Biolimus-eluting stent with biodegradable polymer (Nobori®): an overview of recent clinical results, SORT OUT V and COMPARE II trials

Abstract

Evaluation of: Christiansen E, Jensen L, Thayssen P et al. Biolimus eluting biodegradable polymer coated stent vs durable polymer coated sirolimus eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomized non inferiority trial. Lancet 381, 661–669 (2013); Smits P, Hofma S, Togni M et al. Abluminal biodegradable polymer biolimus-eluting stent vs durable polymer everolimus eluting stent (COMPARE II): a randomized, controlled, non inferiority trial. Lancet 381, 651–660 (2013).

Since their apparition, first generation drug-eluting stents (DESs) have raised concerns regarding the risk of late and very late stent thrombosis as compared to bare metal stents and require prolonged dual antiplatelet therapy. Aside from delayed strut endothelialisation, positive vessel remodelling and late stent mal-apposition due to chronic inflammation may be a leading cause for these stent thromboses. In fact, the persistence of the durable polymer after complete drug release is responsible for local hypersensitivity and inflammatory reactions. Third generation DESs with biocompatible or biodegradable polymer have subsequently been developed to address this issue. In this article, we evaluate and discuss the results of two recent publications investigating safety and efficacy of a third generation DES with biodegradable polymer as compared to first and second generation DESs with durable polymer.

Keywords::

• antiplatelet therapy
• biodegradable polymer
• biolimus-eluting stent
• percutaneous coronary intervention
• stent thrombosis

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• • Biolimus-eluting stent (BES; Nobori) is a third generation drug-eluting stent (DES) with a biodegradable polymer that is metabolized within 6–9 months.

• • Theoretically, this stent has been developed to decrease the risk of late events, especially stent thrombosis after percutaneous coronary intervention (PCI).

• • Theoretically, this stent may allow shorter period of dual antiplatelet therapy as compared to DES with durable polymer after PCI.

• • Data from the literature show contradictory results at 1 year regarding non-inferiority of BES as compared to other DESs.

• • Longer follow-up is required in order to show the potential benefit of BES over other DESs and to show any potential superiority of BES as compared to other DESs in terms of late events after PCI.