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Coronary Artery Disease: HELP
Articles by William Wijns
Based on 119 articles published since 2008
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Between 2008 and 2019, W. Wijns wrote the following 119 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4 · 5
1 Guideline Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary. 2018

Byrne, Robert A / Stefanini, Giulio G / Capodanno, Davide / Onuma, Yoshinobu / Baumbach, Andreas / Escaned, Javier / Haude, Michael / James, Stefan / Joner, Michael / Jüni, Peter / Kastrati, Adnan / Oktay, Semih / Wijns, William / Serruys, Patrick W / Windecker, Stephan. ·Deutsches Herzzentrum München, Technische Universität München, Germany. ·EuroIntervention · Pubmed #28948934.

ABSTRACT: A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device -the Absorb bioresorbable vascular scaffold- has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE- mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

2 Guideline 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. 2013

Anonymous3190768 / Montalescot, Gilles / Sechtem, Udo / Achenbach, Stephan / Andreotti, Felicita / Arden, Chris / Budaj, Andrzej / Bugiardini, Raffaele / Crea, Filippo / Cuisset, Thomas / Di Mario, Carlo / Ferreira, J Rafael / Gersh, Bernard J / Gitt, Anselm K / Hulot, Jean-Sebastien / Marx, Nikolaus / Opie, Lionel H / Pfisterer, Matthias / Prescott, Eva / Ruschitzka, Frank / Sabaté, Manel / Senior, Roxy / Taggart, David Paul / van der Wall, Ernst E / Vrints, Christiaan J M / Anonymous3200768 / Zamorano, Jose Luis / Achenbach, Stephan / Baumgartner, Helmut / Bax, Jeroen J / Bueno, Héctor / Dean, Veronica / Deaton, Christi / Erol, Cetin / Fagard, Robert / Ferrari, Roberto / Hasdai, David / Hoes, Arno W / Kirchhof, Paulus / Knuuti, Juhani / Kolh, Philippe / Lancellotti, Patrizio / Linhart, Ales / Nihoyannopoulos, Petros / Piepoli, Massimo F / Ponikowski, Piotr / Sirnes, Per Anton / Tamargo, Juan Luis / Tendera, Michal / Torbicki, Adam / Wijns, William / Windecker, Stephan / Anonymous3210768 / Knuuti, Juhani / Valgimigli, Marco / Bueno, Héctor / Claeys, Marc J / Donner-Banzhoff, Norbert / Erol, Cetin / Frank, Herbert / Funck-Brentano, Christian / Gaemperli, Oliver / Gonzalez-Juanatey, José R / Hamilos, Michalis / Hasdai, David / Husted, Steen / James, Stefan K / Kervinen, Kari / Kolh, Philippe / Kristensen, Steen Dalby / Lancellotti, Patrizio / Maggioni, Aldo Pietro / Piepoli, Massimo F / Pries, Axel R / Romeo, Francesco / Rydén, Lars / Simoons, Maarten L / Sirnes, Per Anton / Steg, Ph Gabriel / Timmis, Adam / Wijns, William / Windecker, Stephan / Yildirir, Aylin / Zamorano, Jose Luis. ·The disclosure forms of the authors and reviewers are available on the ESC website www.escardio.org/guidelines. ·Eur Heart J · Pubmed #23996286.

ABSTRACT: -- No abstract --

3 Guideline Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the European Association of Percutaneous Cardiovascular Interventions and Working Groups on Acute Cardiac Care** and Thrombosis of the European Society of Cardiology. 2013

Hamon, Martial / Pristipino, Christian / Di Mario, Carlo / Nolan, James / Ludwig, Josef / Tubaro, Marco / Sabate, Manel / Mauri-Ferré, Josepa / Huber, Kurt / Niemelä, Kari / Haude, Michael / Wijns, William / Dudek, Dariusz / Fajadet, Jean / Kiemeneij, Ferdinand / Anonymous3350748 / Anonymous3360748 / Anonymous3370748. ·Recherche Clinique, Bureau 364, Centre Hospitalier Universitaire de Caen, Avenue Côte de Nacre, 14033 Caen, Normandie, France. hamon-m@chu-caen.fr ·EuroIntervention · Pubmed #23354100.

