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OBJECTIVES: Statin usage has been shown to stabilize atherosclerotic plaque, decrease mortality after surgical procedures, and is linked to anti-inflammatory effects. The objective of this study was to evaluate preoperative administration of statins and longitudinal amputation-free survival after lower extremity (LE) revascularization.
METHODS: Patients were selected from the Medicare MedPAR, Carrier, and Part D files (2007-2008) using ICD-9-CM diagnosis codes (claudication, rest pain, and ulceration/gangrene) and CPT codes for LE endovascular revascularization (ENDO) and LE open surgery (OPEN). Amputations over time were identified using CPT codes and preoperative statin use was identified by querying the National Drug Code Directory and Part D files. Chi-square test, multivariable logistic regression, Kaplan-Meier and Cox regression methods were utilized.
RESULTS: 22,954 patients undergoing LE vascular procedures (14,353 ENDO and 8,601 OPEN) were identified. Indications included: Claudication (8,128); Rest pain (3,056); and Ulceration/gangrene (11,770). 11,687 (50.9%) were identified as statin users before revascularization. Overall, statin users compared to non-users had lower amputation rates at 30 days (11.5% vs. 14.4%; P<0.0001), 90 days (15.5% vs. 19.3%; P<0.0001) and 1 year (20.9% vs. 25.6%; P<0.0001). This association was noted after both ENDO and OPEN. Multivariate logistic regression adjusted by age, gender, race, comorbidities, and procedure demonstrated non-statin users were more likely to undergo amputation at 30 days (OR=1.26; 95%CI 1.16-1.36), 90 days (OR=1.28; 95%CI 1.19-1.38), and 1 year (OR=1.30; 95%CI 1.22-1.39). Survival analysis demonstrated improved amputation-free survival during 1 year for statin-users compared to non-users for the diagnosis of claudication (P=0.0025), a similar trend for rest pain (P=0.059), and no improvement for ulceration/gangrene (P=0.61). Statin users with a diagnosis of claudication underwent secondary bypass at 30 days (0.90%) and 90 days (1.91%) at a significantly lower rate compared to non-statin users (1.48%; P=0.04 and 3.00%; P=0.008, respectively). This association was not found with other procedure indications.
CONCLUSIONS: Overall, preoperative statins were significantly associated with improved 1-year amputation-free survival after lower extremity revascularization. Statin usage among patients with the diagnosis of claudication was more effective compared to patients with rest pain and ulceration/gangrene. Further focused evaluation of preoperative statins and the severity of peripheral vascular disease is warranted to assess the possible benefits of this pharmacotherapy on amputation-free survival.