Association between primary graft function and 5-year outcomes of islet allogeneic transplantation in type 1 diabetes: a retrospective, multicentre, observational cohort study in 1210 patients from the Collaborative Islet Transplant Registry
Allogeneic islet transplantation is a validated therapy in type 1 diabetes; however, there is decline of transplanted islet graft function over time and the mechanisms underlying this decline are unclear. We evaluated the distinct association between primary graft function (PGF) and 5-year islet tra...
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| Veröffentlicht in: | The lancet. Diabetes & endocrinology 2023-06, Vol.11 (6), p.391-401 |
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| creator | Chetboun, Mikaël Drumez, Elodie Ballou, Cassandra Maanaoui, Mehdi Payne, Elizabeth Barton, Franca Kerr-Conte, Julie Vantyghem, Marie-Christine Piemonti, Lorenzo Rickels, Michael R Labreuche, Julien Pattou, François Alejandro, R Aull, M Bellin, M Berney, T Borja-Cacho, D Brayman, K Cagliero, E Caiazzo, R Cattral, M Coates, T Danielson, K Defrance, F De Koning, E Desai, C Desai, N Gaber, A O Gmyr, V Gores, P Goss, J A Gottllieb, P Greenbaum, C Hardy, M Harlan, D Hering, B Kandeel, F Kaufman, D Kay, T Keymeulen, B Khan, K Kudva, Y Larsen, C Le Mapihan, K Levy, G Levy, M Loudovaris, T Lundgren, T Maffi, P Markmann, J Marks, W H Naji, A O'Connell, P Oberholzer, J Odorico, J Onaca, N Pattou, F Piemonti, L Pipeleers, D Posselt, A Rajab, A Raverdy, V Rickels, M R Ricordi, C Rossini, A A Saudek, F Schrope, B Secchi, A Senior, P Shapiro, A M J Shaw, J Stock, P Thomas, D Thompson, M J Vantyghem, M C Vargas, L Wang, H Wiseman, A Witkowski, P Yoon, K |
| description | Allogeneic islet transplantation is a validated therapy in type 1 diabetes; however, there is decline of transplanted islet graft function over time and the mechanisms underlying this decline are unclear. We evaluated the distinct association between primary graft function (PGF) and 5-year islet transplantation outcomes.
In this retrospective, multicentre, observational cohort study, we enrolled all patients from the Collaborative Islet Transplant Registry who received islet transplantation alone (ITA recipients) or islet-after-kidney transplantation (IAK recipients) between Jan 19, 1999, and July 17, 2020, with a calculable PGF (exposure of interest), measured 28 days after last islet infusion with a validated composite index of islet graft function (BETA-2 score). The primary outcome was cumulative incidence of unsuccessful islet transplantation, defined as an HbA1c of 7·0% (53 mmol/mol) or higher, or severe hypoglycaemia (ie, requiring third-party intervention to correct), or a fasting C-peptide concentration of less than 0·2 ng/mL. Secondary outcomes were graft exhaustion (fasting C-peptide |
| doi_str_mv | 10.1016/S2213-8587(23)00082-7 |
| format | Article |
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In this retrospective, multicentre, observational cohort study, we enrolled all patients from the Collaborative Islet Transplant Registry who received islet transplantation alone (ITA recipients) or islet-after-kidney transplantation (IAK recipients) between Jan 19, 1999, and July 17, 2020, with a calculable PGF (exposure of interest), measured 28 days after last islet infusion with a validated composite index of islet graft function (BETA-2 score). The primary outcome was cumulative incidence of unsuccessful islet transplantation, defined as an HbA1c of 7·0% (53 mmol/mol) or higher, or severe hypoglycaemia (ie, requiring third-party intervention to correct), or a fasting C-peptide concentration of less than 0·2 ng/mL. Secondary outcomes were graft exhaustion (fasting C-peptide <0·3 ng/mL); inadequate glucose control (HbA1c ≥7·0% [53 mmol/mol] or severe hypoglycaemia); and requirement for exogenous insulin therapy (≥14 consecutive days). Associations between PGF and islet transplantation outcomes were explored with a competing risk analysis adjusted for all covariates suspected or known to affect outcomes. A predictive model based on PGF was built and internally validated by using bootstraps resampling method.
