PRACTICE CHANGER
HMG-CoA reductase inhibitors (statins), initiated 30 days before noncardiac vascular surgery, reduce the incidence of postoperative cardiac complications, including fatal myocardial infarction.1,2
STRENGTH OF RECOMMENDATION
A: 1 new randomized controlled trial (RCT), and 1 smaller, older RCT.
Schouten O, Boersma E, Hoeks S, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med. 2009;361:980-989.
Durazzo AE, Machado FS, Ikeoka DT, et al. Reduction in cardiovascular events after vascular surgery with atorvastatin: a randomized trial. J Vasc Surg. 2004;39:967-975.
ILLUSTRATIVE CASE
A 67-year-old man with recurrent transient ischemic attacks comes in for a preoperative evaluation for carotid endarterectomy. The patient’s total cholesterol is 207 mg/dL and his low-density lipoprotein cholesterol (LDL-C) is 109 mg/dL. He takes metoprolol and lisinopril for hypertension.
Should you start him on a statin before surgery?
Nearly 25% of patients with peripheral vascular disease suffer from a cardiac event within 72 hours of elective, noncardiac vascular surgery.3 While most of these “complications” have minimal clinical impact and are detected by biochemical markers alone, some patients experience serious cardiac complications—including fatal myocardial infarction (MI).
That’s not surprising, given that most patients who require noncardiac vascular surgery suffer from severe coronary vascular disease.4 What is surprising is that most candidates for noncardiac vascular surgery are not put on statins prior to undergoing surgery.1,2,5
Statins were thought to increase—not prevent—complications
Until recently, taking statins during the perioperative period was believed to increase complications, including statin-associated myopathy. Indeed, guidelines from the American Heart Association (AHA), American College of Cardiology (ACC), and National Heart, Lung and Blood Institute (NHLBI) suggest that it is prudent to withhold statins during hospitalization for major surgery.6
1 small study hinted at value of perioperative statins
A small Brazilian trial conducted in 2004 called the AHA/ACC/NHLBI guidelines into question. the researchers studied 100 patients slated for noncardiac vascular surgery who were randomized to receive either 20 mg atorvastatin (Lipitor) or placebo preoperatively —and monitored them for cardiac events 6 months postoperatively. They found that the incidence of cardiac events (cardiac death, nonfatal MI, stroke, or unstable angina) was more than 3 times higher in the placebo group compared with patients receiving atorvastatin (26% vs 8%, number needed to treat [NNT]=5.6; P=.031).2
The results of this small single study, although suggestive, were not sufficiently convincing to change recommendations about the preoperative use of statins, however. A more comprehensive study was needed to alter standard practice, and the Schouten study that we report on below fits the bill.1
STUDY SUMMARY: Preoperative statin use cuts risk in half
Schouten et al followed 500 patients, who were randomized to receive either 80 mg extended-release fluvastatin (Lescol XL) or placebo for a median of 37 days prior to surgery.1 All enrollees were older than 40 years of age and were scheduled for noncardiac vascular surgery. the reasons for the surgery were abdominal aortic aneurysm repair (47.5%), lower limb arterial reconstruction (38.6%), or carotid artery endarterectomy (13.9%). Patients who were taking long-term beta-blocker therapy were continued on it; otherwise, bisoprolol 2.5 mg was initiated at the screening visit. Patients who were already taking statins (<50% of potential subjects) were excluded. Other exclusions were a contraindication to statin therapy; emergent surgery; and a repeat procedure within the last 29 days. Patients with unstable coronary artery disease or extensive stress-induced ischemia consistent with left main artery disease (or its equivalent) were also excluded.
The primary study outcome was myocardial ischemia, determined by continuous electrocardiogram (EKG) monitoring in the first 48 hours postsurgery and by 12-lead EKG recordings on days 3, 7, and 30. Troponin T levels were measured on postoperative days 1, 3, 7, and 30, as well. the principal secondary end point was either death from cardiovascular causes or nonfatal MI. MI was diagnosed by characteristic ischemic symptoms, with EKG evidence of ischemia or positive troponin T with characteristic rising and falling values.
To gauge fluvastatin’s effect on biomarkers, lipids, high-sensitivity C-reactive protein, and interleukin-6 were measured upon initiation of the medication and on the day of admission for surgery. Serum creatine kinase, alanine aminotransferase (ALT) levels, clinical myopathy, and rhabdomyolysis were monitored as safety measures, with levels measured prior to randomization, on the day of admission, and on postoperative days 1, 3, 7, and 30.
Both groups were similar in age (mean of 66 years), total serum cholesterol levels, risk factors for cardiac events, and medication use. About 75% of the enrollees were men. At baseline, 51% of the participants had a total cholesterol <213 mg/dL, and 39% had an LDL-C <116 mg/dL. Within 30 days after surgery, 27 (10.8%) of those in the fluvastatin group and 47 (19%) of patients in the placebo group had evidence of myocardial ischemia (hazard ratio=0.55; 95% confidence interval [CI], 0.34-0.88; P=.01). the NNT to prevent 1 patient from experiencing myocardial ischemia was 12.