David Amar1, Bernard Park2, Hao Zhang3, Weiji Shi4, Martin Fleisher5, Howard T Thaler4, Valerie W Rusch2. 1. Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center, New York, NY. Electronic address: amard@mskcc.org. 2. Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY. 3. Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center, New York, NY. 4. Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY. 5. Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Abstract
OBJECTIVES: Statins improve overall outcomes after noncardiac surgery. The primary aim of the study was to determine whether use of perioperative atorvastatin reduced the rate of postoperative complications in patients undergoing pulmonary resection. METHODS: This was a prospective, randomized, placebo-controlled, double-blind trial of patients undergoing elective pulmonary resection who receivedatorvastatin (40 mg daily) or placebo beginning 1 week before surgery and continued for 1 week postoperatively. Patient characteristics and postoperative complications were recorded. Plasma inflammatory markers were sampled at baseline, in the post-anesthesia care unit, and on postoperative day 3. Because of difficulty enrolling statin-naive patients, the study was stopped at the interim analysis. RESULTS:Postoperative complications occurred in 16 of 72 patients (22%) receiving placebo and in 8 of 65 patients (12%) receiving atorvastatin (P = .13). For patients undergoing major anatomic resection, there were 24 complications in 15 of 45 placebo-treated patients and 8 complications in 7 of 43 atorvastatin-treated patients (P = .04). Plasma levels of C-reactive protein, tumor necrosis factor-α, and myeloperoxidase did not differ between the 2 treatment arms during the study. CONCLUSIONS: After a 2-week perioperative course of atorvastatin (40 mg) in statin-naïve patients undergoing major pulmonary resection, we found evidence of a reduction in the number of clinically important cardiovascular and pulmonary complications compared with placebo. These promising results merit evaluation in a larger, perhaps multicenter study.
RCT Entities:
OBJECTIVES: Statins improve overall outcomes after noncardiac surgery. The primary aim of the study was to determine whether use of perioperative atorvastatin reduced the rate of postoperative complications in patients undergoing pulmonary resection. METHODS: This was a prospective, randomized, placebo-controlled, double-blind trial of patients undergoing elective pulmonary resection who received atorvastatin (40 mg daily) or placebo beginning 1 week before surgery and continued for 1 week postoperatively. Patient characteristics and postoperative complications were recorded. Plasma inflammatory markers were sampled at baseline, in the post-anesthesia care unit, and on postoperative day 3. Because of difficulty enrolling statin-naive patients, the study was stopped at the interim analysis. RESULTS:Postoperative complications occurred in 16 of 72 patients (22%) receiving placebo and in 8 of 65 patients (12%) receiving atorvastatin (P = .13). For patients undergoing major anatomic resection, there were 24 complications in 15 of 45 placebo-treated patients and 8 complications in 7 of 43 atorvastatin-treated patients (P = .04). Plasma levels of C-reactive protein, tumor necrosis factor-α, and myeloperoxidase did not differ between the 2 treatment arms during the study. CONCLUSIONS: After a 2-week perioperative course of atorvastatin (40 mg) in statin-naïve patients undergoing major pulmonary resection, we found evidence of a reduction in the number of clinically important cardiovascular and pulmonary complications compared with placebo. These promising results merit evaluation in a larger, perhaps multicenter study.
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