Rafel Ramos1, Maria García-Gil2, Marc Comas-Cufí3, Miquel Quesada4, Jaume Marrugat5, Roberto Elosua6, Joan Sala7, María Grau8, Ruth Martí9, Anna Ponjoan9, Lia Alves-Cabratosa3, Jordi Blanch3, Bonaventura Bolíbar10. 1. Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Catalunya, Spain; ISV Research Group, Research Unit in Primary Care, Primary Care Services, Girona, Catalan Institute of Health (ICS), Catalunya, Spain; Biomedical Research Institute, Girona (IdIBGi), ICS, Catalunya, Spain; TransLab Research Group, Department of Medical Sciences, School of Medicine, University of Girona, Girona, Spain. Electronic address: ramos.girona.ics@gencat.cat. 2. Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Catalunya, Spain; ISV Research Group, Research Unit in Primary Care, Primary Care Services, Girona, Catalan Institute of Health (ICS), Catalunya, Spain; TransLab Research Group, Department of Medical Sciences, School of Medicine, University of Girona, Girona, Spain. 3. Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Catalunya, Spain; ISV Research Group, Research Unit in Primary Care, Primary Care Services, Girona, Catalan Institute of Health (ICS), Catalunya, Spain. 4. Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Catalunya, Spain; ISV Research Group, Research Unit in Primary Care, Primary Care Services, Girona, Catalan Institute of Health (ICS), Catalunya, Spain; Biomedical Research Institute, Girona (IdIBGi), ICS, Catalunya, Spain; TransLab Research Group, Department of Medical Sciences, School of Medicine, University of Girona, Girona, Spain. 5. Cardiovascular Epidemiology and Genetics Research Group, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain; Coronary Unit and Cardiology, Hospital Josep Trueta, Girona, Spain. 6. TransLab Research Group, Department of Medical Sciences, School of Medicine, University of Girona, Girona, Spain; Cardiovascular Epidemiology and Genetics Research Group, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. 7. Biomedical Research Institute, Girona (IdIBGi), ICS, Catalunya, Spain; Coronary Unit and Cardiology, Hospital Josep Trueta, Girona, Spain. 8. Cardiovascular Epidemiology and Genetics Research Group, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. 9. Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Catalunya, Spain; ISV Research Group, Research Unit in Primary Care, Primary Care Services, Girona, Catalan Institute of Health (ICS), Catalunya, Spain; Biomedical Research Institute, Girona (IdIBGi), ICS, Catalunya, Spain. 10. Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Catalunya, Spain; Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain.
Abstract
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.
RCT Entities:
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.
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