The Effect of Dialysis Modality on Annual Mortality: a Prospective Cohort Study

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The Effect of Dialysis Modality on Annual Mortality: a Prospective Cohort Study

https://doi.org/10.21203/rs.3.rs-3636029/v1

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published 18 Jun, 2024

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Despite several studies on the effect of each dialysis modality on mortality, the subject is still controversial. We investigated the hazard rate of mortality for patients with incident end-stage renal disease with respect to initial dialysis modality (hemodialysis vs. peritoneal dialysis). We used a nationwide, multicenter, prospective cohort of patients with end-stage renal disease who were undergoing dialysis in South Korea. Among the 2 207 patients, 1 647 (74.6%) underwent hemodialysis. We performed the intention-to-treatment analysis, and employed inverse probability treatment weighting to reduce bias and the weighted Fine and Gray model over the follow-up period. Landmark analysis was used to identify the changing effect of the dialysis modality on individuals who remained event-free at each landmark point. No significant difference in hazard rate was observed between the two dialysis modalities when all participants were considered. However, the hazard rate in the peritoneal dialysis group was significantly higher than that in the hemodialysis group among patients aged <65 years after 4- and 5-year follow-up. A similar pattern was observed among patients with diabetes mellitus. Landmark analysis showed that the hazard ratio in the peritoneal dialysis group was significantly higher than that in the hemodialysis group at 2 years in both the education-others and married groups. This study could be useful for choosing a dialysis modality for young patients, especially in the presence of diabetes. Moreover, hemodialysis may be preferred to peritoneal dialysis when the follow-up duration is >3 years.

Health sciences/Nephrology

Health sciences/Nephrology/Renal replacement therapy

hemodialysis

peritoneal dialysis

mortality

end-stage renal disease

This study aimed to find out whether there is any relationship between death and the modality of dialysis used at the initiation of treatment for patients who have kidney failure and require dialysis. We found that hemodialysis is preferable to peritoneal dialysis for patients who are younger than 65 years, especially if they also have diabetes mellitus. The study is important because it will help to guide individualized treatment of patients with end-stage renal disease.

Among the 127 068 patients with prevalent end-stage renal disease (ESRD) in Korea in 2021, 78.1% (n = 99 198) underwent hemodialysis (HD), 4.4% (n = 5 610) underwent peritoneal dialysis (PD), and 17.5% (n = 22 260) underwent renal transplantation. However, the prevalence of ESRD continues to increase, and the incidence rates of HD, PD, and renal transplantation were 83.6%, 5.1%, and 11.3%, respectively in 2021. ¹

Although the exact reason for the decreasing prevalence of PD in Korea is not known, this observation is not unique to Korea. The incidence of PD has decreased since the mid-1980s in the United States, ² and the preference for HD may be affected by the increasing age of patients with ESRD and insufficient information or education about the guidelines for choosing dialysis modality. ^3–5

Although the effect of each dialysis modality on survival rate has been investigated, it is still a controversial issue among nephrologists. ^3,4,6 Johanna et al. ⁷ tried to conduct a randomized controlled trial to compare different initial dialysis modalities, but the study was stopped owing to poor feasibility. ⁷ Less than 5% of the eligible patients agreed to be randomized. Several related studies have been conducted using diverse statistical analyses in the United States, Europe, Taiwan, and Korea^8–17; however, the results have not been consistent.

In this study, we used data from a clinical research center (CRC) for ESRD (NCT00931970) to investigate the hazard rate of mortality for patients with incident ESRD in relation to the initial dialysis modality (HD vs. PD).

Study participants

The CRC for ESRD cohort was a nationwide, multicenter, prospective cohort of patients with ESRD who were undergoing dialysis in South Korea. The cohort began registering patients with ESRD for dialysis in July 2008, and 31 hospitals in South Korea are currently participating in the study. To be eligible for inclusion in the primary cohort, patients must have been at least 18 years old at the time of enrollment. We excluded 458 patients due to missing information. The patient inclusion and exclusion processes are described in Fig. 1.

