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

Published

Journal Article

Preliminary evidence suggests that statins may prevent major perioperative vascular complications.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.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).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.

Full Text

Duke Authors

Cited Authors

  • 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,

Published Date

  • February 2017

Published In

Volume / Issue

  • 184 /

Start / End Page

  • 88 - 96

PubMed ID

  • 27892891

Pubmed Central ID

  • 27892891

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

International Standard Serial Number (ISSN)

  • 0002-8703

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2016.11.001

Language

  • eng