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13 results on '"Grunwald, I"'

1. Initial Experience Using the Gore Embolic Filter in Carotid Interventions.

Author

Hornung M, Franke J, Bertog SC, Gafoor S, Grunwald I, and Sievert H

Subjects
Aged, Female, Germany epidemiology, Humans, Intracranial Embolism etiology, Ischemic Attack, Transient etiology, Male, Middle Aged, Outcome and Process Assessment, Health Care, Stroke etiology, Carotid Stenosis diagnosis, Carotid Stenosis epidemiology, Carotid Stenosis surgery, Embolic Protection Devices statistics & numerical data, Endarterectomy, Carotid adverse effects, Endarterectomy, Carotid instrumentation, Endarterectomy, Carotid methods, Intracranial Embolism prevention & control, Ischemic Attack, Transient prevention & control, Postoperative Complications etiology, Postoperative Complications prevention & control, Stroke prevention & control
Abstract

Background: This is the first clinical report on experience in the use of the Gore embolic filter in carotid interventions. It was designed as a guidewire and embolic protection system in carotid, peripheral, and coronary interventions. The ability to capture debris is driven by the frame of the filter, which is designed to improve vessel wall apposition and allows a short landing zone., Methods: We report the results of the first 20 consecutive patients undergoing carotid artery stenting using the Gore embolic filter in our institution. We analyzed technical success as well as the occurrence of transient ischemic attack (TIA), stroke, or death periprocedurally and through 30 days of follow-up. Mean patient age was 72 years and 12 patients (60%) were male. Seven patients were symptomatic and 4 patients suffered recurrent neurological events., Results: Technical success was achieved in all procedures. In 1 patient, the retrieval catheter was caught between the proximal struts of the stent and required further retrieval maneuvers. Within 30 days of follow-up, 1 patient had a TIA. No stroke, death, or myocardial infarction occurred., Conclusion: This initial experience suggests that the Gore embolic filter device can be used safely for distal embolic protection during carotid stenting procedures with high technical success.

Published
2016

2. Evaluation of proximal protection devices during carotid artery stenting as the first choice for embolic protection.

Author

Hornung M, Bertog SC, Franke J, Id D, Grunwald I, and Sievert H

Subjects
Aged, Aged, 80 and over, Carotid Stenosis diagnostic imaging, Cerebral Angiography, Female, Humans, Ischemic Attack, Transient prevention & control, Male, Middle Aged, Stroke prevention & control, Carotid Stenosis surgery, Embolic Protection Devices, Endovascular Procedures instrumentation, Intracranial Embolism prevention & control, Ischemic Attack, Transient surgery, Stents, Stroke surgery
Abstract

Aims: To assess the use of proximal protection devices in consecutive patients as the preferred means of cerebral embolic protection for primary carotid stenting., Methods and Results: This was a prospective single-centre study to evaluate the technical and clinical success of proximal protection devices as the first choice for embolic protection in symptomatic (≥50%) and asymptomatic (≥70%) carotid stenosis. Proximal protection devices were used for embolic protection in 124 consecutive patients. No patients were excluded for anatomical reasons. The GORE Flow Reversal System (W.L. Gore, Flagstaff, AZ, USA) was used in 92 patients, and the Mo.Ma Ultra device (Medtronic, Minneapolis, MN, USA) in 32 patients. Follow-up duration was 30 days. Mean age was 71±8 years. Seventy-five percent of patients were male (n=93). Twenty-six of 124 (21%) treated stenoses were symptomatic. Technical success was achieved in 122 of 124 cases (98%). Due to anatomical conditions, in two patients flow reversal could not be established. In both cases additional distal filter devices were used. Carotid stenting was successful in 124 lesions (100%). Ten patients (8.1%) had contraindications to flow reversal (three high-grade ostial stenoses of the external carotid artery, seven contralateral occlusions of the internal carotid artery) in none of whom complications occurred. There were no procedural neurologic events. Within 30 days of follow-up, one patient had an ischaemic stroke (on day 11)., Conclusions: Proximal protection is a safe method as the first choice for embolic protection. It can be used with a high rate of technical success.

Published
2015
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3. Complications during carotid artery stenting.

