For patients with chronic limb-threatening ischemia (CLTI) from peripheral artery disease below the knee, treatment options have been limited and not durable. But last month’s Food and Drug Administration approval of a new device, an everolimus-eluting resorbable scaffold, opens the doors for an option that can greatly improve the quality of life for patients with this devastating condition.
Brian G. DeRubertis, MD, FACS, Chief of the Division of Vascular & Endovascular Surgery at NewYork-Presbyterian and Weill Cornell Medicine, and Sahil A. Parikh, MD, Director of Endovascular Services at NewYork-Presbyterian and Columbia, served as lead investigators in the U.S. for the pivotal LIFE-BTK trial that proved the safety and efficacy of the device. They were also among the first in the country to perform cases using the device since its approval. Below, they discuss what this FDA approval means for the field of interventional vascular medicine.
Treating a Disease With Few Options
Patients with CLTI often experience pain, nonhealing wounds, and even gangrene, putting them at high risk for amputation if they do not receive revascularization treatment. The standard-of-care treatment for CLTI is angioplasty, but the procedure has several drawbacks, including a low patency rate and need for repeat procedures.
Every time an artery we treat below the knee closes back down, which is common, the patient must undergo another procedure. Each time they have another procedure, they are not only at risk for complications, but they must come in and out of the hospital for invasive procedures multiple times a year, which dramatically impacts their quality of life.
We’ve needed to do better for these patients for a long time, and we have tried. There have been several clinical trials that we’ve been involved with looking at devices to help prevent narrowing of the arteries below the knee. Unfortunately, they’ve all been unsuccessful at meeting the endpoints, and none led to an FDA approval until the LIFE-BTK trial.
Last year, we published the findings from this pivotal trial which showed the safety and efficacy of the device. In the trial, we randomized adults into a two-to-one fashion to receive treatment with the everolimus-eluting resorbable scaffold or with angioplasty, and the findings showed overwhelmingly that this device produces better results than angioplasty.
Approval of this device has been nearly a decade in the making and something we have put our heart and soul into. The idea that we can develop a scaffold that can open an artery to deliver a drug to prevent scar tissue formation and keep the vessel open for longer than conventional therapies, is going to impact a lot of patients — particularly patients who come from relatively underserved backgrounds who are at higher risk for CLTI.
Approval of this device has been nearly a decade in the making and something we have put our heart and soul into. The idea that we can develop a scaffold that can open an artery to deliver a drug to prevent scar tissue formation and keep the vessel open for longer than conventional therapies, is going to impact a lot of patients — particularly patients who come from relatively underserved backgrounds who are at higher risk for CLTI.
Opening the Door to Additional Therapies
With this new device, which uses a poly-L-lactic acid scaffold structure, we now have an option that solves many of the problems of angioplasty and metal stents and improves the patency rate. The everolimus drug coating helps prevent scar tissue buildup and restenosis, and because the device is resorbable instead of metal like traditional stents, it allows for future procedures without the limitations of existing hardware. This device also allows us to improve the degree of perfusion that patients get beyond angioplasty alone. While we are excited about this approval, it’s important to note that having one treatment option is still not enough. The success we’ve had with this device and in the LIFE-BTK trial has opened the door to additional trials in which we’re evaluating other devices that could be an adjunct to this one. No one single device makes up the whole therapy for patient care — this is one part of a much bigger puzzle, and we’re excited for the potential opportunities this has created for patients with CLTI.
While we are excited about this approval, it’s important to note that having one treatment option is still not enough. The success we’ve had with this device and in the LIFE-BTK trial has opened the door to additional trials in which we’re evaluating other devices that could be an adjunct to this one. No one single device makes up the whole therapy for patient care — this is one part of a much bigger puzzle, and we’re excited for the potential opportunities this has created for patients with CLTI.
At NewYork-Presbyterian, we strive for clinical excellence and want to win battles against the diseases we treat. Being involved in a trial that leads to device approvals is a big win for us personally and professionally. Most of all, to be able to treat these patients more effectively with a minimally invasive technique that can both save limbs and lives is something that’s incredibly gratifying.
