Author + information
- Received October 23, 2013
- Revision received December 18, 2013
- Accepted January 4, 2014
- Published online May 1, 2014.
- Jeffrey W. Chambers, MD∗∗ (, )
- Robert L. Feldman, MD†,
- Stevan I. Himmelstein, MD‡,
- Rohit Bhatheja, MD§,
- Augusto E. Villa, MD‖,
- Neil E. Strickman, MD¶,
- Richard A. Shlofmitz, MD#,
- Daniel D. Dulas, MD∗,
- Dinesh Arab, MD∗∗,
- Puneet K. Khanna, MD††,
- Arthur C. Lee, MD‡‡,
- Magdi G.H. Ghali, MD§§,
- Rakesh R. Shah, MD‖‖,
- Thomas P. Davis, MD¶¶,
- Christopher Y. Kim, MD##,
- Zaheed Tai, DO∗∗∗,
- Kirit C. Patel, MD†††,
- Joseph A. Puma, DO‡‡‡,
- Prakash Makam, MD§§§,
- Barry D. Bertolet, MD‖‖‖ and
- Georges Y. Nseir, MD¶¶¶
- ∗Metropolitan Heart and Vascular Institute, Mercy Hospital, Minneapolis, Minnesota
- †Central Florida Heart Center, Ocala, Florida
- ‡The Stern Cardiovascular Center, Memphis, Tennessee
- §Florida Heart Group, Orlando, Florida
- ‖Palm Beach Cardiovascular Clinic, Jupiter, Florida
- ¶The Texas Heart Institute, Houston, Texas
- #St. Francis Hospital–The Heart Center, Roslyn, New York
- ∗∗Florida Hospital Memorial Medical Center, Daytona Beach, Florida
- ††Desert Cardiology Center, Rancho Mirage, California
- ‡‡The Cardiac and Vascular Institute, Gainesville, Florida
- §§Iowa Heart Center, Des Moines, Iowa
- ‖‖Comprehensive Cardiology Consultants, Langhorne, Pennsylvania
- ¶¶Eastlake Cardiovascular Associates, St. Clair Shores, Michigan
- ##Utah Cardiology, Layton, Utah
- ∗∗∗Gessler Clinic, Winter Haven, Florida
- †††Cardiology and Vascular Associates, Bloomfield Hills, Michigan
- ‡‡‡Lenox Hill Heart and Vascular Institute of New York, New York, New York
- §§§Cardiology Associates of Northwest Indiana, Munster, Indiana
- ‖‖‖Cardiology Associates of North Mississippi, Tupelo, Mississippi
- ¶¶¶Premier Cardiovascular Center, Chandler, Arizona
- ↵∗Reprint requests and correspondence:
Dr. Jeffrey W. Chambers, Metropolitan Heart and Vascular Institute, Mercy Hospital, The Heart Center, Suite 120, 4040 Coon Rapids Boulevard, Minneapolis, Minnesota 55433.
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)
The ORBIT II trial was sponsored by Cardiovascular Systems, Inc. Dr. Chambers receives consulting and presentation fees from Cardiovascular Systems, Inc. (CSI), Vascular Solutions, Boston Scientific, and Covidien. Dr. Himmelstein is a physician proctor for and receives training fees from CSI. Dr. Bhatheja has received consulting fees from CSI. Dr. Shlofmitz has received training fees from CSI. Dr. Arab has received training fees from CSI; has received consulting fees from CSI, Cordis Corp., and Medtronic; and owns stock in CSI. Dr. Khanna owns stock in CSI. Dr. Lee has received consulting and training fees from and owns stock in CSI. Dr. Davis has received training fees from CSI. Dr. Kim has received speaking fees from Abbott Vascular. Dr. Tai serves on the Speakers' Bureaus of Spectranetics and Terumo. Dr. Makam has received speaking and training fees from and owns stock in CSI. Dr. Nseir has received consulting and speaking fees from CSI. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 23, 2013.
- Revision received December 18, 2013.
- Accepted January 4, 2014.
- American College of Cardiology Foundation