title: Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial).
abstract: Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients with severely calcified lesions.
authors.affiliation: Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York; Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Québec, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.affiliation: The Cardiac and Vascular Institute, Gainesville, Florida.
authors.forename: Arthur C
authors.initials: AC
authors.lastname: Lee
authors.affiliation: Utah Cardiology, Layton, Utah.
authors.forename: Christopher Y
authors.initials: CY
authors.lastname: Kim
authors.affiliation: UCLA Medical Center, Los Angeles, California.
authors.forename: Michael
authors.initials: M
authors.lastname: Lee
authors.affiliation: St. Francis Hospital-The Heart Center, Rosyln, New York.
authors.forename: Richard
authors.initials: R
authors.lastname: Shlofmitz
authors.affiliation: Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.affiliation: Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: Metropolitan Heart and Vascular Institute, Mercy Hospital, Minneapolis, Minnesota. Electronic address: J.Chambers@mhvi.com.
authors.forename: Jeff W
authors.initials: JW
authors.lastname: Chambers
mesh_terms: D000368:Aged; D017073:Atherectomy / Q000379:methods*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000401:mortality / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012720:Severity of Illness Index; D015607:Stents; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D061205:Vascular Calcification / Q000401:mortality / Q000628:therapy*