Researchers found in a review of data from three large studies that a minimally invasive treatment to treat peripheral artery disease offers a safe alternative to standard surgery.
Peripheral artery disease is a common circulatory problem in which the arteries become narrow from plaque buildup and blood flow to the limbs is reduced. The condition affects from 8 to 12 million Americans. The most common symptom is leg pain that occurs while walking or climbing but goes away with rest. For many patients, treatment includes lifestyle changes or medication. Those with severe plaque buildup may need vascular surgery or a minimally invasive procedure to clear the blockage.
The goal of this study was to analyze outcomes of patients treated with a minimally invasive, nonsurgical procedure using the orbital atherectomy system, which helps restore blood flow in the common femoral artery by using a rotating device to sand down the plaque into microparticles that the bloodstream flushes away.
The study reviewed data from three large, multi-center, non-randomized registries (called CONFIRM I, II and III) of 3,135 patients with severely calcified peripheral arterial disease who were treated with the orbital atherectomy system from October 2009 to June 2011.
Further studies are needed to compare orbital atherectomy with the surgical option called endarterectomy and to evaluate longer-term outcomes.
Although endarterectomy has been considered the standard of care for more than 50 years, the ideal treatment for these patients remains unknown. For some patients, such as older people or those with multiple health issues, surgery is considered too risky. This study shows that the orbital atherectomy treatment can offer patients a safe and effective alternative to surgery.
The authors of the study are Dr. Michael Lee and Dr. Daniel Heikali of UCLA; Dr. Jihad Mustapha of Metro Health Hospital in Wyoming, Mich.; Dr. George Adams of Rex Healthcare in Raleigh, N.C.; and Dr. Ehtisham Mahmud of UC San Diego.
This study was published by the peer-reviewed journal Vascular Medicine.
This research was funded Cardiovascular Systems Inc., the makers of the orbital atherectomy device.
Drs. Lee, Mustapha and Adams received funding from Cardiovascular Systems. The remaining authors disclose no conflicts.