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Abstract：
This analysis of pooled individual patient data (IPD) aimed to evaluate the safety and efficacy of a bioresorbable polymer sirolimus eluting stent system (BP-SES; Orsiro) compared to a durable polymer everolimus eluting stent system (DP-EES; Xience) in the pooled population as well as in subgroups.
IPD with up to 12 months follow-up of the randomized controlled trials BIOFLOW-II (NCT01356888), -IV (NCT01939249), and -V (NCT02389946) as well as the all comers registry BIOFLOW-III (NCT01553526) were pooled. A total of 3,717 subjects (2,923 in BP-SES and 794 in DP-EES) with 5,328 lesions (4,225 lesions in BP-SES and 1,103 in DP-EES) were included in the IPD. The primary endpoint was target lesion failure (TLF) at 12 months follow-up. Subgroups analyzed included diabetes, age (≥65 years), gender, complex lesions (B2/C), small vessels (reference vessel diameter ≤2.75 mm), multivessel treatment, renal disease, and patients with acute coronary syndrome.
Overall, TLF at 12 months was significantly lower with 5.2%in the BP-SES group versus 7.6% in the DP-EES group (p = .0098). Similarly, target vessel myocardial infarction (TV-MI) was 3.1 versus 5.7% (p = .0005). The rate of stent thrombosis was similar in both groups (0.004%). By regression analysis, an independent stent effect in favor of BP-SES was observed for TLF (p = .0043) and TV-MI (p = .0364) in small vessels.
Results of this IPD analysis suggest that the BP-SES with ultrathin struts is as safe as and more efficacious than DP-EES in the overall cohort and especially in small vessels.
IPD with up to 12 months follow-up of the randomized controlled trials BIOFLOW-II (NCT01356888), -IV (NCT01939249), and -V (NCT02389946) as well as the all comers registry BIOFLOW-III (NCT01553526) were pooled. A total of 3,717 subjects (2,923 in BP-SES and 794 in DP-EES) with 5,328 lesions (4,225 lesions in BP-SES and 1,103 in DP-EES) were included in the IPD. The primary endpoint was target lesion failure (TLF) at 12 months follow-up. Subgroups analyzed included diabetes, age (≥65 years), gender, complex lesions (B2/C), small vessels (reference vessel diameter ≤2.75 mm), multivessel treatment, renal disease, and patients with acute coronary syndrome.
Overall, TLF at 12 months was significantly lower with 5.2%in the BP-SES group versus 7.6% in the DP-EES group (p = .0098). Similarly, target vessel myocardial infarction (TV-MI) was 3.1 versus 5.7% (p = .0005). The rate of stent thrombosis was similar in both groups (0.004%). By regression analysis, an independent stent effect in favor of BP-SES was observed for TLF (p = .0043) and TV-MI (p = .0364) in small vessels.
Results of this IPD analysis suggest that the BP-SES with ultrathin struts is as safe as and more efficacious than DP-EES in the overall cohort and especially in small vessels.
摘要：
对汇总的个体患者数据（IPD）的分析旨在评估生物可吸收聚合物西罗莫司洗脱支架系统（BP-SES；Orsiro）与耐用聚合物依维莫司洗脱支架系统（DP-EES；Xence）在汇总人群以及亚组中的安全性和有效性。
对随机对照试验BIOFLOW-II（NCT01356888）进行长达12个月的IPD随访，-IV（NCT01939249），和-V(NCT02389946)以及所有角落注册表BIOFLOW-III(NCT01553526)被合并。IPD中包括总共3,717名受试者（BP-SES中的2,923名和DP-EES中的794名），其中5,328个病变（BP-SES中的4,225个病变和DP-EES中的1,103个病变）。主要终点为随访12个月时的靶病变失效(TLF)。分析的亚组包括糖尿病，年龄（≥65岁），性别,复杂病变（B2/C），小血管（参考血管直径≤2.75mm），多支血管治疗,肾脏疾病,和急性冠脉综合征患者。
总的来说，12个月时的TLF显著低于BP-SES组5.2%，而DP-EES组7.6%(p=.0098)。同样，目标血管心肌梗死（TV-MI）为3.1和5.7％（p=0.0005）。两组的支架血栓形成率相似(0.004%)。通过回归分析，对于小血管中的TLF(p=.0043)和TV-MI(p=.0364),观察到支持BP-SES的独立支架效应.
该IPD分析的结果表明，在整个队列中，尤其是在小血管中，具有超薄支柱的BP-SES与DP-EES一样安全，并且更有效。
对随机对照试验BIOFLOW-II（NCT01356888）进行长达12个月的IPD随访，-IV（NCT01939249），和-V(NCT02389946)以及所有角落注册表BIOFLOW-III(NCT01553526)被合并。IPD中包括总共3,717名受试者（BP-SES中的2,923名和DP-EES中的794名），其中5,328个病变（BP-SES中的4,225个病变和DP-EES中的1,103个病变）。主要终点为随访12个月时的靶病变失效(TLF)。分析的亚组包括糖尿病，年龄（≥65岁），性别,复杂病变（B2/C），小血管（参考血管直径≤2.75mm），多支血管治疗,肾脏疾病,和急性冠脉综合征患者。
总的来说，12个月时的TLF显著低于BP-SES组5.2%，而DP-EES组7.6%(p=.0098)。同样，目标血管心肌梗死（TV-MI）为3.1和5.7％（p=0.0005）。两组的支架血栓形成率相似(0.004%)。通过回归分析，对于小血管中的TLF(p=.0043)和TV-MI(p=.0364),观察到支持BP-SES的独立支架效应.
该IPD分析的结果表明，在整个队列中，尤其是在小血管中，具有超薄支柱的BP-SES与DP-EES一样安全，并且更有效。
