STAR VaS--Short Term Atorvastatin Regime for Vasculopathic Subjects: a randomized
placebo-controlled trial evaluating perioperative atorvastatin therapy in
noncardiac surgery.
Author(s): Neilipovitz DT, Bryson GL, Taljaard M.
Affiliation(s): Department of Critical Care Medicine, The Ottawa Hospital, University of Ottawa,
Civic Campus, Room F202a, 1053 Carling Avenue, Box 249C, Ottawa, ON, K1Y 4E9,
Canada. dneilipovitz@toh.on.ca
Publication date & source: 2012, Can J Anaesth. , 59(6):527-37
PURPOSE: Evidence suggests that statins reduce cardiovascular complications in
patients undergoing noncardiac surgery, although questions remain regarding the
mechanism of benefit and the preferred dosing strategy. In this trial, we
evaluated the perioperative effects on C-reactive protein (CRP) that resulted
from starting atorvastatin within seven days of noncardiac surgery. The objective
was to identify anti-inflammatory effects of atorvastatin prior to conducting a
large randomized trial with clinical end points.
METHODS: In a single centre, parallel group, placebo-controlled trial, sixty high
cardiac risk participants over age 45 yr undergoing noncardiac surgery were
assigned randomly to one of three groups to receive atorvastatin 80 mg (A) and/or
placebo (P). Group AA (n = 26) received atorvastatin seven days before surgery,
the day of surgery, and for seven days post surgery. Group PA (n = 17) received
placebo seven days before surgery, atorvastatin on the day of surgery, and
atorvastatin for seven days post surgery. Group PP (n = 17) received placebo at
all times. All participants, health care professionals, research assistants, and
outcome adjudicators were masked to treatment allocation. Analyses were by
intention to treat. The primary outcome was the C-reactive protein level at 48
hr.
RESULTS: Fifty-six participants completed the 30-day follow-up. The mean
(standard deviation) changes in CRP levels from baseline at 48 hr in Groups AA,
PA, and PP were 141.0 (72.4), 153.5 (42.2), and 111.2 (84.6), respectively. The
mean differences (95% confidence interval) at 48 hr for AA vs PA, AA vs PP, and
PA vs PP were: -20.1 (-81.2 to 41.1), 22.7 (-31.7 to 77.2), and 42.8 (-20.0 to
105.7), respectively, adjusting for baseline CRP, type of procedure, presence of
coronary artery disease, use of medications, and for multiple comparisons using
Tukey's method.
CONCLUSIONS: Administration of atorvastatin, initiated within seven days
preoperatively, was not associated with clinically significant reductions in CRP
levels.
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