Jeffrey W Chambers1, Robert L Feldman2, Stevan I Himmelstein3, Rohit Bhatheja4, Augusto E Villa5, Neil E Strickman6, Richard A Shlofmitz7, Daniel D Dulas8, Dinesh Arab9, Puneet K Khanna10, Arthur C Lee11, Magdi G H Ghali12, Rakesh R Shah13, Thomas P Davis14, Christopher Y Kim15, Zaheed Tai16, Kirit C Patel17, Joseph A Puma18, Prakash Makam19, Barry D Bertolet20, Georges Y Nseir21. 1. Metropolitan Heart and Vascular Institute, Mercy Hospital, Minneapolis, Minnesota. Electronic address: J.Chambers@mhvi.com. 2. Central Florida Heart Center, Ocala, Florida. 3. The Stern Cardiovascular Center, Memphis, Tennessee. 4. Florida Heart Group, Orlando, Florida. 5. Palm Beach Cardiovascular Clinic, Jupiter, Florida. 6. The Texas Heart Institute, Houston, Texas. 7. St. Francis Hospital-The Heart Center, Roslyn, New York. 8. Metropolitan Heart and Vascular Institute, Mercy Hospital, Minneapolis, Minnesota. 9. Florida Hospital Memorial Medical Center, Daytona Beach, Florida. 10. Desert Cardiology Center, Rancho Mirage, California. 11. The Cardiac and Vascular Institute, Gainesville, Florida. 12. Iowa Heart Center, Des Moines, Iowa. 13. Comprehensive Cardiology Consultants, Langhorne, Pennsylvania. 14. Eastlake Cardiovascular Associates, St. Clair Shores, Michigan. 15. Utah Cardiology, Layton, Utah. 16. Gessler Clinic, Winter Haven, Florida. 17. Cardiology and Vascular Associates, Bloomfield Hills, Michigan. 18. Lenox Hill Heart and Vascular Institute of New York, New York, New York. 19. Cardiology Associates of Northwest Indiana, Munster, Indiana. 20. Cardiology Associates of North Mississippi, Tupelo, Mississippi. 21. Premier Cardiovascular Center, Chandler, Arizona.
Abstract
OBJECTIVES: The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. BACKGROUND: Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. METHODS: ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. RESULTS: The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis <50% post-stent without in-hospital major adverse cardiac events) was 88.9% compared with the performance goal of 82%. Stent delivery occurred successfully in 97.7% of cases with <50% stenosis in 98.6% of subjects. Low rates of in-hospital Q-wave myocardial infarction (0.7%), cardiac death (0.2%), and target vessel revascularization (0.7%) were reported. CONCLUSIONS: The ORBIT II coronary OAS trial met both the primary safety and efficacy endpoints by significant margins. Preparation of severely calcified plaque with the OAS not only helped facilitate stent delivery, but improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in this difficult-to-treat patient population. (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions [ORBIT II]; NCT01092416).
OBJECTIVES: The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. BACKGROUND: Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. METHODS: ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. RESULTS: The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis <50% post-stent without in-hospital major adverse cardiac events) was 88.9% compared with the performance goal of 82%. Stent delivery occurred successfully in 97.7% of cases with <50% stenosis in 98.6% of subjects. Low rates of in-hospital Q-wave myocardial infarction (0.7%), cardiac death (0.2%), and target vessel revascularization (0.7%) were reported. CONCLUSIONS: The ORBIT II coronary OAS trial met both the primary safety and efficacy endpoints by significant margins. Preparation of severely calcified plaque with the OAS not only helped facilitate stent delivery, but improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in this difficult-to-treat patient population. (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions [ORBIT II]; NCT01092416).
Authors: Ata Doost; James Marangou; Thato Mabote; Gerald Yong; Sharad Shetty; Alan Whelan; Matthew Erickson; Michael Nguyen; Christopher Judkins; Anthony Putrino; Abdul Rahman Ihdayhid; Richard Clugston; James Rankin Journal: AsiaIntervention Date: 2022-03-15
Authors: Qingwen Kawaji; Chen Dun; Christi Walsh; Rebecca A Sorber; David P Stonko; Christopher J Abularrage; James H Black; Bruce A Perler; Martin A Makary; Caitlin W Hicks Journal: J Vasc Surg Date: 2022-03-08 Impact factor: 4.860