Clinical Performance of Drug-eluting Stents with Biodegradable Polymeric Coating: a Meta-analysis and Systematic Review

Aims: 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.

Methods And Results: 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).

Conclusions: 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.