Key result
Perioperative simvastatin fails to reduce postoperative cardiopulmonary complications versus placebo in one-lung ventilation.
Why the study?
Surgeries requiring one-lung ventilation carry high rates of postoperative cardiopulmonary complications, and statins may limit the inflammation involved in their development.
Does perioperative simvastatin reduce the composite incidence of ARDS, postoperative pulmonary complications, MI, or MINS in adult patients undergoing one-lung ventilation for elective thoracic surgery?
RCT (n=251)
Double-blind
1:1 allocation ratio with a variable block size stratified by centre
Yes
Does perioperative simvastatin reduce the composite incidence of ARDS, postoperative pulmonary complications, MI, or MINS in adult patients undergoing one-lung ventilation for elective thoracic surgery?
Perioperative initiation of simvastatin did not reduce the incidence of postoperative cardiopulmonary complications in patients undergoing one-lung ventilation for thoracic surgery.
No role for perioperative simvastatin in one-lung ventilation; confirms weak consensus against benefit.
RATIONALE: Surgeries that require one-lung ventilation have high rates of postoperative cardiopulmonary complications with associated morbidity and mortality. Statins may limit inflammation involved in the development of these complications. OBJECTIVES: We tested the hypothesis that perioperative simvastatin use reduces postoperative cardiopulmonary complications, compared with placebo, in surgery requiring one-lung ventilation. METHODS: Randomised, double-blind, multicentre trial of simvastatin versus placebo in patients undergoing elective oesophagectomy, lobectomy or pneumonectomy at 15 sites throughout the UK. Planned sample size is 452 patients. Participants were randomised to either simvastatin 80 mg or placebo for 4 days preoperatively and up to 7 days postoperatively. MEASUREMENTS: The primary outcome measure was a composite endpoint of the incidence of acute respiratory distress syndrome, postoperative pulmonary complications, myocardial infarction and/or myocardial ischaemia during the first 7 days postoperatively or until hospital discharge. A modified intention-to-treat analysis excluded patients who did not receive the intervention preoperatively or proceed with the planned surgery. MAIN RESULTS: 251 patients were randomised, 126 assigned to simvastatin and 125 to placebo, with 208 included in the modified intention-to-treat population. The trial was stopped early because of futility following recommendations from the data monitoring and ethics committee. The primary outcome occurred in 45/106 patients (42.5%) in the simvastatin group and 39/102 patients (38.2%) in the placebo group (OR 1.19 (95% CI 0.68 to 2.08); p=0.54). Secondary and safety outcomes were similar between the groups. CONCLUSION: In patients undergoing one-lung ventilation, simvastatin did not reduce the incidence of postoperative cardiopulmonary complications. TRIAL REGISTRATION NUMBER: isrctn.org identifier, ISRCTN48095567.
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Glass et al. (2025) conducted an RCT in Elective surgery requiring one-lung ventilation (oesophagectomy, lobectomy, or pneumonectomy) (n=251). Simvastatin vs. Placebo was evaluated on Composite of acute respiratory distress syndrome, postoperative pulmonary complications, myocardial infarction, and/or myocardial ischaemia during the first 7 days postoperatively or until hospital discharge (OR 1.19, 95% CI 0.68 to 2.08, p=0.54). Perioperative simvastatin did not reduce the incidence of postoperative cardiopulmonary complications compared with placebo in patients undergoing one-lung ventilation (OR 1.19).
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