Current status of clinically available bioresorbable scaffolds in percutaneous coronary interventions

Drug-eluting stents (DES) are widely used as first choice devices in percutaneous coronary interventions. However, certain concerns are associated with the use of DES, i.e. delayed arterial healing with a subsequent risk of neo-atherosclerosis, late stent thrombosis and hypersensitivity reactions to the DES polymer. Bioresorbable vascular scaffolds are the next step in percutaneous coronary interventions introducing the concept of supporting the natural healing process following initial intervention without leaving any foreign body materials resulting in late adverse events. The first-generation devices have shown encouraging results in multiple studies of selected patients up to the point of full bioresorption, supporting the introduction in regular patient care. During its introduction in daily clinical practice outside the previously selected patient groups, a careful approach should be followed in which outcome is continuously monitored.

[1]  P. Serruys,et al.  Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial. , 2013, JACC. Cardiovascular interventions.

[2]  Yoshinobu Onuma,et al.  Long-Term (>10 Years) Clinical Outcomes of First-in-Human Biodegradable Poly-l-Lactic Acid Coronary Stents: Igaki-Tamai Stents , 2012, Circulation.

[3]  Z. Siudak,et al.  Bioresorbable vascular scaffolds in patients with acute coronary syndromes: the POLAR ACS study. , 2014, Polskie Archiwum Medycyny Wewnetrznej.

[4]  J. Brachmann,et al.  Beyond the early stages: insights from the ASSURE registry on bioresorbable vascular scaffolds. , 2015, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[5]  Bernard Chevalier,et al.  First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold: A Multi-Imaging Modality Study , 2012, Circulation. Cardiovascular interventions.

[6]  E. Antman,et al.  Prasugrel versus clopidogrel in patients with acute coronary syndromes. , 2007, The New England journal of medicine.

[7]  R. Whitbourn,et al.  The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. , 2015, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[8]  Gijs van Soest,et al.  OCT assessment of the long-term vascular healing response 5 years after everolimus-eluting bioresorbable vascular scaffold. , 2014, Journal of the American College of Cardiology.

[9]  EuroPCR EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. , 2005 .

[10]  P. Serruys,et al.  ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease c , 2012, American heart journal.

[11]  J. Wykrzykowska,et al.  Appropriate use of bioresorbable vascular scaffolds in percutaneous coronary interventions: a recommendation from experienced users , 2015, Netherlands Heart Journal.

[12]  Yoshinobu Onuma,et al.  Bioresorbable scaffolds: rationale, current status, challenges, and future. , 2014, European heart journal.

[13]  P. Serruys,et al.  Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study. , 2014, European heart journal.

[14]  M. Schalij,et al.  Role of the ECG in initial acute coronary syndrome triage: primary PCI regardless presence of ST elevation or of non-ST elevation , 2014, Netherlands Heart Journal.

[15]  P. Serruys,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 , 2015, The Lancet.

[16]  V. Kocka,et al.  Bioresorbable vascular scaffolds in acute ST-segment elevation myocardial infarction: a prospective multicentre study ‘Prague 19’ , 2014, European heart journal.

[17]  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.

[18]  R. Whitbourn,et al.  Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. , 2014, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society 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]  E. Boersma,et al.  Adoption of prasugrel into routine practice: rationale and design of the Rijnmond Collective Cardiology Research (CCR) study in percutaneous coronary intervention for acute coronary syndromes , 2013, Netherlands Heart Journal.

[21]  Antonio Colombo,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. , 2015, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[22]  S. Achenbach,et al.  Short-term outcome of patients with ST-segment elevation myocardial infarction (STEMI) treated with an everolimus-eluting bioresorbable vascular scaffold , 2014, Clinical Research in Cardiology.

[23]  A. Colombo,et al.  Comparison of early clinical outcomes between ABSORB bioresorbable vascular scaffold and everolimus‐eluting stent implantation in a real‐world population , 2015, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[24]  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.

[25]  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.

[26]  T. Münzel,et al.  Early outcome after implantation of Absorb bioresorbable drug-eluting scaffolds in patients with acute coronary syndromes. , 2014, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[27]  R. Whitbourn TCT-31 ABSORB EXTEND: An Interim Report on the 24-month Clinical Outcomes from the First 250 Patients Enrolled , 2013 .

[28]  J. Tijssen,et al.  Initial experience and clinical evaluation of the Absorb bioresorbable vascular scaffold (BVS) in real-world practice: the AMC Single Centre Real World PCI Registry. , 2015, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[29]  Elias Sanidas,et al.  A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results. , 2014, JACC. Cardiovascular interventions.