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Major Adverse Cardiovascular Events Following Simultaneous Pancreas

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Major Adverse Cardiovascular Events Following Simultaneous Pancreas Diabetes Care Volume 42, April 2019 665 Petros Yiannoullou,1,2 Angela Summers,1,2 Major Adverse Cardiovascular Shu C. Goh,2 Catherine Fullwood,3 Hussein Khambalia,1,2 Zia Moinuddin,1,2 Events Following Simultaneous Iestyn M. Shapey,1,2 Josephine Naish,4,5 Christopher Miller,4,5,6 Titus Augustine,1,2 Pancreas and Kidney Martin K. Rutter,2,7 and David van Dellen1,2 Transplantation in the United Kingdom Diabetes Care 2019;42:665–673 | https://doi.org/10.2337/dc18-2111 1Department of Renal and Pancreatic Transplan- tation, Manchester University NHS Foundation Trust, Manchester, U.K. 2Division of Diabetes, Endocrinology and Gas- troenterology, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, U.K. 3Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Bi- OBJECTIVE ology, Medicine and Health, University of Man- chester, Manchester Academic Health Science People with type 1 diabetes and kidney failure have an increased risk for major Centre, Research and Innovation, Manchester adverse cardiovascular events (MACE). Simultaneous pancreas and kidney trans- University NHS Foundation Trust, Manchester, plantation (SPKT) improves survival, but the long-term risk for MACE is uncertain. U.K. 4Division of Cardiovascular Sciences, School of RESEARCH DESIGN AND METHODS Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sci- We assessed the frequency and risk factors for MACE (defined as fatal cardiovascular ence Centre, University of Manchester, Man- disease and nonfatal myocardial infarction or stroke) and related nonfatal MACE to chester, U.K. 5 allograft failure in SPKT recipients with type 1 diabetes who underwent trans- Wellcome Centre for Cell-Matrix Research, Di- vision of Cell-Matrix Biology and Regenerative plantation between 2001 and 2015 in the U.K. In a subgroup, we related a Medicine, School of Biology, Faculty of Biology, pretransplant cardiovascular risk score to MACE. Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, RESULTS Manchester, U.K. 6 During 5 years of follow-up, 133 of 1,699 SPKT recipients (7.8%) experienced a MACE. North West Heart Centre, Manchester Univer- CARDIOVASCULAR AND METABOLIC RISK – sity NHS Foundation Trust, Manchester, U.K. In covariate-adjusted models, age (hazard ratio 1.04 per year [95% CI 1.01 1.07]), 7Manchester Diabetes Centre, Manchester Uni- prior myocardial infarction (2.6 [1.3–5.0]), stroke (2.3 [1.2–4.7]), amputation versity NHS Foundation Trust, Manchester Aca- (2.0 [1.02–3.7]), donor history of hypertension (1.8 [1.05–3.2]), and waiting time demic Health Science Centre, Manchester, U.K. (1.02 per month [1.0–1.04]) were significant predictors. Nonfatal MACE predicted Corresponding author: Petros Yiannoullou, subsequent allograft failure (renal 1.6 [1.06–2.6]; pancreas 1.7 [1.09–2.6]). In the [email protected] subgroup, the pretransplant cardiovascular risk score predicted MACE (1.04 per 1% Received 9 October 2018 and accepted 14 Jan- uary 2019 increment [1.02–1.06]). This article contains Supplementary Data online CONCLUSIONS at http://care.diabetesjournals.org/lookup/suppl/ doi:10.2337/dc18-2111/-/DC1. We report a high rate of MACE in SPKT recipients. There are a number M.K.R. and D.v.D. contributed equally to this of variables that predict MACE, while nonfatal MACE increase the risk of sub- work. fi sequent allograft failure. It may be bene cial that organs from hypertensive The views expressed in this publication are those donors are matched to recipients with lower cardiovascular risk. Pretransplant of the authors and not necessarily those of the cardiovascular risk scoring may help to identify patients who would benefitfrom National Health Service, National Health Service fi risk factor optimization or alternative transplant therapies and warrants valida- Blood and Transplant, the Of ce for National Statistics, the National Institute for Health Re- tion nationally. search, or the Department of Health. © 2019 by the American Diabetes Association. Type 1 diabetes affects ;400,000 people in the U.K. (1). Type 1 diabetes significantly Readers may use this article as long as the work is properly cited, the use is educational and not reduces life expectancy predominantly because of cardiovascular disease (CVD) for profit, and the work is not altered. More infor- complications (2,3). The addition of chronic kidney disease further increases CVD risk mation is available at http://www.diabetesjournals (4). We have shown that simultaneous pancreas and kidney transplantation (SPKT) .org/content/license. 