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Accelerated Allograft Vasculopathy With Rituximab After Cardiac Transplantation
Journal article   Open access   Peer reviewed

Accelerated Allograft Vasculopathy With Rituximab After Cardiac Transplantation

Randall C Starling, Brian Armstrong, Nancy D Bridges, Howard Eisen, Michael M Givertz, Abdallah G Kfoury, Jon Kobashigawa, David Ikle, Yvonne Morrison, Sean Pinney, …
Journal of the American College of Cardiology, v 74(1)
09 Jul 2019
DOI: https://doi.org/10.1016/j.jacc.2019.04.056
PMID: 31272550
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://doi.org/10.1016/j.jacc.2019.04.056View
Published, Version of Record (VoR) Open

Abstract

Adult Allografts Double-Blind Method Female Heart Transplantation Humans Immunologic Factors - therapeutic use Male Middle Aged Postoperative Complications - prevention & control Prospective Studies Rituximab - therapeutic use Vascular Diseases - prevention & control Young Adult
The CTOT-11 (Prevention of Cardiac Allograft Vasculopathy Using Rituximab Therapy in Cardiac Transplantation [Clinical Trials in Organ Transplantation-11]) study was a randomized, placebo-controlled, multicenter, double-blinded clinical trial in nonsensitized primary heart transplant (HTX) recipients. The study sought to determine whether B cell depletion therapy would attenuate the development of cardiac allograft vasculopathy. A total of 163 HTX recipients were randomized to rituximab 1,000 mg intravenous or placebo on days 0 and 12 post-transplant. Primary outcome was change in percent atheroma volume (PAV) from baseline to 1 year measured by intravascular ultrasound. Secondary outcomes included treated episodes of acute rejection, de novo anti-HLA antibodies (including donor-specific antibodies), and phenotypic differentiation of B cells. There were no significant differences at study entry between the rituximab and placebo groups. Paired intravascular ultrasound measures were available at baseline and 1 year in 86 subjects (49 rituximab, 37 placebo). The mean ± SD change in PAV at 12 months was +6.8 ± 8.2% rituximab versus +1.9 ± 4.4% placebo (p = 0.0019). Mortality at 12 months was 3.4% rituximab versus 6.8% placebo (p = 0.47); there were no retransplants or post-transplant lymphoproliferative disorder. The rate of treated rejection was 24.7% rituximab versus 32.4% placebo (p = 0.28). Rituximab therapy effectively eliminated CD20 /CD19 B cells followed by a gradual expansion of a CD19 cell population in the rituximab-treated group. A marked, unexpected increase in coronary artery PAV with rituximab was observed during the first year in HTX recipients. One-year mortality was not impacted; however, longer-term follow-up and mechanistic explanations are required. (Prevention of Cardiac Allograft Vasculopathy Using Rituximab [Rituxan] Therapy in Cardiac Transplantation; NCT01278745).

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42 citations in Web of Science
42 citations in Scopus

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Collaboration types
Industry collaboration
Domestic collaboration
Web of Science research areas
Cardiac & Cardiovascular Systems
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