Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia (BEST-CLI)—Clinical

Why is this study important?

There are few prospective randomized trials that compare endovascular techniques with surgical revascularization for peripheral artery disease. There is also great heterogeneity in preprocedural planning as well as endovascular procedure techniques in the treatment of patients with critical limb ischemia (CLI).

What question was this study supposed to answer?

Over the last few decades, the widespread adoption of endovascular techniques has led to a significant increase in their application in the treatment of patients with CLI. Multiple studies showed excellent clinical outcomes and limb preservation rates. In contrast to surgical bypass, endovascular therapy was associated with decreased peri-procedural morbidity and mortality. The durability, cost, and appropriate case selection between the two treatment modalities were yet to be assessed.

Is an endovascular or an open surgical revascularization the best approach, in patients with CLI and infrainguinal arterial occlusive disease who are candidates for both open and endovascular treatment

What did the study show?

Among patients with CLI in whom both surgical and endovascular interventions were feasible, surgical revascularization with a great saphenous venous conduit was superior to endovascular intervention in reducing major adverse limb events, primarily driven by a reduction in major adverse limb events. Outcomes were similar between surgery and endovascular therapies, when a great saphenous vein conduit was not available.

What are the study limitations?

Procedural heterogeneity; e.g. Atherectomy was only performed in 154 out of 1250 endovascular procedures.
Lower success rates for the endovascular approach (84% in group 1, 80% in group 2) compared to open surgical (98.3% in group 1, 100% in group 2),
The study included interventional cardiologists and interventional radiologists but the majority of operators were vascular surgeons (72%) which may not reflect all procedural skill sets.
Successful intervention was also operator-determined.
Intravascular imaging -which has been shown to improve endovascular outcomes- was not part of the study protocol.

Future studies evaluating a standard contemporary endovascular approach vs. open surgical approach can help overcome some of the existing limitations.