Statins in Patients With Low Ankle Brachial Index
What is the effectiveness of statin therapy in patients with asymptomatic peripheral arterial disease (PAD)?
Data were obtained from 2006-2013 from the Catalan primary care system’s clinical records database (SIDIAP). Patients aged 35-85 years with an ankle brachial index ≤0.95 and without clinically recognized cardiovascular disease (CVD) were included. Participants were categorized as statin non-users or new-users (first prescription or re-prescribed 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 major adverse cardiac events (MACE: myocardial infarction, cardiac revascularization, and ischemic stroke) and all-cause mortality.
The matched-pair cohort included 5,480 patients (mean age, 67 years; 44% women) treated/non-treated with statins. Ten-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 non-users, respectively. Total mortality rates also differed: 24.8 vs. 30.3 per 1,000 person-years, respectively. Hazard ratios were 0.80 for MACE and 0.81 for overall mortality. One-year number needed to treat was 200 for MACE and 239 for all-cause mortality.
The authors concluded that statin therapy was associated with a reduction in MACE and all-cause mortality among participants without clinical CVD but with asymptomatic PAD, regardless of its low CVD risk.
This study reports that statin therapy was safe and significantly associated with a reduction in both MACE and total mortality in study participants without clinical CVD, but with asymptomatic PAD. The absolute reduction was comparable to that achieved in secondary prevention. These results would appear to support the use of statins in asymptomatic patients with a low ABI, regardless of CVD risk assessment. Prospective randomized clinical trials with hard clinical safety and efficacy endpoints are indicated to confirm these findings.
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