Abstract 2886: Fluvastatin Xl Use Is Associated With Improved Cardiac Outcome After Major Vascular Surgery. Results From A Randomized Placebo Controlled Trial: Decrease III
Background: Perioperative cardiac events are the major cause of adverse outcome in vascular surgery patients. The pathofysiology of a perioperative myocardial infarction (MI) is complex. Coronary plaque instability leading to plaque rupture and thrombosis plays a major role.
Aim: To assess the cardioprotective effect of fluvastatin XL on top of beta-blocker therapy in vascular surgery patients.
Methods: Statin naïve patients were randomized to fluvastatin XL 80 mg daily or placebo prior to vascular surgery. All patients were on beta-blockers. A non-invasive stress test was performed to assess the presence and extent of ischemia. Patients with unstable cardiac symptoms or left main disease were excluded. The primary endpoint was the occurrence of myocardial ischemia assessed by continuous 12-lead ECG registration and troponin T release measured on day 1, 3, 7, and 30. The secondary endpoint was the composite of cardiac death and MI.
Results: A total of 500 patients were enrolled, 253 allocated to fluvastatin XL and 247 to placebo. The study medication was started at a median time of 34 days prior to surgery. The distribution of cardiac risk factors and stress induced ischemia was similar between allocated groups. The incidence of the primary endpoint in fluvastatin XL and placebo allocated groups was 10.9% vs 18.9% respectively; OR 0.56; 95% CI 0.35– 0.89. The incidence of the secondary endpoint was 4.8% vs 10.0% respectively; OR 0.48; 95% CI 0.24 – 0.95. No patients experienced myopathy or rhabdomyolysis.
Conclusions: Fluvastatin XL on top of beta-blocker therapy was associated with improved postoperative cardiac outcome in high-risk patients undergoing elective vascular surgery.