Author

Bertog SC, Grunwald IQ, Kühn AL, Franke J, Vaskelyte L, Hofmann I, Id D, Hornung M, and Sievert H

Subjects
Humans, Blood Vessel Prosthesis Implantation adverse effects, Carotid Arteries surgery, Carotid Stenosis surgery, Intraoperative Complications, Stents
Abstract

Carotid stenting has become a commonly used procedure for the treatment of carotid artery stenosis. Though equipment and techniques have improved tremendously over the recent 3 decades, complications do occur. It is important for carotid operators to be familiar with potential complications and adverse events. In this article complications and adverse events of carotid stenting including those that are related to the vascular access site, vessel spasm, dissection, perforation, thrombotic occlusion and hemodynamic instability and arrhythmias are reviewed. In addition, management strategies are discussed.

Published
2013

4. Comparison of stent free cell area and cerebral lesions after unprotected carotid artery stent placement.

Author

Grunwald IQ, Reith W, Karp K, Papanagiotou P, Sievert H, Walter S, Kühn AL, Fassbender K, and Krick C

Subjects
Aged, Angioplasty adverse effects, Brain Ischemia diagnosis, Carotid Stenosis complications, Carotid Stenosis diagnosis, Diffusion Magnetic Resonance Imaging, Female, Germany, Humans, Male, Multivariate Analysis, Predictive Value of Tests, Prosthesis Design, Retrospective Studies, Risk Assessment, Risk Factors, Severity of Illness Index, Treatment Outcome, Angioplasty instrumentation, Brain Ischemia etiology, Carotid Stenosis therapy, Stents
Abstract

Objective: This study evaluates the correlation between closed, semi-closed and open-cell stent design and the association between stent type and clinical outcome as well as magnetic resonance imaging (MRI) findings., Design: A total of 194 patients who underwent unprotected carotid artery stenting (CAS) as well as diffusion-weighted magnetic resonance imaging (DW-MRI) before and after intervention were retrospectively reviewed., Materials and Methods: Three stent designs were studied: closed cell, semi-closed cell and open cell. Spearman's Rho test was performed between the stent free cell area and the number and area of ischaemic lesions found after intervention. Adverse events were evaluated., Results: There was no significant difference in clinical outcome between the three stent groups (Zilver, Cook Europe, Denmark; Smart, Codman, MA; and Wallstent, Stryker, MN, USA). A significant correlation was found between the stent free cell area and the number and area of new ischaemic lesions on DW-MRI (P = 0.023). There were significantly fewer new lesions with an open-cell design (Zilver; 12.76 mm(2) free cell area) than with a closed-cell design (Wallstent; 1.08 mm(2) free cell area)., Conclusions: Open-cell stent was related to a lower number and area of silent cerebral ischaemic lesions after unprotected CAS. However, clinical outcome, measured by incidence of adverse events and clinical neurologic assessment, was not significantly different between patients with different stent designs., (Copyright © 2011. Published by Elsevier Ltd.)

Published
2012
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5. [With or without? The dilemma with protection].

Author

Kühn AL and Grunwald IQ

Subjects
Diffusion Magnetic Resonance Imaging, Humans, Intracranial Embolism diagnosis, Intracranial Embolism etiology, Randomized Controlled Trials as Topic, Treatment Outcome, Ultrasonography, Doppler, Transcranial, Angioplasty, Brain blood supply, Carotid Stenosis therapy, Embolic Protection Devices, Intracranial Embolism prevention & control, Stents
Published
2011
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6. Controversies around carotid stenting.

Author

Grunwald IQ and Kühn AL

Subjects
Carotid Stenosis surgery, Clinical Competence, Embolic Protection Devices, Endarterectomy, Carotid, Humans, Patient Selection, Platelet Aggregation Inhibitors therapeutic use, Randomized Controlled Trials as Topic, Stroke prevention & control, Treatment Outcome, Carotid Stenosis therapy, Endovascular Procedures methods, Stents
Abstract

In the last 10 years, CAS became an important alternative to surgery. However, many of the trials regarding stroke prevention had controversial requirements regarding the endovascular approach, leading to questionable conclusions. This review critically addresses results from previous randomized studies on efficacy and safety of the first established therapy for carotid artery stenosis, carotid endarterectomy (CEA) compared to the challenger, carotid artery stenting (CAS), as a newer and less invasive endovascular technique.

