학술논문
Atorvastatin for high-risk statin-naïve patients undergoing noncardiac surgery: The Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose (LOAD) randomized trial
Document Type
Academic Journal
Author
Berwanger, Otavio; de Barros e Silva, Pedro G.M.; Barbosa, Roberto Ramos; Precoma, Dalton Bertolim; Figueiredo, Estêvão Lanna; Hajjar, Ludhmila Abrahão; Kruel, Cleber Dario Pinto; Alboim, Carolina; Almeida, Adail Paixão; Dracoulakis, Marianna Deway Andrade; Filho, Hugo Vargas; Carmona, Maria José Carvalho; Maia, Lília Nigro; de Oliveira Filho, João Bosco; Saraiva, Jose Francisco Kerr; Soares, Rafael M.; Damiani, Lucas; Paisani, Denise; Kodama, Alessandra A.; Gonzales, Beatriz; Ikeoka, Dimas T.; Devereaux, Philip J.; Lopes, Renato D.
Source
American Heart Journal. Feb 01, 2017 184:88-96
Subject
Language
English
ISSN
0002-8703
Abstract
BACKGROUND: Preliminary evidence suggests that statins may prevent major perioperative vascular complications. METHODS: We randomized 648 statin-naïve patients who were scheduled for noncardiac surgery and were at risk for a major vascular complication. Patients were randomized to a loading dose of atorvastatin or placebo (80 mg anytime within 18 hours before surgery), followed by a maintenance dose of 40 mg (or placebo), started at least 12 hours after the surgery, and then 40 mg/d (or placebo) for 7 days. The primary outcome was a composite of all-cause mortality, nonfatal myocardial injury after noncardiac surgery, and stroke at 30 days. RESULTS: The primary outcome was observed in 54 (16.6%) of 326 patients in the atorvastatin group and 59 (18.7%) of 316 patients in the placebo group (hazard ratio [HR] 0.87, 95% CI 0.60-1.26, P = .46). No significant effect was observed on the 30-day secondary outcomes of all-cause mortality (4.3% vs 4.1%, respectively; HR 1.14, 95% CI 0.53-2.47, P = .74), nonfatal myocardial infarction (3.4% vs 4.4%, respectively; HR 0.76, 95% CI 0.35-1.68, P = .50), myocardial injury after noncardiac surgery (13.2% vs 16.5%; HR 0.79, 95% CI 0.53-1.19, P = .26), and stroke (0.9% vs 0%, P = .25). CONCLUSION: In contrast to the prior observational and trial data, the LOAD trial has neutral results and did not demonstrate a reduction in major cardiovascular complications after a short-term perioperative course of statin in statin-naïve patients undergoing noncardiac surgery. We demonstrated, however, that a large multicenter blinded perioperative statin trial for high-risk statin-naïve patients is feasible and should be done to definitely establish the efficacy and safety of statin in this patient population.