Fecha de la publicación: 28/04/2020
Autor: Elena González Cañas (1), Salvador Florit López (2), Roser Vives Vilagut (3), Kerbi Alejandro Guevara-Noriega (4), Marta Santos Espí (2), José Rios (5), Salvador Navarro Soto (6), Antonio Giménez Gaibar (2)
1Department of Vascular Surgery, Parc Taulí Hospital Universitari, Sabadell, Barcelona, Spain. Electronic address: firstname.lastname@example.org.
2Department of Vascular Surgery, Parc Taulí Hospital Universitari, Sabadell, Barcelona, Spain.
3Department of Pharmacology, Therapeutics, and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain.
4Department of General Surgery, Jackson Memorial Hospital, University of Miami, Miami, Fla.
5Biostatistics Unit, Universitat Autònoma de Barcelona, Barcelona, Spain; Medical Statistics Core Facility, Institut Investigacions Biomèdiques Audgust Pi I Sunyer (IDIBAPS) and Hospital Clinic, Barcelona, Spain.
6Department of General Surgery, Parc Taulí Hospital Universitari, Sabadell, Barcelona, Spain.
Objective: The quality of available evidence regarding new minimally invasive techniques to abolish great saphenous vein reflux is moderate. The present study assessed whether radiofrequency ablation (RFA) was noninferior to high ligation and stripping (HLS) and conservative hemodynamic cure for venous insufficiency (CHIVA) for clinical and ultrasound recurrence at 2 years in patients with primary varicose veins (VVs) due to great saphenous vein (GSV) insufficiency.
Methods: We performed a randomized, single-center, open-label, controlled, noninferiority trial to compare RFA and 2 surgical techniques for the treatment of primary VVs due to GSV insufficiency. The noninferiority margin was set at 15% for absolute differences. Patients aged >18 years with primary VVs and GSV incompetence, with or without clinical symptoms, C2 to C6 CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) clinical class, and GSV diameter >4 mm were randomized with a 1:1:1 ratio to RFA, HLS, or CHIVA. The rate of clinical recurrence at 24 months was the primary endpoint and was analyzed using a delta noninferiority margin of 15%. Ultrasound recurrence, safety, and quality of life were secondary endpoints.
Results: From December 2012 to June 2015, 225 limbs had been randomized to RFA, HLS, or CHIVA (n = 74, n = 75, and n = 76). Clinical follow-up and Doppler ultrasound examinations were performed at 1 week and 1, 6, 12, and 24 months postoperatively. No differences in postoperative complications or pain were observed among the three groups. RFA was noninferior to HLS and CHIVA for clinical recurrence at 24 months, with an estimated difference in recurrence of 3% (95% confidence interval [CI], -4.8% to 10.7%; noninferiority P = .002) and -7% (95% CI, -17% to 3%; P < .001), respectively. For ultrasound recurrence, RFA was noninferior to CHIVA, with an estimated difference of -34% (95% CI, -47% to -20%; noninferiority P < .001) at 24 months. However, noninferiority could not be demonstrated compared with HLS (5.9%; 95% CI, -4.1 to 15.9; P = .073). No differences were found in quality of life among the three groups.
Conclusions: RFA was shown to be noninferior in terms of clinical recurrence to HLS and CHIVA in the treatment of VVs due to GSV insufficiency.
Trial registration: ClinicalTrials.gov NCT02454452.
Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.