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Open Access Highly Accessed Study protocol

Incidence of cardiovascular events after kidney transplantation and cardiovascular risk scores: study protocol

Salvador Pita-Fernández1*, Sonia Pértega-Díaz1, Francisco Valdés-Cañedo2, Rocío Seijo-Bestilleiro1, Teresa Seoane-Pillado1, Constantino Fernández-Rivera2, Angel Alonso-Hernández2, Dolores Lorenzo-Aguiar2, Beatriz López-Calviño1 and Andres López-Muñiz2

Author Affiliations

1 Clinical Epidemiology and Biostatistics Unit, A Coruña Hospital, Hotel de Pacientes 7ª Planta, As Xubias 84, A Coruña, 15006, Spain

2 Department of Nephrology, A Coruña Hospital, As Xubias 84, A Coruña, 15006, Spain

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BMC Cardiovascular Disorders 2011, 11:2  doi:10.1186/1471-2261-11-2

Published: 10 January 2011

Abstract

Background

Cardiovascular disease (CVD) is the major cause of death after renal transplantation. Not only conventional CVD risk factors, but also transplant-specific risk factors can influence the development of CVD in kidney transplant recipients.

The main objective of this study will be to determine the incidence of post-transplant CVD after renal transplantation and related factors. A secondary objective will be to examine the ability of standard cardiovascular risk scores (Framingham, Regicor, SCORE, and DORICA) to predict post-transplantation cardiovascular events in renal transplant recipients, and to develop a new score for predicting the risk of CVD after kidney transplantation.

Methods/Design

Observational prospective cohort study of all kidney transplant recipients in the A Coruña Hospital (Spain) in the period 1981-2008 (2059 transplants corresponding to 1794 patients).

The variables included will be: donor and recipient characteristics, chronic kidney disease-related risk factors, pre-transplant and post-transplant cardiovascular risk factors, routine biochemistry, and immunosuppressive, antihypertensive and lipid-lowering treatment. The events studied in the follow-up will be: patient and graft survival, acute rejection episodes and cardiovascular events (myocardial infarction, invasive coronary artery therapy, cerebral vascular events, new-onset angina, congestive heart failure, rhythm disturbances and peripheral vascular disease).

Four cardiovascular risk scores were calculated at the time of transplantation: the Framingham score, the European Systematic Coronary Risk Evaluation (SCORE) equation, and the REGICOR (Registre Gironí del COR (Gerona Heart Registry)), and DORICA (Dyslipidemia, Obesity, and Cardiovascular Risk) functions.

The cumulative incidence of cardiovascular events will be analyzed by competing risk survival methods. The clinical relevance of different variables will be calculated using the ARR (Absolute Risk Reduction), RRR (Relative Risk Reduction) and NNT (Number Needed to Treat).

The ability of different cardiovascular risk scores to predict cardiovascular events will be analyzed by using the c index and the area under ROC curves. Based on the competing risks analysis, a nomogram to predict the probability of cardiovascular events after kidney transplantation will be developed.

Discussion

This study will make it possible to determine the post-transplant incidence of cardiovascular events in a large cohort of renal transplant recipients in Spain, to confirm the relationship between traditional and transplant-specific cardiovascular risk factors and CVD, and to develop a score to predict the risk of CVD in these patients.