Bioresorbable Scaffold: The Advent of a New Era in Percutaneous Coronary and Peripheral Revascularization?

The invention of balloon angioplasty as a percutaneous treatment for obstructive coronary disease by Andreas Gruntzig in 1977 was a huge leap forward in cardiovascular medicine and undoubtedly will always be remembered as a revolution in the field of revascularization. However, this technique was plagued by multiple problems, including the risk of acute vessel closure secondary to occlusive coronary dissection, sometimes necessitating emergency coronary artery bypass surgery.1,–,3 Although late luminal enlargement and vascular remodeling could take place, more often restenosis4,–,8 would occur instead. The restenosis would essentially be caused by constrictive remodeling9,–,13 and, to a lesser extent, by elastic recoil14 or the neointimal hyperplastic healing response.15,–,17 The advent of bare metal stenting (BMS) and the landmark Belgian-Netherlands Stent Study (BENESTENT) and Stent Restenosis Study (STRESS) trials have established BMS as the second revolution in interventional cardiology.18,19 This technology provided a solution to acute vessel occlusion by sealing the dissection flaps and preventing recoil. The rate of subacute occlusion was reduced to 1.5%, making emergency bypass surgery a rare occurrence. Restenosis rates were further reduced from 32% to 22% at 7 months, but this rate was still high, and neointimal hyperplasia inside the stent was even more prominent than with angioplasty, necessitating repeat treatment in numerous patients.18 Because the vessel was now caged with metal, late luminal enlargement and advantageous vascular remodeling could no longer occur. Another problem, namely late stent thrombosis (ST), was also first described.20 To solve the problem of in-stent restenosis, after the historic failure of brachytherapy to resolve this problem,21,22 drug-eluting stents (DES) were introduced. The first 45 patients implanted with the sirolimus-eluting Bx velocity stent (Cordis, Johnson …

[1]  Frits Mastik,et al.  Incidence of High-Strain Patterns in Human Coronary Arteries: Assessment With Three-Dimensional Intravascular Palpography and Correlation With Clinical Presentation , 2004, Circulation.

[2]  A Haverich,et al.  Left main coronary artery fistula exiting into the right atrium , 2003, Heart.

[3]  Patrick Hunziker,et al.  Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. , 2006, Journal of the American College of Cardiology.

[4]  M. Vert Bioabsorbable polymers in medicine: an overview. , 2009, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[5]  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.

[6]  W. Edwards,et al.  Differential histopathology of primary atherosclerotic and restenotic lesions in coronary arteries and saphenous vein bypass grafts: analysis of tissue obtained from 73 patients by directional atherectomy. , 1991, Journal of the American College of Cardiology.

[7]  Joseph Kost,et al.  Handbook of Biodegradable Polymers , 1998 .

[8]  J. Margolis,et al.  Hideo Tamai memorial , 2009 .

[9]  I. Palacios,et al.  Coronary stenting decreases restenosis in lesions with early loss in luminal diameter 24 hours after successful PTCA. , 1995, Circulation.

[10]  J. English,et al.  Polyglycolide and polylactide , 1998 .

[11]  Bernard Chevalier,et al.  Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. , 2011, Journal of the American College of Cardiology.

[12]  M. Zwahlen,et al.  Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study. , 2008, Journal of the American College of Cardiology.

[13]  G L Kimmel,et al.  Aliphatic polyesters II. The degradation of poly (DL-lactide), poly (epsilon-caprolactone), and their copolymers in vivo. , 1981, Biomaterials.

[14]  Benno J. Rensing,et al.  Sustained Suppression of Neointimal Proliferation by Sirolimus-Eluting Stents: One-Year Angiographic and Intravascular Ultrasound Follow-Up , 2001, Circulation.

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

[16]  K. Robinson,et al.  Novel fully bioabsorbable salicylate-based sirolimus-eluting stent. , 2009, EuroIntervention.

[17]  W Siegenthaler,et al.  Long-term follow-up after percutaneous transluminal coronary angioplasty. The early Zurich experience. , 1987, The New England journal of medicine.

[18]  Michael Joner,et al.  Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. , 2006, Journal of the American College of Cardiology.

[19]  Bernard Chevalier,et al.  Comparison of in vivo acute stent recoil between the bioabsorbable everolimus‐eluting coronary stent and the everolimus‐eluting cobalt chromium coronary stent: Insights from the ABSORB and SPIRIT trials , 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[20]  Johan Lindbäck,et al.  Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. , 2007, The New England journal of medicine.

[21]  Antonio Colombo,et al.  5-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions. , 2010, Journal of the American College of Cardiology.

[22]  A. Maseri,et al.  Racial heterogeneity in coronary artery vasomotor reactivity: differences between Japanese and Caucasian patients. , 1999, Journal of the American College of Cardiology.

[23]  P D Verdouw,et al.  Development of a polymer endovascular prosthesis and its implantation in porcine arteries. , 1992, Journal of interventional cardiology.

[24]  Karl-Heinz Waldmann,et al.  Safety and efficacy of bioabsorbable magnesium alloy stents in porcine coronary arteries , 2006, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[25]  P. Serruys,et al.  Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions , 2007, Circulation.