Published
2011
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7. Lesion load in unprotected carotid artery stenting.

Author

Grunwald IQ, Papanagiotou P, Roth C, Fassbender K, Karp K, Krick C, Schieber H, Müller M, Haass A, and Reith W

Subjects
Female, Humans, Male, Treatment Outcome, Blood Vessel Prosthesis, Carotid Stenosis diagnosis, Carotid Stenosis surgery, Diffusion Magnetic Resonance Imaging methods, Stents
Abstract

Introduction: The purpose of the study was to determine the incidence of new ischemic lesions found on diffusion-weighted MR imaging (DWI) in nonselected patients after unprotected carotid artery stent placement., Materials and Methods: We retrospectively reviewed a nonrandomized cohort of 197 patients presenting with carotid occlusive disease who underwent unprotected carotid artery stent placement between 2003 and 2006. Mean degree of stenosis was 86.94% +/- 9.72. In all patients, DWI was obtained before and 24 h after stent placement. New lesions were evaluated according to size and location., Results: In 59 of 197 patients (29.9%), new ischemic lesions were found on DWI in the vessel dependent area. In 23 of 197 patients (11.7%), new ischemic lesions were found in the vessel independent area. Combined stroke/death rate was 3.63%., Conclusion: In our series of unprotected carotid angioplasty with stent, we found new DWI lesions in 34% of the patients. Further studies should now show in how far protection devices can reduce these lesions.

Published
2009
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8. [Carotid artery stenting for acute stroke].

Author

Papanagiotou P, Roth C, Grunwald IQ, Ahlhelm F, Ernst N, Haass A, and Reith W

Subjects
Carotid Stenosis complications, Humans, Stroke etiology, Blood Vessel Prosthesis, Carotid Stenosis surgery, Embolization, Therapeutic instrumentation, Embolization, Therapeutic methods, Stents, Stroke surgery
Abstract

For patients with acute ischemic stroke due to total occlusion of the internal carotid artery (ICA), an effective intervention to improve neurologic symptoms and clinical outcome has not yet been established. Some authors have reported successful revascularization for patients with acute stroke symptoms secondary to ICA occlusion only in isolated series and case reports. Emergency recanalization and carotid artery stent placement can improve neurologic outcome in selected patients with acute ischemic stroke and total occlusion of the ICA.

Published
2009
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9. Cognitive changes after carotid artery stenting.

Author

Grunwald IQ, Supprian T, Politi M, Struffert T, Falkai P, Krick C, Backens M, and Reith W

Subjects
Aged, Aged, 80 and over, Carotid Artery, Internal, Carotid Stenosis complications, Cognition Disorders etiology, Cognition Disorders physiopathology, Female, Humans, Male, Middle Aged, Neuropsychological Tests, Statistics, Nonparametric, Carotid Stenosis therapy, Cognition Disorders therapy, Stents
Abstract

Introduction: We aimed to test changes in cognitive performance after carotid artery stenting (CAS)., Method: Ten patients were neuropsychologically tested at least 24 h before and 48 h after CAS. To diminish thromboembolic events, we used a proximal protection device. The following neuropsychological tests were selected: The Mini Mental State Examination (MMSE), symbol digit test and subtests of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) battery (verbal fluency, constructional practice, word list memory and delayed recall). Affective state was determined by the Beck Depression Score (BDS)., Results: No patient suffered from depression (BDS <1) or dementia (MMSE 29.9+/-1.5). Nine of the ten patients (P=0.12) showed increased speed in the Number Connection Test (NCT) (corresponding to trail making test). Most patients showed better or similar results concerning delayed recall (P=0.31). No change was observed in the symbol digit test, word list memory, verbal fluency or constructional practice. Better results concerning NCT and delayed recall after carotid stenting might be due to improved brain perfusion., Conclusion: After CAS, cognitive and memory performance seem to improve. Further studies with different time intervals and more refined testing, as well as perfusion-weighted imaging, are needed.

Published
2006
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10. [Technique and approach to carotid stenting].