Data collection

Data were extracted from the CRC database for outcome analyses. Baseline characteristics included age, sex, body mass index (BMI), comorbid conditions, occupation, marital status, family support, level of education, smoking history, ambulatory status, and visual acuity. Dialysis modality was defined as the modality used at the initiation of dialysis. Comorbid conditions include coronary artery disease (CAD), diabetes mellitus (DM), cerebrovascular disease (CVD), peripheral vascular disease (PVD), tumor, and hypertension. In the occupational survey, three categories were investigated: blue-collar workers, white-collar workers, and others. In addition, we collected data on family support and classified patients as thoroughly supported, 50 ~ 100% supported, < 50% supported, and independent. For level of education, we investigated two categories: college education or higher, and others. Ambulatory state was recorded in four categories: normal, walking with assistance (e.g., a person, cane, or walker), requiring a wheelchair, and bedridden.

Clinical outcomes

The primary outcome was time to death from any cause following the initiation of dialysis. Transplantation was treated as a competing event. Transplantation time was determined using registration on a list of transplant recipients.

Statistical analysis

We compared the hazard rates between patients who underwent HD and those who underwent PD. An intention-to-treat design was used to compare the effects of initiating HD and PD. To reduce bias arising from differences in baseline characteristics between the HD and PD groups, we employed inverse probability treatment weighting (IPTW). To prevent the use of extreme weights, the weights were truncated at the 99.9th percentile of their distribution. ¹⁸ Then, we checked the balance among baseline characteristics in terms of absolute standardized mean differences (ASD) before and after IPTW. We calculated the sub-distribution hazard ratio (SHR) using the weighted Fine and Gray model^19,20 for mortality between the two dialysis groups over the follow-up period. In addition, we employed landmark analysis to identify the changing effects of dialysis in individuals who remained event-free at each landmark point. ²¹ We considered five landmark points: 1, 2, 3, 4, and 5 years. In the landmark analysis, all estimates were obtained by applying IPTW at each landmark point.

Cumulative incidence curves were estimated non-parametrically using IPTW. Subgroup analyses were conducted for age (< 65 and > 65 years), presence of DM, educational level, and marital status. All statistical tests were evaluated using a two-tailed 95% confidence interval (CI), and statistical significance was set at P < 0.05. All statistical analyses were performed using R version 4.2.3.

Ethical aspects

The study protocol complied with the Declaration of Helsinki and was approved by the Institutional Review Board of Seoul National University Hospital (H-1405-060-579). The study protocol of the CRC for ESRD was approved by the institutional review board of each participating center, and all patients provided written informed consent.

Baseline characteristics

Among the 2 207 patients who participated in the study, 1 647 (74.6%) were in the HD group, of which there were 592 deaths, 106 transplants, 8650.40 person-years of observation data, and median follow-up time of 5.70 years. For the PD group, there were 167 deaths, 46 transplants, 3330.11 person-years of data, and median follow-up time of 6.57 years.

Table 1 presents the baseline characteristics of the patients before and after IPTW. Before IPTW, age, BMI, comorbid condition, occupation, marital status, educational status, ambulation, and visual acuity had ASD > 0.1 between the two groups. After IPTW, these covariates were well-balanced and had ASD < 0.1, as shown in Supplementary Figure S1. ^22,23 The covariate balances in each of the subgroups by age (< 65 and > 65 years), presence of DM, level of education, and marital status are shown in Supplementary Figure S2. The covariates were well balanced within most of the subgroups, except for the subgroups of patients older than 65 years and those with marital status categorized as “others.”

