Two-year follow-up of patients in the first-ever prospective, multi-center clinical trial evaluating a plaque removal product show promising results after treatment with the Diamondback 360® PAD System, a minimally invasive catheter system that removes hardened plaque to restore blood flow in arteries. Dr. Barry Weinstock, Mid-Florida Cardiovascular Specialists, Orlando, Fla., will present the data from the OASIS follow-up study in a Tuesday, September 22 poster session (No. 578, Hall D), from 8 a.m. to 10 a.m. PT, at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, sponsored by the Cardiovascular Research Foundation.
In patients with peripheral arterial disease (PAD), plaque that accumulates in leg or foot arteries reduces blood flow and leads to leg pain, immobility and potentially amputation. In the United States alone, as many as 12 million patients suffer from PAD. Cardiovascular Systems, Inc., (CSI) (Nasdaq: CSII) provides comprehensive solutions for treating PAD, including the Diamondback 360°.
“At CSI, we are committed to clinical studies that provide scientifically sound long-term data to help physicians evaluate therapies and better treat PAD patients,” said David L. Martin, president and chief executive officer. “The two-year follow-up of patients from our landmark OASIS clinical trial reinforces our excitement about treatment with the Diamondback 360°, its ability to help save legs and lives, and restore quality of life for patients and their families. Further, in this cost-conscious healthcare environment, we are mindful of the economic benefits of keeping PAD patients mobile and independent. Additional clinical studies of the Diamondback 360° are under way to further enhance our understanding of our product.”
“Our goal is to treat PAD patients, restore their ability to walk pain-free and keep their legs for life,” said Dr. Weinstock. “This two-year data of OASIS patients adds to our confidence in the safety and efficacy of the Diamondback 360°, and further encourages me to use the device as a first option in treating this prevalent disease.”
The OASIS study (Orbital Atherectomy System for the Treatment of Peripheral Vascular Stenosis), a non-randomized, IDE study, demonstrated the safety and efficacy of the Diamondback 360° in treating 124 patients with PAD with follow-up out to six months. The primary endpoints were met with a 59-percent reduction in stenosis in the 201 lesions treated and a 4-percent rate of device-related serious adverse events. No patients had major amputations, and ankle-brachial index (ABI) scores remained significantly improved (p<0.0001) at six months.
A retrospective look at two-year outcomes of 64 available OASIS patients showed durable results by several measures:
- The target lesion and vessel revascularization rates (TLR/TVR), or reintervention in the originally treated lesion or vessel, were 13.6 percent and 15.5 percent, respectively.
- A 100-percent limb salvage rate was maintained.
- Ankle-brachial index (ABI) scores, a measure of blood flow to the ankle, remained significantly improved by an average score of 0.29 (p<0.001) over the baseline.
This subset of patients from 12 of the 17 enrolling medical centers had characteristics similar to those in the entire OASIS population. The mean age was 73 years, and 72 percent were men. In this group, 52 percent had diabetes, 81 percent had hypertension, 71 percent had hyperlipidemia (elevation of fats in the bloodstream), and 57 percent were current or former smokers. Eighty percent of the lesions were located below the knee, 56 percent were calcified, and narrowings averaged 27 mm in length.