Jean-Louis Mas1, Caroline Arquizan2, David Calvet2, Alain Viguier2, Jean-François Albucher2, Philippe Piquet2, Pierre Garnier2, Fausto Viader2, Maurice Giroud2, Hassan Hosseini2, Grégoire Hinzelin2, Pascal Favrole2, Hilde Hénon2, Jean-Philippe Neau2, Xavier Ducrocq2, Raymond Padovani2, Loic Milandre2, François Rouanet2, Valérie Wolff2, Denis Saudeau2, Marie-Hélène Mahagne2, Denis Sablot2, Pierre Amarenco2, Vincent Larrue2, Bernard Beyssen2, Didier Leys2, Thierry Moulin2, Michel Lièvre2, Gilles Chatellier2. 1. From the Hôpital Sainte-Anne, Université Paris-Descartes, INSERM U894, DHU Neurovasc-Paris Sorbonne, Paris, France (J.-L.M., D.C.); Hôpital Gui de Chauliac, Université Montpellier 1, Montpellier, France (C.A.); Hôpital Rangueil (A.V., V.L.) and Hôpital Purpan (J.-F.A.), Université Paul Sabatier, Toulouse, France; Hôpital de la Timone, Université de la Méditerranée, Marseille, France (P.P., L.M.); Hôpital Nord, Université Jean Monnet, Saint-Etienne, France (P.G.); Hôpital Côte de Nacre, Université de Caen, Caen, France (F.V.); Hôpital Général, Université de Bourgogne, Dijon, France (M.G.); Hôpital Henri Mondor, Université Paris-Val-de-Marne, Créteil, France (H. Hosseini); Nouvelles Cliniques Nantaises, Nantes, France (G.H.); Hôpital Lariboisière (P.F.) and Hôpital Bichat-Claude Bernard (P.A.), Université Paris Diderot, Paris, France; Hôpital Roger Salengro, Université du Droit et de la Santé, Lille, France (H. Hénon, D.L.); Hôpital La Milétrie, Université de Poitiers, Poitiers, France (J.-P.N.); Hôpital Saint-Julien, Université Henri Poincaré, Nancy, France (X.D.); Fondation Hôpital Saint-Joseph, Marseille, France (R.P.); Hôpital Pellegrin Tripode, Université de Bordeaux, Bordeaux, France (F.R.); Hôpital de Hautepierre, Université de Strasbourg, Strasbourg, France (V.W.); Hôpital Bretonneau, Université François Rabelais, Tours, France (D.S.); Hôpital Saint-Roch, Université Nice Sophia Antipolis, Nice, France (M.-H.M.); Hôpital Saint-Jean, Perpignan, France (D.S.); Hôpital Européen Georges Pompidou, Université Paris-Descartes, Paris, France (B.B., G.C.); Hôpital Jean Minjoz, Université de Franche-Comté, Besançon, France (T.M.); and Université Claude Bernard, Lyon, France (M.L.). jl.mas@ch-sainte-anne.fr. 2. From the Hôpital Sainte-Anne, Université Paris-Descartes, INSERM U894, DHU Neurovasc-Paris Sorbonne, Paris, France (J.-L.M., D.C.); Hôpital Gui de Chauliac, Université Montpellier 1, Montpellier, France (C.A.); Hôpital Rangueil (A.V., V.L.) and Hôpital Purpan (J.-F.A.), Université Paul Sabatier, Toulouse, France; Hôpital de la Timone, Université de la Méditerranée, Marseille, France (P.P., L.M.); Hôpital Nord, Université Jean Monnet, Saint-Etienne, France (P.G.); Hôpital Côte de Nacre, Université de Caen, Caen, France (F.V.); Hôpital Général, Université de Bourgogne, Dijon, France (M.G.); Hôpital Henri Mondor, Université Paris-Val-de-Marne, Créteil, France (H. Hosseini); Nouvelles Cliniques Nantaises, Nantes, France (G.H.); Hôpital Lariboisière (P.F.) and Hôpital Bichat-Claude Bernard (P.A.), Université Paris Diderot, Paris, France; Hôpital Roger Salengro, Université du Droit et de la Santé, Lille, France (H. Hénon, D.L.); Hôpital La Milétrie, Université de Poitiers, Poitiers, France (J.-P.N.); Hôpital Saint-Julien, Université Henri Poincaré, Nancy, France (X.D.); Fondation Hôpital Saint-Joseph, Marseille, France (R.P.); Hôpital Pellegrin Tripode, Université de Bordeaux, Bordeaux, France (F.R.); Hôpital de Hautepierre, Université de Strasbourg, Strasbourg, France (V.W.); Hôpital Bretonneau, Université François Rabelais, Tours, France (D.S.); Hôpital Saint-Roch, Université Nice Sophia Antipolis, Nice, France (M.-H.M.); Hôpital Saint-Jean, Perpignan, France (D.S.); Hôpital Européen Georges Pompidou, Université Paris-Descartes, Paris, France (B.B., G.C.); Hôpital Jean Minjoz, Université de Franche-Comté, Besançon, France (T.M.); and Université Claude Bernard, Lyon, France (M.L.).
