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http://dx.doi.org/10.4070/kcj.2017.0194

Bioresorbable Scaffolds in Coronary Intervention: Unmet Needs and Evolution  

Capodanno, Davide (Division of Cardiology, Cardio-Thoracic-Vascular Department, Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele" and Department of General Surgery and Medical-Surgical Specialties, University of Catania)
Publication Information
Korean Circulation Journal / v.48, no.1, 2018 , pp. 24-35 More about this Journal
Abstract
Bioresorbable scaffolds (BRS) represent a novel paradigm in the 40-year history of interventional cardiology. Restoration of cyclic pulsatility and physiologic vasomotion, adaptive vascular remodeling, plaque regression, and removal of the trigger for late adverse events are expected BRS benefits over current metallic drug-eluting stents. However, first-generation BRS devices have significant manufacturing limitations and rely on optimal implantation technique to avoid experiencing an excess of clinical events. There are currently at least 22 BRS devices in different stages of development, including many trials of device iterations with thinner (<$150{\mu}m$) struts than first-generation BRS. This article reviews the outcomes of commercially available and potentially upcoming BRS, focusing on the most recent stages of clinical development and future directions for each scaffold type.
Keywords
Bioresorbable scaffolds; ABSORB; Biodegradable stents; Angioplasty; Coronary stents;
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1 Palmerini T, Biondi-Zoccai G, Della Riva D, et al. Stent thrombosis with drug-eluting stents: is the paradigm shifting? J Am Coll Cardiol 2013;62:1915-21.   DOI
2 Kereiakes DJ, Onuma Y, Serruys PW, Stone GW. Bioresorbable vascular scaffolds for coronary revascularization. Circulation 2016;134:168-82.   DOI
3 Capodanno D, Angiolillo DJ. Antiplatelet therapy after implantation of bioresorbable vascular scaffolds: a review of the published data, practical recommendations, and future directions. JACC Cardiovasc Interv 2017;10:425-37.   DOI
4 Capodanno D. Bioresorbable scaffolds: clinical outcomes and considerations. Interv Cardiol Clin 2016;5:357-63.
5 Capodanno D, Gori T, Nef H, et al. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention 2015;10:1144-53.   DOI
6 Serruys PW, Chevalier B, Dudek D, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet 2015;385:43-54.   DOI
7 Kimura T, Kozuma K, Tanabe K, et al. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J 2015;36:3332-42.   DOI
8 Gao R, Yang Y, Han Y, et al. Bioresorbable vascular scaffolds versus metallic stents in patients with coronary artery disease: ABSORB China Trial. J Am Coll Cardiol 2015;66:2298-309.   DOI
9 Ellis SG, Kereiakes DJ, Metzger DC, et al. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. N Engl J Med 2015;373:1905-15.   DOI
10 Cassese S, Byrne RA, Ndrepepa G, et al. Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials. Lancet 2016;387:537-44.   DOI
11 Stone GW, Gao R, Kimura T, et al. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet 2016;387:1277-89.   DOI
12 Serruys PW, Chevalier B, Sotomi Y, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet 2016;388:2479-91.   DOI
13 Wykrzykowska JJ, Kraak RP, Hofma SH, et al. Bioresorbable scaffolds versus metallic stents in routine PCI. N Engl J Med 2017;376:2319-28.   DOI
14 Abizaid A, Costa RA, Schofer J, et al. Serial multimodality imaging and 2-year clinical outcomes of the novel DESolve novolimus-eluting bioresorbable coronary scaffold system for the treatment of single de novo coronary lesions. JACC Cardiovasc Interv 2016;9:565-74.
15 Ali ZA, Serruys PW, Kimura T, et al. 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. Lancet 2017;390:760-72.   DOI
16 Nef HM, Wiebe J, Foin N, et al. A new novolimus-eluting bioresorbable coronary scaffold: present status and future clinical perspectives. Int J Cardiol 2017;227:127-33.   DOI
17 Verheye S, Ormiston JA, Stewart J, et al. A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results. JACC Cardiovasc Interv 2014;7:89-99.   DOI
18 Haude M, Erbel R, Erne P, et al. Safety and performance of the DRug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicentre, firstin-man BIOSOLVE-I trial. EuroIntervention 2016;12:e160-6.   DOI
19 Haude M, Erbel R, Erne P, et al. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial. Lancet 2013;381:836-44.   DOI
20 Fajadet J, Haude M, Joner M, et al. Magmaris preliminary recommendation upon commercial launch: a consensus from the expert panel on 14 April 2016. EuroIntervention 2016;12:828-33.   DOI
21 Seth A, Onuma Y, Costa R, et al. First-in-human evaluation of a novel poly-L-lactide based sirolimuseluting bioresorbable vascular scaffold for the treatment of de novo native coronary artery lesions: MeRes-1 trial. EuroIntervention 2017;13:415-23.   DOI
22 Haude M, Ince H, Abizaid A, et al. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet 2016;387:31-9.   DOI
23 Haude M, Ince H, Abizaid A, et al. Sustained safety and performance of the second-generation drugeluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. Eur Heart J 2016;37:2701-9.   DOI
24 Haude M, Ince H, Kische S, et al. Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months: pooled outcomes of BIOSOLVE-II and BIOSOLVE-III. EuroIntervention 2017;13:432-9.   DOI
25 Tenekecioglu E, Serruys PW, Onuma Y, et al. Randomized comparison of Absorb bioresorbable vascular scaffold and Mirage microfiber sirolimus-eluting scaffold using multimodality imaging. JACC Cardiovasc Interv 2017;10:1115-30.   DOI
26 Zhang YJ, Wang XZ, Fu G, et al. Clinical and multimodality imaging results at 6 months of a bioresorbable sirolimus-eluting scaffold for patients with single de novo coronary artery lesions: the NeoVas first-inman trial. EuroIntervention 2016;12:1279-87.   DOI
27 Wu Y, Shen L, Ge L, et al. Six-month outcomes of the XINSORB bioresorbable sirolimus-eluting scaffold in treating single de novo lesions in human coronary artery. Catheter Cardiovasc Interv 2016;87 Suppl 1:630-7.   DOI