In 39 centres worldwide, we enrolled 1210 patients with a calculable PGF (of those without missing data, mean age 47 years [SD 10], 712 [59·5%] were female, and 865 (97·9%) were White), who received a median of 10·8 thousand islet-equivalents per kg of bodyweight (IQR 7·4–13·5). 986 (82·4%) were ITA recipients and 211 (17·6%) were IAK recipients. Of 1210 patients, 452 (37·4%) received a single islet infusion and 758 (62·6%) received multiple islet infusions. Mean PGF was 14·3 (SD 8·8). The 5-year cumulative incidence of unsuccessful islet transplantation was 70·7% (95% CI 67·2–73·9), and was inversely and linearly related to PGF, with an adjusted subhazard ratio (sHR) of 0·77 (95% CI 0·72–0·82) per 5-unit increase of BETA-2 score (p<0·0001). Secondary endpoints were similarly related to PGF. The model-adjusted median C-statistic values of PGF for predicting 5-year cumulative incidences of unsuccessful islet transplantation, graft exhaustion, inadequate glucose control, and exogenous insulin therapy were 0·70 (range 0·69–0·71), 0·76 (0·74–0·77), 0·65 (0·64–0·66), and 0·72 (0·71–0·73), respectively.
This global multicentre study reports a linear and independent association between PGF and 5-year clinical outcomes of islet transplantation. The main study limitations are its retrospective design and the absence of analysis of complications.
Public Health Service Research, National Institutes of Health, Juvenile Diabetes Research Foundation International, Agence National de la Recherche, Fondation de l'Avenir, and Fonds de Dotation Line Renaud-Loulou Gasté.</description><identifier>ISSN: 2213-8587</identifier><identifier>EISSN: 2213-8595</identifier><identifier>DOI: 10.1016/S2213-8587(23)00082-7</identifier><identifier>PMID: 37105208</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Blood Glucose ; C-Peptide - therapeutic use ; Diabetes Mellitus, Type 1 - complications ; Diabetes Mellitus, Type 1 - surgery ; Female ; Glycated Hemoglobin ; Humans ; Hypoglycemia - complications ; Insulin - therapeutic use ; Islets of Langerhans Transplantation - methods ; Life Sciences ; Male ; Middle Aged ; Registries ; Retrospective Studies ; Transplantation, Homologous ; Treatment Outcome</subject><ispartof>The lancet. Diabetes & endocrinology, 2023-06, Vol.11 (6), p.391-401</ispartof><rights>2023 Elsevier Ltd</rights><rights>Copyright © 2023 Elsevier Ltd. All rights reserved.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c498t-39ae20a447eeb37c4c2d83bc3cd87b758867c637995037d054bbc72cab3896153</citedby><cites>FETCH-LOGICAL-c498t-39ae20a447eeb37c4c2d83bc3cd87b758867c637995037d054bbc72cab3896153</cites><orcidid>0000-0001-8388-3766</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37105208$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.univ-lille.fr/hal-04546266$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Chetboun, Mikaël</creatorcontrib><creatorcontrib>Drumez, Elodie</creatorcontrib><creatorcontrib>Ballou, Cassandra</creatorcontrib><creatorcontrib>Maanaoui, Mehdi</creatorcontrib><creatorcontrib>Payne, Elizabeth</creatorcontrib><creatorcontrib>Barton, Franca</creatorcontrib><creatorcontrib>Kerr-Conte, Julie</creatorcontrib><creatorcontrib>Vantyghem, Marie-Christine</creatorcontrib><creatorcontrib>Piemonti, Lorenzo</creatorcontrib><creatorcontrib>Rickels, Michael