Introduction: The most recent peripheral artery disease (PAD) treatment guidelines by ACC/AHA recommend the initiation of high intensity statins rather than moderate or low intensity statins. However, there is a lack of literature to support this recommendation regarding PAD outcomes, such as major adverse limb events (MALE). The purpose of this study is to investigate the occurrence of MALE after initiating high intensity versus moderate or low intensity statins in patients with peripheral artery disease undergoing lower extremity revascularization.
Methods: We conducted a multicenter, retrospective cohort study utilizing an electronic health record from June 2014 to August 2022 to evaluate the occurrence of MALEs after statin initiation. Patients were included if they were 18 years or older, underwent lower extremity revascularization, not on a statin prior to admission, and were prescribed a statin at discharge. Patients were excluded if they were not reassessed for 24 months after index event, previously experienced lower extremity revascularization or ischemia, had acute liver failure or decompensated cirrhosis, active or history of necrotizing fasciitis or traumatic limb events, or presented with a hemorrhagic stroke or traumatic brain injury.
Results: A total of 395 patients were evaluated, resulting in 93 patients included, with 31 in the high intensity statin group (HI group) and 62 in the moderate or low intensity statin group (MLI group). Baseline characteristics were largely similar between the groups. The primary outcome of 24-month MALEs occurred in 41.9% of the HI group and 46.8% in the MLI group (p = 0.66). However, there were 0 amputations in the HI group and 5 amputations in the MLI group (p = 0.17). The occurrence of major adverse cardiac events occurred in 12.9% of the HI group and 11.3% of the MLI group (p = 0.87). The occurrence of statin associated muscle symptoms occurred in 20.4% of the HI group and 22.6% of the MLI group (p = 0.59).
Conclusions: High intensity statins were not shown to have a statistically significant benefit in preventing MALE compared to moderate or low intensity statins in patients with PAD undergoing lower extremity revascularization. However, high intensity statins may be of benefit in sparing patients from follow-up amputations.