666 Cardiovascular Events Following SPKT in U.K. Diabetes Care Volume 42, April 2019 improves survival in recipients compared electronic patient records and case notes The General Register Office of the U.K. with those individuals on the waiting list at a single U.K. transplant center in Man- Government records the details of all (5). However, there are limited data on chester. Cardiovascular risk was calcu- U.K. deaths into the Register of Births, the long-term risk for major adverse lated from pretransplant variables using Deaths, and Marriages from death cer- cardiovascular events (MACE) in contem- the QRISK2-2017 calculator available at tificates. The Office for National Statistics porary SPKT cohorts (6,7). https://qrisk.org/2017/. (ONS) is the recognized national statistical Cardiovascular death with a function- Current or ex–tobacco smokers were institute of the U.K. It quality assures ing graft (DWFG) accounts for a large defined as having a history of tobacco mortality data and provides data reports. proportion of allograft loss in transplant smoke exposure. We defined unem- To improve the completeness and accuracy populations (8,9). However, the relation- ployed as being able to work but not of outcome data, cause of death data ship between nonfatal cardiovascular working or unable to work because of were obtained from the ONS and linked events and subsequent allograft loss in disease. Amputation was defined as limb at patient level by the NHSBT. SPKT recipients is unknown. or digit amputation. For the local cohort, Nonfatal MACE is recorded into the The QRISK2 calculator was developed retinopathy was defined as preprolifer- UKTR using forms that are completed within the U.K. general population to ative or proliferative changes or macul- annually by clinicians or transplant co- estimate an individual’s 10-year risk of opathy. An ankle-brachial pressure index ordinators. The event time for nonfatal CVD, without modification of risk factors. score #0.9 or the presence of flow- events was taken as the midpoint be- The QRISK2 variables include modifiable limiting arterial stenosis on angiography tween annual follow-up appointments. and nonmodifiable factors, ethnicity, was used to identify patients with pe- We analyzed a secondary outcome of and level of social deprivation estimated ripheral arterial disease. fatal CVD. from an individual’s U.K. postal code No ethical approval was required for A tertiary outcome of allograft loss was (Supplementary Table 1) (10). A score this study as only restricted data were included for analysis. The definition of of $10% is the current threshold for requested in accordance with NHSBT pancreas allograft failure varies among statin therapy; a score of $20% is con- data access policy available at http:// centers: some use C-peptide measure- sidered severe risk (10). Its ability to www.odt.nhs.uk/statistics-and-reports/ ment, while others use a return to ex- predict MACE in SPKT recipients has data-access-policy/. As per the National ogenous insulin use. The NHSBT records never been assessed. Health Service Code of Practice on Con- pancreas survival to the earlier of those We aimed to assess the long-term fidentiality and in accordance with the definitions or death. Kidney allograft sur- risk for MACE and identify asso- Declaration of Helsinki (https://www vival is determined as the earlier date ciated risk factors in the full U.K. co- .wma.net/policies-post/wma-declaration- between return to dialysis or death. hort of SPKT recipients. We also aimed of-helsinki-ethical-principles-for-medical- to relate posttransplant nonfatal research-involving-human-subjects/), Statistical Methods MACE to subsequent allograft loss. NHSBT prospectively obtained informed Parameters are expressed as the mean In a Manchester-based subgroup, we consent from transplant candidates for (SD) or median (interquartile range [IQR]) aimed to relate a pretransplant QRISK2 inclusion of their data in the UKTR data- as appropriate. Continuous variables score to MACE. base. Informed consent is also obtained by were compared using either the Student NHSBT for the use of restricted data (non- t test or Mann-Whitney U test. Categor- identifiable data) by third parties for the ical variables were compared using the RESEARCH DESIGN AND METHODS purpose of transplant-related research. Pearson x2 or Fisher exact test. Survival Cohort, Exposures, and Covariates Patients were excluded if they had analyses were visualized using Kaplan- The National Health Service Blood and received any prior transplant. Meier plots. Transplant (NHSBT) prospectively re- All cases were closed for analysis on Cox regression models were used to cords recipient and donor data, from the 27 April 2017. relate covariates to MACE and cardio- all U.K. centers, into the UK Transplant vascular mortality. Covariates were Registry (UKTR) (11). All SPKT recipients Outcomes tested for colinearity using the Pearson with type 1 diabetes who were $18 The primary outcome measure was the correlation coefficient or x2 test and years of age and had undergone trans- first recorded MACE following transplan- were included in multivariable models plantation between 2001 (the first year tation. MACE was defined as fatal CVD if they were considered clinically impor- of robust national data) and 2015 were (ICD-10 codes: I11, hypertensive heart tant or if univariable P values were #0.1.
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