R</creatorcontrib><creatorcontrib>Labreuche, Julien</creatorcontrib><creatorcontrib>Pattou, François</creatorcontrib><creatorcontrib>Alejandro, R</creatorcontrib><creatorcontrib>Aull, M</creatorcontrib><creatorcontrib>Bellin, M</creatorcontrib><creatorcontrib>Berney, T</creatorcontrib><creatorcontrib>Borja-Cacho, D</creatorcontrib><creatorcontrib>Brayman, K</creatorcontrib><creatorcontrib>Cagliero, E</creatorcontrib><creatorcontrib>Caiazzo, R</creatorcontrib><creatorcontrib>Cattral, M</creatorcontrib><creatorcontrib>Coates, T</creatorcontrib><creatorcontrib>Danielson, K</creatorcontrib><creatorcontrib>Defrance, F</creatorcontrib><creatorcontrib>De Koning, E</creatorcontrib><creatorcontrib>Desai, C</creatorcontrib><creatorcontrib>Desai, N</creatorcontrib><creatorcontrib>Gaber, A O</creatorcontrib><creatorcontrib>Gmyr, V</creatorcontrib><creatorcontrib>Gores, P</creatorcontrib><creatorcontrib>Goss, J A</creatorcontrib><creatorcontrib>Gottllieb, P</creatorcontrib><creatorcontrib>Greenbaum, C</creatorcontrib><creatorcontrib>Hardy, M</creatorcontrib><creatorcontrib>Harlan, D</creatorcontrib><creatorcontrib>Hering, B</creatorcontrib><creatorcontrib>Kandeel, F</creatorcontrib><creatorcontrib>Kaufman, D</creatorcontrib><creatorcontrib>Kay, T</creatorcontrib><creatorcontrib>Keymeulen, B</creatorcontrib><creatorcontrib>Khan, K</creatorcontrib><creatorcontrib>Kudva, Y</creatorcontrib><creatorcontrib>Larsen, C</creatorcontrib><creatorcontrib>Le Mapihan, K</creatorcontrib><creatorcontrib>Levy, G</creatorcontrib><creatorcontrib>Levy, M</creatorcontrib><creatorcontrib>Loudovaris, T</creatorcontrib><creatorcontrib>Lundgren, T</creatorcontrib><creatorcontrib>Maffi, P</creatorcontrib><creatorcontrib>Markmann, J</creatorcontrib><creatorcontrib>Marks, W H</creatorcontrib><creatorcontrib>Naji, A</creatorcontrib><creatorcontrib>O'Connell, P</creatorcontrib><creatorcontrib>Oberholzer, J</creatorcontrib><creatorcontrib>Odorico, J</creatorcontrib><creatorcontrib>Onaca, N</creatorcontrib><creatorcontrib>Pattou, F</creatorcontrib><creatorcontrib>Piemonti, L</creatorcontrib><creatorcontrib>Pipeleers, D</creatorcontrib><creatorcontrib>Posselt, A</creatorcontrib><creatorcontrib>Rajab, A</creatorcontrib><creatorcontrib>Raverdy, V</creatorcontrib><creatorcontrib>Rickels, M R</creatorcontrib><creatorcontrib>Ricordi, C</creatorcontrib><creatorcontrib>Rossini, A A</creatorcontrib><creatorcontrib>Saudek, F</creatorcontrib><creatorcontrib>Schrope, B</creatorcontrib><creatorcontrib>Secchi, A</creatorcontrib><creatorcontrib>Senior, P</creatorcontrib><creatorcontrib>Shapiro, A M J</creatorcontrib><creatorcontrib>Shaw, J</creatorcontrib><creatorcontrib>Stock, P</creatorcontrib><creatorcontrib>Thomas, D</creatorcontrib><creatorcontrib>Thompson, M J</creatorcontrib><creatorcontrib>Vantyghem, M C</creatorcontrib><creatorcontrib>Vargas, L</creatorcontrib><creatorcontrib>Wang, H</creatorcontrib><creatorcontrib>Wiseman, A</creatorcontrib><creatorcontrib>Witkowski, P</creatorcontrib><creatorcontrib>Yoon, K</creatorcontrib><creatorcontrib>Collaborative Islet Transplant Registry (CITR) Investigators study group</creatorcontrib><title>Association between primary graft function and 5-year outcomes of islet allogeneic transplantation in type 1 diabetes: a retrospective, multicentre, observational cohort study in 1210 patients from the Collaborative Islet Transplant Registry</title><title>The lancet. Diabetes & endocrinology</title><addtitle>Lancet Diabetes Endocrinol</addtitle><description>Allogeneic islet transplantation is a validated therapy in type 1 diabetes; however, there is decline of transplanted islet graft function over time and the mechanisms underlying this decline are unclear. We evaluated the distinct association between primary graft function (PGF) and 5-year islet transplantation outcomes.
