Device to Sand Away Severe Calcium in Coronary Arteries Shows Long-Term Positive Results in a Difficult-to-Treat Patient Population

SAN DIEGO, May 7, 2015 /PRNewswire/ -- After two years, patients treated with orbital atherectomy, a device that sands away severely calcified plaque in the coronary arteries prior to stenting, continued to show positive results, according to new data from the ORBIT II trial presented today as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2015 Scientific Sessions.

ORBIT II is the first atherectomy study to exclusively investigate severely calcified lesions. It included patients who are usually excluded from large clinical trials, such as patients on hemodialysis or with low left ventricular ejection fraction (<25 percent). In patients treated with percutaneous coronary intervention (PCI), calcified lesions may prevent the stent from fully expanding in the artery and patients may need a repeat coronary intervention or coronary artery bypass graft surgery (CABG).

For the clinical trial, investigators enrolled 443 patients at 49 U.S. sites. The Diamondback 360 Orbital Atherectomy System (OAS) catheter was used to treat severely calcified lesions prior to stent placement. The device's eccentric crown creates an elliptical orbit in the artery to sand the calcified portion of the plaque into minuscule particles. The device received FDA approval in October 2013 and demonstrated favorable safety outcomes in hospital, at 30 days and at one year.

The new data followed patients to two years after their procedure. Results showed 19.4 percent of patients experienced a major adverse cardiac event (MACE), including cardiac death (4.3 percent) and the need for a repeat procedure to open the target vessel (8.1 percent).

"ORBIT II includes some of the most high-risk PCI patients," said Jeffrey Chambers, MD, FSCAI, director of the Cardiac Catheterization Laboratory, Mercy Hospital, Minneapolis, and the study's principal investigator. "We found that preparing the artery prior to stent placement with orbital atherectomy is associated with low complication rates and may allow many of these patients to avoid more invasive surgery."

Further, the study found similar rates of MACE in both diabetic and non-diabetic patients, even though diabetics typically have higher rates of MACE than non-diabetics post-PCI.

A cost analysis presented by study investigators found OAS is a cost-effective treatment at one year. Total cost savings were projected to be up to $4,913. When the cost of the orbital atherectomy device ($3,795) was taken into account, there was still a potential cost savings of up to 1,118 dollars.

Dr. Chambers receives consulting fees/honoraria from Cardiovascular Systems, Inc.

Dr. Chambers presented "Orbital Atherectomy Treatment of Severely Calcified Coronary Lesions: Two Year Results of the ORBIT II Trial and Long-Term Economic Analysis," on Thursday, May 7, at 11:30 a.m. (Pacific Time).

About SCAI

The Society for Cardiovascular Angiography and Interventions is a 4,500-member professional organization representing invasive and interventional cardiologists in approximately 70 nations. SCAI's mission is to promote excellence in invasive/interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's public education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit  www.SCAI.org or www.SecondsCount.org. Follow  @SCAI and @SCAINews on Twitter for the latest heart health news. Use #SCAI2015 to stay up-to-date and join the annual meeting conversation.

SOURCE SCAI

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