October 6, 2014

Statins in Critical Limb Ischemia – Study Review

Association Between Statin Medications and Mortality, Major Adverse Cardiovascular Event, and Amputation-Free Survival in Patients with Critical Limb Ischemia.
Westin G, Armstrong E, Bang H, et al
JACC February 25h 2014

What was the study question?

This study sought to determine whether the use of statin medications was associated with a reduction in the rates of major adverse cardiovascular and cerebrovascular events (MACCE) and major amputations in patients with critical limb ischemia (CLI).
Why was the study needed?
The evidence on the utility of statins in patients with peripheral arterial disease (PAD) has been well documented in patients with claudication and/or abnormal ankle-brachial indexes (ABIs). There is, however, very limited data with regards to the efficacy of statins particularly in the subgroup of patients with CLI.

What were the main results?

After adjusting for baseline differences using propensity weighting, statin therapy was associated with better outcomes, primarily driven by a lower rate of mortality at follow-up. Interestingly, statin use was also associated with improved lesion patency among patients undergoing infrapopliteal angioplasty.

What where the study strengths and limitations?

This study is the first to report major outcomes of statin use in patients with CLI, effectively reinforcing the existing guidelines in the treatment of patients with PAD. While the study showed a clear difference in mortality, it was not powered to detect a difference in individual outcomes such as amputation, myocardial infarction or stroke. Lastly, despite the authors’ best attempt to control for measured confounding variables using propensity score weighting, the retrospective and nonrandomized nature of the study makes it difficult to eliminate other biases.


In patients with critical limb ischemia, the use of statins is likely beneficial and may perhaps be associated with better outcomes after infrapopliteal angioplasty. In the absence of major contraindications, all patients with CLI should be treated with statins.

  1. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology,Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease). Circulation 2006;113:e463–654
  2. Grundy SM, Cleeman JI, Merz CNB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation 2004;110:227–39.

A. Garvey Rene, MD, Jay Giri, MD
Topic (s):
Critical limb ischemia, statin, peripheral arterial disease