ABSTRACT: Radial access use has been growing steadily but, despite encouraging results, still varies greatly among operators, hospitals, countries and continents. Twenty years from its introduction, it was felt that the time had come to develop a common evidence-based view on the technical, clinical and organisational implications of using the radial approach for coronary angiography and interventions. The European Association of Percutaneous Cardiovascular Interventions (EAPCI) has, therefore, appointed a core group of European and non-European experts, including pioneers of radial angioplasty and operators with different practices in vascular access supported by experts nominated by the Working Groups on Acute Cardiac Care and Thrombosis of the European Society of Cardiology (ESC). Their goal was to define the role of the radial approach in modern interventional practice and give advice on technique, training needs, and optimal clinical indications.

4 Guideline Meeting report ESC forum on drug eluting stents, European Heart House, Nice, 27-28 September 2007. 2009

Daemen, Joost / Simoons, Maarten L / Wijns, William / Bagust, Adrian / Bos, Gert / Bowen, James M / Braunwald, Eugene / Camenzind, Edoardo / Chevaliers, Bernard / DiMario, Carlo / Fajadeto, Jean / Gitt, Anselm / Guagliumi, Giulio / Hillege, Hans L / James, Stefan / Jüni, Peter / Kastrati, Adnan / Kloth, Sabine / Kristensen, Steen D / Krucoff, Mitchell / Legrand, Victor / Pfisterer, Matthias / Rothman, Martin / Serruys, Patrick W / Silber, Sigmund / Steg, Philippe G / Tariah, Ibrahim / Wallentin, Lars / Windecker, Stephan W / Aimonetti, A / Allocco, D / Berenger, M / Boam, A / Calle, J P / Campo, G / Carlier, S / de Schepper, J / Di Bisceglie, G / Dobbels, H / Farb, A / Ghislain, J C / Hellbardt, S / ten Hoedt, R / Isaia, C / de Jong, P / Lekehal, M / LeNarz, L / Mhullain, F Ni / Nagai, H / Patteet, A / Paunovic, D / Potgieter, A / Purdy, I / Raveau-Landon, C / Ternstrom, S / Van Wuytswinkel, J / Waliszewski, M / Anonymous830624. ·Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #19284063.

ABSTRACT: -- No abstract --

5 Editorial Polymeric bioresorbable coronary scaffolds: the hype is over, but the dream lives on. 2018

Pyxaras, Stylianos A / Wijns, William. ·Medizinische Klinik I, Landshut-Achdorf Krankenhaus, Landshut, Germany. ·EuroIntervention · Pubmed #29345240.

ABSTRACT: -- No abstract --

6 Editorial PCR Peripheral @ GISE: a unique educational link between peripheral endovascular solutions and interventional cardiologists. 2017

Nicosia, Antonino / Cernetti, Carlo / Cremonesi, Alberto / Goktekin, Omer / Sauguet, Antoine / Wijns, William / Musumeci, Giuseppe. ·M.P. Arezzo Hospital, Ragusa, Italy. ·EuroIntervention · Pubmed #29033385.

ABSTRACT: -- No abstract --

7 Editorial Let's talk BIG DATA. 2016

Wijns, William / Barbato, Emanuele. ·The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, and Saolta University Healthcare Group, Galway, Ireland. ·EuroIntervention · Pubmed #27753594.

ABSTRACT: -- No abstract --

8 Editorial "De-risking" risk reduction: should coronary artery calcium scoring be the gatekeeper to preventive pharmacotherapy with the polypill? 2014

Wijns, William / Rusinaru, Dan. ·Cardiovascular Research Centre, Aalst, Belgium. Electronic address: William.Wijns@olvz-aalst.be. · Cardiovascular Research Centre, Aalst, Belgium. ·J Am Coll Cardiol · Pubmed #24161326.

ABSTRACT: -- No abstract --

9 Editorial Chasing numbers: the reinvention of clinical science. 2013

Wijns, William / Pyxaras, Stylianos A. · ·JACC Cardiovasc Interv · Pubmed #23517832.

