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Atorvastatin for high-risk statin-naïve patients undergoing noncardiac surgery: The Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose (LOAD) randomized trial.

Publication ,  Journal Article
Berwanger, O; de Barros E Silva, PGM; Barbosa, RR; Precoma, DB; Figueiredo, EL; Hajjar, LA; Kruel, CDP; Alboim, C; Almeida, AP; Dracoulakis, MDA ...
Published in: Am Heart J
February 2017

UNLABELLED: 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 18hours before surgery), followed by a maintenance dose of 40 mg (or placebo), started at least 12hours after the surgery, and then 40 mg/d (or placebo) for 7days. The primary outcome was a composite of all-cause mortality, nonfatal myocardial injury after noncardiac surgery, and stroke at 30days. 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.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2017

Volume

184

Start / End Page

88 / 96

Location

United States

Related Subject Headings

  • Troponin
  • Surgical Procedures, Operative
  • Stroke
  • Risk Assessment
  • Proportional Hazards Models
  • Postoperative Complications
  • Perioperative Care
  • Myocardial Ischemia
  • Myocardial Infarction
  • Middle Aged
 

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Berwanger, O., de Barros E Silva, P. G. M., Barbosa, R. R., Precoma, D. B., Figueiredo, E. L., Hajjar, L. A., … LOAD Investigators, . (2017). Atorvastatin for high-risk statin-naïve patients undergoing noncardiac surgery: The Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose (LOAD) randomized trial. Am Heart J, 184, 88–96. https://doi.org/10.1016/j.ahj.2016.11.001
Berwanger, Otavio, Pedro G. M. de Barros E Silva, Roberto Ramos Barbosa, Dalton Bertolim Precoma, Estêvão Lanna Figueiredo, Ludhmila Abrahão Hajjar, Cleber Dario Pinto Kruel, et al. “Atorvastatin for high-risk statin-naïve patients undergoing noncardiac surgery: The Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose (LOAD) randomized trial.Am Heart J 184 (February 2017): 88–96. https://doi.org/10.1016/j.ahj.2016.11.001.
Berwanger O, de Barros E Silva PGM, Barbosa RR, Precoma DB, Figueiredo EL, Hajjar LA, et al. Atorvastatin for high-risk statin-naïve patients undergoing noncardiac surgery: The Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose (LOAD) randomized trial. Am Heart J. 2017 Feb;184:88–96.
Berwanger O, de Barros E Silva PGM, Barbosa RR, Precoma DB, Figueiredo EL, Hajjar LA, Kruel CDP, Alboim C, Almeida AP, Dracoulakis MDA, Filho HV, Carmona MJC, Maia LN, de Oliveira Filho JB, Saraiva JFK, Soares RM, Damiani L, Paisani D, Kodama AA, Gonzales B, Ikeoka DT, Devereaux PJ, Lopes RD, LOAD Investigators. Atorvastatin for high-risk statin-naïve patients undergoing noncardiac surgery: The Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose (LOAD) randomized trial. Am Heart J. 2017 Feb;184:88–96.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2017

Volume

184

Start / End Page

88 / 96

Location

United States

Related Subject Headings

  • Troponin
  • Surgical Procedures, Operative
  • Stroke
  • Risk Assessment
  • Proportional Hazards Models
  • Postoperative Complications
  • Perioperative Care
  • Myocardial Ischemia
  • Myocardial Infarction
  • Middle Aged