#3321 Which patients benefit most from hemodiafiltration compared with hemodialysis: prediction of the individualized treatment effects

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Abstract Background and Aims Randomised trials showed that (high dose) hemodiafiltration (HDF) compared to hemodialysis (HD) reduces mortality risk. No differences in treatment effects were found in subgroup analyses for specific patient populations when defined on a single characteristic. Yet, it is unclear to what extent individual patients, characterized by a combination of clinical characteristics, may benefit from HDF. Therefore, we aimed to develop and internally validate a treatment effect prediction model based on a combination of individual clinical characteristics to determine which individual patients would benefit most from high-dose HDF, compared with HD, in terms of survival. Method Individual patient data from five European randomized controlled trials (CONTRAST, ESHOL, Turkish HDF study, French HDF study, CONVINCE) comparing HDF with HD on all-cause mortality were used. The 4153 patients included in the trials were aged 18 year or above and at least three months on (low or high flux) hemodialysis before randomisation. Patients were randomised to HDF or continue with (low or high flux) HD. Routine clinical patient characteristics were obtained at baseline, notably age, biological sex, body mass index, diabetes mellitus, history of cardiovascular disease, creatinine levels, and c-reactive protein levels. High-dose HDF was defined as a convection volume of at least 23 liters per session. Royston-Parmar models were derived for exploring the prediction of absolute treatment effect of HDF in terms of survival based on pre-specified patient and disease characteristics. Internal validation of the model was performed using internal-external cross validation with discrimination and calibration metrics. Results Among 4153 participants, with a median follow-up of 30 months (Q1–Q3: 24–36), 558 patients (27.2%) died. The median predicted survival benefit of HDF compared with HD was 6.9 (Q1–Q3: 5.6–9.0) months, with a range of 2 to 42 months. Thus all patients on HDF had survival benefit. Those benefiting most from HDF (i.e., estimated survival >12 months more than when treated with HD) were younger, less likely to have diabetes or a cardiovascular history and had higher serum creatinine levels. The predicted gain in median survival was higher when HDF was delivered as high-dose (Fig. 1). Internal-external cross validation showed adequate discrimination and calibration. Conclusion Our results suggest that with readily available patient and disease characteristics, the clinician is able to identify those dialysis patients who are estimated to especially benefit from HDF than from HD in terms of survival. The absolute length of survival benefit is likely to be (much) bigger, since follow up was truncated in this dataset, due to the design of the trials. Hence, long-term effectiveness of HDF, within a real-world setting, will have to be determined.

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