Statins for prevention of cardiovascular events in a low-risk population with low ankle brachial index

BACKGROUND: Evidence is lacking about the effectiveness of risk reduction interventions in patients with asymptomatic peripheral arterial disease. OBJECTIVES: This study aimed to assess whether statin therapy was associated with a reduction in major adverse cardiovascular events (MACE) and mortality in this population. METHODS: Data were obtained from 2006 through 2013 from the Catalan primary care system's clinical records database (SIDIAP). Patients age 35 to 85 years with an ankle-brachial index ≤0.95 and without clinically recognized cardiovascular disease (CVD) were included. Participants were categorized as statins nonusers or new-users (first prescription or represcribed after at least 6 months) and matched 1:1 by inclusion date and propensity score for statin treatment. Conditional Cox proportional hazards modeling was used to compare the groups for the incidence of MACE (myocardial infarction, cardiac revascularization, and ischemic stroke) and all-cause mortality. RESULTS: The matched-pair cohort included 5,480 patients (mean age 67 years; 44% women) treated/nontreated with statins. The 10-year coronary heart disease risk was low (median: 6.9%). Median follow-up was 3.6 years. Incidence of MACE was 19.7 and 24.7 events per 1,000 person-years in statin new-users and nonusers, respectively. Total mortality rates also differed: 24.8 versus 30.3 per 1,000 person-years, respectively. Hazards ratios were 0.80 for MACE and 0.81 for overall mortality. The 1-year number needed to treat was 200 for MACE and 239 for all-cause mortality. CONCLUSIONS: Statin therapy was associated with a reduction in MACE and all-cause mortality among participants without clinical CVD but with asymptomatic peripheral arterial disease, regardless of its low CVD risk. The absolute reduction was comparable to that achieved in secondary prevention. This project was supported by clinical research grants from the Ministerio de Salud (EC10-84, EC10-83); Spain’s Ministry of Science and Innovation through the Carlos III Health Institute, cofinanced with European Union ERDF funds (Network for Prevention and Health Promotion in primary Care RedIAPP RD12/0005, Programa HERACLES RD12/0042, and Miguel Servet Contract CP12/03287); and by the Departament de Salut, Generalitat de Catalunya, Agency for Health Technology Assessment (AATRM 034/33/02), and Agency for Management of University and Research Grants (2005SGR00577). Drs. Ramos and Garcia-Gil collaborate (without receiving any personal fee) in 2 projects of primary care for the institute IDIAP Jordi Gol funded by AstraZeneca and AMGEN that are unrelated to the present work. Dr. Marrugat has received lecture fees from Ferrer-in-Code; holds a patent with Gendiag SL; and has received payment for development of educational presentations from AstraZeneca.