Fully Biodegradable Coronary Stents

Abstract

The limitations of currently available metallic drug-eluting stents have renewed interest in biodegradable stents (BDS). Apart from removing the (offending) foreign material that may potentiate a thrombotic event, BDS have the advantage of avoiding 'full metal jackets,' and thus can preclude subsequent coronary surgery. In addition, they do not interfere with the diagnostic evaluation of non-invasive imaging such as cardiac magnetic resonance and CT. There are now several BDS in development or in clinical trials that incorporate a variety of biodegradable polymer technologies. Two broad categories of materials are generally used: those made from organic biopolymers and those made from corrodible metals. However, to date, none of the materials/stents tested have been able to establish a perfect balance between biocompatibility, the kinetics of degradation needed to maintain mechanical strength to limit recoil, and inflammation. However, studies, such as the ABSORB trial with the everolimus eluting poly-L-lactide stent, which demonstrated comparable restenotic rates with bare metallic stents and a low incidence of major adverse cardiac events (MACE) at 12 months of 3.3%, with only one patient having a non-Q-wave myocardial infarction and no target lesion revascularization, suggest that there has been significant progress with respect to the earlier prototypes. The acute recoil observed could potentially be addressed with the polytyrosine REVA stent currently being evaluated in the RESORB trial, which incorporates a novel locking mechanism within its design. Alternative BDS designs include the combination of an antiproliferative drug with endothelial progenitor cell capturing antibodies to facilitate epithelialization and/or dual eluting having, in addition to the antiproliferative drug, polymeric salicyclic acid to limit inflammation. Compared with biodegradable polymers, there are fewer metals used in the manufacture of BDS. The only metal BDS in trials is the Biotronik absorbable magnesium stent, which showed a MACE of 26.7% at 12 months without deaths, stent thrombosis, or acute myocardial infarction in the PROGRESS-AMS trial. Unlike magnesium stents, there has been little progress with iron stents, which remain in the pre-clinical phase, and this may be partly due to the longer degradation times needed and potential issues related with iron clearance.