ABSTRACT: -- No abstract --

10 Editorial The one-stop shop offering both coronary anatomy and myocardial perfusion: may well be opening soon, around the corner. 2012

Wijns, William. · ·JACC Cardiovasc Imaging · Pubmed #23153910.

ABSTRACT: -- No abstract --

11 Editorial Nonobstructive coronary plaque matters. 2011

Wijns, William / Schuijf, Joanne D. · ·J Am Coll Cardiol · Pubmed #21777750.

ABSTRACT: -- No abstract --

12 Editorial Elevated troponin in stable coronary artery disease: the sound of silence. 2011

Wijns, William / Crea, Filippo. · ·Heart · Pubmed #21270078.

ABSTRACT: -- No abstract --

13 Editorial The AUTAX (Austrian Multivessel TAXUS-Stent) registry: another useful registry on stented angioplasty for multivessel disease? 2009

Wijns, William. · ·JACC Cardiovasc Interv · Pubmed #19695540.

ABSTRACT: -- No abstract --

14 Editorial Late stent thrombosis after drug-eluting stent: seeing is understanding. 2009

Wijns, William. · ·Circulation · Pubmed #19620496.

ABSTRACT: -- No abstract --

15 Review Step-by-step manual for planning and performing bifurcation PCI: a resource-tailored approach. 2018

Milasinovic, Dejan / Wijns, William / Ntsekhe, Mpiko / Hellig, Farrel / Mohamed, Awad / Stankovic, Goran. ·Department of Cardiology, Clinical Center of Serbia, Belgrade, Serbia. ·EuroIntervention · Pubmed #29175768.

ABSTRACT: As bifurcation PCI can often be resource-demanding due to the use of multiple guidewires, balloons and stents, different technical options are sometimes being explored, in different local settings, to meet the need of optimally treating a patient with a bifurcation lesion, while being confronted with limited material resources. Therefore, it seems important to keep a proper balance between what is recognised as the contemporary state of the art, and what is known to be potentially harmful and to be discouraged. Ultimately, the resource-tailored approach to bifurcation PCI may be characterised by the notion of minimum technical requirements for each step of a successful procedure. Hence, this paper describes the logical sequence of steps when performing bifurcation PCI with provisional SB stenting, starting with basic anatomy assessment and ending with the optimisation of MB stenting and the evaluation of the potential need to stent the SB, suggesting, for each step, the minimum technical requirement for a successful intervention.

16 Review State of the art: coronary angiography. 2017

Collet, Carlos / Grundeken, Maik J / Asano, Taku / Onuma, Yoshinobu / Wijns, William / Serruys, Patrick W. ·Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. ·EuroIntervention · Pubmed #28844026.

ABSTRACT: In the early days of coronary angiography, the precise quantification of luminal narrowing was challenging. The introduction of balloon angioplasty (percutaneous transluminal coronary angioplasty [PTCA]) by Andreas Grüntzig in 1977 was perhaps the greatest incentive to the development of quantitative coronary angiography (QCA). QCA has played a crucial role in evaluating interventional techniques and assessing the results of new technologies. With the advent of drug-eluting stents (DES), QCA metrics such as late lumen loss and diameter stenosis (restenosis) proved to be instrumental in assessing new technologies. Refinements in QCA with the advent of dedicated bifurcation analysis and three-dimensional (3D) QCA have broadened the application of QCA. Beyond angiographic metrics, new developments in the field of QCA have introduced the functional component in the assessment of coronary lesions. Angiography-derived fractional flow reserve (FFR) may be a good tool for diagnosing ischaemia-producing lesions in patients with non-complex coronary artery disease. Furthermore, the incremental functional information can be used to expand the traditional late lumen loss (LLL) and restenosis concepts.

17 Review Fractional flow reserve to guide and to assess coronary artery bypass grafting. 2017

Pellicano, Mariano / De Bruyne, Bernard / Toth, Gabor G / Casselman, Filip / Wijns, William / Barbato, Emanuele. ·Cardiovascular Research Center Aalst, OLV Clinic, Moorselbaan n 164, B 9300 Aalst, Belgium. · Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy. · University Heart Center Graz, Medical University Graz, Graz, Austria. · The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway and Saolta University Healthcare Group, Galway, Ireland. ·Eur Heart J · Pubmed #28025191.

