Session Time: 3:15pm-4:00pm
Presentation Time: 3:30pm-4:00pm
*Purpose: The TEAMMATE (Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients using the MATE Score) Trial is the first multicenter effort to address key scientific questions in pediatric heart transplant using a randomized trial design. Given that pediatric trials present unique challenges with respect to enrollment, we sought to examine our screening patterns, recruitment performance, and the characteristics of the randomized cohort.
*Methods: TEAMMATE has 26 participating US study sites. Six-month heart transplant survivors are randomized in a 1:1 ratio to everolimus/low-dose tacrolimus (EVL/LDTAC) or tacrolimus/mycophenolate mofetil (TAC/MMF) and are followed for 30 months. Patient screening and recruitment began in Feb 2018 and will be completed by spring 2020. The TEAMMATE Trial Coordinating Centers (Clinical: Stanford/Lucile Packard Hospital; Data: Harvard/Boston Children’s Hospital) developed several tools including a public website (http://med.stanford.edu/teammate.html) and an informed consent video in two languages, approved by a central IRB. The target sample size is 210 patients. Original design assumptions were 85% eligibility and 80% consent, for a yield of 68% of total screened.
*Results: As of 12/05/19, a total of 504 patients were screened for trial eligibility. Of these, 56% were potentially eligible and approached for consent. The consent rate was 63% and 162 were randomized (32% of total screened). The most common reasons (not mutually exclusive) for the 214 screen failures were a) inability to return to study site for study visits (n=52, 24%); b) prior qualifying rejection (n=34, 16%); c) past reaction to MMF (n=32, 15%); d) history of non-adherence to immunosuppression regimen (n=30, 14%); and e) participation in a concurrent pediatric heart transplant trial (n=18, 8%). The randomized cohort (n=81 EVL/LDTAC, n=81 TAC/MMF to date) is age 7.9±6.2 years (17% infants). One-half (48%) had a cardiomyopathy diagnosis and 47% had congenital heart disease (n=64 single ventricle and n=11 two ventricle). Nearly half (49%) are insured by Medicare/Medicaid/CHIP. One quarter (24%) experienced rejection prior to trial enrollment (15% grade 1R and 7% grade 2R acute cellular rejection; 1% grade 1 and 2% grades 2-3 antibody-mediated rejection).
*Conclusions: Actual eligibility and informed consent rates for the TEAMMATE Trial were lower than expected for multiple reasons; but innovative trial tools and close collaboration have led to successful, albeit longer duration of, recruitment in this medically complex population. The randomized cohort will provide unique information on the safety and relative efficacy of EVL/LDTAC with respect to long-term complications of heart transplant in children.
To cite this abstract in AMA style:Daly KP, Sleeper LA, Addonizio LJ, Alejos JC, Auerbach S, Bock MJ, Butto A, Carlo WF, Castleberry C, Dreyer WJ, Feingold B, Lamour JM, Albers EL, Hollander SA, Klein GL, Lal A, Pahl E, Peng D, Punnoose AR, Rossano JW, Ryan TD, Su J, Sutcliffe DL, Zangwill S, Almond CS. Recruitment in the Pediatric Heart Transplant TEAMMATE Trial: Observed vs. Expected [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/recruitment-in-the-pediatric-heart-transplant-teammate-trial-observed-vs-expected/. Accessed April 15, 2021.
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