Atorvastatin for high-risk statin-naïve patients undergoing noncardiac surgery: The Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose (LOAD) randomized trial
| Autor: | João Bosco de Oliveira Filho, Ludhmila Abrahão Hajjar, Marianna Deway Andrade Dracoulakis, Beatriz Gonzales, Maria José Carvalho Carmona, Otavio Berwanger, Pedro Gabriel Melo de Barros e Silva, Cleber Dario Pinto Kruel, Dalton Bertolim Précoma, Adail Paixão Almeida, Denise M. Paisani, Lucas P. Damiani, Roberto Ramos Barbosa, Philip J. Devereaux, Dimas Ikeoka, Renato D. Lopes, Hugo Vargas Filho, Carolina Alboim, José Francisco Kerr Saraiva, Rafael M. Soares, Estêvão Lanna Figueiredo, Lilia Nigro Maia, Alessandra A. Kodama |
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| Rok vydání: | 2017 |
| Předmět: |
Male
Atorvastatin Myocardial Infarction Myocardial Ischemia 030204 cardiovascular system & hematology FÁRMACOS DO SANGUE E SISTEMA HEMATOPOÉTICO Placebo Risk Assessment Loading dose Perioperative Care law.invention Electrocardiography 03 medical and health sciences Postoperative Complications 0302 clinical medicine Randomized controlled trial law Humans Medicine cardiovascular diseases 030212 general & internal medicine Stroke Aged Proportional Hazards Models business.industry Maintenance dose Hazard ratio Perioperative Middle Aged medicine.disease Troponin Surgical Procedures Operative Anesthesia Female Hydroxymethylglutaryl-CoA Reductase Inhibitors Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | Repositório Institucional da USP (Biblioteca Digital da Produção Intelectual) Universidade de São Paulo (USP) instacron:USP |
| ISSN: | 0002-8703 |
| DOI: | 10.1016/j.ahj.2016.11.001 |
| Popis: | Background Preliminary evidence suggests that statins may prevent major perioperative vascular complications. Methods We randomized 648 statin-naive 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-naive patients undergoing noncardiac surgery. We demonstrated, however, that a large multicenter blinded perioperative statin trial for high-risk statin-naive patients is feasible and should be done to definitely establish the efficacy and safety of statin in this patient population. |
| Databáze: | OpenAIRE |
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