ABSTRACT: The aim of this review is to highlight the role of invasive functional evaluation in patients in whom coronary artery bypass graft (CABG) is indicated, and to examine the clinical evidence available in favour of fractional flow reserve (FFR) adoption in these patients, outline appropriate use, as well as point out potential pitfalls. FFR after CABG will also be reviewed, highlighting its correct interpretation and adoption when applied to both native coronary arteries and bypass grafts. Practice European guidelines support the use of FFR to complement coronary angiography with the highest degree of recommendation (Class IA) for the assessment of coronary stenosis before undertaking myocardial revascularization when previous non-invasive functional evaluation is unavailable or not conclusive. As a result, FFR has been adopted in routine clinical practice to guide clinicians decision as to whether or not perform a revascularization. Of note, due to the increasing confidence of the interventional cardiologists, FFR guidance is also being implemented to indicate or guide CABG. This is in anticipation of supportive clear-cut evidence, since recommendations for FFR adoption were based on randomized clinical trials investigating percutaneous coronary intervention (PCI) strategies in which patients with typical indications for CABG were excluded (e.g. left main disease, valvular disease, and coronary anatomy unsuitable for PCI). Based on the critical appraisal of the literature, FFR can play an important role in risk stratification and determining management strategy of patients either before or after CABG.

18 Review The year in cardiology 2015: coronary intervention. 2016

Steg, Philippe Gabriel / Serruys, Patrick W / Abdelghani, Mohammad / Wijns, William. ·FACT (French Alliance for Cardiovascular clinical Trials), an F-CRIN network, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France Université Paris-Diderot, Sorbonne Paris Cité, Paris, France INSERM U-1148, Paris F-75018, France NHLI, Imperial College, Royal Brompton Hospital, London, UK gabriel.steg@aphp.fr gabriel.steg@bch.ap-hop-paris.fr gabriel.steg@bch.aphp.fr pgsteg@noos.fr. · International Centre for Circulatory Health, NHLI, Imperial College London, London, UK. · Academic Medical Center, Amsterdam, The Netherlands. · Cardiovascular Research Center Aalst, Aalst, Belgium. ·Eur Heart J · Pubmed #26726048.

ABSTRACT: -- No abstract --

19 Review Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary. 2015

Byrne, Robert A / Serruys, Patrick W / Baumbach, Andreas / Escaned, Javier / Fajadet, Jean / James, Stefan / Joner, Michael / Oktay, Semih / Jüni, Peter / Kastrati, Adnan / Sianos, George / Stefanini, Giulio G / Wijns, William / Windecker, Stephan. ·Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. · Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands. · Bristol Heart Institute, Bristol, UK. · Interventional Cardiology, Hospital San Carlos, Madrid, Spain. · Interventional Cardiology, Clinique Pasteur, Toulouse, France. · Clinical Research Center, Uppsala University, Uppsala, Sweden. · CVPath Institute, Inc., Gaithersburg, USA. · Cardio Med Device Consultants, Baltimore, USA. · Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. · AHEPA University Hospital, Thessaloniki, Greece. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. · Cardiovascular Center O.L.V.Z., Aalst, Belgium. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland stephan.windecker@insel.ch. ·Eur Heart J · Pubmed #26071600.

ABSTRACT: The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

20 Review The year in cardiology 2014: coronary intervention. 2015

Iqbal, Javaid / Serruys, Patrick W / Albuquerque, Felipe N / Wijns, William. ·Manchester Heart Centre, Manchester Royal Infirmary, Manchester, UK. · Erasmus Medical Centre, Rotterdam, the Netherlands Imperial College, London, UK. · Montefiore Medical Centre, Albert Einstein College of Medicine, New York, NY, USA. · Cardiovascular Research Centre, OLV Hospital, Aalst, Belgium william.wijns@olvz-aalst.be. ·Eur Heart J · Pubmed #25559135.

