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Accelerated Allograft Vasculopathy With Rituximab After Cardiac Transplantation
- Source :
- Journal of the American College of Cardiology. 74(1)
- Publication Year :
- 2018
-
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)
- Subjects :
- Adult
Male
medicine.medical_specialty
medicine.medical_treatment
Population
030204 cardiovascular system & hematology
Placebo
Gastroenterology
03 medical and health sciences
Young Adult
0302 clinical medicine
Postoperative Complications
Double-Blind Method
hemic and lymphatic diseases
Internal medicine
Intravascular ultrasound
medicine
Humans
Immunologic Factors
030212 general & internal medicine
Prospective Studies
Vascular Diseases
education
CD20
education.field_of_study
medicine.diagnostic_test
biology
business.industry
Immunosuppression
Middle Aged
Allografts
Transplantation
Clinical trial
biology.protein
Heart Transplantation
Rituximab
Female
Cardiology and Cardiovascular Medicine
business
medicine.drug
Subjects
Details
- ISSN :
- 15583597
- Volume :
- 74
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Journal of the American College of Cardiology
- Accession number :
- edsair.doi.dedup.....ce37b32e10cc5b2e2a85c6e16247b9e0