title: Long-term safety and performance of the orbital atherectomy system for treating calcified coronary artery lesions: 5-Year follow-up in the ORBIT I trial.
abstract: OBJECTIVE
  The ORBIT I trial, a first-in-man study, was conducted to evaluate the safety and performance of the orbital atherectomy system (OAS) in treating de novo calcified coronary lesions.
  
  
  METHODS
  Fifty patients were enrolled between May and July 2008 based on several criteria, and were treated with the OAS followed by stent placement. The safety and performance of the OAS were evaluated by procedural success, device success, and overall major adverse cardiovascular event (MACE) rates, including cardiac death, myocardial infarction (MI) and need for target lesion revascularization (TLR). Our institution enrolled and treated 33 of the 50 patients and continued follow-up for 5 years.
  
  
  RESULTS
  Average age was 54 years and 91% were males. Mean lesion length was 15.9 mm. Device success was 100%, and average number of orbital atherectomy devices (OAD) used per patient was 1.3. Stents were placed directly after OAS in 31/32 patients (96.9%). All stents (average stent per lesion 1.1) were successfully deployed with 0.3% residual stenosis. The overall cumulative MACE rate was 6.1% in-hospital, 9.1% at 30 days, 12.1% at 6 months, 15.2% at 2 years, 18.2% at 3 years and 21.2% at 5 years (4 total cardiac deaths). None of the patients had Q-wave MIs. Angiographic complications were observed in 5 patients. No flow/slow flow due to distal embolization was observed.
  
  
  CONCLUSIONS
  The ORBIT I trial suggests that OAS treatment continues to offer a safe and effective method to change compliance of calcified coronary lesions to facilitate optimal stent placement in these difficult-to-treat patients.
authors: Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat, India.
authors: Parloop
authors: P
authors: Bhatt
authors: Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat, India.
authors: Parth
authors: P
authors: Parikh
authors: Internal Medicine, Cleveland Clinic Foundation, Cleveland, OH, USA.
authors: Apurva
authors: A
authors: Patel
authors: Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat, India.
authors: Milan
authors: M
authors: Chag
authors: Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat, India.
authors: Anish
authors: A
authors: Chandarana
authors: Internal Medicine, Cleveland Clinic Foundation, Cleveland, OH, USA.
authors: Roosha
authors: R
authors: Parikh
authors: Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat, India. Electronic address: keyur.parikh@cims.me.
authors: Keyur
authors: K
authors: Parikh
mesh_terms: D000328:Adult; D000368:Aged; D017073:Atherectomy / Q000009:adverse effects / Q000379:methods; D003324:Coronary Artery Disease / Q000628:therapy*; D023921:Coronary Stenosis / Q000628:therapy*; D003331:Coronary Vessels / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome
keywords: Coronary artery disease; De novo calcified coronary lesions; Orbital atherectomy; Percutaneous coronary intervention