In this retrospective, multicentre, observational cohort study, we enrolled all patients from the Collaborative Islet Transplant Registry who received islet transplantation alone (ITA recipients) or islet-after-kidney transplantation (IAK recipients) between Jan 19, 1999, and July 17, 2020, with a calculable PGF (exposure of interest), measured 28 days after last islet infusion with a validated composite index of islet graft function (BETA-2 score). The primary outcome was cumulative incidence of unsuccessful islet transplantation, defined as an HbA1c of 7·0% (53 mmol/mol) or higher, or severe hypoglycaemia (ie, requiring third-party intervention to correct), or a fasting C-peptide concentration of less than 0·2 ng/mL. Secondary outcomes were graft exhaustion (fasting C-peptide <0·3 ng/mL); inadequate glucose control (HbA1c ≥7·0% [53 mmol/mol] or severe hypoglycaemia); and requirement for exogenous insulin therapy (≥14 consecutive days). Associations between PGF and islet transplantation outcomes were explored with a competing risk analysis adjusted for all covariates suspected or known to affect outcomes. A predictive model based on PGF was built and internally validated by using bootstraps resampling method.
In 39 centres worldwide, we enrolled 1210 patients with a calculable PGF (of those without missing data, mean age 47 years [SD 10], 712 [59·5%] were female, and 865 (97·9%) were White), who received a median of 10·8 thousand islet-equivalents per kg of bodyweight (IQR 7·4–13·5). 986 (82·4%) were ITA recipients and 211 (17·6%) were IAK recipients. Of 1210 patients, 452 (37·4%) received a single islet infusion and 758 (62·6%) received multiple islet infusions. Mean PGF was 14·3 (SD 8·8). The 5-year cumulative incidence of unsuccessful islet transplantation was 70·7% (95% CI 67·2–73·9), and was inversely and linearly related to PGF, with an adjusted subhazard ratio (sHR) of 0·77 (95% CI 0·72–0·82) per 5-unit increase of BETA-2 score (p<0·0001). Secondary endpoints were similarly related to PGF. The model-adjusted median C-statistic values of PGF for predicting 5-year cumulative incidences of unsuccessful islet transplantation, graft exhaustion, inadequate glucose control, and exogenous insulin therapy were 0·70 (range 0·69–0·71), 0·76 (0·74–0·77), 0·65 (0·64–0·66), and 0·72 (0·71–0·73), respectively.
This global multicentre study reports a linear and independent association between PGF and 5-year clinical outcomes of islet transplantation. The main study limitations are its retrospective design and the absence of analysis of complications.