ABSTRACT: -- No abstract --

21 Review Novel antiplatelet agents: ALX-0081, a Nanobody directed towards von Willebrand factor. 2013

Bartunek, Jozef / Barbato, Emanuele / Heyndrickx, Guy / Vanderheyden, Marc / Wijns, William / Holz, Josefin-Beate. ·Cardiovascular Center Aalst, OLV Clinic, Moorselbaan 164, 9300 Aalst, Belgium. ·J Cardiovasc Transl Res · Pubmed #23307200.

ABSTRACT: This manuscript reviews the studies performed with ALX-0081 (INN: caplacizumab), a Nanobody targeting von Willebrand factor, in the context of current antithrombotic therapy in coronary artery disease. ALX-0081 specifically inhibits platelet adhesion to the vessel wall, and may control platelet aggregation and subsequent clot formation without increasing bleeding risk. A substantial number of antithrombotics are aimed at this cascade; however, their generally indiscriminative mode of action can result in a narrow therapeutic window, defined by the risk for bleeding complications, and thrombotic events. Nonclinically, ALX-0081 compared favorably to several antithrombotics. In Phase I studies in healthy subjects and stable angina patients undergoing percutaneous coronary intervention (PCI), ALX-0081 was well tolerated, and effectively inhibited pharmacodynamic markers. Following these results, a phase II study was initiated in high-risk acute coronary syndrome patients undergoing PCI. Based on its mechanism of action, ALX-0081 is also being developed for acquired thrombotic thrombocytopenic purpura.

22 Review STEMI guidelines: from formulation to implementation. 2012

Di Mario, Carlo / Syrseloudis, Dimitrios / James, Stefan / Viceconte, Nicola / Wijns, William. ·Cardiovascular Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom. ·EuroIntervention · Pubmed #22917781.

ABSTRACT: -- No abstract --

23 Clinical Trial In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris - DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial. 2018

Garcia-Garcia, Hector M / Haude, Michael / Kuku, Kayode / Hideo-Kajita, Alexandre / Ince, Hüseyin / Abizaid, Alexandre / Tölg, Ralph / Lemos, Pedro Alves / von Birgelen, Clemens / Christiansen, Evald Høj / Wijns, William / Escaned, Javier / Dijkstra, Jouke / Waksman, Ron. ·Department of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address: hector.m.garciagarcia@medstar.net. · Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. · Department of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. · Department of Cardiology, Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany. · Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil. · Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany. · Instituto do Coração - HCFMUSP, University of Sao Paulo, São Paulo, Brazil. · Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, The Netherlands. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. · Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. · LKEB, Leiden University, Leiden, The Netherlands. ·Int J Cardiol · Pubmed #29292064.

ABSTRACT: RATIONALE: Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall. OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). METHODS AND RESULTS: The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58°; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (Δ 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (Δ 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months. Likewise, by echogenicity, hyperechogenic structures decreased significantly from post-procedure at 6months; thereafter, they remained unchanged. CONCLUSION: Following implantation of DREAMS 2G, restoration of the vessel geometry, vasomotion and bioresorption signs were observed at up to 12months; importantly, these changes occurred with preservation of the lumen size between 6 and 12months. NCT01960504.

