Department of Cardiology, Maimonides Medical Center, Brooklyn, New York.
Department of Cardiology, Rush University Medical Center, Chicago, Illinois.
Catheter Cardiovasc Interv. 2020 Feb;95(2):216-223. doi: 10.1002/ccd.28290. Epub 2019 Apr 19.
This meta-analysis sought to evaluate the outcomes of absorb bioresorbable vascular scaffolds (BVS) compared with second-generation drug-eluting stents (DES) after 3 years, the approximate time of complete polymer bioresorption.
BVS were found to be inferior to second-generation DES in early and mid-term outcomes with a higher rate of target vessel myocardial infarction (TV-MI) and device thrombosis (DT). Improper implantation techniques and incomplete bioresorption of the poly-l-lactide (PLLA) polymer were sighted as possible reasons.
We conducted an electronic database search for all randomized control trials that compared absorb BVS to second-generation DES and reported outcomes of interest after 3 years of absorb BVS implantation. Assuming interstudy heterogeneity, a random-effects analysis was conducted with odds ratio as the effect size of choice to compare the event rates between the two groups.
A total of four studies (n = 3,245, BVS = 2075, DES = 1,170) were included in the final analysis. Pooled analysis revealed that there was no difference between absorb BVS and second-generation DES with respect to target lesion failure (TLF) (OR = 1.23, 95% CI = 0.73-2.07, p = 0.44), TV-MI (OR = 1.03, 95% CI = 0.42-2.53, p = 0.95), target lesion revascularization (TLR) (OR = 1.61, 95% CI = 0.77-3.33, p = 0.20) and definite/probable DT (OR = 0.71, 95% CI = 0.10-5.07, p = 0.74). Also, there was no difference in cardiac mortality (OR = 0.66, 95% CI = 0.22-1.94, p = 0.45).
Between 3 and 4 years of follow-up, patients receiving absorb BVS did not have significantly different outcomes, in terms of TLF, TV-MI, TLR, DT, and cardiac mortality, compared to DES.
本荟萃分析旨在评估在聚合物完全生物吸收约 3 年后(即完全生物吸收聚乳酸(PLLA)聚合物的近似时间),生物可吸收血管支架(BVS)与第二代药物洗脱支架(DES)的 3 年结局。
BVS 在早期和中期结果中被发现不如第二代 DES,其靶血管心肌梗死(TV-MI)和器械血栓形成(DT)发生率更高。聚合物聚 L-乳酸(PLLA)植入技术不当和不完全生物吸收被认为是可能的原因。
我们对所有比较 BVS 和第二代 DES 的随机对照试验进行了电子数据库检索,并报告了 BVS 植入 3 年后的感兴趣结局。由于存在研究间异质性,因此采用随机效应分析,选择比值比作为选择的效应量来比较两组之间的事件发生率。
共有 4 项研究(n=3245,BVS=2075,DES=1170)纳入最终分析。汇总分析显示,BVS 与第二代 DES 相比,在靶病变失败(TLF)方面无差异(OR=1.23,95%CI=0.73-2.07,p=0.44)、TV-MI(OR=1.03,95%CI=0.42-2.53,p=0.95)、靶病变血运重建(TLR)(OR=1.61,95%CI=0.77-3.33,p=0.20)和确定/可能的 DT(OR=0.71,95%CI=0.10-5.07,p=0.74)。此外,心脏死亡率也无差异(OR=0.66,95%CI=0.22-1.94,p=0.45)。
在 3 至 4 年的随访中,与 DES 相比,接受 BVS 的患者在 TLF、TV-MI、TLR、DT 和心脏死亡率方面没有显著不同的结局。