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Coronary Artery Disease: HELP
Articles by William Wijns
Based on 149 articles published since 2009
(Why 149 articles?)
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Between 2009 and 2019, William Wijns wrote the following 149 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4 · 5 · 6
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 2014 ESC/EACTS Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). 2014

Kolh, Philippe / Windecker, Stephan / Alfonso, Fernando / Collet, Jean-Philippe / Cremer, Jochen / Falk, Volkmar / Filippatos, Gerasimos / Hamm, Christian / Head, Stuart J / Jüni, Peter / Kappetein, A Pieter / Kastrati, Adnan / Knuuti, Juhani / Landmesser, Ulf / Laufer, Günther / Neumann, Franz-Josef / Richter, Dimitrios J / Schauerte, Patrick / Sousa Uva, Miguel / Stefanini, Giulio G / Taggart, David Paul / Torracca, Lucia / Valgimigli, Marco / Wijns, William / Witkowski, Adam / Anonymous7870804 / Zamorano, Jose Luis / Achenbach, Stephan / Baumgartner, Helmut / Bax, Jeroen J / Bueno, Héctor / Dean, Veronica / Deaton, Christi / Erol, Çetin / 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 / Anonymous7880804 / Sousa Uva, Miguel / Achenbach, Stephan / Pepper, John / Anyanwu, Anelechi / Badimon, Lina / Bauersachs, Johann / Baumbach, Andreas / Beygui, Farzin / Bonaros, Nikolaos / De Carlo, Marco / Deaton, Christi / Dobrev, Dobromir / Dunning, Joel / Eeckhout, Eric / Gielen, Stephan / Hasdai, David / Kirchhof, Paulus / Luckraz, Heyman / Mahrholdt, Heiko / Montalescot, Gilles / Paparella, Domenico / Rastan, Ardawan J / Sanmartin, Marcelo / Sergeant, Paul / Silber, Sigmund / Tamargo, Juan / ten Berg, Jurrien / Thiele, Holger / van Geuns, Robert-Jan / Wagner, Hans-Otto / Wassmann, Sven / Wendler, Olaf / Zamorano, Jose Luis / Anonymous7890804 / Anonymous7900804. ·(Belgium) philippe.kolh@chu.ulg.ac.be stephan.windecker@insel.ch. · (Switzerland) philippe.kolh@chu.ulg.ac.be stephan.windecker@insel.ch. · (Spain). · (France). · (Germany). · (Switzerland). · (Greece). · (Netherlands). · (Finland). · (Austria). · (Portugal). · (UK). · (Italy). · (Belgium). · (Poland). · (Turkey). · (Israel). · (Germany/UK). · (Czech Republic). · (Norway). · (USA). · (UK/Germany). ·Eur J Cardiothorac Surg · Pubmed #25173601.

ABSTRACT: -- No abstract --

3 Guideline 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). 2014

Anonymous7760804 / Windecker, Stephan / Kolh, Philippe / Alfonso, Fernando / Collet, Jean-Philippe / Cremer, Jochen / Falk, Volkmar / Filippatos, Gerasimos / Hamm, Christian / Head, Stuart J / Jüni, Peter / Kappetein, A Pieter / Kastrati, Adnan / Knuuti, Juhani / Landmesser, Ulf / Laufer, Günther / Neumann, Franz-Josef / Richter, Dimitrios J / Schauerte, Patrick / Sousa Uva, Miguel / Stefanini, Giulio G / Taggart, David Paul / Torracca, Lucia / Valgimigli, Marco / Wijns, William / Witkowski, Adam. · ·Eur Heart J · Pubmed #25173339.

ABSTRACT: -- No abstract --

4 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 --

5 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.

6 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 --

7 Editorial Anatomical or Functional Assessment of Coronary Artery Disease in Aortic Stenosis: Haven't We Been Down This Road Before? 2019

Mylotte, Darren / Wijns, William. ·The Lambe Institute for Translational Medicine and Curam Saolta University Healthcare Group Galway Ireland. ·J Am Heart Assoc · Pubmed #31718440.

ABSTRACT: -- No abstract --

8 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 --

9 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 --

10 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 --

11 Editorial Are we ready for a new paradigm shift in percutaneous revascularization of chronically occluded vessels with well-developed collaterals?: from leaving 'em all to stenting 'em all. 2015

Barbato, Emanuele / Wijns, William. ·Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy. · Cardiovascular Research Center Aalst, Onze-Lieve Vrouw Hospital, Aalst, Belgium. Electronic address: William.wijns@olvz-aalst.be. ·JACC Cardiovasc Interv · Pubmed #25700751.

ABSTRACT: -- No abstract --

12 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 --

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

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

ABSTRACT: -- No abstract --

14 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 --

15 Editorial Nonobstructive coronary plaque matters. 2011

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

ABSTRACT: -- No abstract --

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

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

ABSTRACT: -- No abstract --

17 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 --

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

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

ABSTRACT: -- No abstract --

19 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.

20 Review Invasive assessment of coronary artery disease. 2018

Pyxaras, Stylianos A / Wijns, William / Reiber, Johan H C / Bax, Jeroen J. ·Cardiology Department, Coburg-Clinic, Ketschendorfer Str. 33, 96450, Coburg, Germany. steliospyxaras@gmail.com. · The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway and Saolta University Healthcare Group, Galway, Ireland. · Division of Image Processing, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands. · Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. ·J Nucl Cardiol · Pubmed #28849416.

ABSTRACT: Coronary artery disease is associated to high mortality and morbidity rates and an accurate diagnostic assessment during heart catheterization has a fundamental role in prognostic stratification and treatment choices. Coronary angiography has been integrated by intravascular imaging modalities, namely intravascular ultrasound and optical coherence tomography, which allow the precise quantification of the atherosclerotic burden of coronary arteries. The hemodynamic relevance of a given coronary stenosis can be assessed using stress or resting indexes: fractional flow reserve and instantaneous wave-free ratio are both coronary flow surrogates, used to guide percutaneous coronary interventions. This review summarizes the current state-of-the-art of invasive diagnostic methods during heart catheterization and highlights the potential role that an integration of anatomical and functional information enables.

21 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.

22 Review The year in cardiology 2016: coronary interventions. 2017

Di Mario, Carlo / Sorini Dini, Carlotta / Wijns, William. ·Structural Interventional Cardiology Division, Careggi University Hospital, Largo Brambilla 3, 50134 Florence, Italy. · National Heart and Lung Institute, Imperial College, Sydney Street, Chelsea, London SW3 6NP, London. · Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway and Saolta University Healthcare Group, University Road, Galway, Ireland. ·Eur Heart J · Pubmed #28043975.

ABSTRACT: -- No abstract --

23 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.

24 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 --

25 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.

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