Clinical Response to Combination Therapy in the Treatment of Varicose Veins

Abstract

Varicose vein ablation procedures are being performed with increasing frequency; however, there is a lack of consensus on the relative efficacy of combined treatment of saphenous incompetence and symptomatic varicosities vs a staged approach. In this study, we examined the impact on symptom severity when a procedure to eliminate varicosities is added to standard endovenous saphenous ablation. The American Venous Registry Varicose Vein Module was established by the American Venous Forum in 2010 and collected data from 53 physicians from 37 clinical centers during a 2-year period. Our analysis includes patients with Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class C2S disease severity and without prior treatment. Combination therapy (CT) is defined as the use of a varicosity-treating secondary procedure (stab phlebectomy or injection of sclerosant into varicosity) in combination with endovenous saphenous vein ablation. Unimodal therapy (UT) is defined as endovenous saphenous vein ablation alone (radiofrequency or laser). Symptom severity change is assessed using the pretreatment and 1-month follow-up Venous Clinical Severity Score (VCSS). Bivariate statistics are calculated comparing the CT and UT groups, with P values calculated using the Student t-test or Pearson χ2 test as appropriate. A multivariable linear regression model assesses the association of CT with the change in VCSS. There were 1031 patients included for analysis (UT, 478; CT, 553). UT patients were older (35.9% were >64 years vs 20.7%; P < .001), were more likely to be white (79.3% vs 65.5%; P < .001) and to have a higher initial VCSS (7.28 vs 6.15; P < .001), and were assessed at an earlier follow-up visit (25.9 days postoperatively vs 32.9 days; P < .001). Compared with UT, CT was associated with an additional 1-point reduction in VCSS on bivariate analysis (−3.50 points for UT vs −4.54 points for CT; P < .001; Table). Thrombotic complications were not different between the two groups (UT, 1.04%; CT, 0.72%; P = .58). On the multivariable model, after adjustment for follow-up day, age group, ethnicity, and initial VCSS, CT was associated with a reduction in VCSS of 1.07 points beyond the reduction seen in UT alone (P < .001). Invasive treatment of C2S chronic venous insufficiency improves symptom severity. Whereas treatment of venous reflux is essential to address venous symptoms, our results suggest that patients further benefit from additional direct treatment of varicosities. For select patients, combined therapy may present a more effective treatment strategy than saphenous ablation alone.TableCompared with unimodal therapy (UT), combination therapy (CT) is associated with an additional 1-point reduction in Venous Clinical Severity Score (VCSS) on bivariate analysisTotal (N = 1031)UT (n = 478)CT (n = 553)P valueDay of follow-up29.7 (8.23)25.9 (0.40)32.9 (6.20)<.001bAge, years<.001a <45253 (24.6)85 (17.9)168 (30.4) 45-55221 (21.5)103 (21.6)118 (21.4) 55-64269 (26.2)117 (24.6)152 (27.5) >64285 (27.7)171 (35.9)114 (20.7)Female733 (71.1)342 (71.6)391 (70.7).766aWhite741 (71.9)379 (79.3)362 (65.5)<.001aInitial VCSS6.68 (3.87)7.28 (4.52)6.15(3.10)<.001bVCSS change−4.06 (3.27)−3.50 (3.95)−4.54 (2.46)<.001bCategorical variables are presented as number (%). Continuous variables are presented as mean (standard deviation).aPearson χ2.bStudent t-test. Open table in a new tab