What happened to 5-year outcomes?


I recently returned from Professor Roger Greenhalgh’s excellent Charing Cross meeting in London. A plethora of exciting new developments was presented to almost 4,000 attendees from all over the world. As impressive as these presentations may have been, I became acutely aware that most of what was presented consisted of short-term data. Perhaps I am dating myself, but before the advent of endovascular technology, one could hardly get a presentation accepted at a major meeting without long-term, preferably 5-year-data.

Dr. D. Emerick Szilagyi, a pioneer of vascular surgery and former editor of the Journal of Vascular Surgery, having experienced the early failure of homografts, was renowned for stating that a new treatment required a 5-year track record before it could be deemed beneficial. Perhaps 5 years was chosen because that was an average life span for patients undergoing what was then major vascular surgery. Or was it because we knew that, at least in the short term, most vascular procedures worked but needed multiple revisions. Who would have anticipated that after aortic endografts were first inserted, we would soon be dealing with a new “condition,” which we now refer to as an endoleak?

Dr. Russell H. Samson

Regardless, at recent symposia and in our journals, we seem to receive predominately premature information. It is now commonplace to be presented with 1-year outcomes but more often with 90-, 30-, or even 7-day results. An even shorter interval is described in reports detailing “technical success.”

It is as if we have won a victory of sorts when we do something that actually works until the end of the procedure! It appears that the announcement of every new product or treatment is accompanied by a proclamation of a new “breakthrough,” a “paradigm shift,” or a new major addition to our armamentarium. I wonder if we have succumbed to an embarrassing new malady that I will euphemistically describe as “premature congratulation.”

I find these reports particularly common in cardiology and interventional radiology journals. They are also appearing with increasing frequency in our vascular literature and at scientific meetings. In fact, my own presentation at this year?s Charing Cross meeting was only a 4-year comparison of heparin bonded ePTFE vs. standard ePTFE. Perhaps even this could be considered to be too short a follow-up. Furthermore, can we forget how our popular press touted the advent of carotid stents when the original SAPPHIRE paper was presented? Using premature data, the newspaper USA Today announced the demise of carotid endarterectomy. Another example is how ezetimibe became a best-selling drug to treat hypercholesterolemia, and it still has yet to show any clinical benefit (JAMA 2014;311:11279 [doi:10.1001/jama.2014.2896]).

Admittedly, it may be important for new technologies or methods to be announced before they have been proven to be helpful, since these new “advances” may inspire more fruitful modifications to established procedures. On occasion, they may also uncover new avenues of investigation which may lead to new inventions or techniques. The question remains: how should we as vascular physicians respond to short-term data? Should we embrace new devices before they have stood the test of time? Or should we avoid their use, perhaps preventing a patient from receiving a life- or limb-saving procedure simply because we are unsure of its longevity or unforeseeable complication?

This is a quandary that our meeting organizers and journal editors must also face. Should they reject new material until it has been proven to have lasting benefit? I believe that the answer is no, but would interject a cautionary note in the general adoption of new methods until more definitive data are available. I have had personal experience with premature adoption of new technology when I was guilty of publishing excellent 1-year data with a balloon system only to later publish disappointing 2-year results. Of course, there is a benefit to having to retract earlier reports — you become the author of two peer-reviewed manuscripts. Sarcasm aside, we do need to be kept informed about all new developments in our field. But it may be beneficial for proponents and experts to emphasize the true potential as well as possible drawbacks and complications of the new methods. It is also our responsibility to maintain an open mind.

While we can be cautiously optimistic, it is inadvisable to rush headlong into performing every new modality. Early adopters should be reminded that there is little to celebrate when a procedure?s benefits are brief. To avoid “premature congratulation,” follow the slow and steady mantra that has served us well in other areas of life.


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