Reply to Letter Re: Endovenous laser ablation with and without high ligation compared with high ligation and stripping in the treatment of great saphenous varicose veins: Initial results of a multicenter,randomized controlled trial

Dear Miss Aslam,

Thank you very much for the honor and your effort to give us a detailed analysis of our work. ¹

You mentioned that we included 449 instead of the calculated 469 patients to reach full statistical power. As described in the paper we calculated a 10% drop out rate over 2 years. Full power would be reached with 422 patients so that the published data in this paper are indeed of some relevance. You are absolutely right that the primary endpoint is at 2 years. We thought the perioperative data concerning the comfort of the portrayed methods are so valuable that it was worth publishing them as it is one of the main points of interest for the patient to know how irritating a method may be.

You discussed the relevance of inguinal reflux (IR) for clinical recurrence, a point that we could not yet get into our focus as in this paper we described the perioperative period up to 2 months. Up to that point of time no relevant frequency of clinical recurrence occurred. Of course, it will be of major interest for the following analysis of our data to describe just this relation. After 6 months we found no direct relation between IR and clinical recurrence. ² But these data did not meet the primary endpoint of 2 years.

You told us your opinion that the third strategy of combining endovenous laser ablation (EVLA) with high ligation (HL) is an unnecessary one.³ Yes, we agree; but after this investigation. It is exactly one of the subject matters that we wanted to observe when defining the secondary endpoints. Compared with the “pure” strategies of EVLA and HL/stripping we found most side effects in this group. To our understanding it is one of the most interesting results of this paper. We created this third arm of the study to learn more about the importance of HL in the development of IR and clinical recurrence. At the point of time when we created the design of this study the frequency of these issues and the side effects of the combined strategy were both unknown.

Altogether we still believe that our paper contributes to the knowledge about endoluminal thermal therapies in comparison with modern forms of open operative strategies for the treatment of great saphenous varicose vein. For sure the primary endpoint of the observation of IR and clinical recurrence after 2 years has to be reached. Related data and those of a longer follow-up will be published soon.