OhioHealth Riverside Methodist Hospital is nation’s first to use
recently-approved drug-coated stent
OhioHealth Riverside Methodist Hospital is now treating patients with peripheral artery disease (PAD) with the first drug-eluting stent to be used outside of the heart. Cook Medical's Zilver PTX is a drug-coated stent that is used to reopen a long thigh artery, located above the knee (the femoropopliteal artery), narrowed or blocked due to PAD. This is the most common artery for PAD blockages. Riverside Methodist was the first hospital in the United States to use the recently Food and Drug Administration-approved stent. Opal Ridenour, 90 of Columbus, was the first patient to receive the new stent.
"With this approval, treatment of PAD in the United States is expected to undergo the same revolution that drug elution did for treating coronary artery disease," said interventional cardiologist Gary Ansel, MD, system medical chief of the vascular program at OhioHealth. Dr. Ansel, along with Michael Dake, MD, from Stanford University Medical Center, were co-national principle investigators for the Zilver PTX clinical trial.
"It will keep arteries open longer and reduce the need for repeated procedures among a large part of the PAD population. In my opinion, drug-eluting stents will quickly become the standard of care for PAD patients nationwide."
Peripheral artery disease, which affects eight to 12 million Americans, is a common circulatory problem characterized by reduced blood flow to the limbs, usually the legs. One in three people over the age of 50 have PAD. These blockages are the same as those found in the heart and neck. People with PAD often experience leg pain and serious complications including gangrene and skin ulcers.
The approval of the drug-eluting stent provides patients with a new treatment option. Current treatments include exercise, medication, balloon angioplasty, bare metal stents and surgical bypass.
A stent is a small metal mesh tube inserted after a balloon angioplasty into a blocked or narrowed artery to keep it open. A drug-eluting stent contains medication slowly released over time that further prevents the artery from re-closing.
Zilver PTX is a unique combination therapy device that combines the mechanical support of stenting with the drug paclitaxel, which limits cell growth that can reclog the artery. The combination has been shown to maintain arterial blood flow to the superficial femoral artery (SFA) in seven out of ten patients through 24 months after implantation.
Riverside Methodist was among study sites in the United States and Japan that participated in a large clinical trial that demonstrated the safety and efficacy of the device.
The study showed that eight in 10 patients treated with the new stent still had open arteries after one year, compared to three in 10 treated with angioplasty alone. The results have demonstrated durability to at least three years. It also indicated that patients who received a bare metal stent required more than twice as many repeat procedures to reopen the artery as patients who received the new stent.
"Up to 80 percent of patients with lower leg blockage can be treated with this stent because it is designed for one of the most common sites of blockage in the peripheral vasculature," Ansel said. "This stent is also great news for diabetics. The study demonstrated equal benefit among diabetics and non-diabetics, which is not typically the case when treating PAD."
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Based in Columbus, Ohio, it is a family of 21,000 associates, physicians and volunteers, 18 hospitals, 23 health and surgery centers, home-health providers, medical equipment and health service suppliers throughout a 40-county area. OhioHealth member hospitals include Riverside Methodist Hospital, Grant Medical Center, Doctors Hospital-Columbus, Grady Memorial Hospital, Dublin Methodist Hospital, Doctors Hospital-Nelsonville, Hardin Memorial Hospital and Marion General Hospital. For more information, please visit our website at www.ohiohealth.com.