Very Late Scaffold Thrombosis

Fro De Tri ter Kin (33 Wi spe rec On gra Bio an Ma BACKGROUND Bioresorbable scaffolds provide transient lumen support followed by complete resorption. OBJECTIVES This study examined whether very late scaffold thrombosis (VLScT) occurs when resorption is presumed to be nearly complete. METHODS Patients with VLScT at 3 tertiary care centers underwent thrombus aspiration followed by optical coherence tomography (OCT). Thrombus aspirates were analyzed by histopathological and spectroscopic examination. RESULTS Between March 2014 and February 2015, 4 patients presented with VLScT at 44 (case 1), 19 (cases 2 and 4), and 21 (case 3) months, respectively, after implantation of an Absorb Bioresorbable Vascular Scaffold 1.1 (Abbott Laboratories, Abbott Park, Illinois). At the time of VLScT, all patients were taking low-dose aspirin, and 2 patients were also taking prasugrel. OCT showed malapposed scaffold struts surrounded by thrombus in 7.1%, 9.0%, and 8.9% of struts in cases 1, 2, and 4, respectively. Scaffold discontinuity with struts in the lumen center was the cause of malapposition in cases 2 and 4. Uncovered scaffold struts with superimposed thrombus were the predominant findings in case 3. OCT percent area stenosis at the time of VLScT was high in case 1 (74.8%) and case 2 (70.9%) without evidence of excessive neointimal hyperplasia. Spectroscopic thrombus aspirate analysis showed persistence of intracoronary polymer fragments in case 1. CONCLUSIONS VLScT may occur at advanced stages of scaffold resorption. Potential mechanisms specific for VLScT include scaffold discontinuity and restenosis during the resorption process, which appear delayed in humans; these findings suggest an extended period of vulnerability for thrombotic events. (J AmColl Cardiol 2015;66:1901–14) © 2015 by the American College of Cardiology Foundation. m the *Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland; yCardiology partment, Thorax Institute, IDIBAPS, Hospital Clinic, University of Barcelona, Barcelona, Spain; zCardiology Department, emlispital, Zurich, Switzerland; xCvPath Institute, Gaithersburg, Maryland; kThoraxcenter, Erasmus University Hospital, Rotdam, the Netherlands; and the {International Centre for Cardiovascular Health, Imperial College London, London, United gdom. This study was supported by institutional grants and a grant from the Swiss National Science Foundation CM30_140336 I 1). Dr. Räber is on the advisory board of Abott Vascular; and received speaker fees from St. Jude Medical. Drs. ndecker, Sabaté, and Serruys have received research grants and speaker fees from Abbott Vascular. Dr. Windecker has received aker’s honoraria from AstraZeneca, Eli Lilly, Boston Scientific, Biosensors, Biotronik, Medtronic, and Edwards; and has eived grants to the institution from Abbott Vascular, Boston Scientific, Biosensors, Biotronik, Medtronic, and Edwards. Dr. uma is on the advisory board of Abbott Vascular. Dr. Freixa is a proctor for St. Jude Medical. Dr. Eberli has received institutional nts from Abbott Vascular, Biotronik, and Terumo. Dr. Joner has received institutional grants from Abbott Vascular, Biosensors, tronic, Boston Scientific, CeloNova, Medtronic, MicroPort, Stentys, OrbusNeich Medical, SINO Medical Technology, Terumo, d W.L. Gore. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. nuscript received July 15, 2015; revised manuscript received August 5, 2015, accepted August 11, 2015. ABBR EV I A T I ON S

[1]  Julia Kastner,et al.  Spectroscopy Of Polymers , 2016 .

[2]  G. Richardt,et al.  Very late thrombosis observed on optical coherence tomography 22 months after the implantation of a polymer-based bioresorbable vascular scaffold. , 2015, European heart journal.

[3]  M. Togni,et al.  Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds. , 2015, Journal of the American College of Cardiology.

[4]  P. Stella,et al.  Very late bioresorbable vascular scaffold thrombosis following discontinuation of antiplatelet therapy. , 2015, European heart journal.

[5]  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.

[6]  R. Whitbourn,et al.  Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb Everolimus-Eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (A Clinical Evaluation of the Bioabsorbable Ev , 2014, JACC. Cardiovascular interventions.

[7]  R. Virmani,et al.  Vascular healing and integration of a fully bioresorbable everolimus-eluting scaffold in a rabbit iliac arterial model. , 2014, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[8]  L. Mauri,et al.  Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent: 4-year results of the PROTECT randomized trial. , 2014, European heart journal.

