Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
EuroIntervention. 2011 Aug;7(4):505-16. doi: 10.4244/EIJV7I4A81.
Different biodegradable-polymer drug-eluting stents have not yet been systematically analysed. We sought to; 1) evaluate the risk of target lesion revascularisation (TLR) and definite stent thrombosis (DST) among different groups of biodegradable-polymer (BioPol) DES, and 2) to compare them with permanent polymer (PermPol) DES.
We searched PubMed and relevant sources from January 2005 until October 2010. Inclusion criteria were (a) Implantation of a drug-eluting stent with biodegradable polymer; (b) available follow-up data for at least one of the clinical end-points (TLR/DST) at short term (30 days) and/or mid-term (one year). A total of 22 studies, including randomised and observational studies, with 8264 patients met the selection criteria; nine studies (2042 patients) in whom biodegradable-polymer sirolimus eluting stents (BioPol-SES) were implanted, eight studies (1731 patients) in whom biodegradable-polymer paclitaxel eluting stents (BioPol-PES) were implanted, and seven studies (4491 patients) in whom biodegradable-polymer biolimus-A9 eluting stents (BioPol-BES) were implanted. At 30 days, there was a higher risk of DST (p=0.04) and subsequently TLR (p=0.006) in the BioPol-BES compared to BioPol-SES, with no significant difference in the other stent comparisons. At 1-year, there was higher risk of TLR in the BioPol-PES (p=0.01), and the BioPol-SES (p=0.04) compared to BioPol-BES. One-year stent thrombosis was not statistically different between the studied groups (overall p=0.2). In another analysis comprising seven randomised trials comparing BioPol-DES (3778 patients) and PermPol-DES (3291 patients), the risks of TLR and stent thrombosis at 1-year were not significantly different (p=0.5 for both).
Performance of different BioPol-DES seems to vary from each other. The short- and mid-term success rates may not be superimposable. Furthermore, they may not be necessarily better than PermPol-DES.
不同的可生物降解聚合物药物洗脱支架尚未进行系统分析。我们旨在：1）评估不同可生物降解聚合物（BioPol）DES 组中靶病变血运重建（TLR）和确定的支架血栓形成（DST）的风险，以及 2）将它们与永久性聚合物（PermPol）DES 进行比较。
我们从 2005 年 1 月至 2010 年 10 月在 PubMed 和相关来源中进行了搜索。纳入标准为：a）植入药物洗脱支架，采用可生物降解聚合物；b）在短期（30 天）和/或中期（一年）至少有一个临床终点（TLR/DST）的随访数据。共有 22 项研究，包括随机和观察性研究，共 8264 例患者符合选择标准；其中 9 项研究（2042 例患者）植入了可生物降解聚合物西罗莫司洗脱支架（BioPol-SES），8 项研究（1731 例患者）植入了可生物降解聚合物紫杉醇洗脱支架（BioPol-PES），7 项研究（4491 例患者）植入了可生物降解聚合物生物素 A9 洗脱支架（BioPol-BES）。在 30 天内，与 BioPol-SES 相比，BioPol-BES 的 DST（p=0.04）和随后的 TLR（p=0.006）风险更高，而其他支架比较则无显著差异。在 1 年时，与 BioPol-BES 相比，BioPol-PES（p=0.01）和 BioPol-SES（p=0.04）的 TLR 风险更高。在研究组之间，1 年支架血栓形成无统计学差异（总体 p=0.2）。在另一项比较 BioPol-DES（3778 例患者）和 PermPol-DES（3291 例患者）的 7 项随机试验的分析中，1 年时 TLR 和支架血栓形成的风险无显著差异（两者均为 p=0.5）。
不同的 BioPol-DES 的性能似乎彼此不同。短期和中期成功率可能无法叠加。此外，它们不一定比 PermPol-DES 更好。