Public Health Service Research, National Institutes of Health, Juvenile Diabetes Research Foundation International, Agence National de la Recherche, Fondation de l'Avenir, and Fonds de Dotation Line Renaud-Loulou Gasté.</description><subject>Blood Glucose</subject><subject>C-Peptide - therapeutic use</subject><subject>Diabetes Mellitus, Type 1 - complications</subject><subject>Diabetes Mellitus, Type 1 - surgery</subject><subject>Female</subject><subject>Glycated Hemoglobin</subject><subject>Humans</subject><subject>Hypoglycemia - complications</subject><subject>Insulin - therapeutic use</subject><subject>Islets of Langerhans Transplantation - methods</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Registries</subject><subject>Retrospective Studies</subject><subject>Transplantation, Homologous</subject><subject>Treatment 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; Maanaoui, Mehdi ; Payne, Elizabeth ; Barton, Franca ; Kerr-Conte, Julie ; Vantyghem, Marie-Christine ; Piemonti, Lorenzo ; Rickels, Michael R ; Labreuche, Julien ; Pattou, François ; Alejandro, R ; Aull, M ; Bellin, M ; Berney, T ; Borja-Cacho, D ; Brayman, K ; Cagliero, E ; Caiazzo, R ; Cattral, M ; Coates, T ; Danielson, K ; Defrance, F ; De Koning, E ; Desai, C ; Desai, N ; Gaber, A O ; Gmyr, V ; Gores, P ; Goss, J A ; Gottllieb, P ; Greenbaum, C ; Hardy, M ; Harlan, D ; Hering, B ; Kandeel, F ; Kaufman, D ; Kay, T ; Keymeulen, B ; Khan, K ; Kudva, Y ; Larsen, C ; Le Mapihan, K ; Levy, G ; Levy, M ; Loudovaris, T ; Lundgren, T ; Maffi, P ; Markmann, J ; Marks, W H ; Naji, A ; O'Connell, P ; Oberholzer, J ; Odorico, J ; Onaca, N ; Pattou, F ; Piemonti, L ; Pipeleers, D ; Posselt, A ; Rajab, A ; Raverdy, V ; Rickels, M R ; Ricordi, C ; Rossini, A A ; Saudek, F ; Schrope, B ; Secchi, A ; Senior, P ; Shapiro, A M J ; Shaw, J ; Stock, P ; Thomas, D ; Thompson, M J ; Vantyghem, M C ; Vargas, L ; Wang, H ; Wiseman, A ; Witkowski, P ; Yoon, K</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c498t-39ae20a447eeb37c4c2d83bc3cd87b758867c637995037d054bbc72cab3896153</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Blood Glucose</topic><topic>C-Peptide - therapeutic use</topic><topic>Diabetes Mellitus, Type 1 - complications</topic><topic>Diabetes Mellitus, Type 1 - surgery</topic><topic>Female</topic><topic>Glycated Hemoglobin</topic><topic>Humans</topic><topic>Hypoglycemia - complications</topic><topic>Insulin - therapeutic use</topic><topic>Islets of Langerhans Transplantation - methods</topic><topic>Life Sciences</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Registries</topic><topic>Retrospective Studies</topic><topic>Transplantation, Homologous</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chetboun, Mikaël</creatorcontrib><creatorcontrib>Drumez, Elodie</creatorcontrib><creatorcontrib>Ballou, Cassandra</creatorcontrib><creatorcontrib>Maanaoui, Mehdi</creatorcontrib><creatorcontrib>Payne, Elizabeth</creatorcontrib><creatorcontrib>Barton, Franca</creatorcontrib><creatorcontrib>Kerr-Conte, Julie</creatorcontrib><creatorcontrib>Vantyghem, Marie-Christine</creatorcontrib><creatorcontrib>Piemonti, Lorenzo</creatorcontrib><creatorcontrib>Rickels, Michael R</creatorcontrib><creatorcontrib>Labreuche, Julien</creatorcontrib><creatorcontrib>Pattou, François</creatorcontrib><creatorcontrib>Alejandro, R</creatorcontrib><creatorcontrib>Aull, M</creatorcontrib><creatorcontrib>Bellin, M</creatorcontrib><creatorcontrib>Berney, T</creatorcontrib><creatorcontrib>Borja-Cacho, D</creatorcontrib><creatorcontrib>Brayman, K</creatorcontrib><creatorcontrib>Cagliero, 