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VIDEO: Orbital atherectomy yields sustained outcomes at 3 years
ORLANDO, Fla. — Three-year data from the ORBIT II trial demonstrate durable outcomes after use of an orbital atherectomy device in severely calcified arteries prior to stent placement, Jeffrey W. Chambers, MD, said during a video interview.
The single-arm, prospective ORBIT II study included 443 patients at 49 U.S. sites. The device (Diamondback 360 Coronary Atherectomy System Classic Crown, Cardiovascular Systems Inc.) was used in “more severely calcified [arteries] than any other study before,” Chambers, director of the cardiac catheterization lab at Metropolitan Heart and Vascular Institute, Mercy Hospital, Minneapolis, said.
At 3 years, cardiac death was 6%, target lesion revascularization was 7.8%, TLR/target vessel revascularization was 10.2% and MI (CK-MB greater than three times the upper limit of normal) was 11.2%.
Chambers and fellow investigators also looked at a gender subset analysis to compare outcomes in men vs. women. They found no difference in TLR, TVR or MACE between the sexes.
“[These findings show that] the events are durable and males and females are essentially equivalent in terms of their outcomes,” he said.
Editor's note: This article was updated on May 11, 2016 to fix a typo in the data.