Finally! A randomized controlled trial (RCT) which proves what we all kind of expected but which until now was unsupported by available literature. That is that endovenous ablation (EVA) in the presence of a concomitant venous ulcer not only decreases ulcer recurrence rates and increases ulcer-free time, it also significantly hastens ulcer healing times. I don’t know about you, but it always made sense to me that treatment of an incompetent saphenous vein, a known cause of ulceration, could be a factor in the time to ulcer healing.
But that’s what a whole host of retrospective and or nonrandomized studies seemed to suggest: Garbage in, garbage out. Enter the RCT – Issue resolved? Yes, with some caveats, and maybe no.
First, as the authors readily admit, the compression therapy which was applied to patients in both arms of the study was of “high quality” and would not likely be reproduced in real world practice. The authors also suggest that, in a real-world, clinical practice, the benefits of early EVA may prove to be even more pronounced because of poor patient compliance with compression. Not sure about that. In fact, if – in a real-world setting – the rate of compliance with compression in both groups turned out to be less than optimal, particularly in the patients who had EVA, the benefits of early ablation with respect to ulcer healing times might disappear.
In other words, we do not know from this study whether there would be the same advantages to early saphenous vein intervention without the addition of compression as compared with compression alone. This might explain why shorter ulcer healing times of EVA have been difficult to prove in non-RCT, more real-world studies. Perhaps a randomized trial comparing ulcer healing times with early EVA without compression versus compression therapy only? Hmmm.
Also, would the outcomes of the current study be similar on this side of the pond? Only 31.7% of limbs were treated with endothermal ablation only, by far the most common form of ablation performed in the United States. Almost 65% of limbs in the study were ablated with either foamed sclerotherapy alone or in conjunction with endothermal or mechanical modalities – not a common form of treatment here in the colonies. Inexplicably, the authors do not indicate whether outcomes were in any way influenced by the type of ablation performed. I am going to assume for now that it did not.
In summary, this study does not answer all the questions related to the use of EVA for the treatment of venous ulcers, but it comes pretty close. My take away is that there is no downside (or none that I can think of) to the use of EVA early on in the treatment of venous ulcers but a whole lot of potential upside for the patient. Now I, and probably you, have proof that what we were already doing really does have some increased benefit. Finally!
Alan M Dietzek, MD, is the Linda and Stephen R. Cohen Chair in Vascular Surgery at Danbury (Conn.) Hospital and a clinical professor of surgery at the University of Vermont, Burlington. He is also an associate medical editor for Vascular Specialist.
