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Accelerated Allograft Vasculopathy With Rituximab After Cardiac Transplantation.

Abstract：

BACKGROUND: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. OBJECTIVES:The study sought to determine whether B cell depletion therapy would attenuate the development of cardiac allograft vasculopathy. METHODS: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. RESULTS: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. CONCLUSIONS: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).

journal_name

J Am Coll Cardiol

journal_title

Journal of the American College of Cardiology

authors

Starling RC,Armstrong B,Bridges ND,Eisen H,Givertz MM,Kfoury AG,Kobashigawa J,Ikle D,Morrison Y,Pinney S,Stehlik J,Tripathi S,Sayegh MH,Chandraker A,CTOT-11 Study Investigators.

doi

10.1016/j.jacc.2019.04.056

subject

Has Abstract

pub_date

2019-07-09 00:00:00

pages

36-51

issue

eissn

0735-1097

issn

1558-3597

pii

S0735-1097(19)35161-7

journal_volume

pub_type

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Accelerated Allograft Vasculopathy With Rituximab After Cardiac Transplantation.