Introduction: The new technology of biodegradable scaffolds has the advantage of "leaving nothing behind", whilst allowing the vessel to restore to normal wall integrity. This new approach attempts to circumvent the chronic local inflammatory reaction due to permanent implantation of a foreign body. The aim of this paper was to examine the published literature on the use of biodegradable stents in the treatment of peripheral arterial diseases (PAD).
Evidence acquisition: Systematic review was formulated under the instruction of PRIMSA guideline. Papers published from January 2005 to March 2015 in English language were included. Published studies on biodegradable scaffolds or stents in the treatment of PAD were systematically searched and reviewed through a computerized search of Pubmed and Ovid MEDLINE and cross-referenced. Key words include "biodegradable scaffolds", "biodegradable stents", "femoral", "lower limb", "peripheral arterial disease" and "peripheral vascular disease". All relevant published papers which fulfilled these criteria were reviewed. On-going studies from other electronic databases were also examined.
Evidence synthesis: A total of 75 non-duplicated publications were identified, but only 6 articles were eligible into our qualitative analysis (one animal study, 3 case-cohort studies, and 2 randomized studies). In all, 325 stents were used in 282 patients. Technical success rates were 100%. These studies had a short to medium follow-up period up to 58 months. The primary and secondary patency rates were 60.8% (range 32-77%) and 88.4% (range 79-97%) respectively. There are also four on-going studies internationally.
Conclusions: Contemporary published literature suggests that biodegradable scaffold is safe and effective in the treatment of PAD, but these studies were heterogeneous and were limited by their study design, relatively small sample size, and short follow-up period; and therefore do not produce a high enough level of evidence to show superiority that leads to a change in current treatment guidelines.