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Kidney Week

Abstract: TH-PO1139

Representation of Kidney Disease in Peripheral Artery Disease Therapy: A Systematic Review of Randomized Controlled Trials

Session Information

Category: CKD (Non-Dialysis)

  • 1902 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Wen, Yumeng, Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Potok, O. Alison, University of California San Diego Medical Center, San Diego, California, United States
  • Malhotra, Rakesh, University of California San Diego Medical Center, San Diego, California, United States
  • Chan, Lili, Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Konstantinidis, Ioannis, Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Nadkarni, Girish N., Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Coca, Steven G., Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Garimella, Pranav S., University of California San Diego Medical Center, San Diego, California, United States
Background

Kidney disease (KD) patients have a higher risk of peripheral artery disease (PAD) with worse outcomes than the general population. We assessed the inclusion of KD patients in randomized controlled trials (RCT) of PAD therapy.

Methods

We searched PubMed for RCTs of PAD therapy that reported clinical outcomes, randomized ≥ 50 subjects and were published in English from 01/2000 to 04/2018. Two independent reviewers selected studies and extracted data, including trial characteristics, criteria for KD patients’ exclusion, proportion of KD patients and number of subgroup analyses by non-renal or renal parameters.

Results

We included 228 trials randomizing 122924 subjects. KD patients were excluded in 98 (42.6%) trials with 29 (29.6%) of these not reporting kidney specific exclusion criteria. The remainder excluded KD patients based on varied cutoffs for creatinine, glomerular filtration rate and need for dialysis. Trials assessing ACC/AHA class I or II recommendations were less likely to exclude KD patients (38.4 % vs 51.2%, p=0.04). Characteristics associated with a higher likelihood of KD patient exclusion were multicenter studies (47.4% vs. 33.8% in single center studies, p=0.04), industry funding (53.5% vs. 35.0% in academic grant or government-funding, p=0.02) and smaller patient samples (43.2% of studies with <100 subjects, vs 10.0% of studies with ≥1000 subjects, p=0.04). Only 9.6% (22/228) of the trials reported kidney function and 1.3% (3/228) reported subgroup analyses based on it. Exclusion of KD patients by diagnostic category and therapeutic class is depicted in the Figure.

Conclusion

Numerous PAD trials exclude KD patients, a majority uses non-specific renal criteria. Including KD patients in PAD trials is needed to improve the quality of evidence for interventions in this vulnerable population.