Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), yesterday presented six-month data from the COMPLIANCE 360° study of severely calcified above-the-knee lesions at the 23rd Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, sponsored by the Cardiovascular Research Foundation. COMPLIANCE 360° is a prospective multi-center study which randomized treatment 1:1 with CSI’s Diamondback 360° against percutaneous transluminal angioplasty (PTA). Data demonstrated that, compared to PTA alone, orbital atherectomy with low-pressure PTA using CSI’s Diamondback 360° leads to better luminal gain by improving lesion compliance with less need for adjunctive stenting. Additionally, the Diamondback 360° arm required significantly less bailout stent replacement than the PTA arm. Dr. Raymond Dattilo, St. Francis Health Center, Topeka, Kan., principal investigator of the COMPLIANCE 360° study noted, “The COMPLIANCE 360° study demonstrated that orbital atherectomy is superior to balloon angioplasty in its ability to achieve a good angiographic result with markedly decreased need for bailout stenting. At six months, patency in the orbital group was similar to the balloon group, despite stents used in just 5 percent of lesions in the orbital group versus 78 percent in the balloon group.” Dr. Dattilo presented the following six-month data in an oral presentation:
|Diamondback 360° Arm||PTA Arm|
|<30% stenosis without bailout stent placement||92.1% of 38 lesions||21.4% of 28 lesions|
|Mean maximum balloon pressure (p < 0.0001) (measure of lesions compliance)||3.97 atm||9.15 atm|
|Percent of patients free from TLR or restenosis at 6 months||72.7%||8.3%|
“As longer-term data becomes available, we are excited to see durable outcomes demonstrating that our orbital systems — Stealth 360 °, Predator 360° and Diamondback 360° — provide safe, effective, durable treatment solutions for PAD anywhere in the leg. Additionally, we are pleased by the strong mid-term data from ORBIT I, our coronary feasibility study, which demonstrates 85 percent freedom from adverse events at 24 months in an extremely sick patient population. These patients would have been excluded from most other clinical studies due to the severity of their calcified lesions. We are excited about the possibility of treating this patient population as we continue to advance our ORBIT II study toward FDA clearance in treating severely calcified coronary lesions.”ORBIT I was the initial feasibility study which enabled the ORBIT II trial to begin enrollment in the United States. Coronary Arterial Disease Clinical Study Results Two poster presentations by Dr. Keyur Parikh, Care Institute of Medical Science, Ahmedabad, India, analyzed data from ORBIT I, a feasibility study for a coronary application using CSI’s orbital mechanism of action. The prospective, multi-center, single-arm study enrolled 50 patients in India. Performing percutaneous coronary intervention (PCI) with varied coronary devices on calcified lesions can lead to adverse event rates as high as 24 percent at 30 days, perforation and other procedural issues. In Dr. Parikh’s studies:
- Six-month, 50 patient follow-up data showed a low major adverse cardiac events (MACE) rate of 8 percent, demonstrating that the Diamondback 360° offers a new procedural method to debulk calcified coronary lesions and successfully facilitate stent delivery at the time of the procedure. Click here to read the full abstract.
- Two-year data from a subset of 33 patients at a single center showed a MACE rate of 15.2 percent at two years. Click here to read the full abstract.
- Six-Month Outcomes of Prospective, Randomized CALCIUM 360° Study Demonstrate the Advantages of Plaque Modification with the Orbital Technology Versus Treatment with Balloon Angioplasty in Patients with Critical Limb Ischemia, presented by Dr. Nicolas W. Shammas, Trinity Medical Center, Bettendorf, Iowa.CALCIUM 360° is a prospective, multi-center randomized study comparing treatment of below-the-knee lesions with the Diamondback 360° versus PTA. All 50 patients had critical limb ischemia (CLI) and calcified lesions. These conditions are challenging to treat in the small arteries below the knees and often a precursor to amputation.At six months, the Diamondback 360° provided superior outcomes:
|Diamondback 360º||Balloon Angioplasty|
|Bailout stenting||2 (6.7%)||4 (11.4%)|
|Final residual stenosis ≤30% without bailout stent||82.8%||61.8%|
|Deaths at six months||0 (0%)||3 (17.6%)|
|TLR/TVR at six months||0 (0%)||2 (11.8%)|
- CONFIRM II Predator data, presented by Dr. Gaurav Aggarwala, Utah Cardiology, Layton, Utah.CONFIRM II Predator is a prospective registry of 1,127 patients treated with the Predator 360°, collected by 153 investigators at 122 institutions. The study is designed to determine device utility and procedural success in a real-world patient population. Device run time averaged 103 seconds per patient, followed, in a majority of lesions, by low-pressure angioplasty (mean 5.3 atms). Bailout stents were placed only in approximately 5 percent of lesions.Dr. Aggarwala commented, “The CONFIRM II study validates the use of orbital technology in restoring flow by changing lesions compliance, thus allowing low-pressure balloon angioplasty with limited complications and reduced need for bailout stenting.” Click here to read the full abstract.
- Use of Orbital Treatment in a High-Volume Clinical Practice Modifies Non-Compliant Plaque to Deliver Durable Long-Term Results, presented by Dr. Prakash Makam, Community Hospital, Munster, Ind.Dr. Makam reported on a single-center study of 46 patients with fibrotic or calcified lesions who were treated with the Predator 360°. Average pre-treatment stenosis was 89 percent; in 84 percent of cases, low pressure balloon inflation was utilized to achieve a mean residual stenosis of 10.5 percent. No bailout stenting was required. Only five patients (10.9 percent) returned for retreatment of the target lesion within the 12-month follow-up period, validating previous long-term data reported in the OASIS LT trial. Click here to read the full abstract.
For more information, visit the company’s website at www.csi360.com.Product Disclosure The Stealth 360° TM, Diamondback 360 ® and Predator 360 ® PAD Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.