Study: Exceptional Safety, Procedural Success With Coronary Orbital Atherectomy

Cardiovascular Systems Inc. (CSI), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced results from a large retrospective observational study of coronary orbital atherectomy. The study shows exceptional safety and high procedural success in 519 patients with severely calcified cardiac disease who were treated with orbital atherectomy prior to stent deployment.
 
“We studied over 500 patients with challenging coronary lesions. The lesions were heavily stenosed and calcified, measuring up to 60 mm in length. Over half were classified as ACC/AHA Type C lesions, the most difficult anatomy. Despite treating these most complex cases, procedural and component angiographic complication rates were all below 1 percent and stents were successfully deployed in all procedures. In this contemporary real-world experience, OAS was found to be safe; successfully streamlining treatment for patients with the most significant coronary disease,” said Nirat Beohar, M.D., professor of Medicine and vice chief, Columbia University Division of Cardiology at the Mount Sinai Medical Center, Miami, Fla., et al.¹
 
Orbital Atherectomy System for Treating De Novo, Severely Calcified Coronary Lesions: A Tertiary Center Experience:

• Patients: 519
• Percent Stenosed: 86.8 percent
• Type C Lesions: 53.5 percent
• Average Lesion Length: 22.6 mm

Angiographic Complications:

• Dissection: 0.4 percent
• Perforation: 0.8 percent
• Slow/No Re-flow: 0 percent
• Lesion Cross Rate: 100 percent
• Stent Delivery and Deployment: 100 percent
• Average Fluoroscopy Time: 19.6 minutes
• 30-day MACE² 1.3 percent
• 30-day Cardiac Death: 0.8 percent
• 30-day MI: 0.8 percent

Severe calcification of coronary lesions represents a major challenge to minimize procedural complications and optimize stent delivery, expansion and apposition for best PCI outcomes. The Diamondback 360® Coronary OAS uses a dual mechanism of action to treat both superficial and deep calcium.
 
Scott Ward, Chairman, president and CEO, said, “This study expands our evidence demonstrating the safe, effective use of orbital atherectomy to treat a real-world complex patient population. With 11 studies tracking over 2200 patients to date, CSI continues to extend its leadership in the development of medical evidence for the treatment of patients with severe coronary artery disease.”
 
CAD is a life-threatening condition and a leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. According to estimates, significant arterial calcium is present in nearly 40% of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).
 
The Diamondback 360 Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

References
¹ Orbital Atherectomy System for Treating De Novo, Severely Calcified Coronary Lesions: A Tertiary Center Experience. Authors Nirat Beohar, M.D., Juan M. Vinardell, M.D., Carlos Podesta, M.D., Nafees Mohammed, M.D., Todd Heimowitz, DO, Christian Koelbl, M.D., Ph.D., Helen Parise, Ph.D., and Ajay Kirtane, M.D. SM.
² MACE is defined as the composite of Cardian Death, MI, ischemic CVA and hemorrhagic CVA.