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  • Review Article
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Fully bioresorbable vascular scaffolds: lessons learned and future directions

Nature Reviews Cardiology volume 16, pages 286–304 (2019)Cite this article

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Abstract

Fully bioresorbable scaffolds (BRS) were designed to overcome the limitations of metallic drug-eluting stents, which permanently cage the vessel wall, thereby preventing normal coronary vasomotion, preclude bypass grafting and can provoke long-term foreign-body responses. Although multiple scaffolds have been or are in development, the Absorb Bioresorbable Vascular Scaffold (BVS; Abbott Vascular) was the first FDA-approved device and was widely expected to fulfil the dream of interventional cardiologists of a transient scaffold that would disappear ‘when the job was done’ and would not hamper further treatment options. Although early, small studies and even large, randomized trials showed beneficial outcomes up to 1 year of follow-up, longer-term results have been disappointing, with increased rates of device thrombosis and target-lesion revascularization. The Absorb BVS device was withdrawn from the market because of low demand. In this Review, we summarize the preclinical and clinical data available for BRS to understand how the vascular biological reactions to these devices differ from biological reactions to metallic drug-eluting stents and how these responses translate into clinical outcomes. We also discuss next-generation BRS and outline modifications that are needed to improve the long-term outcomes with these devices so that they eventually become a viable option for patients with symptomatic obstructive coronary artery disease.

Key points

  • Bioresorbable scaffolds (BRS) were designed to overcome the limitations of metallic stents, such as vessel caging with a lack of coronary vasomotion and preclusion of bypass surgery in stented segments.

  • The most advanced fully BRS is the Absorb Bioresorbable Vascular Scaffold (BVS; Abbott Vascular); however, clinical trials have shown higher rates of target-vessel myocardial infarction and stent thrombosis with the Absorb BVS than with current-generation metallic drug-eluting stents.

  • These studies have taught us about the limitations of animal models in predicting the clinical safety of devices in humans.

  • The Absorb BVS has also provided important information about strut thickness, vessel wall coverage and their influence on thrombosis induced by shear forces.

  • The timing of scaffold degradation and its relationship to healing in humans must be better understood before this technology can become mainstream.

  • Newer-generation BRS are being developed with thinner struts, but most have not been examined in large-scale clinical trials or real-world registries; the technology must be rigorously tested before initiating trials in humans.

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Fig. 1: Scaffold discontinuities with the Absorb BVS.
Fig. 2: Micro-CT images after implantation of the Absorb BVS in pig coronary arteries.
Fig. 3: Micro-CT images showing calcification on the abluminal surface of scaffold struts in the Absorb BVS.
Fig. 4: Effect of strut thickness on flow pattern and endothelialization.
Fig. 5: Platelet aggregates with different stents and scaffolds in a pig arteriovenous shunt model.
Fig. 6: Mechanisms of very late scaffold thrombosis.
Fig. 7: Scanning electron microscopy images of the Absorb BVS and the thin-strut metallic drug-eluting stent.
Fig. 8: Micro-CT and histological images of various scaffolds after implantation.

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Authors and Affiliations

  1. CVPath Institute, Gaithersburg, MD, USA

    Hiroyuki Jinnouchi, Sho Torii, Atsushi Sakamoto, Frank D. Kolodgie, Renu Virmani & Aloke V. Finn

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  1. Hiroyuki Jinnouchi
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  2. Sho Torii
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  3. Atsushi Sakamoto
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  4. Frank D. Kolodgie
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  5. Renu Virmani
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  6. Aloke V. Finn
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Contributions

H.J. researched data for the article and wrote the manuscript. S.T., A.S., F.D.K., R.V. and A.V.F. reviewed and edited the manuscript before submission.

Corresponding author

Correspondence to Aloke V. Finn.

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Competing interests

CVPath Institute has received institutional research support from 480 Biomedical, Abbott Vascular, ART, BioSensors International, Biotronik, Boston Scientific, Celonova, Claret Medical, Cook Medical, Cordis, Edwards Lifescience, Medtronic, MicroPort, MicroVention, OrbusNeich, ReCore, SINO Medical Technology, Spectranetics, Surmodics, Terumo Corporation, W.L. Gore and Xeltis. S.T. receives research grants from SUNRISE laboratory. R.V. has received honoraria from 480 Biomedical, Abbott Vascular, Boston Scientific, Cook Medical, Lutonix, Medtronic, Terumo Corporation and W.L. Gore; and is a consultant for 480 Biomedical, Abbott Vascular, Medtronic and W.L. Gore. A.V.F. has received honoraria from Abbott Vascular, Amgen, Boston Scientific, Cook Medical, Lutonix and W.L. Gore. The other authors report no competing interests.

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Jinnouchi, H., Torii, S., Sakamoto, A. et al. Fully bioresorbable vascular scaffolds: lessons learned and future directions. Nat Rev Cardiol 16, 286–304 (2019). https://doi.org/10.1038/s41569-018-0124-7

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