دورية أكاديمية

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

التفاصيل البيبلوغرافية
العنوان: Atorvastatin for high-risk statin-naïve patients undergoing noncardiac surgery: The Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose (LOAD) randomized trial.
المؤلفون: Berwanger O; Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil. Electronic address: oberwanger@hcor.com.br., de Barros E Silva PG; Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil; Brazilian Clinical Research Institute (BCRI), São Paulo, Brazil., Barbosa RR; Santa Casa de Vitória, Vitória, Espírito Santo, Brazil., Precoma DB; Hospital Angelina Caron, Campina Grande do Sul, Paraná, Brazil., Figueiredo EL; Hospital Lifecenter, Belo Horizonte, Minas Gerais, Brazil., Hajjar LA; Instituto do Câncer do estado de São Paulo (ICESP), Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo, Brazil., Kruel CD; Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil., Alboim C; Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil., Almeida AP; Hospital Unimec, Vitória da Conquista, Bahia, Brazil., Dracoulakis MD; Hospital da Bahia, Salvador, Bahia, Brazil., Filho HV; Hospital São Vicente de Paulo, Passo Fundo, Rio Grande do Sul, Brazil., Carmona MJ; Divisão de Anestesia Instituto Central-Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil., Maia LN; Hospital de Base-São José do Rio Preto, São Paulo, Brazil., de Oliveira Filho JB; Instituto de Medicina Integral Prof. Fernando Figueira - IMIP, Recife, Pernambuco, Brazil., Saraiva JF; Hospital e Maternidade Celso Pierro, Campinas, São Paulo, Brazil., Soares RM; Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil., Damiani L; Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil., Paisani D; Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil., Kodama AA; Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil., Gonzales B; Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil., Ikeoka DT; Research Institute-Hospital do Coracao (HCOR), São Paulo, Brazil., Devereaux PJ; Population Health Research Institute (PHRI), Hamilton, Canada., Lopes RD; Brazilian Clinical Research Institute (BCRI), São Paulo, Brazil; Duke Clinical Research Institute, Durham, NC.
مؤلفون مشاركون: LOAD Investigators
المصدر: American heart journal [Am Heart J] 2017 Feb; Vol. 184, pp. 88-96. Date of Electronic Publication: 2016 Nov 09.
نوع المنشور: Journal Article; Multicenter Study; Pragmatic Clinical Trial; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: Mosby Country of Publication: United States NLM ID: 0370465 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6744 (Electronic) Linking ISSN: 00028703 NLM ISO Abbreviation: Am Heart J Subsets: MEDLINE
أسماء مطبوعة: Original Publication: St. Louis, MO : Mosby
مواضيع طبية MeSH: Surgical Procedures, Operative*, Atorvastatin/*therapeutic use , Hydroxymethylglutaryl-CoA Reductase Inhibitors/*therapeutic use , Myocardial Infarction/*prevention & control , Postoperative Complications/*prevention & control , Stroke/*prevention & control, Aged ; Electrocardiography ; Female ; Humans ; Male ; Middle Aged ; Myocardial Infarction/blood ; Myocardial Infarction/diagnosis ; Myocardial Ischemia/blood ; Myocardial Ischemia/diagnosis ; Myocardial Ischemia/prevention & control ; Perioperative Care/methods ; Proportional Hazards Models ; Risk Assessment ; Troponin/blood
مستخلص: 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.
(Copyright © 2016 Elsevier Inc. All rights reserved.)
المشرفين على المادة: 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
0 (Troponin)
A0JWA85V8F (Atorvastatin)
تواريخ الأحداث: Date Created: 20161129 Date Completed: 20170531 Latest Revision: 20181202
رمز التحديث: 20231215
DOI: 10.1016/j.ahj.2016.11.001
PMID: 27892891
قاعدة البيانات: MEDLINE
الوصف
تدمد:1097-6744
DOI:10.1016/j.ahj.2016.11.001