Author

Reith W, Struffert T, Dorenbeck U, and Grunwald IQ

Subjects
Carotid Artery Thrombosis diagnostic imaging, Carotid Artery Thrombosis therapy, Carotid Stenosis diagnostic imaging, Cerebral Angiography, Endarterectomy, Humans, Outcome and Process Assessment, Health Care, Angioplasty, Balloon, Carotid Stenosis therapy, Stents
Abstract

Assuming that the ongoing large randomized controlled trials comparing CAS and endarterectomy support the efficacy and safety of CAS, this method will play a major role in patients with carotid stenosis in the near future. Patient selection, establishing standards of treatment, and systematic training of the interventionist are major issues. This article aims to give an overview of current techniques and devices available in CAS.

Published
2004
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11. [Treatment of arteriosclerotic carotid stenosis: an overview].

Author

Struffert T, Grunwald I, Roth C, and Reith W

Subjects
Brain Ischemia diagnostic imaging, Brain Ischemia therapy, Carotid Artery, Internal, Carotid Stenosis diagnostic imaging, Humans, Intracranial Arteriosclerosis diagnostic imaging, Outcome and Process Assessment, Health Care, Radiography, Angioplasty, Balloon, Carotid Stenosis therapy, Endarterectomy, Intracranial Arteriosclerosis therapy
Abstract

Endarterectomy for extracranial carotid stenosis has proven to be the method of choice for symptomatic patients suffering from ischemia (NASCET, ECST). The effectivity of the operation for asymptomatic stenosis seems to be likely since the publication of the first results of the ACST trial. The safety and efficiency of carotid stenting has not been proven so far and has to be evaluated in randomized trials comparing surgery and endovascular treatment. We provide an overview of the current trials and try to define the role of carotid stenting.

Published
2004
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12. [Proximal protection systems using carotid artery stent].

Author

Grunwald IQ, Dorenbeck U, Axmann C, Roth C, Struffert T, and Reith W

Subjects
Carotid Artery, Internal diagnostic imaging, Carotid Stenosis diagnostic imaging, Equipment Design instrumentation, Humans, Intracranial Embolism diagnostic imaging, Radiography, Angioplasty, Balloon instrumentation, Balloon Occlusion instrumentation, Carotid Stenosis therapy, Filtration instrumentation, Intracranial Embolism prevention & control, Stents
Abstract

Controversies as to whether or not a protection device should be used in carotid artery stenting exist. Currently three temporary cerebral protection devices are being used. These are devices with distal balloon occlusion or filtration baskets and proximal occlusion devices with flow reversal in the internal carotid artery. This article focuses on flow reversal systems and aims to give some advice as to which patients could benefit from their use.

Published
2004
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13. Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

