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Preoperative Atorvastatin and Acute Kidney Injury post Cardiac Surgery

Another strategy fails to reduce risk  of acute kidney injury post cardiac surgery (a complex entity). The paper is available here. The abstract follows:

Abstract

IMPORTANCE

Statins affect several mechanisms underlying acute kidney injury (AKI).

OBJECTIVE

To test the hypothesis that short-term high-dose perioperative atorvastatin
would reduce AKI following cardiac surgery.

DESIGN, SETTING, AND PARTICIPANTS

Double-blinded, placebo-controlled, randomized
clinical trial of adult cardiac surgery patients conducted from November 2009 to October
2014 at Vanderbilt University Medical Center.

INTERVENTIONS

Patients naive to statin treatment (n = 199) were randomly assigned 80mg
of atorvastatin the day before surgery, 40mg of atorvastatin the morning of surgery, and
40mg of atorvastatin daily following surgery (n = 102) or matching placebo (n = 97). Patients
already taking a statin prior to study enrollment (n = 416) continued taking the preenrollment
statin until the day of surgery, were randomly assigned 80mg of atorvastatin the morning of
surgery and 40mg of atorvastatin the morning after (n = 206) or matching placebo
(n = 210), and resumed taking the previously prescribed statin on postoperative day 2.

MAIN OUTCOMES AND MEASURES

Acute kidney injury defined as an increase of0.3mg/dL in
serum creatinine concentration within 48 hours of surgery (Acute Kidney InjuryNetwork criteria).
RESULTS The data and safety monitoring board recommended stopping the group naive to
statin treatment due to increased AKI among these participants with chronic kidney disease
(estimated glomerular filtration rate later recommended stopping for futility after 615 participants (median age, 67 years; 188
[30.6%] were women; 202 [32.8%] had diabetes) completed the study. Among all
participants (n = 615), AKI occurred in 64 of 308 (20.8%) in the atorvastatin group vs 60 of
307 (19.5%) in the placebo group (relative risk [RR], 1.06 [95%CI, 0.78 to 1.46]; P = .75).
Among patients naive to statin treatment (n = 199), AKI occurred in 22 of 102 (21.6%) in the
atorvastatin group vs 13 of 97 (13.4%) in the placebo group (RR, 1.61 [0.86 to 3.01]; P = .15)
and serum creatinine concentration increased by a median of 0.11mg/dL (10th-90th
percentile, −0.11 to 0.56mg/dL) in the atorvastatin group vs by a median of 0.05mg/dL
(10th-90th percentile, −0.12 to 0.33mg/dL) in the placebo group (mean difference, 0.08
mg/dL [95%CI, 0.01 to 0.15mg/dL]; P = .007). Among patients already taking a statin
(n = 416), AKI occurred in 42 of 206 (20.4%) in the atorvastatin group vs 47 of 210 (22.4%) in
the placebo group (RR, 0.91 [0.63 to 1.32]; P = .63).

CONCLUSIONS AND RELEVANCE

Among patients undergoing cardiac surgery, high-dose
perioperative atorvastatin treatment compared with placebo did not reduce the risk
of AKI overall, among patients naive to treatment with statins, or in patients already taking a
statin. These results do not support the initiation of statin therapy to prevent AKI following
cardiac surgery.
TRIAL REGISTRATION clinicaltrials.gov Id

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