Background: Retrospective comparison of treatment-related kidney transplant outcomes may be facilitated by multivariable statistical adjustments and case-matching. Methods: We studied Organ Procurement and Transplantation Network registry data for kidney transplants in 2001 to 2005 managed with thymoglobulin, basiliximab or no antibody induction and discharge maintenance immunosuppression regimens of tacrolimus and mycophenolate mofetil. The primary outcome was the six-month, Food and Drug Administration-approved composite endpoint of rejection, graft failure, or death. Outcomes were according to induction exposure were compared using logistic regression, exposure propensity matching, and outcome risk score matching. Results: All statistical approaches demonstrated lower rates of the six-month triple endpoint with thymoglobulin compared with basiliximab when steroids were present, with approximately 22% adjusted, relative reduction by logistic and 3% absolute reductions by matching approaches. When steroids were absent, risk reduction among thymoglobulin versus basiliximab-treated patients was of larger magnitude but borderline statistical significance. Triple endpoint incidence was lower with both induction regimens compared to no induction across methods. Estimated sample sizes necessary to detect the observed differences between induction types in the presence of steroids in a prospective trial ranged from 1600 to nearly 7000 patients. Conclusions: Consistency of these data across statistical approaches suggests superiority of thymoglobulin compared to basiliximab or no antibody induction therapy for six-month kidney transplant outcomes in the modern immunosuppression era. As the sample sizes necessary to power a prospective superiority trial are likely prohibitive, studies such as these provide clinically relevant information that may not be otherwise attainable
Early outcomes of thymoglobulin and basiliximab induction in kidney transplantation : Application of statistical approaches to reduce bias in observational comparisons / L.M. Willoughby, M.A. Schnitzler, D.C. Brennan, B.W. Pinsky, N. Dzebisashvili, P.M. Buchanan, L. Neri, L.A. Rocca-Rey, K.C. Abbott, K.L. Lentine. - In: TRANSPLANTATION. - ISSN 0041-1337. - 87:10(2009), pp. 1520-1529.
Early outcomes of thymoglobulin and basiliximab induction in kidney transplantation : Application of statistical approaches to reduce bias in observational comparisons
L. Neri;L.A. Rocca-Rey;
2009
Abstract
Background: Retrospective comparison of treatment-related kidney transplant outcomes may be facilitated by multivariable statistical adjustments and case-matching. Methods: We studied Organ Procurement and Transplantation Network registry data for kidney transplants in 2001 to 2005 managed with thymoglobulin, basiliximab or no antibody induction and discharge maintenance immunosuppression regimens of tacrolimus and mycophenolate mofetil. The primary outcome was the six-month, Food and Drug Administration-approved composite endpoint of rejection, graft failure, or death. Outcomes were according to induction exposure were compared using logistic regression, exposure propensity matching, and outcome risk score matching. Results: All statistical approaches demonstrated lower rates of the six-month triple endpoint with thymoglobulin compared with basiliximab when steroids were present, with approximately 22% adjusted, relative reduction by logistic and 3% absolute reductions by matching approaches. When steroids were absent, risk reduction among thymoglobulin versus basiliximab-treated patients was of larger magnitude but borderline statistical significance. Triple endpoint incidence was lower with both induction regimens compared to no induction across methods. Estimated sample sizes necessary to detect the observed differences between induction types in the presence of steroids in a prospective trial ranged from 1600 to nearly 7000 patients. Conclusions: Consistency of these data across statistical approaches suggests superiority of thymoglobulin compared to basiliximab or no antibody induction therapy for six-month kidney transplant outcomes in the modern immunosuppression era. As the sample sizes necessary to power a prospective superiority trial are likely prohibitive, studies such as these provide clinically relevant information that may not be otherwise attainable
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