Association between statin medications and mortality, major adverse cardiovascular event, and amputation-free survival in patients with critical limb ischemia

Abstract

Objectives: The aim of this study was to determine the associations between statin use and major adverse cardiovascular and cerebrovascular events (MACCE) and amputation-free survival in critical limb ischemia (CLI) patients.

Background: CLI is an advanced form of peripheral arterial disease associated with nonhealing arterial ulcers and high rates of MACCE and major amputation. Although statin medications are recommended for secondary prevention in peripheral arterial disease, their effectiveness in CLI is uncertain.

Methods: We reviewed 380 CLI patients who underwent diagnostic angiography or therapeutic endovascular intervention from 2006 through 2012. Propensity scores and inverse probability of treatment weighting were used to adjust for baseline differences between patients taking and not taking statins.

Results: Statins were prescribed for 246 (65%) patients. The mean serum low-density lipoprotein (LDL) level was lower in patients prescribed statins (75 ± 28 mg/dl vs. 96 ± 40 mg/dl, p < 0.001). Patients prescribed statins had more baseline comorbidities including diabetes, coronary artery disease, and hypertension, as well as more extensive lower extremity disease (all p values <0.05). After propensity weighting, statin therapy was associated with lower 1-year rates of MACCE (stroke, myocardial infarction, or death; hazard ratio [HR]: 0.53; 95% confidence interval [CI]: 0.28 to 0.99), mortality (HR: 0.49, 95% CI: 0.24 to 0.97), and major amputation or death (HR: 0.53, 95% CI: 0.35 to 0.98). Statin use was also associated with improved lesion patency among patients undergoing infrapopliteal angioplasty. Patients with LDL levels >130 mg/dl had increased HRs of MACCE and mortality compared with patients with lower levels of LDL.

Conclusions: Statins are associated with lower rates of mortality and MACCE and increased amputation-free survival in CLI patients.

Keywords: lipids and lipoproteins; major adverse cardiac event(s); peripheral artery disease; secondary prevention; statin therapy.