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A</creatorcontrib><creatorcontrib>Saudek, F</creatorcontrib><creatorcontrib>Schrope, B</creatorcontrib><creatorcontrib>Secchi, A</creatorcontrib><creatorcontrib>Senior, P</creatorcontrib><creatorcontrib>Shapiro, A M J</creatorcontrib><creatorcontrib>Shaw, J</creatorcontrib><creatorcontrib>Stock, P</creatorcontrib><creatorcontrib>Thomas, D</creatorcontrib><creatorcontrib>Thompson, M J</creatorcontrib><creatorcontrib>Vantyghem, M C</creatorcontrib><creatorcontrib>Vargas, L</creatorcontrib><creatorcontrib>Wang, H</creatorcontrib><creatorcontrib>Wiseman, A</creatorcontrib><creatorcontrib>Witkowski, P</creatorcontrib><creatorcontrib>Yoon, K</creatorcontrib><creatorcontrib>Collaborative Islet Transplant Registry (CITR) Investigators study group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>The lancet. Diabetes & endocrinology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chetboun, Mikaël</au><au>Drumez, Elodie</au><au>Ballou, Cassandra</au><au>Maanaoui, Mehdi</au><au>Payne, Elizabeth</au><au>Barton, Franca</au><au>Kerr-Conte, Julie</au><au>Vantyghem, Marie-Christine</au><au>Piemonti, Lorenzo</au><au>Rickels, Michael R</au><au>Labreuche, Julien</au><au>Pattou, François</au><au>Alejandro, R</au><au>Aull, M</au><au>Bellin, M</au><au>Berney, T</au><au>Borja-Cacho, D</au><au>Brayman, K</au><au>Cagliero, E</au><au>Caiazzo, R</au><au>Cattral, M</au><au>Coates, T</au><au>Danielson, K</au><au>Defrance, F</au><au>De Koning, E</au><au>Desai, C</au><au>Desai, N</au><au>Gaber, A O</au><au>Gmyr, V</au><au>Gores, P</au><au>Goss, J A</au><au>Gottllieb, P</au><au>Greenbaum, C</au><au>Hardy, M</au><au>Harlan, D</au><au>Hering, B</au><au>Kandeel, F</au><au>Kaufman, D</au><au>Kay, T</au><au>Keymeulen, B</au><au>Khan, K</au><au>Kudva, Y</au><au>Larsen, C</au><au>Le Mapihan, K</au><au>Levy, G</au><au>Levy, M</au><au>Loudovaris, T</au><au>Lundgren, T</au><au>Maffi, P</au><au>Markmann, J</au><au>Marks, W H</au><au>Naji, A</au><au>O'Connell, P</au><au>Oberholzer, J</au><au>Odorico, J</au><au>Onaca, N</au><au>Pattou, F</au><au>Piemonti, L</au><au>Pipeleers, D</au><au>Posselt, A</au><au>Rajab, A</au><au>Raverdy, V</au><au>Rickels, M R</au><au>Ricordi, C</au><au>Rossini, A A</au><au>Saudek, F</au><au>Schrope, B</au><au>Secchi, A</au><au>Senior, P</au><au>Shapiro, A M J</au><au>Shaw, J</au><au>Stock, P</au><au>Thomas, D</au><au>Thompson, M J</au><au>Vantyghem, M C</au><au>Vargas, L</au><au>Wang, H</au><au>Wiseman, A</au><au>Witkowski, P</au><au>Yoon, K</au><aucorp>Collaborative Islet Transplant Registry (CITR) Investigators study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Association between primary graft function and 5-year outcomes of islet allogeneic transplantation in type 1 diabetes: a retrospective, multicentre, observational cohort study in 1210 patients from the Collaborative Islet Transplant Registry</atitle><jtitle>The lancet. Diabetes & endocrinology</jtitle><addtitle>Lancet Diabetes Endocrinol</addtitle><date>2023-06-01</date><risdate>2023</risdate><volume>11</volume><issue>6</issue><spage>391</spage><epage>401</epage><pages>391-401</pages><issn>2213-8587</issn><eissn>2213-8595</eissn><abstract>Allogeneic islet transplantation is a validated therapy in type 1 diabetes; however, there is decline of transplanted islet graft function over time and the mechanisms underlying this decline are unclear. We evaluated the distinct association between primary graft function (PGF) and 5-year islet transplantation outcomes.