Author

Alison Halliday, Richard Bulbulia, Leo H Bonati, Johanna Chester, Andrea Cradduck-Bamford, Richard Peto, Hongchao Pan, John Potter, Hans Henning Eckstein, Barbara Farrell, Marcus Flather, Averil Mansfield, Boby Mihaylova, Kazim Rahimi, David Simpson, Dafydd Thomas, Peter Sandercock, Richard Gray, Andrew Molyneux, Cliff P Shearman, Peter Rothwell, Anna Belli, Will Herrington, Parminder Judge, Peter Leopold, Marion Mafham, Michael Gough, Piergiorgio Cao, Sumaira MacDonald, Vasha Bari, Clive Berry, S Bradshaw, Wojciech Brudlo, Alison Clarke, Robin Cox, Susan Fathers, Kamran Gaba, Mo Gray, Elizabeth Hayter, Constance Holliday, Rijo Kurien, Michael Lay, Steffi le Conte, Jessica McManus, Zahra Madgwick, Dylan Morris, Andrew Munday, Sandra Pickworth, Wiktor Ostasz, Michiel Poorthuis, Sue Richards, Louisa Teixeira, Sergey Tochlin, Lynda Tully, Carol Wallis, Monique Willet, Alan Young, Renato Casana, Chiara Malloggi, Andrea Odero Jr, Vincenzo Silani, Gianfranco Parati, Giuseppe Malchiodi, Giovanni Malferrari, Francesco Strozzi, Nicola Tusini, Enrico Vecchiati, Gioacchino Coppi, Antonio Lauricella, Roberto Moratto, Roberto Silingardi, Jessica Veronesi, Andrea Zini, Emanuele Ferrero, Michelangelo Ferri, Andrea Gaggiano, Carmelo Labate, Franco Nessi, Daniele Psacharopulo, Andrea Viazzo, Giovanni Malacrida, Daniela Mazzaccaro, Giovanni Meola, Alfredo Modafferi, Giovanni Nano, Maria Teresa Occhiuto, Paolo Righini, Silvia Stegher, Stefano Chiarandini, Filippo Griselli, Sandro Lepidi, Fabio Pozzi Mucelli, Marcello Naccarato, Mario D'Oria, Barbara Ziani, Andrea Stella, Mortalla Dieng, Gianluca Faggioli, Mauro Gargiulo, Sergio Palermo, Rodolfo Pini, Giovanni Maria Puddu, Andrea Vacirca, Domenico Angiletta, Claudio Desantis, Davide Marinazzo, Giovanni Mastrangelo, Guido Regina, Raffaele Pulli, Paolo Bianchi, Lea Cireni, Elisabetta Coppi, Rocco Pizzirusso, Filippo Scalise, Giovanni Sorropago, Valerio Tolva, Valeria Caso, Enrico Cieri, Paola DeRango, Luca Farchioni, Giacomo Isernia, Massimo Lenti, Gian Battista Parlani, Guglielmo Pupo, Grazia Pula, Gioele Simonte, Fabio Verzini, Federico Carimati, Maria Luisa Delodovici, Federico Fontana, Gabriele Piffaretti, Matteo Tozzi, Efrem Civilini, Giorgio Poletto, Bernhard Reimers, Barbara Praquin, Sonia Ronchey, Laura Capoccia, Wassim Mansour, Enrico Sbarigia, Francesco Speziale, Pasqualino Sirignano, Danilo Toni, Roberto Galeotti, Vincenzo Gasbarro, Francesco Mascoli, Tiberio Rocca, Elpiniki Tsolaki, Giulia Bernardini, Ester DeMarco, Alessia Giaquinta, Francesco Patti, Massimiliano Veroux, Pierfrancesco Veroux, Carla Virgilio, Nicola Mangialardi, Matteo Orrico, Vincenzo Di Lazzaro, Nunzio Montelione, Francesco Spinelli, Francesco Stilo, Carlo Cernetti, Sandro Irsara, Giuseppe Maccarrone, Diego Tonello, Adriana Visonà, Beniamino Zalunardo, Emiliano Chisci, Stefano Michelagnoli, Nicola Troisi, Maela Masato, Massimo Dei Negri, Andrea Pacchioni, Salvatore Saccà, Giovanni Amatucci, Alfredo Cannizzaro, Federico Accrocca, Cesare Ambrogi, Renzo Barbazza, Giustino Marcucci, Andrea Siani, Guido Bajardi, Giovanni Savettieri, Angelo Argentieri, Riccardo Corbetta, Attilio Odero, Pietro Quaretti, Federico Z Thyrion, Alessandro Cappelli, Domenico Benevento, Gianmarco