[9]  T. Münzel,et al.  Immediate, acute, and subacute thrombosis due to incomplete expansion of bioresorbable scaffolds. , 2014, JACC. Cardiovascular interventions.

[10]  D. Fernández-Rodríguez,et al.  Acute Absorb bioresorbable vascular scaffold thrombosis in ST-segment elevation myocardial infarction: to stent or not to stent? , 2014, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[11]  P. Kolh,et al.  Revascularisation versus medical treatment in patients with stable coronary artery disease: network meta-analysis , 2014, BMJ : British Medical Journal.

[12]  C. Di Mario,et al.  ABSORB biodegradable stents versus second-generation metal stents: a comparison study of 100 complex lesions treated under OCT guidance. , 2014, JACC. Cardiovascular interventions.

[13]  R. Virmani,et al.  Long-Term Safety of an Everolimus-Eluting Bioresorbable Vascular Scaffold and the Cobalt-Chromium XIENCE V Stent in a Porcine Coronary Artery Model , 2014, Circulation. Cardiovascular interventions.

[14]  P. Serruys,et al.  Coronary evaginations are associated with positive vessel remodelling and are nearly absent following implantation of newer-generation drug-eluting stents: an optical coherence tomography and intravascular ultrasound study. , 2014, European heart journal.

[15]  R. V. van Geuns,et al.  Very late bioresorbable scaffold thrombosis after discontinuation of dual antiplatelet therapy , 2014, European heart journal.

[16]  V. Kocka,et al.  ST elevation myocardial infarction treated with bioresorbable vascular scaffold: rationale and first cases. , 2013, European heart journal.

[17]  Seung‐Jung Park,et al.  OCT analysis in patients with very late stent thrombosis. , 2013, JACC. Cardiovascular imaging.

[18]  P. Serruys,et al.  Long-term vascular healing in response to sirolimus- and paclitaxel-eluting stents: an optical coherence tomography study. , 2012, JACC. Cardiovascular interventions.

[19]  Patrick W Serruys,et al.  Endothelial-dependent vasomotion in a coronary segment treated by ABSORB everolimus-eluting bioresorbable vascular scaffold system is related to plaque composition at the time of bioresorption of the polymer: indirect finding of vascular reparative therapy? , 2012, European heart journal.

[20]  P. Serruys,et al.  Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials. , 2012, European heart journal.

[21]  P. Serruys,et al.  Very Late Coronary Stent Thrombosis of a Newer-Generation Everolimus-Eluting Stent Compared With Early-Generation Drug-Eluting Stents: A Prospective Cohort Study , 2012, Circulation.

[22]  F. Eberli,et al.  Impact of incomplete stent apposition on long-term clinical outcome after drug-eluting stent implantation. , 2012, European heart journal.

[23]  Giuseppe Biondi-Zoccai,et al.  Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: findings from optical coherence tomography and intravascular ultrasound imaging. , 2012, JACC. Cardiovascular interventions.

[24]  Patrick W Serruys,et al.  From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? , 2012, European heart journal.

[25]  F. Eberli,et al.  Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial , 2011, The Lancet.

[26]  H. Dauerman The magic of disappearing stents. , 2011, Journal of the American College of Cardiology.

[27]  Patrick W Serruys,et al.  Bioresorbable Scaffold: The Advent of a New Era in Percutaneous Coronary and Peripheral Revascularization? , 2011, Circulation.

[28]  R. Virmani,et al.  Coronary responses and differential mechanisms of late stent thrombosis attributed to first-generation sirolimus- and paclitaxel-eluting stents. , 2011, Journal of the American College of Cardiology.

[29]  Gary S. Mintz,et al.  Strut Coverage and Late Malapposition With Paclitaxel-Eluting Stents Compared With Bare Metal Stents in Acute Myocardial Infarction: Optical Coherence Tomography Substudy of the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial , 2011, Circulation.

[30]  L. Thuesen,et al.  Late coronary stent thrombosis. , 2010, Minerva medica.

[31]  P. Smits,et al.  Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial , 2010, The Lancet.

[32]  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.

[33]  Peter Jüni,et al.  Correlation of Intravascular Ultrasound Findings With Histopathological Analysis of Thrombus Aspirates in Patients With Very Late Drug-Eluting Stent Thrombosis , 2009, Circulation.

[34]  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.

[35]  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.

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

[37]  StéphaneCook,et al.  Incomplete Stent Apposition and Very Late Stent Thrombosis After Drug-Eluting Stent Implantation , 2007 .

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

[39]  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.

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