Yann Gouëffic1, Nellie Della Schiava2, Fabien Thaveau3, Eugenio Rosset4, Jean-Pierre Favre5, Lucie Salomon du Mont6, Jean-Marc Alsac7, Réda Hassen-Khodja8, Thierry Reix9, Eric Allaire10, Eric Ducasse11, Raphael Soler12, Béatrice Guyomarc'h13, Bahaa Nasr14. 1. CHU Nantes, l'institut du thorax, service de chirurgie vasculaire, Nantes, France; Laboratoire de Physiopathologie de la Résorption Osseuse, Inserm-UN UMR-957, Nantes, France; Université de Nantes, Nantes, France. Electronic address: yann.goueffic@chu-nantes.fr. 2. Hôpital Edouard Herriot, service de chirurgie vasculaire, Lyon, France. 3. CHU Strasbourg, Nouvel Hôpital Civil, service de chirurgie vasculaire, Strasbourg, France. 4. CHU Clermont-Ferrand, Hôpital Gabriel Montpied, service de chirurgie vasculaire, Clermont-Ferrand, France. 5. CHU St-Etienne, Hôpital Nord, service de chirurgie vasculaire, Saint Etienne, France. 6. CHU Besançon, Hôpital Jean Minjoz, service de chirurgie vasculaire, Besançon, France. 7. AP-HP, Hôpital Européen Georges Pompidou, service de chirurgie cardiovasculaire, Paris, France. 8. CHU Nice, Hôpital Saint Roch, service de chirurgie vasculaire, Nice, France. 9. CHU Amiens, Hôpital Sud, service de chirurgie vasculaire, Amiens, France. 10. AP-HP, Hôpital Henri Mondor, service de chirurgie vasculaire, Créteil, France. 11. CHU Bordeaux, Hôpital Pellegrin, service de chirurgie vasculaire, Bordeaux, France. 12. AP-HM, Hôpital La Timone, service de chirurgie vasculaire, Marseille, France. 13. CHU Nantes, institut du thorax, INSERM, CNRS, UNIV Nantes, Nantes, France. 14. CHU Brest, service de chirurgie vasculaire, Brest, France.
Abstract
OBJECTIVES: The TECCO (Traitement des Lésions Athéromateuses de l'Artère Fémorale Commune par Technique Endovasculaire Versus Chirurgie Ouverte [Endovascular Versus Open Repairof the Common Femoral Artery]) trial is a randomized comparison of safety and efficacy of stenting versus open surgery for de novo common femoral artery (CFA) stenosis. BACKGROUND: Surgery for CFA lesions is considered effective and durable. Despite the widespread use of endovascular repair for infrainguinal disease, the value of this procedure for such lesions is uncertain. METHODS:From February 23, 2011, to September 5, 2013, a total of 117 patients with de novo atherosclerotic lesions of the CFA were randomly assigned to undergo surgery (n = 61) or stenting (n = 56). The main exclusion criteria were asymptomatic disease, restenosis, and thrombosis of the CFA. The primary outcome was the morbidity and mortality rate within 30 days. This includes any general complications or local complications that caused or prolonged hospitalization and/or re-intervention, lymphorrhea of more than 3 days, and post-operative paresthesia that required drugs. The median duration of follow-up was 2 years (interquartile range [IQR]: 19.8 to 24.9 years). RESULTS: Primary outcome events occurred in 16 of 61 patients (26%) in the surgery group and 7 of 56 patients (12.5%) in the stenting group (odds ratio: 2.5; 95% confidence interval: 0.9 to 6.6; p = 0.05). The mean duration of hospitalization was significantly lower in the stenting group (3.2 ± 2.9 days vs. 6.3 ± 3 days; p < 0.0001). At 24 months, the sustained clinical improvement, the primary patency rate, and the target lesion and extremity revascularization rates were not different in the 2 groups. CONCLUSIONS: In patients with de novo atherosclerotic lesions of the CFA, the perioperative morbidity and mortality rate was significantly lower among patients who underwent endovascular therapy by stenting compared with surgery, whereas clinical, morphological, and hemodynamic outcomes were comparable at mid-term. (Traitement des Lésions Athéromateuses de l'Artère Fémorale Commune par Technique Endovasculaire Versus Chirurgie Ouverte [Endovascular Versus Open Repairof the Common Femoral Artery] [TECCO]; NCT01353651).
RCT Entities:
OBJECTIVES: The TECCO (Traitement des Lésions Athéromateuses de l'Artère Fémorale Commune par Technique Endovasculaire Versus Chirurgie Ouverte [Endovascular Versus Open Repair of the Common Femoral Artery]) trial is a randomized comparison of safety and efficacy of stenting versus open surgery for de novo common femoral artery (CFA) stenosis. BACKGROUND: Surgery for CFA lesions is considered effective and durable. Despite the widespread use of endovascular repair for infrainguinal disease, the value of this procedure for such lesions is uncertain. METHODS: From February 23, 2011, to September 5, 2013, a total of 117 patients with de novo atherosclerotic lesions of the CFA were randomly assigned to undergo surgery (n = 61) or stenting (n = 56). The main exclusion criteria were asymptomatic disease, restenosis, and thrombosis of the CFA. The primary outcome was the morbidity and mortality rate within 30 days. This includes any general complications or local complications that caused or prolonged hospitalization and/or re-intervention, lymphorrhea of more than 3 days, and post-operative paresthesia that required drugs. The median duration of follow-up was 2 years (interquartile range [IQR]: 19.8 to 24.9 years). RESULTS: Primary outcome events occurred in 16 of 61 patients (26%) in the surgery group and 7 of 56 patients (12.5%) in the stenting group (odds ratio: 2.5; 95% confidence interval: 0.9 to 6.6; p = 0.05). The mean duration of hospitalization was significantly lower in the stenting group (3.2 ± 2.9 days vs. 6.3 ± 3 days; p < 0.0001). At 24 months, the sustained clinical improvement, the primary patency rate, and the target lesion and extremity revascularization rates were not different in the 2 groups. CONCLUSIONS: In patients with de novo atherosclerotic lesions of the CFA, the perioperative morbidity and mortality rate was significantly lower among patients who underwent endovascular therapy by stenting compared with surgery, whereas clinical, morphological, and hemodynamic outcomes were comparable at mid-term. (Traitement des Lésions Athéromateuses de l'Artère Fémorale Commune par Technique Endovasculaire Versus Chirurgie Ouverte [Endovascular Versus Open Repair of the Common Femoral Artery] [TECCO]; NCT01353651).
Authors: Ole Grøtta; Tone Enden; Gunnar Sandbæk; Gard Filip Gjerdalen; Carl-Erik Slagsvold; Dag Bay; Nils-Einar Kløw; Antonio Rosales Journal: CVIR Endovasc Date: 2018-11-16