc Interv. 2020 Jun 8;13(11):1343-1353. doi: 10.1016/j.jcin.2020.02.019.
OBJECTIVES
The aim of this study was to compare late-term clinical outcomes among patients treated with ultrathin-strut (60-μm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and thin-strut (81μm) durable-polymer everolimus-eluting stents (DP EES).
BACKGROUND
Emerging evidence from comparative studies of drug-eluting stents demonstrates improved safety and efficacy with ultrathin-strut drug-eluting stents, but limited insight exists regarding late-term outcomes.
METHODS
BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With Up to Three De Novo or Restenotic Coronary Artery Lesions V) is an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure. Analysis of pre-specified 3-year clinical outcomes was performed.
RESULTS
Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 3-year rate of target lesion failure was 8.2% for BP SES and 13.6% for DP EES (p = 0.002), driven by differences in both target vessel myocardial infarction (MI) (5.0% vs. 9.2%; p = 0.003) and clinically driven target lesion revascularization (3.2% vs. 6.7%; p = 0.006). In landmark analysis, significant differences in target vessel MI and target lesion revascularization were observed favoring treatment with BP SES. Definite or probable late or very late stent thrombosis was significantly lower with BP SES (0.1% vs. 1.2%; p = 0.018). Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.
CONCLUSIONS
In a large randomized trial, both target lesion failure and the outcomes of target vessel MI, clinically driven target lesion revascularization, and late or very late stent thrombosis at 3 years were significantly lower among patients treated with BP SES versus DP EES. The results endorse the continued superiority of ultrathin-strut BP SES compared with DP EES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946).
目的
本研究旨在比较使用超薄支架（60μm）生物可吸收聚合物西罗莫司洗脱支架（BP SES）和薄支架（81μm）持久聚合物依维莫司洗脱支架（DP EES）治疗的患者的晚期临床结局。
背景
来自药物洗脱支架比较研究的新证据表明，超薄支架药物洗脱支架具有更好的安全性和疗效，但对晚期结局的了解有限。
方法
BIOFLOW V（Biotronik 前瞻性随机多中心研究，评估 Orsiro 西罗莫司洗脱冠状动脉支架系统在治疗多达 3 个新病变或再狭窄冠状动脉病变患者中的安全性和有效性）是一项国际随机试验，比较了冠状动脉血运重建治疗与 BP SES 和 DP EES 的主要终点为 12 个月的靶病变失败。进行了预先指定的 3 年临床结局分析。
结果
在随机接受 BP SES（n=884）或 DP EES（n=450）治疗的 1334 名患者中，BP SES 的 3 年靶病变失败率为 8.2%，DP EES 的靶病变失败率为 13.6%（p=0.002），这主要归因于靶血管心肌梗死（MI）（5.0% vs. 9.2%；p=0.003）和临床驱动的靶病变血运重建（3.2% vs. 6.7%；p=0.006）的差异。在 landmark 分析中，BP SES 治疗在靶血管 MI 和靶病变血运重建方面具有显著优势。BP SES 的确定或可能的迟发或极迟发支架血栓形成明显较低（0.1% vs. 1.2%；p=0.018）。BP SES 和 DP EES 的心脏死亡或心肌梗死发生率分别为 7.7%和 11.7%（p=0.017）。
结论
在一项大型随机试验中，与 DP EES 相比，接受 BP SES 治疗的患者 3 年时的靶病变失败率以及靶血管 MI、临床驱动的靶病变血运重建和迟发或极迟发支架血栓形成的结局均显著降低。结果支持与 DP EES 相比，超薄支架 BP SES 的持续优越性。（冠状动脉病变患者的 Orsiro 西罗莫司洗脱冠状动脉支架系统的安全性和有效性 [BIOFLOW-V]；NCT02389946）。
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