TRUTH study demonstrates orbital atherectomy’s effectiveness at reducing and modifying calcified lesions with low procedural complications


Cardiovascular Systems unveiled new data about the treatment of arterial calcification at the 2014 Transcatheter Cardiovascular Therapeutics conference (TCT; 13–17 September, Washington DC, USA). Arterial calcium is a common occurrence for the millions of patients suffering from peripheral artery disease and it can lead to significant complications. Calcified plaque is estimated to be present in approximately 65 percent of the population treated annually for peripheral artery disease.

Results from the company’s Tissue removal assessment with ultrasound of the SFA and popliteal (TRUTH) study, a prospective, single-arm, non-randomised feasibility study of 25 patients were featured. TRUTH evaluated the removal of plaque with Cardiovascular Systems’ Peripheral Orbital Atherectomy System by analysing changes in plaque volume and composition via an independent virtual histology (VH) – intravascular ultrasound (IVUS) core laboratory.

In a poster presentation on Saturday, 13 September 2014, at the Walter E Washington Convention Center, physicians Anvar Babaev (NYU Medical Center, New York City), Susanna Zavlunova, (NYU Langone Medical Center, New York City), Michael J Attubato (New York University School of Medicine, New York City) and Akiko Maehara (Cardiovascular Research Foundation and Columbia University Medical Center, New York City) highlighted TRUTH study results demonstrating that Orbital Atherectomy System treatment is effective at reducing and modifying calcium from lesions, resulting in low acute complications and improved Rutherford Classification.

Key TRUTH results included:

  • All patients were asymptomatic two weeks after Orbital Atherectomy System treatment (Rutherford Classification (RC) of 0 (100% asymptomatic) compared to a baseline RC of 3 (96.0%);
  • 100% freedom from recoil, slow flow/no reflow, flow-limiting dissections or perforations after Orbital Atherectomy System treatment;
  • At the treated lesion site, the minimum lumen area increased significantly from 4.0 mm² to 9.1 mm² post-treatment (p <0.0001), accompanied by a decrease in area stenosis;
  • At the site of maximum calcium removal, calcium reduction was responsible for 86% of the lumen area increase; and
  • Calcium modification was directly related to Orbital Atherectomy System usage.