Association between statin therapy and amputation-free survival in patients with critical limb ischemia in the CRITISCH registry

Stavroulakis K., Borowski M., Torsello G., Bisdas T., Adili F., Balzer K., Billing A., Böckler D., Brixner D., Debus S., Eckstein H., Florek H., Gkremoutis A., Grundmann R., Hupp T., Keck T., Gerß J., Klonek W., Lang W., May B., Meyer A., Mühling B., Oberhuber A., Reinecke H., Reinhold C., Ritter R., Schelzig H., Schlensack C., Schmitz-Rixen T., Schulte K., Spohn M., Steinbauer M., Storck M., Trede M., Uhl C., Weis-Müller B., Wenk H., Zeller T., Zhorzel S., Zimmermann A.

Abstract

Objective Secondary prevention in patients with critical limb ischemia (CLI) is crucial for the reduction of cardiovascular morbidity and mortality. Nonetheless, current recommendations are extrapolated from other high-risk populations because of the lack of CLI-dedicated trials. The aim of this explorative study was to evaluate the association of statin therapy with the outcomes of CLI patients. Methods The First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry is a prospective multicenter registry analyzing the effectiveness of all available treatment strategies in 1200 CLI patients. For the purposes of this analysis, patients were divided into two groups based on statin administration. Treatment crossovers and nonadherent patients were excluded from analysis. The primary composite end point of this study was the amputation-free survival (AFS). Major adverse cardiovascular and cerebral events (MACCEs), time to death, and time to major amputation were also analyzed. Results Statin therapy was applied in 445 individuals (37%), 371 (31%) patients received no statins, and 384 subjects were excluded from analysis (treatment crossovers). Patients receiving statins were more likely to be younger (P