STOP-ACEi
Trial question
What is the effect of discontinuation of renin-angiotensin system inhibitors in patients with advanced CKD?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 411
411 patients (130 female, 281 male).
Inclusion criteria: adult patients with advanced and progressive CKD.
Key exclusion criteria: uncontrolled hypertension; history of MI or stroke within the previous 3 months.
Interventions
N=206 renin-angiotensin system inhibitor discontinuation (use of any guideline-recommended antihypertensive agent other than renin-angiotensin system inhibitors).
N=205 renin-angiotensin system inhibitor continuation (renin-angiotensin system inhibitor with/without any other guideline-recommended antihypertensive agent).
Primary outcome
Estimated glomerular filtration rate at 3 years
12.6
13.3
13.3
10.0
6.7
3.3
0.0
Renin-angiotensin system inhibitor
discontinuation
Renin-angiotensin system inhibitor
continuation
No significant
difference ↔
No significant difference in eGFR at 3 years (12.6 vs. 13.3; AD -0.7 , 95% CI -2.5 to 1).
Secondary outcomes
No significant difference in end-stage kidney disease or RRT (62% vs. 56%; HR 1.28, 95% CI 0.99 to 1.65).
No significant difference in patients experiencing > 50% decline in eGFR or initiation of RRT (68% vs. 63%; RR 1.07, 95% CI 0.94 to 1.22).
No significant difference in death (10% vs. 11%; HR 0.85, 95% CI 0.46 to 1.57).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with advanced and progressive CKD, renin-angiotensin system inhibitor discontinuation was not superior to renin-angiotensin system inhibitor continuation with respect to eGFR at 3 years.
Reference
Sunil Bhandari, Samir Mehta, Arif Khwaja et al. Renin-Angiotensin System Inhibition in Advanced Chronic Kidney Disease. N Engl J Med. 2022 Dec 1;387(22):2021-2032.
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