Table 1

Baseline characteristics unadjusted and adjusted by IPTW
		Before IPTW		After IPTW
Variables		Hemodialysis (N = 1,647)	Peritoneal dialysis (N = 561)	Hemodialysis (N = 1,646)	Peritoneal dialysis (N = 558)
Age, years		57.97 ± 14.18	51.38 ± 12.91	56.23 ± 14.51	55.30 ± 13.09
Male, n(%)		62.30%	62.00%	62.00%	62.50%
BMI, kg/m²		23.13 ± 3.60	22.64 ± 3.26	23.01 ± 3.58	23.01 ± 3.26
Comorbidities, n(%)
	CAD	13.80%	10.20%	12.90%	14.00%
	DM	58.60%	46.10%	55.20%	53.70%
	CVD	9.10%	5.40%	8.30%	9.20%
	PVD	7.40%	5.00%	6.90%	7.00%
	Tumor	6.70%	3.00%	5.80%	4.90%
	Hypertension	63.90%	53.20%	61.30%	61.70%
Occupation, n(%)
	White-collar workers	8.10%	12.70%	9.30%	9.30%
	Blue-collar workers	17.80%	28.30%	20.40%	20.70%
	Missing	74.10%	59.00%	70.30%	70.10%
Marital status, n(%)
	Married	27.80%	23.10%	26.80%	24.90%
	Others^#	72.20%	76.90%	73.20%	75.10%
Family support^##, n(%)
	Thoroughly supported	18.20%	15.20%	17.50%	17.00%
	50 ~ 100%	51.50%	48.40%	51.00%	52.90%
	< 50%	18.80%	21.90%	19.50%	18.30%
	Never supported	11.40%	14.50%	12.00%	11.80%
Educational status, n(%)
	College graduation or higher	25.30%	35.50%	28.00%	29.00%
	Others	74.70%	64.50%	72.00%	71.00%
Smoking, n(%)
	Never	54.40%	57.30%	55.10%	54.40%
	Past smoker	34.50%	33.20%	34.30%	35.30%
	Current smoker	11.10%	9.50%	10.70%	10.30%
Ambulation, n(%)
	Bed-ridden or in need of help	15.60%	7.50%	13.60%	14.20%
	Self -ambulation	84.40%	92.50%	86.40%	85.80%
Visual acuity, n(%)
	No issues	80.90%	85.50%	82.00%	83.10%
	Any issues	19.10%	14.50%	18.00%	16.90%
*Abbreviations; CAD, coronary arterial disease; DM, diabetes mellitus; CVD, cerebrovascular disease
#Others; every status except for marriage
##Family support;

The impact of dialysis modality on mortality

When we used the weighted Fine and Gray model with different follow-up durations, there was no significant difference in the hazard ratio between the two groups (Fig. 2). However, there were significant findings in the subgroup analysis (Fig. 2). We identified a significantly higher risk in the PD group among patients < 65 years old. For 4-year follow-up, SHR was 1.52 (95%CI = 1.07–2.16, P = 0.0195), and for 5-year follow-up, SHR was 1.39 (95%CI = 1.00–1.92, P = 0.0473). For participants with DM, the PD group had significantly higher risk of mortality than the HD group during the 4-year (SHR [95% CI] = 1.51 [1.12–2.04], P = 0.0070) and 5-year follow-up (SHR [95% CI] = 1.58 [1.20–2.08], P = 0.0010). In the analysis of the group aged 65 years and above without DM, there were no significant differences. In addition, there was no significant difference in the hazard ratio between the two dialysis groups, irrespective of educational level and marital status. Cumulative incidence plots for all subgroups are shown in Supplementary Figure S3-S4.

Landmark analysis for mortality according to dialysis modality

We performed a landmark analysis to investigate the effect of dialysis modality on individuals during the follow-up period. As shown in Fig. 3, the hazard ratio was lower for PD initiation than HD initiation (SHR [95% CI] = 0.58 [0.32–1.06], P = 0.0757) within 1 year, but it was not statistically significant. However, the PD group had significantly higher hazard ratio than the HD group between 2 and 3 years after the first dialysis (SHR [95% CI] = 1.94 [1.21–3.12], P = 0.0063).

