Author + information
- Received February 12, 2018
- Revision received April 2, 2018
- Accepted April 5, 2018
- Published online August 20, 2018.
- Roxana Mehran, MDa,∗ (, )
- Michela Faggioni, MDa,
- Jaya Chandrasekhar, MBBS, MSa,
- Dominick J. Angiolillo, MD, PhDb,
- Barry Bertolet, MDc,
- Robert Lee Jobe, MDd,
- Bassam Al-Joundi, MDe,
- Somjot Brar, MDf,
- George Dangas, MD, PhDa,
- Wayne Batchelor, MD, MHSg,
- Anand Prasad, MDh,
- Hitinder S. Gurm, MDi,
- James Tumlin, MDj and
- Gregg W. Stone, MDk
- aIcahn School of Medicine at Mount Sinai, New York, New York
- bUniversity of Florida College of Medicine–Jacksonville, Jacksonville, Florida
- cNorth Mississippi Medical Center, Tupelo, Mississippi
- dNorth Carolina Heart & Vascular, Raleigh, North Carolina
- eGateway Cardiology, Saint Louis, Montana
- fKaiser Permanente Los Angeles Medical Center, Los Angeles, California
- gTallahassee Memorial Hospital, Heart and Vascular Center, Tallahassee, Florida
- hDivision of Cardiology, Department of Medicine, The University of Texas Health Science Center San Antonio, San Antonio, Texas
- iDepartment of Internal Medicine, University of Michigan, Ann Arbor, Michigan
- jDepartment of Internal Medicine, Division of Nephrology, University of Tennessee College of Medicine in Chattanooga, Southeast Renal Research Institute, Chattanooga, Tennessee
- kColumbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York
- ↵∗Address for correspondence:
Dr. Roxana Mehran, Mount Sinai Hospital, One Gustave L. Levy Place, Box 1030, New York, New York 10029.
Objectives The aim of the AVERT (AVERT Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN) trial was to test the efficacy of the AVERT system to reduce the contrast media volume (CMV) used during coronary angiographic procedures without impairing image quality and to prevent contrast-induced acute kidney injury (CI-AKI) in patients at risk for CI-AKI.
Background CI-AKI is a common complication of percutaneous coronary procedures, associated with increased morbidity and mortality. The AVERT system alters the coronary injection pressure profile by diverting contrast away from the patient during coronary injection.
Methods The AVERT trial was a prospective, multicenter, 1:1 randomized clinical trial in 578 subjects with either baseline estimated glomerular filtration rate 20 to 30 ml/min/1.73 m2 or estimated glomerular filtration rate 30 to 60 ml/min/1.73 m2 and at least 2 additional risk factors for CI-AKI. Patients undergoing coronary angiography with planned or possible percutaneous coronary intervention (PCI) were randomized to hydration plus the AVERT system (n = 292) or hydration only (n = 286). The primary effectiveness endpoints were: 1) the total CMV used; and 2) the incidence of CI-AKI, defined as a ≥0.3 mg/dl increase in serum creatinine within 5 days post-procedure.
Results Patient demographics were well balanced between the groups, with mean baseline serum creatinine of 1.6 ± 0.4 mg/dl and 64.9% patients with diabetes mellitus. PCI was performed in 42.2% of procedures, with coronary angiography in the remainder. Use of AVERT resulted in a 15.5% relative reduction in CMV overall (85.6 ± 50.5 ml vs. 101.3 ± 71.1 ml; p = 0.02) and a 22.8% relative reduction in CMV among PCI patients (114 ± 55 ml vs. 147 ± 81 ml; p = 0.001). The maximum relative reduction in CMV was 46% (124 ± 48 ml vs. 232 ± 97 ml; p = 0.01) when ≥3 lesions were treated. There were no differences in the rates of CI-AKI (27.0% vs. 26.6%; p = 0.70) between the study groups.
Conclusions Use of the AVERT system was feasible and safe, with acceptable image quality during coronary angiography and PCI. AVERT significantly reduced CMV, with the extent of CMV reduction correlating with procedural complexity. No significant differences in CI-AKI were observed with AVERT in this trial. (AVERT Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN [AVERT]; NCT01976299)
The AVERT trial was sponsored and funded by Osprey Medical. Dr. Mehran has received institutional research grant support from The Medicines Company, Bristol Myers-Squibb, AstraZeneca, and Lilly/Daiichi-Sankyo; is on the advisory board for Janssen (Johnson & Johnson); and has received consulting fees and honoraria from Abbott Vascular, AstraZeneca, Boston Scientific, Covidien, CSL Behring, Janssen (Johnson & Johnson), and Merck. Dr. Angiolillo has received payments as an individual for consulting fees or honoraria from Amgen, AstraZeneca, Bayer, Biosensors, Chiesi, Daiichi-Sankyo, Eli Lilly, Janssen, Merck, PLx Pharma, Pfizer, and Sanofi; and participation in review activities from CeloNova and St. Jude Medical and institutional payments for grants from Amgen, AstraZeneca, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Matsutani Chemical Industry, Merck, Novartis, and Renal Guard Solutions. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 12, 2018.
- Revision received April 2, 2018.
- Accepted April 5, 2018.
- 2018 American College of Cardiology Foundation
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