ORBIT II


The ORBIT II pivotal trial was a prospective, multi-center study conducted in the U.S. that evaluated patients with severely calcified coronary lesions treated with Diamondback 360® Coronary Orbital Atherectomy System (OAS) Classic Crown prior to stent implantation.

Key Takeaways

  • ORBIT II demonstrated long term durable results with a low target lesion revascularization (TLR) rate of 3.4% at 1 year in the drug-eluting stent (DES) subset (N=389/443)
  • ORBIT II met the primary safety and efficacy endpoints by a significant margin

Study Design

  • 443 patients with severely calcified lesions were enrolled at 49 U.S. Sites
  • Designed to evaluate the safety and efficacy of the Diamondback 360 Coronary OAS Classic Crown
  • Primary Safety Endpoint: Major adverse cardiac events (MACE) at 30 days
  • Primary Efficacy Endpoint: Procedural Success defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE

Patient Population

 n=443
History of Diabetes36.1%
History of CABG14.7%
History of Dyslipidemia91.9%
History of Hypertension91.6%
Smoker (current or previous)66.1%

Study Results

Procedural Success88.9%
Successful Stent Delivery97.7%
Less than 50% residual stenosis98.6%
Freedom from in-hospital MACE90.2%

*Procedural success defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE

ORBIT II 30 Day | amCharts
*MI = CK-MB>3X ULN.
Kaplan-Meier method used to estimate event rates.
MACE defined as cardiac death, MI, and TVR/TLR.
ORBIT II 1 Year | amCharts
*MI = CK-MB>3X ULN.
Kaplan-Meier method used to estimate event rates.
MACE defined as cardiac death, MI, and TVR/TLR.

Lee M, et al. Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial. Cardiovasc Revasc Med. 2017;18(4):261-264.

Chambers JW, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv. 2014;7(5):510-8.


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