Bioresorbable polymer or scaffold drug-eluting coronary artery stents
- Donald Cutlip, MD
Donald Cutlip, MD
- Section Editor — Interventional Cardiology
- Professor of Medicine
- Harvard Medical School
- Beth Israel Deaconess Medical Center
- J Dawn Abbott, MD, FACC
J Dawn Abbott, MD, FACC
- Associate Professor of Medicine
- Brown Medical School
Currently available metallic drug-eluting stents (DES) with a durable polymer have shown improved safety outcomes and at least equal effectiveness compared with first generation DES. The results have been achieved in the setting of at least 6 to 12 months dual antiplatelet therapy (DAPT). A low but persistent risk of restenosis and stent thrombosis and increased risk of bleeding with prolonged DAPT remain areas of concern. This topic will present studies of coronary artery stent types including DES with bioresorbable vascular scaffolds. Stent types that have been approved for use are discussed elsewhere. (See "Clinical use of intracoronary bare metal stents" and "Comparison of drug-eluting intracoronary stents".)
The terms "bioresorbable" (also called biodegradeable) and "bioabsorbable" are used in this topic. Bioresorbable refers to the complete breakdown and removal of a material over time and often by a known mechanism. Bioabsorbable refers to incomplete breakdown; the material may be partially digested and remain indefinitely in local tissue. Stent material and polymer may be bioresorbable or bioabsorbable.
BIORESORBABLE POLYMER DES
A potential method to decrease the rate of late stent thrombosis with drug-eluting stents (DES) is to shorten the length of exposure to the drug-containing polymer. (See "Coronary artery stent thrombosis: Incidence and risk factors" and "Coronary artery stent thrombosis: Clinical presentation and management".)
Under these circumstances, the polymer is removed as a potential chronic inflammatory stimulus, and the patient is left in effect with a bare-metal stent. The majority of currently approved DES have a durable polymer, which remains permanently on the stent after the drug is eluted. The polymer itself may result in vascular inflammation or delay endothelialization and healing, therefore contributing to the risk of stent thrombosis. In October 2015, the SYNERGY stent became the first bioresorbable (biodegradable) polymer DES approved by the United States Food and Drug Administration.
Although bioresorbable polymer DES have theoretical advantages over durable polymer DES, the evidence from randomized clinical trials, presented below, suggests that they are comparable to second generation DES (eg, everolimus or zotarolimus) in terms of efficacy and safety at two years.
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