Naeem Al-Shoaibi, MD; David Massel, MD
Does perioperative fluvastatin reduce risk for adverse cardiac events after noncardiac vascular surgery?
Randomized placebo-controlled trial (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography III [DECREASE III] trial). ISRCTN83738615.
Blinded (patients, study personnel, and electrocardiogram [ECG] readers).*
30 days after surgery.
Erasmus Medical Center, Rotterdam, The Netherlands.
497 patients > 40 years of age (mean age 66 y, 75% men) who were scheduled for noncardiac vascular surgery and scored ≥ 51 points on a risk index. Exclusion criteria were current statin therapy, contraindication to statin therapy, planned surgery that could interfere with 12-lead ECG recording, reoperation within 30 days of previous surgery, emergency surgery, unstable coronary artery disease, and stress-induced myocardial ischemia suggestive of left main coronary artery disease or equivalent.
Extended-release fluvastatin, 80 mg (n = 250), or placebo (n = 247), once daily beginning before surgery (median 37 d before surgery) until ≥ 30 days after surgery. Patients not already receiving long-term β-blocker therapy began bisoprolol, 2.5 mg once daily, at screening.
Primary outcome was myocardial ischemia (transient ECG signs or release of troponin T). Secondary outcomes included a composite of death from cardiovascular (CV) causes and nonfatal myocardial infarction (MI).
100% (intention-to-treat analysis).
At 30 days after surgery, fluvastatin reduced risk for myocardial ischemia and the composite outcome (Table).
Perioperative fluvastatin reduced myocardial ischemia and a composite of death from cardiovascular causes and nonfatal myocardial infarction at 30 days after noncardiac vascular surgery.
Perioperative fluvastatin vs placebo in patients having noncardiac vascular surgery†
†Abbreviations defined in Glossary. RRR, NNT, and CI calculated from control event rates and hazard ratios in article.
‡Death from cardiovascular causes (1.6% vs 3.2%, P > 0.05) or nonfatal myocardial infarction (3.2% vs 6.9%, P > 0.05) (both comparisons calculated from data in article, not from Cox analysis).
Al-Shoaibi N, Massel D. Perioperative fluvastatin reduced cardiac events after noncardiac vascular surgery. Ann Intern Med. ;152:JC1–7. doi: 10.7326/0003-4819-152-2-201001190-02007
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Published: Ann Intern Med. 2010;152(2):JC1-7.
Cardiology, Coronary Risk Factors, Dyslipidemia.
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