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Randomized Controlled Trial
. 2014 Mar;52 Suppl 3(0 3):S132-9.
doi: 10.1097/MLR.0b013e3182a53ca8.

Comparative effectiveness of two anemia management strategies for complex elderly dialysis patients

Yi Zhang  1 , Mae Thamer, James Kaufman, Dennis Cotter, Miguel A Hernán
Affiliations
Randomized Controlled Trial

Comparative effectiveness of two anemia management strategies for complex elderly dialysis patients

Yi Zhang et al. Med Care. 2014 Mar.

Abstract

Background: Randomized trials found that use of erythropoiesis-stimulating agents to target normal hematocrit (Hct) levels (>39%) compared with 27%-34.5% increases cardiovascular risk and mortality among chronic kidney disease patients. However, the effects of the most widely used Hct target in the past 2 decades, 34.5%-39%, have never been examined.

Objective: To compare the effects of 2 Hct target strategies-30.0%-34.5% (low) and 34.5%-39.0% (mid) in a high-risk population: elderly dialysis patients with significant comorbidities.

Research design: Observational data from the US Renal Data System were used to emulate a randomized trial in which patients were assigned to either Hct strategy. Follow-up started after completing 3 months of hemodialysis and ended 6 months later. We conducted the observational analogs of intention-to-treat and per-protocol analyses. Inverse-probability weighting was used to adjust for measured time-dependent confounding by indication.

Subjects: A total of 22,474 elderly patients with both diabetes and cardiovascular disease who initiated hemodialysis in 2006-2008.

Measures: Hazard ratios (HRs) and survival probabilities for all-cause mortality and a composite cardiovascular and mortality endpoint.

Results: The intention-to-treat HR (95% confidence interval) for mid versus low Hct strategy was 1.05 (0.99-1.11) for all-cause mortality and 1.03 (0.98-1.08) for the composite endpoint. The per-protocol HR (95% confidence interval) for mid versus low Hct strategy was 0.98 (0.78-1.24) for all-cause mortality and 1.00 (0.81-1.24) for the composite outcome.

Conclusions: Among hemodialysis patients, we did not find differences in 6-month survival or cardiovascular risk between clinical strategies that target Hct at 30.0%-34.5% versus 34.5%-39.0%.

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Figures

Figure 1
Figure 1
Flowchart of patients for an emulated trial of anemia management strategies, USRDS 2006-2008. Low Hct Strategy defined as epoetin therapy to target hematocrit 30.0 to <34.5. Mid Hct Strategy defined as epoetin therapy to target hematocrit 34.5 to< 39.0 %.
Figure 2
Figure 2. Adjusted survival curves in per-protocol analysis, USRDS 2006-2008. (a) Mortality. (b) Composite endpoint
See this image and copyright information in PMC

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