In the subgroup analysis, the hazard ratio in the PD group was significantly higher than in the HD group at 2 and 3 years among the < 65 years subgroup (SHR [95% CI] = 2.71 [1.47–4.99], P = 0.0014 vs. SHR [95% CI] = 2.50 [1.32–4.72], P = 0.0049) and among the DM subgroup (SHR [95% CI] = 2.45 [1.41–4.26], P = 0.0014 vs. SHR [95% CI] = 2.32 [1.35–3.99], P = 0.0023). Moreover, the hazard ratio in the PD group was significantly higher than in the HD group at 2 years in both the other education (SHR [95% CI] = 1.95 [1.17–3.27], P = 0.0107) and married groups (SHR [95% CI] = 1.85 [1.07–3.21], P = 0.0284). The cumulative incidence plots estimated using landmark analysis are shown in Supplementary Figure S5-S6.

This study assessed the relevance of initiation dialysis modality to hazard rate. No significant difference in hazard rate was observed between the two dialysis modalities for all participants. However, the hazard rate in the PD group was significantly higher than that in the HD group among people younger than 65 years over 4-year follow-up, although the statistical significance was marginal (P = 0.0579) in the 5-year follow-up analysis. Moreover, we found that the hazard ratios were over 1.0 (PD vs. HD) from the 2-year follow-up period, even though statistical significance was seen only after 2–3 years of follow-up. Furthermore, among the younger age group (< 65 years), the hazard rate in the PD group was significantly higher than that in the HD group at the follow-ups done at 2–3 years and 3–4 years.

With respect to the risk of mortality, PD and HD have been considered to be equally effective as initial dialysis modalities. ^6,24–26 Observational studies have also previously reported more favorable outcomes in younger patients without comorbidities who undergo PD, compared to patients who undergo HD; however, those outcomes were limited to the first 1–2 years of dialysis, ^27–29 whereas HD was associated with improved survival among patients with cardiovascular disease and diabetes. Liem et al. ³⁰ concluded that the survival advantage of PD over HD decreased over time, with age, and in the presence of diabetes as a primary disease. ³⁰ Thus, dialysis modality conversion has remained subject to consideration, and only a few studies have investigated it. ^31,32 In addition, we need to interpret the results with caution because there were reasons to switch modalities, such as clinical indications that precluded HD, peritonitis, and/or encapsulating peritoneal sclerosis.

Beyond considering dialysis modality conversion, we investigated the survival benefits of each dialysis modality according to the follow-up duration in the current study. To select an appropriate dialysis modality, it is essential to determine the impact of dialysis modality on mortality. Given that evidence from randomized controlled trials is scarce, outcome reports from cohorts or national registries are the major sources of evidence. Understanding these outcome reports requires careful interpretation because of their methodological differences, including the use of prevalent versus incident patients or Cox proportional hazards models versus landmark analysis.

In this study, we included only patients who underwent incident dialysis and reduced immortal-time bias in the patients who underwent prevalent dialysis. In addition, we used the weighted Fine and Gray regression model to reflect competing risks due to transplantation registration and performed landmark analysis to investigate the changing effects of dialysis during the follow-up period.

As previously mentioned, we did not find a significant difference in the hazard rate between the two groups during the median follow-up period of 5.9 years. However, we realized that the hazard ratios were > 1.0 when the follow-up duration was > 3 years, and the hazard rate was significantly higher in the PD than in the HD group among patients younger than 65 years when the follow-up period was over 4 years. We found that more mortalities occurred in the PD group than in the HD group at 2–3 years and 3–4 years among patients in the younger age group. We cannot provide any exact reason for these observations, but possible reasons that could have been explored are decrease in residual renal function, recurrent episodes of peritonitis, and/or other causes of mortality. However, we could not investigate them with the limited data, which is a limitation of the present study. Meanwhile, consistent with several other studies, we posit that HD may be expected to offer greater survival benefit than PD when the follow-up period is > 2 years, especially in younger patients.

