Statin users had fewer MIs. A total of 6 patients receiving fluvastatin died, with 4 deaths attributed to cardiovascular causes. In the placebo group, 12 patients died, 8 of which were ascribed to cardiovascular causes. Eight patients in the fluvastatin group experienced nonfatal MIs, compared with 17 patients in the placebo group (NNT=19 to prevent 1 nonfatal MI or cardiac death (hazard ratio= 0.47; 95% CI, 0.24-0.94; P=.03).
Effects of statins were evident preoperatively. At the time of surgery, patients in the fluvastatin group had, on average, a 20% reduction in their total cholesterol and a 24% reduction in LDL-C; in the placebo group, total cholesterol had fallen by 4% and LDL-C, by 3%.
Patients receiving fluvastatin had an average 21% decrease in C-reactive protein, compared with a 3% increase for the placebo group. Interleukin-6 levels also were reduced far more in the fluvastatin group (33% vs a 4% reduction in the placebo group [P<.001]).
The medication was well tolerated. Overall, 6.8% of participants discontinued the study because of side effects, including 16 (6.4%) patients in the fluvastatin group and 18 (7.3%) in the placebo group. (After surgery, 115 [23.1%] of patients in the statin group temporarily discontinued the drug because of an inability to take oral medications for a median of 2 days.)
Rates of increase in creatine kinase of >10× the upper limit of normal (ULN) were similar between the fluvastatin and placebo groups (4% vs 3.2%, respectively). Increases in ALT to >3× ULN were more frequent in the placebo group compared with the fluvastatin group (5.3%, placebo; 3.2%, fluvastatin). No cases of myopathy or rhabdomyolysis were observed in either group.
WHAT’S NEW: Preop statins can be a lifesaver
The initiation of fluvastatin prior to vascular surgery reduced the incidence of cardiovascular events by 50%—a remarkable result. While patients at the highest risk were excluded from the study, those with lower cardiac risk nonetheless benefi ted from statin therapy. Experts have not typically recommended statins in the perioperative period for this patient population. the results of this study make it clear that they should.
CAVEATS: Extended-release formulation may have affected outcome
The statin used in this study was a longacting formulation, which may have protected patients who were unable to take oral medicines postoperatively. While we don’t know if the extended-release formulation made a difference in this study, we do know that atorvastatin was effective in the Brazilian study discussed earlier.
CHALLENGES TO IMPLEMENTATION: Preop statins may be overlooked
Not all patients see a primary care physician prior to undergoing vascular surgery. This means that it will sometimes be left to surgeons or other specialists to initiate statin therapy prior to surgery, and they may or may not do so.
Optimal timing is unknown. It is not clear how little time a patient scheduled for vascular surgery could spend on a statin and still reap these benefits. Nor do we know if the benefits would extend to patients undergoing other types of surgery; in a large study of patients undergoing all kinds of major noncardiac surgery, no benefits of perioperative statins were found.7
Adherence to the medication regimen presents another challenge, at least for some patients. In this case, however, we think the prospect of preventing major cardiac events postoperatively simply by taking statins for a month should be compelling enough to convince patients to take their medicine.
Acknowledgement
The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center for Research Resources; the grant is a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the ofcial views of either the National Center for Research Resources or the National Institutes of Health.