De Donato, Maria Agnese Mele, Giancarlo Palasciano, Daniela Pieragalli, Alessandro Rossi, Carlo Setacci, Francesco Setacci, Domenico Palombo, Maria Cecilia Perfumo, Edoardo Martelli, Aldo Paolucci, Santi Trimarchi, Viviana Grassi, Luigi Grimaldi, Giuliana La Rosa, Domenico Mirabella, Matteo Scialabba, Leonildo Sichel, Costantino L D'Angelo, Gian Franco Fadda, Holta Kasemi, Mario Marino, Francesco Burzotta, Francesco Alberto Codispoti, Angela Ferrante, Giovanni Tinelli, Yamume Tshomba, Claudio Vincenzoni, Deborah Amis, Dawn Anderson, Martin Catterson, Mike Clarke, Michelle Davis, Anand Dixit, Alexander Dyker, Gary Ford, Ralph Jackson, Sreevalsan Kappadath, David Lambert, Tim Lees, Stephen Louw, James McCaslin, Noala Parr, Rebecca Robson, Gerard Stansby, Lucy Wales, Vera Wealleans, Lesley Wilson, Michael Wyatt, Hardeep Baht, Ibrahim Balogun, Ilse Burger, Tracy Cosier, Linda Cowie, Gunaratnam Gunathilagan, David Hargroves, Robert Insall, Sally Jones, Hannah Rudenko, Natasha Schumacher, Jawaharlal Senaratne, George Thomas, Audrey Thomson, Tom Webb, Ellen Brown, Bernard Esisi, Ali Mehrzad, Shane MacSweeney, Norman McConachie, Alison Southam, Wayne Sunman, Ahmed Abdul-Hamiq, Jenny Bryce, Ian Chetter, Duncan Ettles, Raghuram Lakshminarayan, Kim Mitchelson, Christopher Rhymes, Graham Robinson, Paul Scott, Alison Vickers, Ray Ashleigh, Stephen Butterfield, Ed Gamble, Jonathan Ghosh, Charles N McCollum, Mark Welch, Sarah Welsh, Leszek Wolowczyk, Mary Donnelly, Stephen D'Souza, Anselm A Egun, Bindu Gregary, Thomas Joseph, Christine Kelly, Shuja Punekar, M Asad Rahi, Sonia Raj, Dare Seriki, George Thomson, James Brown, Ragunath Durairajan, Iris Grunwald, Paul Guyler, Paula Harman, Matthew Jakeways, Christopher Khuoge, Ashish Kundu, Thayalini Loganathan, Nisha Menon, Raji O Prabakaran, Devesh Sinha, Vicky Thompson, Sharon Tysoe, Dennis Briley, Chris Darby, Linda Hands, Dominic Howard, Wilhelm Kuker, Ursula Schulz, Rachel Teal, David Barer, Andrew Brown, Susan Crawford, Paul Dunlop, Ramesh Krishnamurthy, Nikhil Majmudar, Duncan Mitchell, Min P Myint, Richard O'Brien, Janice O'Connell, Naweed Sattar, Shanmugam Vetrivel, Jonathan Beard, Trevor Cleveland, Peter Gaines, John Humphreys, Alison Jenkins, Craig King, Daniel Kusuma, Ralph Lindert, Robbie Lonsdale, Raj Nair, Shah Nawaz, Faith Okhuoya, Douglas Turner, Graham Venables, Paul Dorman, Andrea Hughes, Deborah Jones, David Mendelow, Helen Rodgers, Aidas Raudoniitis, Peter Enevoldson, Hans Nahser, Imelda O'Brien, Francesco Torella, Dave Watling, Richard White, Pauline Brown, Dipankar Dutta, Lorraine Emerson, Paula Hilltout, Sachin Kulkarni, Jackie Morrison, Keith Poskitt, Fiona Slim, Sarah Smith, Amanda Tyler, Joanne Waldron, Mark Whyman, Milda Bajoriene, Lucy Baker, Amanda Colston, Bekky Eliot-Jones, Gita Gramizadeh, Catherine Lewis-Clarke, Laura McCafferty, Deborah Oliver, Debbie Palmer, Abhijeet Patil, Suzannah Pegler, Gopi Ramadurai, Aisling Roberts, Tracey Sargent, Shivaprasad Siddegowda, Ravi Singh-Ranger, Akintunde Williams, Lucy Williams, Steve Windebank, Tadas Zuromskis, Lanka Alwis, Jane Angus, Asaipillai Asokanathan, Caroline Fornolles, Diana Hardy, Sophy Hunte, Frances Justin, Duke Phiri, Marie Mitabouana-Kibou, Lakshmanan