STAR VaS--Short Term Atorvastatin Regime for Vasculopathic Subjects: a randomized placebo-controlled trial evaluating perioperative atorvastatin therapy in noncardiac surgery

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00967434.