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Drug-eluting stents with biodegradable polymers: are enough data in for a final assessment?

Matthias Pfisterer, Christoph Kaiser
DOI: http://dx.doi.org/10.1093/eurheartj/ehu037 1098-1100 First published online: 17 February 2014

This editorial refers to ‘Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis’, by S.-H. Kang et al., on page 1147

Polymers of drug-eluting coronary stents (DES) provide a stable matrix for drugs to be diffused into the damaged vessel wall and modulate drug release. They lose their function after all drug is released; however, by disintegration, all durable polymers carry the risk for local inflammation, neoatherosclerosis, and thrombosis. Although polymers are not the only reason for this pathophysiological cascade leading to late stent thrombosis (ST) with related cardiac death and myocardial infarction, it was obvious that new biocompatible or totally bioabsorbable polymers should be developed. The goals of such DES with biodegradable polymers (BP-DES) were therefore to reduce the risk of late or very late ST with no increased rate of target vessel revascularization compared with first-generation DES, thereby limiting the duration of dual antiplatelet therapy (DAPT) needed. In other words, BP-DES should be as effective as durable polymer DES (DP-DES) and, beyond 1 year after implantation, as safe as bare-metal stents (BMS).

Accordingly, BP-DES have been tested in several studies, showing non-inferiority compared with first-generation DES regarding efficacy and safety up to 9–12 months.1,2 The first meta-analyses also including initial comparisons with second-generation DES confirmed these findings but pointed—perhaps surprisingly—to a higher rate of ST for BP-DES within the first year after implantation.3 Results on very late ST, i.e. beyond 1 year, remained limited, but follow-up studies of patients enrolled in the pivotal trials were presented with conflicting results. One major problem of all these trials directly comparing BP-DES with other DP-DES is the low rate of ST events, particularly beyond 1 year, providing uncertain results with wide confidence intervals. Thus, a new meta-analysis …

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