title: Atorvastatin for high-risk statin-naïve patients undergoing noncardiac surgery: The Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose (LOAD) randomized trial.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil. Electronic address: oberwanger@hcor.com.br.
authors.forename: Otavio
authors.initials: O
authors.lastname: Berwanger
authors.affiliation: Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil; Brazilian Clinical Research Institute (BCRI), São Paulo, Brazil.
authors.forename: Pedro G M
authors.initials: PG
authors.lastname: de Barros E Silva
authors.affiliation: Santa Casa de Vitória, Vitória, Espírito Santo, Brazil.
authors.forename: Roberto Ramos
authors.initials: RR
authors.lastname: Barbosa
authors.affiliation: Hospital Angelina Caron, Campina Grande do Sul, Paraná, Brazil.
authors.forename: Dalton Bertolim
authors.initials: DB
authors.lastname: Precoma
authors.affiliation: Hospital Lifecenter, Belo Horizonte, Minas Gerais, Brazil.
authors.forename: Estêvão Lanna
authors.initials: EL
authors.lastname: Figueiredo
authors.affiliation: Instituto do Câncer do estado de São Paulo (ICESP), Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo, Brazil.
authors.forename: Ludhmila Abrahão
authors.initials: LA
authors.lastname: Hajjar
authors.affiliation: Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.
authors.forename: Cleber Dario Pinto
authors.initials: CD
authors.lastname: Kruel
authors.affiliation: Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.
authors.forename: Carolina
authors.initials: C
authors.lastname: Alboim
authors.affiliation: Hospital Unimec, Vitória da Conquista, Bahia, Brazil.
authors.forename: Adail Paixão
authors.initials: AP
authors.lastname: Almeida
authors.affiliation: Hospital da Bahia, Salvador, Bahia, Brazil.
authors.forename: Marianna Deway Andrade
authors.initials: MD
authors.lastname: Dracoulakis
authors.affiliation: Hospital São Vicente de Paulo, Passo Fundo, Rio Grande do Sul, Brazil.
authors.forename: Hugo Vargas
authors.initials: HV
authors.lastname: Filho
authors.affiliation: Divisão de Anestesia Instituto Central-Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
authors.forename: Maria José Carvalho
authors.initials: MJ
authors.lastname: Carmona
authors.affiliation: Hospital de Base-São José do Rio Preto, São Paulo, Brazil.
authors.forename: Lília Nigro
authors.initials: LN
authors.lastname: Maia
authors.affiliation: Instituto de Medicina Integral Prof. Fernando Figueira - IMIP, Recife, Pernambuco, Brazil.
authors.forename: João Bosco
authors.initials: JB
authors.lastname: de Oliveira Filho
authors.affiliation: Hospital e Maternidade Celso Pierro, Campinas, São Paulo, Brazil.
authors.forename: Jose Francisco Kerr
authors.initials: JF
authors.lastname: Saraiva
authors.affiliation: Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil.
authors.forename: Rafael M
authors.initials: RM
authors.lastname: Soares
authors.affiliation: Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil.
authors.forename: Lucas
authors.initials: L
authors.lastname: Damiani
authors.affiliation: Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil.
authors.forename: Denise
authors.initials: D
authors.lastname: Paisani
authors.affiliation: Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil.
authors.forename: Alessandra A
authors.initials: AA
authors.lastname: Kodama
authors.affiliation: Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Gonzales
authors.affiliation: Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil.
authors.forename: Dimas T
authors.initials: DT
authors.lastname: Ikeoka
authors.affiliation: Population Health Research Institute (PHRI), Hamilton, Canada.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Devereaux
authors.affiliation: Brazilian Clinical Research Institute (BCRI), São Paulo, Brazil; Duke Clinical Research Institute, Durham, NC.
authors.forename: Renato D
authors.initials: RD
authors.lastname: Lopes
mesh_terms: D000368:Aged; D000069059:Atorvastatin / Q000627:therapeutic use*; D004562:Electrocardiography; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000175:diagnosis / Q000517:prevention & control*; D017202:Myocardial Ischemia / Q000097:blood / Q000175:diagnosis / Q000517:prevention & control; D019990:Perioperative Care / Q000379:methods; D011183:Postoperative Complications / Q000517:prevention & control*; D016016:Proportional Hazards Models; D018570:Risk Assessment; D020521:Stroke / Q000517:prevention & control*; D013514:Surgical Procedures, Operative; D014336:Troponin / Q000097:blood
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D014336:Troponin; D000069059:Atorvastatin