DM is the main cause of ESRD, and several studies have demonstrated a survival advantage of HD in the presence of DM. Likewise in this study, the hazard rate was significantly higher in the PD group than in the HD group in the presence of DM; however, this only applied to patients over a 4-year follow-up period.

In contrast, no significant differences in hazard rates were observed between the two groups when stratified by educational level and marital status, only except at 2 years. However, this needs to be interpreted cautiously because the participant’s responses were not sufficient for evaluation. Patients were asked to complete a survey, but some were reluctant to provide answers due to privacy concerns. Thus, most patients who responded were likely to have a high level of education and family support. In the future, a more detailed survey with a well-designed study will be helpful in revealing the relationship between dialysis modality, survival benefit, educational level, and family support.

This study had several limitations. First, it was an observational study; therefore, we had limitations in revealing a causal relationship between dialysis modality and mortality. However, we used diverse statistical analyses to avoid selection bias, competing risks, and non-proportional hazards models. Second, there were no guidelines for choosing the dialysis modality before enrollment. Physicians respected the preference of patients in selecting the modality. However, we educated them, showed them each case, and gave them the choice of one of the modalities except for special cases, such as patients who had contraindications for HD and PD. Furthermore, there was no consistency in dialysis initiation. We enrolled a new patient in the cohort when dialysis was initiated for ESRD. However, the decision to initiate dialysis was made by the nephrologists. The possibility of mortality could not be completely excluded because of different dialysis initiations. Moreover, the hazard rate was very low 1 year after dialysis initiation, especially in the PD group. Thus, other factors should be considered when interpreting the survival benefit of PD within a year. However, the median follow-up period was 5.9 years, which means that the current cohort was not sufficient to reveal the long-term impact of dialysis modality on mortality. In the future, we may need to re-investigate this in a well-designed study. Finally, this study was performed only among Korean patients with ESRD, which means that the results should not be generalized, and future studies involving people of diverse ethnicities will be required.

In conclusion, this study could be useful in choosing a dialysis modality for young patients, especially those who have DM. Moreover, HD may be given preference over PD when the follow-up duration is > 3 years. However, future studies with larger populations, including those with diverse ethnicities and modality switches, are needed.

Disclosure statement

No financial issues

Funding statement

This work was supported by a multidisciplinary research grant from the Seoul Metropolitan Government, Seoul National University (SMG-SNU) Boramae Medical Center (No.04-2023-0000). It was also supported by grants from the Korean Healthcare Technology R&D Project and Ministry for Health, Welfare, and Family Affairs, Republic of Korea (A102065 and A111345), and by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health & Welfare, Republic of Korea (HI15C0001).

Authors’ contributions

Yae Hyun Kim: Conceptualization, Study design, Data mining, Writing-Review & Editing

Yeonjin Kim: Methodology, Data analysis, Data curation, Writing-Review & Editing

Nayoung Ha: Methodology, Data analysis, Data curation, Writing-Review & Editing

Woojoo Lee: Conceptualization, Methodology, Data Analysis, Data curation, Writing-Review & Editing.

Hyung Jung Oh: Conceptualization, Study design, Data mining, Writing-Review & Editing

Jang-Hee Cho, Yon Su Kim, Shin-Wook Kang, Nam-Ho Kim, Chul Woo Yang, Young-Lim Kim, and Jung Pyo Lee: Advise on conceptualization, Data collection & Writing-Manuscript draft.

Data availability statement

The datasets used and/or analysed during the current study available as de-identified participant data. Data will be shared following approval of the proposal by the corresponding author and a signed data access agreement.

Acknowledgements

The authors also thank the reviewers for their insightful comments on this paper.

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No competing interests reported.

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The Effect of Dialysis Modality on Annual Mortality: a Prospective Cohort Study

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The impact of dialysis modality on mortality

Landmark analysis for mortality according to dialysis modality

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