Design principles and performance of bioresorbable polymeric vascular scaffolds.

AIMS Bioresorbable polymeric vascular scaffolds may spawn a fourth revolution in percutaneous coronary intervention (PCI) and a novel treatment termed vascular restoration therapy. The principal design considerations for bioresorbable scaffolds are discussed in the context of physiological behaviour using the Bioabsorbable Vascular Solutions (BVS) ABSORB Cohort B scaffold (Abbott Vascular) as an example. METHODS AND RESULTS The lifecycle of a bioresorbable scaffold is divided into three phases: (1) revascularisation; (2) restoration; and (3) resorption. In the revascularisation phase spanning the first three months after intervention, the bioresorbable scaffold should perform comparably to metallic drug-eluting stents (DES) in terms of deliverability, radial strength, recoil, and neointimal thickening. The ensuing restoration phase is characterised by gradual erosion of radial strength and a loss of structural continuity, where the time scale at which each occurs is related to the hydrolytic degradation rate of the polymer. Natural vasomotion in response to external stimuli is theoretically possible at the end of this phase. Finally, in the resorption phase, the passive implant is systematically resorbed and processed by the body. CONCLUSIONS Limited clinical data speak to the potential of bioresorbable scaffolds as a new therapy, and future studies will prove critical to inspiring a fourth revolution in PCI.

[1]  E. Nabel,et al.  Atherosclerosis influences the vasomotor response of epicardial coronary arteries to exercise. , 1989, The Journal of clinical investigation.

[2]  Seiki Nagata,et al.  Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings. , 2006, Journal of the American College of Cardiology.

[3]  B. Hsiao,et al.  Shear-Enhanced Crystallization in Isotactic Polypropylene. 3. Evidence for a Kinetic Pathway to Nucleation , 2002 .

[4]  B. Gersh,et al.  A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods , 2010 .

[5]  John A Ormiston,et al.  Bioabsorbable coronary stents. , 2009, Circulation. Cardiovascular interventions.

[6]  P. Ganz,et al.  Paradoxical vasoconstriction induced by acetylcholine in atherosclerotic coronary arteries. , 1986, The New England journal of medicine.

[7]  P W Serruys,et al.  Incidence of restenosis after successful coronary angioplasty: a time-related phenomenon. A quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months. , 1988, Circulation.

[8]  S. Hossainy,et al.  Modeling of degradation and drug release from a biodegradable stent coating. , 2007, Journal of biomedical materials research. Part A.

[9]  Neville Kukreja,et al.  Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study , 2007, The Lancet.

[10]  M. Hori,et al.  Remodeling of in-stent neointima, which became thinner and transparent over 3 years: serial angiographic and angioscopic follow-up. , 1998, Circulation.

[11]  P. Watt,et al.  Lactate – a signal coordinating cell and systemic function , 2005, Journal of Experimental Biology.

[12]  L. Gladden Lactate metabolism: a new paradigm for the third millennium , 2004, The Journal of physiology.

[13]  R. Virmani,et al.  Pathological Correlates of Late Drug-Eluting Stent Thrombosis: Strut Coverage as a Marker of Endothelialization , 2007, Circulation.

[14]  H. Scheuenstuhl,et al.  Lactate elicits vascular endothelial growth factor from macrophages: a possible alternative to hypoxia , 2000, Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society.

[15]  Sadao Kimura,et al.  A novel potent vasoconstrictor peptide produced by vascular endothelial cells , 1988, Nature.

[16]  Paul J Thornalley,et al.  Fluorimetric assay of D-lactate. , 1992, Analytical biochemistry.

[17]  J F Orr,et al.  Degradation of poly-L-lactide. Part 2: Increased temperature accelerated degradation , 2004, Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine.

[18]  G A Brooks,et al.  Systemic lactate kinetics during graded exercise in man. , 1985, The American journal of physiology.

[19]  A. Schindler,et al.  Aliphatic polyesters. I. The degradation of poly(ϵ‐caprolactone) in vivo , 1981 .

[20]  J F Orr,et al.  Degradation of poly-L-lactide. Part 1: in vitro and in vivo physiological temperature degradation , 2004, Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine.

[21]  Buddy D. Ratner,et al.  Biomaterials Science: An Introduction to Materials in Medicine , 1996 .

[22]  S. Moncada,et al.  Nitric oxide: physiology, pathophysiology, and pharmacology. , 1991, Pharmacological reviews.

[23]  D. Celermajer,et al.  Endothelial dysfunction: does it matter? Is it reversible? , 1997, Journal of the American College of Cardiology.

[24]  Patrick W Serruys,et al.  Coronary-artery stents. , 2006, The New England journal of medicine.

[25]  J. W. Dawson Lactic Acid: Properties and Chemistry of Lactic Acid and Derivatives , 1973 .

[26]  H. Uehata,et al.  Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans. , 2000, Circulation.

[27]  Z. Tadmor,et al.  Principles of Polymer Processing , 1979 .

[28]  G. Zello,et al.  D-lactate in human and ruminant metabolism. , 2005, The Journal of nutrition.

[29]  M. Fishbein,et al.  A paradigm for restenosis based on cell biology: clues for the development of new preventive therapies. , 1991, Journal of the American College of Cardiology.

[30]  Patrick W Serruys,et al.  A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial , 2008, The Lancet.

[31]  G. Schuler,et al.  Effect of Exercise on Coronary Endothelial Function in Patients With Coronary Artery Disease , 2000 .

[32]  A. Pennings BUNDLE-LIKE NUCLEATION AND LONGITUDINAL GROWTH OF FIBRILLAR POLYMER CRYSTALS FROM FLOWING SOLUTIONS , 2007 .

[33]  C. G. Pitt,et al.  Modification of the rates of chain cleavage of poly(ϵ-caprolactone) and related polyesters in the solid state , 1987 .

[34]  Yutaka Tokiwa,et al.  Biodegradation of poly(l-lactide) , 2004, Biotechnology Letters.

[35]  Takeshi Karino,et al.  Molecular Basis of the Shish-Kebab Morphology in Polymer Crystallization , 2007, Science.

[36]  M. Leon,et al.  Arterial remodeling after coronary angioplasty: a serial intravascular ultrasound study. , 1996, Circulation.