Best Therapy for Treating Patients in the Lower Limb: What’s Your Default?
This month I want to continue the ongoing questions regarding what to use for therapy in the “real-world” patients we treat everyday in the lower limb. This question is not one that I use for a self-serving need to challenge us. I really don’t need that kind of ammo here; I think that is clearly evident. I use this question to really get to a root need and question. How do we discuss the outcomes of interventions with our patients and their families with the evidence-based approaches that we are vey accustomed to in the coronary circulation? Clearly, if someone has a 40 mm lesion of 2.2 mm coronary vessel we can have some idea that the restenosis of that artery in a diabetic population is not nearly going to be the same as the non-diabetic patient with a 3.5 mm focal lesion.
Evidence-based medicine (EBM) means that when asked a question, we as physicians then infer to our general population. In the periphery, the EBM inference unfortunately seems more like apples to oranges than it is in the coronary circulation. Now that we have several good trials with outcomes that are scientific we really need to compare these devices to one another. What if the drug-eluting stents (DES) are far better than we thought they were in a comparison with another non-drug-eluting platforms? What if they are not? What happens when a new stent appears that has an even better outcome than anyone thought possible? Again, what about the alternative therapies and their outcomes? Clearly, the need exists to have a more formal approach from here on out regarding what we consider the “gold standard” for these comparisons. Should we only compare with a self-expanding stent (SES) in the superficial femoral artery that is non-drug eluting than compare with the DES platform? Once this is complete what about the other SES platforms on the market and approved? Lastly, what about the alternative therapies and their outcomes when compared with this “gold standard”?
I would bet my paycheck that anyone out there believes that their approach in the superficial femoral artery for their patients is by far the best they can do and that they convey what the patient needs to know about the procedure. I bet that we all fall very short about discussing the shortcomings about these trials with our patients as we feel the message may get lost in the discussion or simply confuse our patients.
Ultimately, the question is, if a trial comes along and hits the outcome endpoint metric of primary patency over 80%, either it be stenting, drug-based, or alternative therapy, then it may become or should it become our default therapy? This question has a ton of implications, both economic and scientific, for our approaches to patients with symptomatic disease. Let’s think about this and next month discuss the upcoming trials and what to look for in October from TCT and VIVA.