Sekaran, Sakthivel Sethuraman, Margaret L Tate, Joyce Akyea-Mensah, Stephen Ball, Angela Chrisopoulou, Elizabeth Keene, Alison Phair, Steven Rogers, John V Smyth, Colin Bicknell, Jeremy Chataway, Nicholas Cheshire, Andrew Clifton, Caroline Eley, Richard Gibbs, Mohammad Hamady, Beth Hazel, Alex James, Michael Jenkins, Nyma Khanom, Austin Lacey, Maz Mireskandari, Joanna O'Reilly, Antony Pereira, Tina Sachs, John Wolfe, Philip Davey, Gill Rogers, Gemma Smith, Gareth Tervit, Ian Nichol, Andrew Parry, Gavin Young, Simon Ashley, James Barwell, Francis Dix, Azlisham M Nor, Chris Parry, Angela Birt, Paul Davies, Jim George, Anne Graham, Leon Jonker, Nicci Kelsall, Caroline Potts, Toni Wilson, Jamie Crinnion, Larissa Cuenoud, Nikola Aleksic, Srdan Babic, Nenad Ilijevski, Đorde Radak, Dragan Sagic, Slobodan Tanaskovic, Momcilo Colic, Vladimir Cvetic, Lazar Davidovic, Dejana R Jovanovic, Igor Koncar, Perica Mutavdžic, Miloš Sladojevic, Ivan Tomic, Eike S Debus, Ulrich Grzyska, Dagmar Otto, Götz Thomalla, Jessica Barlinn, Johannes Gerber, Kathrin Haase, Christian Hartmann, Stefan Ludwig, Volker Pütz, Christian Reeps, Christine Schmidt, Norbert Weiss, Sebastian Werth, Simon Winzer, Janine Gemper, Albrecht Günther, Bianka Heiling, Elisabeth Jochmann, Panagiota Karvouniari, Carsten Klingner, Thomas Mayer, Julia Schubert, Friederike Schulze-Hartung, Jürgen Zanow, Yvonne Bausback, Franka Borger, Spiridon Botsios, Daniela Branzan, Sven Bräunlich, Henryk Hölzer, Janin Lenzer, Christopher Piorkowski, Nadine Richter, Johannes Schuster, Dierk Scheinert, Andrej Schmidt, Holger Staab, Matthias Ulrich, Martin Werner, Hermann Berger, Gábor Biró, Hans-Henning Eckstein, Michael Kallmayer, Kornelia Kreiser, Alexander Zimmermann, Bärbel Berekoven, Klaus Frerker, Vera Gordon, Giovanni Torsello, Sebastian Arnold, Cora Dienel, Martin Storck, Bernhard Biermaier, Hans Martin Gissler, Christof Klötzsch, Tomas Pfeiffer, Ralph Schneider, Leander Söhl, Michael Wennrich, Angelika Alonso, Michael Keese, Christoph Groden, Andreas Cöster, Andreas Engelhardt, Christoph-Maria Ratusinski, Bengt Berg, Martin Delle, Johan Formgren, Peter Gillgren, Lotta Jarl, Torbjörn B Kall, Peter Konrad, Niklas Nyman, Claes Skiöldebrand, Johnny Steuer, Rabbe Takolander, Jonas Malmstedt, Stefan Acosta, Katarina Björses, Kerstin Brandt, Nuno Dias, Anders Gottsäter, Jan Holst, Thorarinn Kristmundsson, Tobias Kühme, Tilo Kölbel, Bengt Lindblad, Mats Lindh, Martin Malina, Tomas Ohrlander, Tim Resch, Viola Rönnle, Björn Sonesson, Margareta Warvsten, Zbigniew Zdanowski, Erik Campbell, Per Kjellin, Hans Lindgren, Johan Nyberg, Björn Petersen, Gunnar Plate, Håkan Pärsson, Peter Qvarfordt, Pavel Ignatenko, Andrey Karpenko, Vladimir Starodubtsev, Mikhail A Chernyavsky, Maria S Golovkova, Boris B Komakha, Nikolay N Zherdev, Andrey Belyasnik, Pavel Chechulov, Dmitry Kandyba, Igor Stepanishchev, Csaba Csobay-Novák, Edit Dósa, László Entz, Balázs Nemes, Zoltán Szeberin, Pál Barzó, Mihaly Bodosi, Eniko Fákó, Béla Fülöp, Tamás Németh, Szilárd Pazdernyik, Krisztina Skoba, Erika Vörös, Eleni Chatzinikou, Athanasios Giannoukas, Christos Karathanos, Stylianos Koutsias, Georgios Kouvelos, Miltiadis Matsagkas, Styliani Ralli, Christos Rountas, Nikolaos