Abstract
BACKGROUND AND PURPOSE: We aimed at comparing the long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis. METHODS: Long-term follow-up study of patients included in Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S), a randomized, controlled trial of carotid stenting versus endarterectomy in 527 patients with recently symptomatic severe carotid stenosis, conducted in 30 centers in France. The main end point was a composite of any ipsilateral stroke after randomization or any procedural stroke or death. RESULTS: During a median follow-up of 7.1 years (interquartile range, 5.1-8.8 years; maximum 12.4 years), the primary end point occurred in 30 patients in the stenting group compared with 18 patients in the endarterectomy group. Cumulative probabilities of this outcome were 11.0% (95% confidence interval, 7.9-15.2) versus 6.3% (4.0-9.8) in the endarterectomy group at the 5-year follow-up (hazard ratio, 1.85; 1.00-3.40; P=0.04) and 11.5% (8.2-15.9) versus 7.6% (4.9-11.8; hazard ratio, 1.70; 0.95-3.06; P=0.07) at the 10-year follow-up. No difference was observed between treatment groups in the rates of ipsilateral stroke beyond the procedural period, severe carotid restenosis (≥70%) or occlusion, death, myocardial infarction, and revascularization procedures. CONCLUSIONS: The long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis favored endarterectomy, a difference driven by a lower risk of procedural stroke after endarterectomy. Both techniques were associated with low and similar long-term risks of recurrent ipsilateral stroke beyond the procedural period. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00190398.
RCT Entities:
BACKGROUND AND PURPOSE: We aimed at comparing the long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis. METHODS: Long-term follow-up study of patients included in Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S), a randomized, controlled trial of carotid stenting versus endarterectomy in 527 patients with recently symptomatic severe carotid stenosis, conducted in 30 centers in France. The main end point was a composite of any ipsilateral stroke after randomization or any procedural stroke or death. RESULTS: During a median follow-up of 7.1 years (interquartile range, 5.1-8.8 years; maximum 12.4 years), the primary end point occurred in 30 patients in the stenting group compared with 18 patients in the endarterectomy group. Cumulative probabilities of this outcome were 11.0% (95% confidence interval, 7.9-15.2) versus 6.3% (4.0-9.8) in the endarterectomy group at the 5-year follow-up (hazard ratio, 1.85; 1.00-3.40; P=0.04) and 11.5% (8.2-15.9) versus 7.6% (4.9-11.8; hazard ratio, 1.70; 0.95-3.06; P=0.07) at the 10-year follow-up. No difference was observed between treatment groups in the rates of ipsilateral stroke beyond the procedural period, severe carotid restenosis (≥70%) or occlusion, death, myocardial infarction, and revascularization procedures. CONCLUSIONS: The long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis favored endarterectomy, a difference driven by a lower risk of procedural stroke after endarterectomy. Both techniques were associated with low and similar long-term risks of recurrent ipsilateral stroke beyond the procedural period. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00190398.
Authors: Winona W Wu; Patric Liang; Thomas F X O'Donnell; Nicholas J Swerdlow; Chun Li; Mark C Wyers; Marc L Schermerhorn Journal: J Vasc Surg Date: 2019-03-08 Impact factor: 4.268
Authors: Leo H Bonati; Stavros Kakkos; Joachim Berkefeld; Gert J de Borst; Richard Bulbulia; Alison Halliday; Isabelle van Herzeele; Igor Koncar; Dominick Jh McCabe; Avtar Lal; Jean-Baptiste Ricco; Peter Ringleb; Martin Taylor-Rowan; Hans-Henning Eckstein Journal: Eur Stroke J Date: 2021-05-11
Authors: Mandy D Müller; Stefanie von Felten; Ale Algra; Jean-Pierre Becquemin; Richard Bulbulia; David Calvet; Hans-Henning Eckstein; Gustav Fraedrich; Alison Halliday; Jeroen Hendrikse; George Howard; John Gregson; Olav Jansen; Martin M Brown; Jean-Louis Mas; Thomas G Brott; Peter A Ringleb; Leo H Bonati Journal: Circ Cardiovasc Interv Date: 2019-08-05 Impact factor: 6.546
Authors: Mandy D Müller; Stefanie von Felten; Ale Algra; Jean-Pierre Becquemin; Martin Brown; Richard Bulbulia; David Calvet; Hans-Henning Eckstein; Gustav Fraedrich; Alison Halliday; Jeroen Hendrikse; John Gregson; George Howard; Olav Jansen; Jean-Louis Mas; Thomas G Brott; Peter A Ringleb; Leo H Bonati Journal: Stroke Date: 2018-11 Impact factor: 7.914
Authors: Clotilde Balucani; Vanessa Arnedo; Jeremy Weedon; Didier Leys; Jean-Louis Mas; Martin Brown; James C Grotta; Nicole R Gonzales; Werner Hacke; Thomas Brott; Steven R Levine Journal: Neurohospitalist Date: 2018-01-17
Authors: A Huibers; D Calvet; F Kennedy; K R Czuriga-Kovács; R L Featherstone; F L Moll; M M Brown; T Richards; G J de Borst Journal: Eur J Vasc Endovasc Surg Date: 2015-07-06 Impact factor: 7.069