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

Berwanger, Otávio; Silva, Pedro Gabriel Melo de Barros e; Barbosa, Roberto Ramos; Précoma, Dalton Bertolim; Figueiredo, Estêvão Lanna; Hajjar, Ludhmila Abrahão; Kruel, Cléber Dario Pinto; Alboim, Carolina; Almeida, A P; Dracoulakis, Marianna Deway Andrade; Filho, Hugo Vargas; Carmona, Maria José Carvalho; Maia, Lília Nigro; Filho, João Bosco de Oliveira; Saraiva, José Francisco Kerr; Soares, Rafael Marques; Damiani, Lucas Petri; Paisani, Denise M.; Kodama, Alessandra A.; Gonzales, Beatriz Alvarenga; Ikeoka, Dimas; Devereaux, P.J.; Lopes, Renato D.

doi:10.1016/j.ahj.2016.11.001

Cited by 52 publications

(41 citation statements)

References 19 publications

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“…Hence, a new appraisal of the current evidence on the effect of statin use in perioperative cardiovascular complication is needed, as other trials have been completed since these reviews were published [26–29, 45, 46]. Thus, our systematic review and meta-analysis of RCTs can provide more reliable and powered evidence to better inform clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…Most of them did not formally assess the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system [25]. Finally, several RCTs have been completed since these reviews were published [26–29], which requires a comprehensive appraisal of current evidence on the use of perioperative statins. Thus, we propose a systematic review to assess the efficacy and safety of perioperative statin use on cardiovascular complications in patients undergoing non-cardiac surgery, including both naïve and patients already on statin therapy.…”

Section: Introductionmentioning

confidence: 99%

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Effects of perioperative statin use on cardiovascular complications in patients submitted to non-cardiac surgery: protocol for a systematic review, meta-analysis, and trial sequential analysis

et al. 2017

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BackgroundPreliminary evidence suggests statins may reduce major perioperative vascular events. However, evidence is limited to observational studies, underpowered trials, and non-comprehensive systematic reviews. This review aims to assess the effects of perioperative statin use on cardiovascular complications in patients submitted to non-cardiac surgery.MethodsWe will search MEDLINE/PubMed, EMBASE, LILACS, CENTRAL, Web of Science, and CINAHL for randomized controlled trials assessing the effects of perioperative statin use in adults undergoing non-cardiac surgery and reporting cardiovascular complications. For patients already using statins for hyperlipidemia, a preoperative loading dose of statin is required in the experimental group. We will place no language or publication restriction on our search. Teams of two reviewers will independently assess eligibility and risk of bias, and will extract data from the included trials. Our primary outcome is a combination of cardiovascular mortality or non-fatal myocardial infarction. We will also assess the following outcomes: individual components of the primary outcome, all-cause mortality, total myocardial infarction, elevated troponin in the first seven postoperative days, total stroke, total venous thromboembolism, postoperative atrial fibrillation, elevation of creatine phosphokinase or liver enzymes, and rates of myalgia or rhabdomyolysis. We will conduct meta-analyses using random-effects model and will use trial sequential analysis to establish monitoring boundaries to limit global type I error due to repetitive testing for our primary outcome. We will rate the quality of evidence using the GRADE system.DiscussionThe results of this systematic review may help to inform clinical practice and also the design of future large-scale randomized trials.Systematic review registrationPROSPERO CRD42016035987 Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-017-0500-0) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Effects of perioperative statin use on cardiovascular complications in patients submitted to non-cardiac surgery: protocol for a systematic review, meta-analysis, and trial sequential analysis

et al. 2017

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“…A recent meta-analysis including these recent RCTs found a trend toward increase in mortality in patients receiving statins [110]. In vascular surgery, a recent meta-analysis highlighted lack of definitive evidence of beneficial effects of perioperative statin administration [111], as did a recent mRCT in noncardiac surgery [112]. According to results of these trials, statins should not be administered perioperatively in statin-naïve patients, while the management of statins in patients already receiving chronic therapy remains controversial, especially considering the possible detrimental effect of statin withdrawal due to rebound effect [113,114].…”

Section: Statinsmentioning

confidence: 99%

Perioperative Renal Pharmacological Protection During Cardiovascular Surgery

Belletti

Licheri

Bove

2019

Visceral Vessels and Aortic Repair

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“…A large RCT is needed. Berwanger and colleagues 26 randomized 648 statin-naïve patients booked for non-cardiac surgery to a loading dose of atorvastatin 80 mg or placebo followed by a maintenance dose of 40 mg (or placebo) for 7 days. Despite not demonstrating a reduction in major cardiovascular complications between the two groups, the point estimates for the main study outcomes are suggestive of a possible beneficial effect of moderate size.…”

Section: What Further Evidence Do We Need?mentioning

confidence: 99%

“…RCTs are feasible and justified but will need to be large. 26 Berwanger and colleagues 26 found that the potential effects of statins are at best moderate. Even coupling this with a high control group event rate at 30 days (18.7%), a future trial would need to enrol >7000 patients to detect a relative risk reduction of 15% on the outcome of death, MINS or stroke at 30 days.…”

Section: What Further Evidence Do We Need?mentioning

confidence: 99%