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Abstract: TH-PO1042

Generalizability of SPRINT-CKD Cohort to CKD Patients Referred to Renal Clinics

Session Information

Category: CKD (Non-Dialysis)

  • 1901 CKD (Non-Dialysis): Epidemiology, Risk Factors, and Prevention

Authors

  • Minutolo, Roberto, University of Campania, Naples, Italy
  • De Nicola, Luca, University of Campania, Naples, Italy
Background

It is unknown whether the SPRINT-CKD sub-cohort is representative of CKD patients under nephrology care. We compared risk profile and outcomes of SPRINT-CKD versus a pooled cohort of four prospective studies enrolling consecutive patients with CKD stage I-V under nephrology care from >6 months in 40 Italian outpatient renal clinics.

Methods

In referred cohorts, we implemented the same inclusion/exclusion criteria adopted in SPRINT and the same endpoints: (1) a composite of myocardial infarction, acute coronary syndrome, stroke, heart failure and CV death (2) all-cause mortality and (3) end-stage renal disease (ESRD) as a composite of chronic dialysis, transplantation or 50% eGFR decline. Referred CKD patients were compared with those in SPRINT-CKD randomized to standard BP arm because management in this group is comparable to that performed in clinical practice where SBP target <140 mmHg is usually pursued. To compare outcomes, we only considered for analysis the events occurring no later than 4.8 years after enrolment, i.e. the maximum follow up available in SPRINT.

Results

From the initial pooled cohorts (n=3225), we deleted 338 duplicate patients, 27 patients without data on SPRINT selection criteria and 13 subjects lost to follow-up. Out of the evaluable 2847 patients, only 20.1% (n=571) of the patients of the referred cohorts could have been potentially eligible for SPRINT trial. These patients had a worse risk profile at baseline (Table). At a median follow-up of 4.0 years (IQR 2.8-4.8), we registered 85 CV events (50 fatal), 78 all-cause death with annual incidence rates higher than those observed in the SPRINT standard group (Table).

Conclusion

In conclusion, we suggest that the SPRINT-CKD cohort is poorly representative of “real-world” CKD population. Ad hoc trials are needed in referred CKD population.

Demographics and clinical characteristics at baseline, and incidence rates of endpoints in the two groups