Discussion
reflux
SECONDARY, REFLUX
In the SAPTAP trial, treatment with SAP was not inferior to treatment with TAP for patients with an incompetent GSV or AASV and one or more incompetent tributaries. This conclusion is based on the finding that the 95 per cent confidence intervals of the difference in VEINES-QOL/Sym scores between the SAP and TAP groups fell within the predetermined non-inferiority margin. This finding is supported by analysis of HRQoL outcomes (VEINES-QOL/Sym, EQ-5D™, and EQ-VAS scores). Twelve months after the first treatment, HRQoL outcomes were similar for the two procedures, and had improved similarly in both groups compared with baseline. Patient-reported satisfaction regarding the treatment and subjective improvement of symptoms were similar in both groups after 12 months.Treating patients with SAP instead of TAP has several advantages. First, only 25.6 per cent of those in the SAP group required additional treatment 9 months after ambulatory phlebectomy. Additional truncal treatment was not required in 73.5 per cent of the patients as they had no symptoms (with or without truncal reflux) at 9-month follow-up. Thus, three-quarters of the patients were relieved of symptoms after one instead of two treatments. Second, the GSV/AASV was spared in these 73.5 per cent of patients by being treated with SAP. Sparing the saphenous trunk may result in abolishment of reflux, owing to reduction of blood volume in the trunk after isolated phlebectomy. Therefore, it is given the opportunity to regain its function as one of the main veins of the superficial venous system. It may even be used as a bypass graft in later life. However, when selecting patients for SAP treatment, they should be informed about the potential need for additional truncal treatment. This extra treatment would cost patients an extra visit to the hospital, as well as an extra day of absence from work or other duties.The findings of the SAPTAP trial in terms of anatomical success are comparable to those of previous studies of the ASVAL method. After 1-year follow-up, GSV/AASV reflux was eliminated in 57.8 per cent of patients in the SAP group, whereas symptoms had decreased in 72.7 per cent of the participants. These outcomes are comparable to those of a prospective observational studyAnatomical success rates after 12 months were clearly higher after TAP than SAP (95.5 From a healthcare-related costs perspective, treatment with SAP was cheaper, saving €630 per patient compared with treatment with TAP. In the Netherlands, around 25 000 EVLA procedures are performed per year for incompetent GSVs or AASVsThis study has shown the non-inferiority of SAP compared with TAP, without application of any selection criteria for SAP. Further research should determine these selection criteria, ideally leading to a smaller number of patients needing an additional EVLA during follow-up.The present study has several limitations. First, the number of patients included for analysis was slightly smaller than originally calculated: a sample size of 472 patients was required and only 464 patients were analysed. A second limitation is the relatively short follow-up time of 1 year. Third, although the primary outcome was clearly defined, multiple secondary outcomes are reported. The findings among secondary outcomes were mostly negative and in accordance with each other, suggesting that multiple comparison bias did not affect the results. Additionally, the SAP group had an additional visit at 9 months, which might have influenced the quality-of-life outcomes. Furthermore, it should be acknowledged that the extra burden for patients undergoing SAP—having to return to the clinic for a supplementary visit after 9 months, including DUS, an additional intervention in 25.6 per cent, and the related absence of work or other activities—has not been taken into account. Indirect costs for both treatment groups were not considered in this study. Moreover, treatment costs were based on prices determined by the health insurance companies, and not on actual costs in different hospitals. Therefore, these costs are only an approximation of the real healthcare costs. Finally, the choice of the non-inferiority margin is somewhat arbitrary. This is always true in non-inferiority studies, but an additional element here is that the VEINES-QOL/Sym is calibrated to have a mean of 50 in any particular sample. This means that differences in scores are relative to the mean quality of life in the sample as a whole, even at the level of individual patients. As a consequence, a 5 per cent difference represents a slightly larger difference in quality of life in samples with relatively healthy patients. The non-inferiority margin was set based on the maximal acceptable loss of HRQoL. Because the VEINES-QOL/Sym score is a relative score, and does not have an absolute value, the absolute meaning of this loss in HRQoL is not known.The SAPTAP trial shows that HRQoL after one year follow-up is equal for patients treated with SAP and with TAP. Treatment with SAP with or without delayed endovenous truncal ablation is a cost-effective alternative for TAP. Treatment with SAP not only resulted to be less expensive, but patients could also avoid an additional saphenous trunk treatment in 73.5% of the cases, based on a follow-up period of one year.