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The impact of aortoiliac stenosis on kidney transplant patients remains unclear. This study aims to investigate the safety and efficacy of kidney transplantation in patients with aortoiliac stenosis.
Kidney transplantation is the optimal treatment for end-stage renal disease (ESRD). Unfortunately, not all ESRD patients are eligible for kidney transplantation. Aortoiliac stenosis, an increasingly common type of peripheral arterial disease in ESRD patients, is considered as relative contra-indication for kidney transplantation. There are several reasons for concern, such as the complexity of the vascular anastomosis and inferior life expectancy. Consequently, it is still debated whether patients with aortoiliac stenosis would benefit from kidney transplantation.
This study aimed to supplement current literature on the safety and efficacy of kidney transplantation in patients with aortoiliac stenosis. To achieve this, all patients undergoing kidney transplantation in Erasmus Medical Center between January 2010 and December 2020 were enrolled, and propensity score matching was used to minimize confounding factors. Additionally, long-term graft function was investigated to evaluate the impact of stenosis on graft function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No-stenosis group | Patients who had no pre-existing aortoiliac stenosis before kidney transplantation. | ||
| TASC A/B stenosis | Patients who had TASC A or B aortoiliac stenosis before kidney transplantation. | ||
| TASC C/D stenosis | Patients who had TASC C or D aortoiliac stenosis before kidney transplantation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival | Patient survival was calculated based on all-cause death from the date of kidney transplantation till the end of follow-up (January, 2023), assessed up to 10 years. | From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Death-censored Graft Survival | Death-censored graft survival was calculated based on death-censored graft failure, from the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years. | From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.
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| Name | Affiliation | Role |
|---|---|---|
| Yitian Fang, MD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yitian Fang | Rotterdam | South Holland | 3015 GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38016127 | Derived | Fang Y, Hamm JJM, den Hartog FPJ, Kimenai HJAN, de Bruin RWF, Minnee RC. Safety and efficacy of kidney transplantation in patients with aortoiliac stenosis: a retrospective cohort study. Int J Surg. 2024 Feb 1;110(2):992-999. doi: 10.1097/JS9.0000000000000926. |
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The data that support this study are not publicly available due to reasons of sensitivity and are available from the principal investigator upon reasonable request.
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We initially identified 2127 participants. Thirty-six patients were excluded according to the exclusion criteria. In the remaining participants, propensity score matching was performed in a nearest neighbor-matching approach with a maximum caliper of 0.1 in a 1 : 4 ratio to match the baseline characteristics of participants with and without aortoiliac stenosis. The matching parameters included age at transplant, dialysis mode, retransplant, donor type, comorbidities, and smoking status.
We initially identified all patients undergoing kidney transplantation in Erasmus Medical Center between January 2010 and December 2020. The exclusion criteria were age less than 18 years when transplanted, combined organ transplantation, or no follow-up data.
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| ID | Title | Description |
|---|---|---|
| FG000 | No-stenosis Group | After PSM, patients who had no pre-existing aortoiliac stenosis before kidney transplantation. |
| FG001 | TASC A/B Stenosis | Patients who had TASC A or B aortoiliac stenosis before kidney transplantation. |
| FG002 | TASC C/D Stenosis | Patients who had TASC C or D aortoiliac stenosis before kidney transplantation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Propensity score matching was performed in a nearest neighbor-matching approach with a maximum caliper of 0.1 in a 1 : 4 ratio to match patients in the stenosis group with individuals from the no-stenosis group who shared similar characteristics. The matching parameters included age, dialysis mode, retransplant, donor type, comorbidities, and smoking status.
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| ID | Title | Description |
|---|---|---|
| BG000 | No-stenosis Group | Patients who had no pre-existing aortoiliac stenosis before kidney transplantation. |
| BG001 | TASC A/B Stenosis Group | Patients who had TASC A/B aortoiliac stenosis before kidney transplantation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Survival | Patient survival was calculated based on all-cause death from the date of kidney transplantation till the end of follow-up (January, 2023), assessed up to 10 years. | Posted | Count of Participants | Participants | From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years. |
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The time frame for adverse event is from the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No-stenosis Group | Patients who had no pre-existing aortoiliac stenosis before kidney transplantation. |
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Firstly, there is a guarantee for selection bias in patients with the most severe aortoiliac stenosis, as these patients might be rejected for kidney transplantation and would not be included in the study. Secondly, the study's single-center design could introduce institutional-specific practices that may not be universally applicable. Lastly, details of stenosis proximal or distal to the transplanted kidney were unknown.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Drs. Yitian Fang | Erasmus Medical Center | +31 645680154 | y.fang.1@erasmusmc.nl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2022 | Dec 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Graft Function | Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at every post transplant year up to 10 years. | From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years. |
| BG002 | TASC C/D Stenosis Group | Patients who had TASC C/D aortoiliac stenosis before kidney transplantation. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| BMI | Median | Inter-Quartile Range | kg/m2 |
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| Type of Dialysis | Count of Participants | Participants |
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| Duration of Dialysis | Median | Inter-Quartile Range | months |
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| Retransplant | Count of Participants | Participants |
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| Donor Type | Count of Participants | Participants |
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| Smoking Status | Count of Participants | Participants |
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| TASC C/D Stenosis |
Patients who had TASC C or D aortoiliac stenosis before kidney transplantation. |
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| Secondary | Death-censored Graft Survival | Death-censored graft survival was calculated based on death-censored graft failure, from the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years. | Posted | Count of Participants | Participants | From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years. |
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| Secondary | Graft Function | Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at every post transplant year up to 10 years. | The discrepancy in the number of participants analyzed in one or more rows compared to the overall number of participants was due to attrition from graft failure or patient death over time. | Posted | Median | Inter-Quartile Range | mL/min/1.73m2 | From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years. |
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| 202 |
| 524 |
| 0 |
| 524 |
| 0 |
| 524 |
| EG001 | TASC A/B Stenosis | Patients who had TASC A or B aortoiliac stenosis before kidney transplantation. | 48 | 96 | 0 | 96 | 0 | 96 |
| EG002 | TASC C/D Stenosis | Patients who had TASC C or D aortoiliac stenosis before kidney transplantation. | 29 | 35 | 0 | 35 | 0 | 35 |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| Male |
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| Hemodialysis |
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| Peritoneal Dialysis |
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| Combined Modality |
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| DBD |
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| DCD |
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| Former Smoker |
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| Current Smoker |
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| 2 years posttransplant |
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| 5 years posttransplant |
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| 6 years posttransplant |
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| 7 years posttransplant |
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| 8 years posttransplant |
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| 9 years posttransplant |
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| 10 years posttransplant |
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