24 Clinical Trial A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial. 2018

de Winter, Robbert J / Katagiri, Yuki / Asano, Taku / Milewski, Krzysztof P / Lurz, Philipp / Buszman, Pawel / Jessurun, Gillian A J / Koch, Karel T / Troquay, Roland P T / Hamer, Bas J B / Ophuis, Ton Oude / Wöhrle, Jochen / Wyderka, Rafał / Cayla, Guillaume / Hofma, Sjoerd H / Levesque, Sébastien / Żurakowski, Aleksander / Fischer, Dieter / Kośmider, Maciej / Goube, Pascal / Arkenbout, E Karin / Noutsias, Michel / Ferrari, Markus W / Onuma, Yoshinobu / Wijns, William / Serruys, Patrick W. ·Academic Medical Center, Amsterdam, Netherlands. · Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji PAKS, American Heart of Poland SA, Tychy, Poland. · Department of Internal Medicine and Cardiology, University of Leipzig-Heart Center, Leipzig, Germany. · Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland. · Department of Cardiology, Treant Zorggroep, Emmen, Netherlands. · VieCuri Medical Center for Northern Limburg, Venlo, Netherlands. · Meander Medisch Centrum, Amersfoort, Netherlands. · Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands. · Universitätsklinikum Ulm, Ulm, Germany. · Zgierskie Centrum Kardiologii Med-Pro, Zgierz, Poland. · Department of Cardiology, CHU Nîmes, Université de Montpellier, Montpellier, France. · Medisch Centrum Leeuwarden, Leeuwarden, Netherlands. · CHU de Poitiers, Poitiers, France. · Małopolskie Centrum Sercowo-Naczyniowe PAKS, Chrzanow, Poland. · Universitätsklinikum Münster, Münster, Germany. · Oddzial Kardiologiczny PAKS, Bełchatów, Poland. · CH Sud Francilien Corbeil Essonne, Corbeil Essonnes, France. · Department of Cardiology, Tergooi Hospital, Blaricum, Netherlands. · Department of Cardiology, Pneumonology and Intensive Care Medicine, Clinic for Internal Medicine I, University Hospital Jena, Friedrich-Schiller-University, Jena, Germany. · Dr Horst Schmidt Kliniken Wiesbaden, Wiesbaden, Germany. · ThoraxCenter, Erasmus Medical Center, Rotterdam, Netherlands. · Cardiovascular Research Center Aalst, Aalst, Belgium; National University of Ireland Galway, The Lambe Institute for Translational Medicine and CURAM, Galway, Ireland. · National Heart and Lung Institute, Imperial College London, London, UK. Electronic address: patrick.w.j.c.serruys@gmail.com. ·Lancet · Pubmed #29203070.

ABSTRACT: BACKGROUND: MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. METHODS: We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. FINDINGS: Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45 patients (6·5%) in the everolimus-eluting stent group (absolute difference -0·8% [95% CI -3·3 to 1·8], p INTERPRETATION: The sirolimus-eluting bioabsorbable polymer stent was non-inferior to the everolimus-eluting durable polymer stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. MiStent seems a reasonable alternative to other stents in clinical practice. FUNDING: The European Cardiovascular Research Institute, Micell Technologies (Durham, NC, USA), and Stentys (Paris, France).

25 Clinical Trial Sustained safety and performance of the second-generation drug-eluting 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. 2016

Haude, Michael / Ince, Hüseyin / Abizaid, Alexandre / Toelg, Ralph / Lemos, Pedro Alves / von Birgelen, Clemens / Christiansen, Evald Høj / Wijns, William / Neumann, Franz-Josef / Kaiser, Christoph / Eeckhout, Eric / Lim, Soo Teik / Escaned, Javier / Onuma, Yoshinobu / Garcia-Garcia, Hector M / Waksman, Ron. ·Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Preussenstr. 84, 41464 Neuss, Germany mhaude@lukasneuss.de michael.haude@uni-due.de. · Department of Cardiology, Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany. · Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil. · Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany. · Instituto do Coração - HCFMUSP, University of Sao Paulo, São Paulo, Brazil. · Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, The Netherlands. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. · Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany. · Department of Cardiology, University Hospital, Basel, Switzerland. · Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland. · Department of Cardiology, National Heart Center Singapore, Singapore, Singapore. · Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. · Cardialysis BV, Rotterdam, The Netherlands. · Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. ·Eur Heart J · Pubmed #27190094.

ABSTRACT: AIMS: Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomes of a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesium scaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device. METHODS AND RESULTS: The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and-if subjects consented-at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42 patients: in-segment late lumen loss 0.20 ± 0.21 mm vs. 0.25 ± 0.22 mm, P = 0.117, Δ 0.05 ± 0.21 mm (95% CI: -0.01;0.12); in-scaffold late lumen loss 0.37 ± 0.25 mm vs. 0.39 ± 0.27 mm, P = 0.446, Δ 0.03 ± 0.22 (95% CI: -0.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroborated the QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional event occurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienced a definite or probable scaffold thrombosis. CONCLUSION: The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile up to 12 months and stable angiographic parameters between 6 and 12 months. CLINICALTRIALSGOV IDENTIFIER: NCT01960504.

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