The same processes that cause dangerous narrowing of the blood vessels that supply the heart can also cause damage in other parts of the body. When the femoral artery and other vessels supplying the lower body are involved, the situation can become so severe that relentless pain, difficulty walking, non-healing wounds, and ultimately the possibility of amputation can loom over a patient.
In response to this problem, the industry developed stents designed to improve blood flow in peripheral vascular disease.
"The problem with earlier stents was that restenosis tended to occur too quickly" Hutton Brantley, DO of Cardiology PC said. "The procedure often had to be repeated within only a year or so.
"The next generations of stents were coated with a slow release medication aimed at limiting the proliferation of cells that can cause restenosis. This strategy was promising, but we still didn't see the kind of results we were hoping to achieve. Since I work with a lot of PVD patients, I was keeping a close watch on the success the Eluvia stent was having in the IMPERIAL trial. It was the first head to head comparison, and the results were remarkable."
Clinical trial results showed a primary patency rate at 12 months of 88.5 percent compared to 79.5 percent with the other option. The revascularization rate of the target lesion was half as high, and 95.1 percent of the Eluvia patients were free of major adverse events compared with 91 percent with the other system.
"I contacted Boston Scientific to learn more, and the rep helped us prepare so we'd be ready to offer the Eluvia stent to our patients as soon as FDA approval came through," Brantley said.
In early October of last year, Brantley used the Eluvia stent in a procedure for the first time in Alabama. Since then, it has been the stent of choice for 16 of his patients.
"After we place the stent in the artery, it continues to deliver paclitaxel for an extended period," he said. "So far, we are very pleased with the results. If we continue to see the kind of performance the Eluvia stent showed in trials, it is going to make a major difference for many of our patients."
Made with polymers on a purpose-designed platform to fit the twists and turns of the leg's vascular system, the Eluvia stent is available in multiple lengths and diameters.
When the stenosis isn't too severe, the condition may be asymptomatic and can be managed with medication, walking and lifestyle changes. But when the narrowing becomes symptomatic and the muscle is starved of blood, the patient can be in a great deal of pain with their quality of life diminished.
Patients might assume the pain is arthritis and that nothing can be done beyond their arthritis medication, which can leave them suffering needlessly as the condition progresses. If they have symptoms or the same factors that put them at risk for heart disease--cholesterol and lipid problems, smoking, age, inactivity or metabolic problems like diabetes--they should be screened for peripheral vascular disease.
"In the office, you can check for abnormal pulses in their legs or use ultrasound or other imaging," Brantley said. "Finding the condition early and beginning treatment could help to slow down the progression."
After the procedure, Brantley encourages his patients to follow up with lifestyle changes to help keep their stent clear and the blood flowing.
"Stopping smoking, eating healthy and working to keep cholesterol down, while walking more can make a difference," he said. "With the relief the stent gives them, patients find it easier to be more active. It improves their quality of life. I work with many different types of cardiology conditions, and I find that PVD patients seem to be the most excited about being able to once again do the things they enjoy without pain."