Atorvastatin for high-risk statin-naïve patients undergoing noncardiac surgery: The Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose (LOAD) randomized trial - 18/04/17
, Pedro G.M. de Barros e Silva, MD, MHS, PhD a, b, Roberto Ramos Barbosa, MD c, Dalton Bertolim Precoma, MD, PhD d, Estêvão Lanna Figueiredo, MD, MSC e, Ludhmila Abrahão Hajjar, MD, PhD f, Cleber Dario Pinto Kruel, MD, PhD g, Carolina Alboim, MD, PhD g, Adail Paixão Almeida, MD h, Marianna Deway Andrade Dracoulakis, MD, PhD i, Hugo Vargas Filho, MD j, Maria José Carvalho Carmona, MD, PhD k, Lília Nigro Maia, MD, PhD l, João Bosco de Oliveira Filho, MD, PhD m, Jose Francisco Kerr Saraiva, MD, PhD n, Rafael M. Soares, RD, MSc a, Lucas Damiani, STAT, MSC a, Denise Paisani, MT, PhD a, Alessandra A. Kodama, IT a, Beatriz Gonzales, R.PH a, Dimas T. Ikeoka, MD, PhD a, Philip J. Devereaux, MD, PhD o, Renato D. Lopes, MD, MHS, PhD b, pon behalf of the
LOAD Investigators
Background |
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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| Clinical trial registration: Clinicaltrials.gov Identifier: NCT01543555 |
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| Funding/Support: This study was funded by the Brazilian Ministry of Health in Partnership with Hospital do Coracao–“Programa Hospitais de Excelencia a Servico do SUS” (Brazilian Public Health System)–PROADI-SUS” and study drugs were provided by “EMS Indústria Farmaceutica.” These sources had no role in study design and had no influence on the study execution, analyses, final manuscript writing, and decision about publication, all of which were the responsibility of the Trial Steering Committee. The authors declare that they have no competing interests. |
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| Charles J. Davidson, MD served as guest editor for this article. |
Vol 184
P. 88-96 - février 2017 Retour au numéro
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