OBJECTIVE: The objective of this randomized study was to compare the efficacy of the CHIVA method for the treatment of varicose veins with respect to the standard treatment of stripping. CONTEXT: Varicose veins are a sign of chronic venous disorder. For over a century, varicose veins have been treated with surgical ablative techniques, with stripping being the standard treatment. Currently, postsurgical varicose veins recurrence (20%-80%) is a common, complex, and costly problem. Ambulatory Conservative Hemodynamic Management of Varicose Veins (CHIVA) is a new option for treating chronic venous disorder. METHODS: In this open-label, randomized controlled trial, 501 adult patients with primary varicose veins were treated in a single center. They were assigned to an experimental group, the CHIVA method (n = 167) and 2 control groups: stripping with clinic marking (n = 167) and stripping with duplex marking (n = 167). The outcome measure was clinical recurrence within 5 years, assessed clinically by previously trained independent observers. Duplex ultrasonography was also used to assess recurrences and causes. RESULTS: In an intention-to-treat analysis, clinical outcomes in the CHIVA group were better (44.3% cure, 24.6% improvement, 31.1% failure) than in both the stripping with clinic marking (21.0% cure, 26.3% improvement, 52.7% failure) and stripping with duplex marking (29.3% cure, 22.8% improvement, 47.9% failure) groups. The ordinal odds ratio between the stripping with clinic marking and CHIVA groups, of recurrence at 5 years of follow-up, was 2.64, (95% confidence interval [CI]: 1.76-3.97, P < 0.001). The ordinal odds ratio of recurrence at 5-years of follow-up, between the stripping with duplex marking and CHIVA group, was 2.01 (95% CI: 1.34-3.00, P < 0.001). This trial is registered at ISRCTN and carries the following ID number: ISRCTN52861672, available at: http://isrctn.org. CONCLUSIONS: The present results indicate that, thanks to specific venous hemodynamic evaluation, the CHIVA method is more effective than stripping with clinical marking or stripping with duplex marking to treat varicose veins. When carrying out a stripping intervention, Duplex marking does not improve the clinical results of this ablative technique.
RCT Entities:
OBJECTIVE: The objective of this randomized study was to compare the efficacy of the CHIVA method for the treatment of varicose veins with respect to the standard treatment of stripping. CONTEXT: Varicose veins are a sign of chronic venous disorder. For over a century, varicose veins have been treated with surgical ablative techniques, with stripping being the standard treatment. Currently, postsurgical varicose veins recurrence (20%-80%) is a common, complex, and costly problem. Ambulatory Conservative Hemodynamic Management of Varicose Veins (CHIVA) is a new option for treating chronic venous disorder. METHODS: In this open-label, randomized controlled trial, 501 adult patients with primary varicose veins were treated in a single center. They were assigned to an experimental group, the CHIVA method (n = 167) and 2 control groups: stripping with clinic marking (n = 167) and stripping with duplex marking (n = 167). The outcome measure was clinical recurrence within 5 years, assessed clinically by previously trained independent observers. Duplex ultrasonography was also used to assess recurrences and causes. RESULTS: In an intention-to-treat analysis, clinical outcomes in the CHIVA group were better (44.3% cure, 24.6% improvement, 31.1% failure) than in both the stripping with clinic marking (21.0% cure, 26.3% improvement, 52.7% failure) and stripping with duplex marking (29.3% cure, 22.8% improvement, 47.9% failure) groups. The ordinal odds ratio between the stripping with clinic marking and CHIVA groups, of recurrence at 5 years of follow-up, was 2.64, (95% confidence interval [CI]: 1.76-3.97, P < 0.001). The ordinal odds ratio of recurrence at 5-years of follow-up, between the stripping with duplex marking and CHIVA group, was 2.01 (95% CI: 1.34-3.00, P < 0.001). This trial is registered at ISRCTN and carries the following ID number: ISRCTN52861672, available at: http://isrctn.org. CONCLUSIONS: The present results indicate that, thanks to specific venous hemodynamic evaluation, the CHIVA method is more effective than stripping with clinical marking or stripping with duplex marking to treat varicose veins. When carrying out a stripping intervention, Duplex marking does not improve the clinical results of this ablative technique.