More than 90 percent of patients with symptomatic peripheral artery disease (PAD) did not have major adverse events within 30 days of undergoing endovascular procedures with the Diamondback 360 peripheral orbital atherectomy system and other devices to treat claudication and critical limb ischemia.
Cardiovascular Systems, the manufacturer of the Diamondback 360, released the results on Aug. 11. George Adams, MD, director of Cardiovascular and Peripheral Vascular Research at Rex Hospital in Raleigh, North Carolina, also presented the findings during a late-breaking presentation at the Amputation Prevention Symposium in Chicago.
The prospective, observational, multicenter LIBERTY 360° trial enrolled 1,204 patients with various levels of PAD based on the Rutherford Classification scale at 51 sites in the U.S. The analysis evaluated 500 Rutherford class 2-3 patients, 589 Rutherford class 4-5 patients and 100 Rutherford class 6 patients.
Most patients received balloons and atherectomy devices. Approximately 45 percent of Rutherford class 2-5 patients and more than 60 percent of Rutherford class 6 patients received the Diamondback 360.
The 30-day freedom from major adverse events rates were 99.0 percent for Rutherford class 2-3 patients, 95.7 percent for Rutherford class 4-5 patients and 90.7 percent for Rutherford class 6 patients. The 30-day freedom from major amputations rates were 100 percent, 98.8 percent and 95.8 percent, respectively, while the freedom from target vessel revascularization rates were 99.4 percent, 96.9 percent and 97.9 percent, respectively.
Further, 99.6 percent, 99.7 percent and 95.9 percent of patients, respectively, were alive after 30 days. Cardiovascular Systems added that quality of life improved from baseline in all Rutherford classes, as well.
The FDA has granted 510(k) clearance for using the Diamondback 260 in peripheral arteries and coronary arteries.
Cardiovascular Systems stopped enrolling patients in the LIBERTY 360° trial in February. The company plans on continuing to follow-up with patients and complete the study in December 2020.