[26]  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.

[27]  A. Takeshita,et al.  Evidence of impaired endothelium-dependent coronary vasodilatation in patients with angina pectoris and normal coronary angiograms. , 1993, The New England journal of medicine.

[28]  Raimund Erbel,et al.  Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial , 2007, The Lancet.

[29]  J. Sixma,et al.  Thrombogenicity of the human arterial wall after interventional thermal injury. , 1996, Journal of vascular research.

[30]  E J Topol,et al.  Sustained local delivery of dexamethasone by a novel intravascular eluting stent to prevent restenosis in the porcine coronary injury model. , 1997, Journal of the American College of Cardiology.

[31]  B Meier,et al.  Restenosis after successful coronary angioplasty in patients with single-vessel disease. , 1986, Circulation.

[32]  William Wijns,et al.  Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. , 2007, Circulation.

[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]  Patrick W Serruys,et al.  Late angiographic stent thrombosis (LAST) events with drug-eluting stents. , 2005, Journal of the American College of Cardiology.

[35]  O. Hess,et al.  Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction. , 2005, Journal of the American College of Cardiology.

[36]  F Joffre,et al.  Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. , 1987, The New England journal of medicine.

[37]  P. Serruys,et al.  Late Stent Thrombosis: A Nuisance in Both Bare Metal and Drug-Eluting Stents , 2007 .

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

[39]  P. Serruys,et al.  Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. , 2010, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[40]  David Rotger,et al.  Late stent recoil of the bioabsorbable everolimus-eluting coronary stent and its relationship with plaque morphology. , 2008, Journal of the American College of Cardiology.

[41]  P. Serruys,et al.  Incidence, predictors, and management of acute coronary occlusion after coronary angioplasty. , 1994, American heart journal.

[42]  M. Leon,et al.  Remodeling of human coronary arteries undergoing coronary angioplasty or atherectomy. , 1997, Circulation.

[43]  L. Pendyala,et al.  The first-generation drug-eluting stents and coronary endothelial dysfunction. , 2009, JACC. Cardiovascular interventions.

[44]  Antonio Colombo,et al.  Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. , 2009, The New England journal of medicine.

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

[46]  Raimund Erbel,et al.  Early- and long-term intravascular ultrasound and angiographic findings after bioabsorbable magnesium stent implantation in human coronary arteries. , 2009, JACC. Cardiovascular interventions.

[47]  P. Serruys,et al.  Characterizing Vulnerable Plaque Features With Intravascular Elastography , 2003, Circulation.

[48]  E. Topol,et al.  Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. , 1996, Circulation.

[49]  M. Nobuyoshi,et al.  Restenosis after successful percutaneous transluminal coronary angioplasty: serial angiographic follow-up of 229 patients. , 1988, Journal of the American College of Cardiology.

[50]  J O Hollinger,et al.  Biodegradable bone repair materials. Synthetic polymers and ceramics. , 1986, Clinical orthopaedics and related research.

[51]  R. Erbel,et al.  Initial evidence for the return of coronary vasoreactivity following the absorption of bioabsorbable magnesium alloy coronary stents. , 2009, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[52]  Michael Joner,et al.  Vascular Responses to Drug Eluting Stents: Importance of Delayed Healing , 2007, Arteriosclerosis, thrombosis, and vascular biology.

[53]  Jeffrey J. Popma,et al.  Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries: A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study , 2001, Circulation.

[54]  C von Birgelen,et al.  Quantitative assessment with intracoronary ultrasound of the mechanisms of restenosis after percutaneous transluminal coronary angioplasty and directional coronary atherectomy. , 1995, The American journal of cardiology.

[55]  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.

[56]  P. Serruys,et al.  Biodegradable stents and non-biodegradable stents. , 2009, Minerva cardioangiologica.

[57]  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.

[58]  H. M. Payne,et al.  Validation of A Doppler Guide Wire for Intravascular Measurement of Coronary Artery Flow Velocity , 1992, Circulation.

[59]  M. Leon,et al.  Patterns and mechanisms of in-stent restenosis. A serial intravascular ultrasound study. , 1996, Circulation.

[60]  M. Fishbein,et al.  Coronary artery restenosis after balloon angioplasty in humans is associated with circumferential coronary constriction. , 1996, Arteriosclerosis, thrombosis, and vascular biology.

[61]  G. D. De Meyer,et al.  Selective clearance of macrophages in atherosclerotic plaques by autophagy. , 2007, Journal of the American College of Cardiology.

[62]  Richard L. Kronenthal,et al.  BIODEGRADABLE POLYMERS IN MEDICINE AND SURGERY , 1975 .

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

[64]  C Vallbracht,et al.  Recurrence rate after successful coronary angioplasty. , 1985, European heart journal.

[65]  William Wijns,et al.  A Cause for Concern , 2007 .

[66]  Janita F. J. Vos,et al.  Coronary restenosis elimination with a sirolimus eluting stent: first European human experience with 6-month angiographic and intravascular ultrasonic follow-up. , 2001, European heart journal.

[67]  F. Verheugt,et al.  Predictors of coronary stent thrombosis: the Dutch Stent Thrombosis Registry. , 2009, Journal of the American College of Cardiology.

