Fluvastatin and Perioperative Events in Patients Undergoing Vascular Surgery
Open accessAbstract
BACKGROUND: Adverse cardiac events are common after vascular surgery. We hypothesized that perioperative statin therapy would improve postoperative outcomes. METHODS: In this double-blind, placebo-controlled trial, we randomly assigned patients who had not previously been treated with a statin to receive, in addition to a beta-blocker, either 80 mg of extended-release fluvastatin or placebo once daily before undergoing vascular surgery. Lipid, interleukin-6, and C-reactive protein levels were measured at the time of randomization and before surgery. The primary end point was the occurrence of myocardial ischemia, defined as transient electrocardiographic abnormalities, release of troponin T, or both, within 30 days after surgery. The secondary end point was the composite of death from cardiovascular causes and myocardial infarction. RESULTS: A total of 250 patients were assigned to fluvastatin, and 247 to placebo, a median of 37 days before vascular surgery. Levels of total cholesterol, low-density lipoprotein cholesterol, interleukin-6, and C-reactive protein were significantly decreased in the fluvastatin group but were unchanged in the placebo group. Postoperative myocardial ischemia occurred in 27 patients (10.8%) in the fluvastatin group and in 47 (19.0%) in the placebo group (hazard ratio, 0.55; 95% confidence interval [CI], 0.34 to 0.88; P=0.01). Death from cardiovascular causes or myocardial infarction occurred in 12 patients (4.8%) in the fluvastatin group and 25 patients (10.1%) in the placebo group (hazard ratio, 0.47; 95% CI, 0.24 to 0.94; P=0.03). Fluvastatin therapy was not associated with a significant increase in the rate of adverse events. CONCLUSIONS: In patients undergoing vascular surgery, perioperative fluvastatin therapy was associated with an improvement in postoperative cardiac outcome. (Current Controlled Trials number, ISRCTN83738615.)
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Dyslipidaemias are very common in recipients of heart, lung, liver, kidney, or blood-forming stem cell transplants.
“Dyslipidaemias are very common in patients who have undergone heart, lung, liver, kidney, or allogenic haematopoietic stem cell transplantation, and predispose such patients to an increased risk of developing ASCVD and transplant arterial vasculopathy [497-501].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [499]
These dyslipidaemias increase the risk of atherosclerotic cardiovascular disease and transplant arterial vasculopathy in transplant recipients.
“Dyslipidaemias are very common in patients who have undergone heart, lung, liver, kidney, or allogenic haematopoietic stem cell transplantation, and predispose such patients to an increased risk of developing ASCVD and transplant arterial vasculopathy [497-501].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [499]
In another double-blind placebo-controlled trial in 497 patients undergoing vascular surgery, perioperative fluvastatin 80 mg/day was associated with improvement in post-operative cardiac outcome.
“In another double-blind placebo-controlled trial in 497 patients undergoing vascular surgery, perioperative fluvastatin therapy (80 mg/day) was associated with an improvement in post-operative cardiac outcome.209”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [209]
There is no conclusive evidence that statin treatment reduces perioperative cardiovascular disease morbidity and mortality in patients with abdominal aortic aneurysm.
“Although abdominal aortic aneurysm is also a CHD risk-equivalent condition, there is no conclusive evidence that treatment with statins reduces perioperative CVD morbidity and mortality in these patients.220,487”
From European Guidelines on cardiovascular disease prevention in clinical practice (version 2012) (2012) · cites this paper as [487]
Abdominal aortic aneurysm is a coronary heart disease risk-equivalent condition.
“Although abdominal aortic aneurysm is also a CHD risk-equivalent condition, there is no conclusive evidence that treatment with statins reduces perioperative CVD morbidity and mortality in these patients.220,487”
From European Guidelines on cardiovascular disease prevention in clinical practice (version 2012) (2012) · cites this paper as [487]
In another double-blind placebo-controlled trial in 497 patients undergoing vascular surgery, perioperative fluvastatin 80 mg/day was associated with improvement in postoperative cardiac outcome.
“In another double-blind placebocontrolled trial in 497 patients undergoing vascular surgery, perioperative fluvastatin therapy (80 mg/day) was associated with an improvement in postoperative cardiac outcome.418”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [418]
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- Authors
- Schouten, O., Boersma, E., Hoeks, S. E., Benner, R., van Urk, H., van Sambeek, M. R. H. M., Verhagen, H. J. M., Khan, N. A., Dunkelgrun, M., Bax, J. J., & Poldermans, D.
- Affiliations
- Erasmus MC (NL)
- Leiden University Medical Center (NL)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2009-09-03
- Volume
- 361
- Issue
- 10
- Pages
- 980-989
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2144623639
- Cited by
- 374
- References
- 30
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 6 · 2023: 4 · 2022: 5 · 2021: 11 · 2020: 15 · 2019: 13 · 2018: 10 · 2017: 24 · 2016: 28 · 2015: 18 · 2014: 32 · 2013: 29 · 2012: 56
- FWCI
- 37.52
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
- Funders
- Bristol-Myers Squibb
- Boston Scientific Corporation
- European Society of Cardiology
- Erasmus Medisch Centrum
- St. Jude Medical
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac, Anesthesia and Surgical Outcomes
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cardiac and Coronary Surgery Techniques
- Keywords
- fluvastatin, perioperative statin therapy, vascular surgery, postoperative myocardial ischemia, cardiovascular mortality, myocardial infarction, beta-blockers, interleukin-6, C-reactive protein, lipid lowering, troponin T
- MeSH terms
- Fluvastatin, Adrenergic beta-Antagonists, C-Reactive Protein, Cardiovascular Diseases, Cholesterol, Double-Blind Method, Electrocardiography, Fatty Acids, Monounsaturated, Humans, Indoles, Postoperative Period, Vascular Surgical Procedures, Interleukin-6, Myocardial Ischemia, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Perioperative Care, Troponin T, Kaplan-Meier Estimate
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