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.
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。