[68]  Ousa,et al.  A RANDOMIZED COMPARISON OF A SIROLIMUS-ELUTING STENT WITH A STANDARD STENT FOR CORONARY REVASCULARIZATION , 2002 .

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

[70]  P. Serruys,et al.  Quantitative multi-modality imaging analysis of a bioabsorbable poly-L-lactic acid stent design in the acute phase: a comparison between 2- and 3D-QCA, QCU and QMSCT-CA. , 2008, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[71]  P. Serruys,et al.  Three‐dimensional and quantitative analysis of atherosclerotic plaque composition by automated differential echogenicity , 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[72]  Patrick W Serruys,et al.  Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy , 2004, The Lancet.

[73]  S. Pocock,et al.  Development and validation of a prognostic risk score for major bleeding in patients undergoing percutaneous coronary intervention via the femoral approach. , 2007, European heart journal.

[74]  Matthias Stuber,et al.  Artifact-Free Coronary Magnetic Resonance Angiography and Coronary Vessel Wall Imaging in the Presence of a New, Metallic, Coronary Magnetic Resonance Imaging Stent , 2005, Circulation.

[75]  K. Robinson,et al.  Novel bioabsorbable salicylate‐based polymer as a drug‐eluting stent coating , 2008, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[76]  P. Serruys,et al.  Late coronary occlusion after intracoronary brachytherapy. , 1999, Circulation.

[77]  H Shimokawa,et al.  Intramural delivery of a specific tyrosine kinase inhibitor with biodegradable stent suppresses the restenotic changes of the coronary artery in pigs in vivo. , 1998, Journal of the American College of Cardiology.

[78]  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.

[79]  A. Quyyumi,et al.  Prognostic Value of Coronary Vascular Endothelial Dysfunction , 2002, Circulation.

[80]  M. Reidy,et al.  Kinetics of cellular proliferation after arterial injury. I. Smooth muscle growth in the absence of endothelium. , 1983, Laboratory investigation; a journal of technical methods and pathology.

[81]  J. Oldenburg,et al.  Hemophilia A Patients with Undetectable Mutations: Current Knowledge and Future Directions* , 2006, Transfusion Medicine and Hemotherapy.

[82]  W Rutsch,et al.  A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. , 1994, The New England journal of medicine.

[83]  H. Shimokawa,et al.  Cellular and molecular mechanisms of coronary artery spasm: lessons from animal models. , 2000, Japanese circulation journal.

[84]  Bernard Chevalier,et al.  Evaluation of the Second Generation of a Bioresorbable Everolimus Drug-Eluting Vascular Scaffold for Treatment of De Novo Coronary Artery Stenosis: Six-Month Clinical and Imaging Outcomes , 2010, Circulation.

[85]  P. Serruys,et al.  Assessment of the absorption process following bioabsorbable everolimus-eluting stent implantation: temporal changes in strain values and tissue composition using intravascular ultrasound radiofrequency data analysis. A substudy of the ABSORB clinical trial. , 2009, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[86]  Simon Wandel,et al.  Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis , 2007, The Lancet.

[87]  Yoshinobu Onuma,et al.  In vivo evaluation of stent strut distribution patterns in the bioabsorbable everolimus-eluting device: An OCT ad hoc analysis of the revision 1.0 and revision 1.1 stent design in the ABSORB clinical trial , 2010 .

[88]  P. Teirstein,et al.  A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. , 1994, The New England journal of medicine.

[89]  R. Rapoza,et al.  Design principles and performance of bioresorbable polymeric vascular scaffolds. , 2009, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[90]  Patrick W Serruys,et al.  A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods , 2009, The Lancet.

[91]  Bernd Heublein,et al.  Preliminary Results after Application of Absorbable Metal Stents in Patients with Critical Limb Ischemia , 2005, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists.

[92]  S. Higano,et al.  Long-term follow-up of patients with mild coronary artery disease and endothelial dysfunction. , 2000, Circulation.

[93]  R. Kronenthal,et al.  Polymers in medicine and surgery , 1975 .

[94]  W. Siegenthaler,et al.  Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. , 1979, The New England journal of medicine.

[95]  P. Serruys,et al.  A comparison of two methods to measure coronary flow reserve in the setting of coronary angioplasty: intracoronary blood flow velocity measurements with a Doppler catheter, and digital subtraction cineangiography. , 1989, European heart journal.

[96]  S. Lobodzinski,et al.  Bioabsorbable coronary stents. , 2008, Cardiology journal.

[97]  M. Nobuyoshi,et al.  Restenosis after percutaneous transluminal coronary angioplasty: pathologic observations in 20 patients. , 1991, Journal of the American College of Cardiology.

[98]  R. Waksman,et al.  Late thrombosis after radiation. Sitting on a time bomb. , 1999, Circulation.

[99]  P. Serruys,et al.  Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation. , 2006, European heart journal.

[100]  P. Hunold,et al.  Images in cardiovascular medicine. Novel magnetic resonance-compatible coronary stent: the absorbable magnesium-alloy stent. , 2005, Circulation.