A randomized clinical trial of isolated ambulatory phlebectomy versus saphenous thermal ablation with concomitant phlebectomy (SAPTAP Trial)

Abstract

Background: Current treatment of patients with saphenous trunk and tributary incompetence consists of truncal ablation with concomitant, delayed or no treatment of the tributary. However, reflux of the saphenous trunk may be reversible after treatment of the incompetent tributary. The aim of this study was to determine whether single ambulatory phlebectomy with or without delayed endovenous truncal ablation (SAP) is non-inferior to thermal endovenous ablation with concomitant phlebectomy (TAP), and whether SAP is a cost-effective alternative to TAP.

Methods: A multicentre, non-inferiority RCT was conducted in patients with an incompetent great saphenous vein or anterior accessory saphenous vein with one or more incompetent tributaries. Participants were randomized to receive SAP or TAP. After 9 months, additional truncal treatment was considered for SAP patients with remaining symptoms. The primary outcome was VEnous INsufficiency Epidemiological and Economic Study Quality of Life/Symptoms (VEINES-QOL/Sym score) after 12 months. Secondary outcomes were, among others, cost-effectiveness, perceived improvement of symptoms, and anatomical success.

Results: Some 464 patients received the allocated treatment (SAP 227, TAP 237). VEINES-QOL scores were 52.7 (95 per cent c.i. 51.9 to 53.9) for SAP and 53.8 (53.3 to 55.1) for TAP; VEINES-Sym scores were 53.5 (52.6 to 54.4) and 54.2 (54.0 to 55.6) respectively. Fifty-eight patients (25.6 per cent) in the SAP group received additional truncal ablation. Treatment with SAP was less costly than treatment with TAP.

Conclusion: One year after treatment, participants who underwent SAP had non-inferior health-related quality of life compared with those who had TAP. Treatment with SAP was a cost-effective alternative to TAP at 12 months.

Registration number: NTR 4821 (www.trialregister.nl).

Fig. 1

CONSORT diagram for trial SAP, isolated ambulatory phlebectomy with or without delayed endovenous truncal ablation; TAP, thermal ablation with concomitant phlebectomy; EVLA, endovenous laser ablation; ITT, intention to treat.

Fig. 2

VEINES-QOL/Sym scores at baseline and 12 months’ follow-up Values are means with 95% confidence intervals. VEINES-QOL/Sym, VEnous INsufficiency Epidemiological and Economic Study Quality of Life/Symptoms; SAP, isolated ambulatory phlebectomy with or without delayed endovenous truncal ablation; TAP, thermal ablation with concomitant phlebectomy.

Fig. 3

Mean difference in VEINES-QOL/sym scores between treatment groups, and non-inferiority margin Values are mean differences with 95% confidence interval; dotted line indicates non-inferiority line. VEINES-QOL/Sym, VEnous INsufficiency Epidemiological and Economic Study Quality of Life/Symptoms; SAP, isolated ambulatory phlebectomy with or without delayed endovenous truncal ablation; TAP, thermal ablation with concomitant phlebectomy.

Fig. 4

Perceived improvement after 3 and 12 months’ follow-up SAP, isolated ambulatory phlebectomy with or without delayed endovenous truncal ablation; TAP, thermal ablation with concomitant phlebectomy.

Fig. 5

Anatomical success, according to duplex ultrasonography after 9–12 months SAP, isolated ambulatory phlebectomy with or without delayed endovenous truncal ablation; TAP, thermal ablation with concomitant phlebectomy. P <0.001 for anatomical success at 12 months (χ² test).

Fig. 6

Cost-effectiveness planes for VEINES-QOL (a) and VEINES-Sym (b). VEINES-QOL/Sym, VEnous INsufficiency Epidemiological and Economic Study Quality of Life/Symptoms; SAP, isolated ambulatory phlebectomy with or without delayed endovenous truncal ablation; TAP, thermal ablation with concomitant phlebectomy.