The study findings add significant clinical knowledge to the practicing vascular specialist. In the great scheme of things, one great answer here is that CLI is a serious disease and must be treated. The manuscript eloquently and clearly supports both open vascular surgical revascularization and endovascular revascularization. It’s a powerful message to the current multidisciplinary operators. Based on the training background of the treating physician, the treatment of CLI can only benefit patients with CLI — and sooner rather than later.
Based on the data from the manuscript, it appears that open surgery first was associated with poorer amputation-free survival, whereas an endovascular-first approach was associated with a higher rate of reintervention. It makes logical and scientific sense to why endovascular first has more reinterventions. First, the negative comorbidities in the endovascular-first group were statistically higher than in the open surgery-first group. Most important are the patients with renal failure or diabetes. It is well known that both of these comorbidities are associated with a higher rate of procedural complexity, failure and reinterventions.
Despite the high comorbidities in the endovascular-first group, long-term outcomes were not worse than the open surgical cohort, which has statistically lower associated comorbidities. So in the setting of clinical practice, operators should keep in mind that patients with CLI at high risk for reintervention — patients with CAD, hyperlipidemia, hypertension, chronic kidney disease, diabetes, smoking, to mention a few — should still be treated, as the long-term outcome is favorable for the endovascular-first approach. The most common comorbidities that favor endovascular first are renal failure and diabetes (P < .05 for both).
It is difficult to determine a randomized controlled trial that would scientifically tell us one treatment is superior to the other. Historically, almost all CLI trials exclude patients with renal failure. In real-world practice, we find patients with CLI to have a high prevalence of renal failure. By selecting out the sicker patients with CLI based on the comorbidities, absence of venous conduits and body habitus, just to mention a few, the result of any trial will be biased and will yield low clinical evidence to guide specialists into the proper treatment pathway. On the other hand, if a perfect randomized controlled trial for CLI patients were to commence, it would include a 1:1 randomization to all-comers. This type of research will answer the question that everyone wonders about and that is which treatment modalities serve CLI patients better — endovascular first of surgical first?
A recent study (Mustapha JA, et al. J Am Heart Assoc. 2018;doi:10.1161/JAHA.118.009724) showed no difference in long-term benefit between the two treatment modalities. In this manuscript, despite the early poorer amputation-free survival with open surgery, both treatments showed similar beneficial long-term outcomes. I recommend more research in areas we can control such as post-operative care, medical therapy, wound care, awareness and proper surveillance. All of these lead to detecting the disease earlier and keeping it in check.
It is worth mentioning that over the last 5 years, many large retrospective studies similar to the current manuscript have shown trends that we must not ignore. We have seen data from Philip P. Goodney, MD, MS, and colleagues where more than 50% of patients with CLI underwent major amputation without a prior angiogram (Goodney PP, et al. Circ Cardiovasc Qual Outcomes. 2012;doi:10.1161/CIRCOUTCOMES.111.962233.). We learned that racial disparities are associated with much higher amputation rates among minorities. Also, geographic locations impact outcomes for patients with CLI. Those that live in the southern United States have worse outcomes than those that live in other parts of the country. The final concern and alarming findings from the recent JAHA study is the correlation between level of CLI disease at presentation and amputation followed with death. The fact that CLI patients who receive amputation end up with a high mortality rate should make awareness a No. 1 priority for all health care providers.
Patients with CLI must be referred to a vascular specialist — that is, any practitioner trained to treat CLI such as interventional cardiology, interventional radiology or vascular surgery. At the same time, patients should also be referred to wound care, podiatry and infectious disease (if known or suspected osteomyelitis is present). We must work together to overcome the current poor outcomes in CLI, again, primarily due to late presentation which is due to the lack of awareness of CLI by health care providers and the community at large. When you are presented with a patient with CLI, do not hesitate. Treat early.
Jihad A. Mustapha, MD, FACC, FSCAI
CEO, Advanced Cardiac and Vascular Centers for Amputation Prevention
Grand Rapids, Michigan
Clinical Associate Professor of Medicine
Michigan State University College of Osteopathic Medicine
Disclosures: Mustapha reports no relevant financial disclosures.