In this retrospective, multicentre, observational cohort study, we enrolled all patients from the Collaborative Islet Transplant Registry who received islet transplantation alone (ITA recipients) or islet-after-kidney transplantation (IAK recipients) between Jan 19, 1999, and July 17, 2020, with a calculable PGF (exposure of interest), measured 28 days after last islet infusion with a validated composite index of islet graft function (BETA-2 score). The primary outcome was cumulative incidence of unsuccessful islet transplantation, defined as an HbA1c of 7·0% (53 mmol/mol) or higher, or severe hypoglycaemia (ie, requiring third-party intervention to correct), or a fasting C-peptide concentration of less than 0·2 ng/mL. Secondary outcomes were graft exhaustion (fasting C-peptide <0·3 ng/mL); inadequate glucose control (HbA1c ≥7·0% [53 mmol/mol] or severe hypoglycaemia); and requirement for exogenous insulin therapy (≥14 consecutive days). Associations between PGF and islet transplantation outcomes were explored with a competing risk analysis adjusted for all covariates suspected or known to affect outcomes. A predictive model based on PGF was built and internally validated by using bootstraps resampling method.
In 39 centres worldwide, we enrolled 1210 patients with a calculable PGF (of those without missing data, mean age 47 years [SD 10], 712 [59·5%] were female, and 865 (97·9%) were White), who received a median of 10·8 thousand islet-equivalents per kg of bodyweight (IQR 7·4–13·5). 986 (82·4%) were ITA recipients and 211 (17·6%) were IAK recipients. Of 1210 patients, 452 (37·4%) received a single islet infusion and 758 (62·6%) received multiple islet infusions. Mean PGF was 14·3 (SD 8·8). The 5-year cumulative incidence of unsuccessful islet transplantation was 70·7% (95% CI 67·2–73·9), and was inversely and linearly related to PGF, with an adjusted subhazard ratio (sHR) of 0·77 (95% CI 0·72–0·82) per 5-unit increase of BETA-2 score (p<0·0001). Secondary endpoints were similarly related to PGF. The model-adjusted median C-statistic values of PGF for predicting 5-year cumulative incidences of unsuccessful islet transplantation, graft exhaustion, inadequate glucose control, and exogenous insulin therapy were 0·70 (range 0·69–0·71), 0·76 (0·74–0·77), 0·65 (0·64–0·66), and 0·72 (0·71–0·73), respectively.
This global multicentre study reports a linear and independent association between PGF and 5-year clinical outcomes of islet transplantation. The main study limitations are its retrospective design and the absence of analysis of complications.
Public Health Service Research, National Institutes of Health, Juvenile Diabetes Research Foundation International, Agence National de la Recherche, Fondation de l'Avenir, and Fonds de Dotation Line Renaud-Loulou Gasté.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>37105208</pmid><doi>10.1016/S2213-8587(23)00082-7</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-8388-3766</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2213-8587 |
| ispartof | The lancet. Diabetes & endocrinology, 2023-06, Vol.11 (6), p.391-401 |
| issn | 2213-8587 2213-8595 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_04546266v1 |
| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Blood Glucose C-Peptide - therapeutic use Diabetes Mellitus, Type 1 - complications Diabetes Mellitus, Type 1 - surgery Female Glycated Hemoglobin Humans Hypoglycemia - complications Insulin - therapeutic use Islets of Langerhans Transplantation - methods Life Sciences Male Middle Aged Registries Retrospective Studies Transplantation, Homologous Treatment Outcome |
| title | Association between primary graft function and 5-year outcomes of islet allogeneic transplantation in type 1 diabetes: a retrospective, multicentre, observational cohort study in 1210 patients from the Collaborative Islet Transplant Registry |
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