title: ORBIT II sub-analysis: Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System.
abstract: OBJECTIVE
  To investigate the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare severely calcified lesions for stent deployment in patients grouped by renal function.
  
  
  BACKGROUND
  Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with increased rates of major adverse cardiac events (MACE), including death, myocardial infarction (MI), and target vessel revascularization (TVR) compared with PCI of non-calcified vessels. Patients with chronic kidney disease (CKD) are at increased risk for MACE after PCI. The impact of CKD on coronary orbital atherectomy treatment has not been well characterized.
  
  
  METHODS
  ORBIT II was a prospective, multicenter trial in the U.S., which enrolled 443 patients with severely calcified coronary lesions. The MACE rate was defined as a composite of cardiac death, MI, and target vessel revascularization.
  
  
  RESULTS
  Of the 441 patients enrolled with known estimated glomerular filtration rate (eGFR) values at baseline, 333 (75.5%) patients had eGFR < 90 ml/min/1.73 m2and 108 patients had eGFR ≥ 90 ml/min/1.73 m2. The mean eGFR at baseline in the eGFR < 90 ml/min/1.73 m2and eGFR ≥ 90 ml/min/1.73 m2groups was 65.0 ± 0.9 ml/min/1.73 m2and 109.1 ± 2.0 ml/min/1.73 m2, respectively. Freedom from MACE was lower in the eGFR < 90 ml/min/1.73 m2group at 30 days (87.4% vs. 96.3%, P = 0.02) and 1-year (80.6% vs. 90.7%, P = 0.02).
  
  
  CONCLUSIONS
  Patients with renal impairment had a higher MACE rate through one year follow-up due to a higher rate of periprocedural MI. Interestingly, the rates of cardiac death and revascularization through 1-year were similar in patients with eGFR < 90 ml/min/1.73 m2and eGFR ≥ 90 ml/min/1.73 m2. Future studies are needed to identify the ideal revascularization strategy for patients with renal impairment and severely calcified coronary lesions. © 2016 Wiley Periodicals, Inc.
authors: UCLA Medical Center, Los Angeles, California.
authors: Michael S
authors: MS
authors: Lee
authors: The Cardiac and Vascular Institute, Gainesville, Florida.
authors: Arthur C
authors: AC
authors: Lee
authors: St. Francis Hospital-The Heart Center, Roslyn, New York.
authors: Richard A
authors: RA
authors: Shlofmitz
authors: Cardiovascular Systems, Inc, Saint Paul, Minnesota.
authors: Brad J
authors: BJ
authors: Martinsen
authors: Cardiovascular Systems, Inc, Saint Paul, Minnesota.
authors: Nick J
authors: NJ
authors: Hargus
authors: Detroit Medical Center - Heart Hospital Detroit, Michigan.
authors: Mahir D
authors: MD
authors: Elder
authors: New York-Presbyterian Hospital and Columbia University Medical & Cardiovascular Research Foundation, New York, New York.
authors: Philippe
authors: P
authors: Généreux
authors: Metropolitan Heart and Vascular Institute, Mercy Hospital, Minneapolis, Minnesota.
authors: Jeffrey W
authors: JW
authors: Chambers
mesh_terms: D000368:Aged; D017225:Atherectomy, Coronary / Q000009:adverse effects* / Q000379:methods; D002114:Calcinosis / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D002423:Cause of Death / Q000639:trends; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000502:physiology*; D006801:Humans; D015994:Incidence; D008297:Male; D009203:Myocardial Infarction / Q000453:epidemiology* / Q000209:etiology; D011183:Postoperative Complications; D011446:Prospective Studies; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000175:diagnosis / Q000503:physiopathology; D012307:Risk Factors; D012720:Severity of Illness Index; D015996:Survival Rate / Q000639:trends; D014481:United States / Q000453:epidemiology
keywords: atherectomy; calcification; cardiovascular intervention; coronary artery disease; renal disease