Rousas, Konstantinos Spanos, Elias Brountzos, John D Kakisis, Andreas Lazaris, Konstantinos G Moulakakis, Leonidas Stefanis, Georgios Tsivgoulis, Spyros Vasdekis, Constantine N Antonopoulos, Ion Bellenis, Dimitrios Maras, Antonios Polydorou, Victoria Polydorou, Antonios Tavernarakis, Nikolaos Ioannou, Maria Terzoudi, Miltos Lazarides, Michalis Mantatzis, Kostas Vadikolias, Lukasz Dzieciuchowicz, Marcin Gabriel, Zbigniew Krasinski, Grzegorz Oszkinis, Fryderyk Pukacki, Maciej Slowinski, Michal-Goran Stanišic, Ryszard Staniszewski, Jolanta Tomczak, Maciej Zielinski, Piotr Myrcha, Dorota Rózanski, Stanislaw Drelichowski, Wojciech Iwanowski, Katarzyna Koncewicz, Pawel Bialek, Zbigniew Biejat, Wojciech Czepel, Anna Czlonkowska, Anatol Dowzenko, Julia Jedrzejewska, Adam Kobayashi, Jerzy Leszczynski, Andrzej Malek, Jerzy Polanski, Robert Proczka, Maciej Skorski, Mieczyslaw Szostek, Piotr Andziak, Maciej Dratwicki, Robert Gil, Miroslaw Nowicki, Jaroslaw Pniewski, Jaroslaw Rzezak, Piotr Seweryniak, Pawel Dabek, Michal Juszynski, Grzegorz Madycki, Bartosz Pacewski, Witold Raciborski, Piotr Slowinski, Walerian Staszkiewicz, Martin Bombic, Vladimír Chlouba, Jirí Fiedler, Karel Hes, Petr Koštál, Jindrich Sova, Zdenek Kríž, Mojmír Prívara, Michal Reif, Robert Staffa, Robert Vlachovský, Bohuslav Vojtíšek, Tomáš Hrbác, Martin Kuliha, Václav Procházka, Martin Roubec, David Školoudík, David Netuka, Anna Šteklácová, Vladimír Beneš III, Pavel Buchvald, Ladislav Endrych, Miroslav Šercl, Walter Campos Jr, Ivan B Casella, Nelson de Luccia, André E V Estenssoro, Calógero Presti, Pedro Puech-Leão, Celso R B Neves, Erasmo S da Silva, Cid J Sitrângulo Jr, José A T Monteiro, Gisela Tinone, Marcelo Bellini Dalio, Edwaldo E Joviliano, Octávio M Pontes Neto, Mauricio Serra Ribeiro, Patrick Cras, Jeroen M H Hendriks, Mieke Hoppenbrouwers, Patrick Lauwers, Caroline Loos, Laetitia Yperzeele, Mia Geenens, Dimitri Hemelsoet, Isabelle van Herzeele, Frank Vermassen, Parla Astarci, Frank Hammer, Valérie Lacroix, André Peeters, Robert Verhelst, Silvana Cirelli, Pol Dormal, Annelies Grimonprez, Bart Lambrecht, Philipe Lerut, Eddy Thues, Guy De Koster, Quentin Desiron, Alain Maertens de Noordhout, Danielle Malmendier, Mireille Massoz, Georges Saad, Marc Bosiers, Joren 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Subjects
Male, medicine.medical_specialty, Time Factors, Time Factor, medicine.medical_treatment, Carotid Stenosi, MEDLINE, Carotid endarterectomy, Rate ratio, Risk Assessment, Asymptomatic, law.invention, Randomized controlled trial, law, Risk Factors, carotid artery stenting (CAS), carotid endarterectomy (CEA), Stent, medicine, Humans, Carotid Stenosis, Stroke, Endarterectomy, Aged, Endarterectomy, Carotid, business.industry, carotid artery, Risk Factor, Articles, General Medicine, trial, medicine.disease, Settore MED/22 - CHIRURGIA VASCOLARE, Surgery, Stenosis, Treatment Outcome, Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, Female, Stents, Human medicine, medicine.symptom, business, Human
Abstract

Summary Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding UK Medical Research Council and Health Technology Assessment Programme.

Published
2021

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