In patients with previous MI, therapy with high-dose atorvastatin significantly decreased the incidence of peripheral arterial disease compared with moderate-dose simvastatin, according to data from the IDEAL study.
Further, patients with a history of PAD at baseline had greater risk for future CV events, but this risk was lowered with high-dose atorvastatin.
“These findings provide support for the recommendation in the recently updated American College of Cardiology/American Heart Association guideline that high-risk patients, including patients with PAD, should be initially treated with high-intensity statin therapy,” researchers wrote.
The prospective, randomized, open-label, blinded–outcome-assessment trial compared atorvastatin 80 mg/day (n=4,439) with simvastatin 20 mg/day to 40 mg/day (n=4,449; Zocor, Merck) in patients aged 80 years and older with previous MI. Follow-up occurred at 12 and 24 weeks and then every 6 months. At 24 weeks, simvastatin dose could be increased to 40 mg/day if plasma total cholesterol was greater than 190 mg/dL. Atorvastatin dose could be decreased to 40 mg/day if adverse events were observed.
The prespecified outcome was incident PAD. Among patients without PAD at baseline, this outcome was defined as a new clinical diagnosis necessitating diagnostic procedures or interventions. In patients with a history at baseline, this outcome was defined as recurrence of PAD requiring hospitalization. An exploratory post-hoc analysis examined the effect of baseline PAD on clinical outcomes and the benefits of high-dose vs. usual-dose statin treatment. The primary outcome for this analysis was the rate of major coronary events (coronary death, hospitalization for nonfatal MI or cardiac arrest with resuscitation).
During a median follow-up of 4.8 years, incident PAD was reported in 2.2% of the high-dose atorvastatin group vs. 3.2% of the moderate-dose simvastatin group (HR = 0.7; 95% CI, 0.53-0.91).
Patients with PAD at baseline had an almost twofold greater risk for major coronary events; however, this trend did not persist after researchers adjusted for adverse CV risk profile.
Among patients with PAD, major coronary events were less common in the high-dose atorvastatin group (14.4% vs. 20.1%; HR = 0.68; 95% CI, 0.41-1.11).
Treatment with high-dose atorvastatin yielded significant decreases in overall CV (P = .046) and coronary events (P = .007) as well as need for coronary revascularization (P = .007).
According to the researchers, this is the first study to show the benefit of high-dose vs. moderate-dose statin therapy for the prevention of incident PAD in post-MI patients.
Disclosure: The IDEAL study was sponsored by Pfizer. Several researchers report financial relationships with Aegerion, Amgen, AstraZeneca, Genzyme, MSD, Orion Company, Pfizer and Roche.