(RxWiki News) Patients with more severe forms of peripheral artery disease (PAD) generally have fewer treatment options available, and those that are offered aren't always a home run. A trial has found that two types of stents both offer effective treatment.
PAD patients suffer from painful blood clots in their legs, while those with a severe type of PAD in the iliac arteries, which carry blood to the legs, tend to experience severe chronic pain even while resting.
Moreover, they may become permanently disabled as a result of the condition.
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The recent MOBILITY trial included patients with this more severe form, finding that both self-expanding and balloon-expandable stents could benefit this group.
Michael R. Jaff, DO, FSCAI, medical director of the Vascular Ultrasound Core Laboratory at Massachusetts General Hospital, said the trial showed that both stents are effective in real-world patients, noting that nine months after study patients received the stents, they saw improvements in their ability to walk and climb stairs.
They also had few new blockages and low rates of adverse events.
Researchers enrolled 304 severe PAD patients, including those at risk of losing limbs to amputation, in the multi-center MOBILITY trial. The participants had a total of 384 artery-blocking lesions, including some that were very complex. Of those patients, 151 were treated with the Absolute Pro Peripheral Self-Expanding Stent System, while 153 received treatment with the Omnilink Elite Peripheral Balloon-Expandable Stent System.The patients were followed for nine months.
At nine months, 6 percent of patients that received treatment with the expandable stent experienced major adverse events compared to 5 percent in the balloon stent group. This was well below the trial goal of 20 percent since many of the patients had severe limb-threatening forms of PAD. In 90 percent of patients, doctors noted moderate to severe calcification.
Both groups had improved walking ability. Of those who received the expandable stent, 8 percent suffered new artery blockages compared to 9 percent in the balloon stent group. Patients with this severe type of PAD are usually excluded from studies.
“The study shows even patients with severe lesions can be successfully treated, helping restore their movement," said Dr. Jaff.
Dr. Jaff serves as a non-compensated advisor to Abbott Vascular, which produces and markets the Absolute Pro stent used in the study. The research was recently presented at the Society for Cardiovascular Angiography and Interventions 2012 Scientific Sessions.