Can long-term antibiotic treatment prevent progression of peripheral arterial occlusive disease? A large, randomized, double-blinded, placebo-controlled trial.

Purpose: The purpose was to investigate in a large, randomized, double-blinded, placebo-controlled trial, whether antibiotic treatment can prevent progression of peripheral arterial disease (PAD).

Material And Methods: Five hundred and seven patients were included; all patients had an established diagnosis of PAD. Their mean age was 66 years (36-85), and 59% were males. Patients were randomized to Roxithromycin 300 mg daily for 28 days. Baseline investigations were ankle blood pressure, ankle-brachial blood pressure index (ABPI), walking distance, C. pneumoniae serology, cholesterol and medical history. Follow-up was performed every 6 months. Primary events were defined as death, peripheral revascularization and major lower limb amputation. Secondary events were thrombosis, stroke, transient cerebral ischaemic attack and myocardial infarction. Change in ABPI was also investigated. Data were analyzed mainly by Cox regression and linear regression.

Results: Included patients with PAD were randomized. Two patients withdrew. Of the remaining, 248 received roxithromycin and 257 placebo. In the treatment group 55% were seropositive and 53% in the placebo group. Mean follow-up was 2.1 years (range 0.06-5.1 years). In the placebo group, 26 died and 80 primary events occurred in total. In the treatment group, 28 died and 74 primary events were observed. The hazard ratio of death was 1.13 (95% CI: 0.68; 1.90), and of primary events 0.92 (95% CI: 0.67; 1.26). Also on secondary events and ABPI changes, no significant differences were found.

Conclusion: Long-term treatment with roxithromycin is ineffective in preventing death, amputation, peripheral revascularization, myocardial infarction, stroke, transient cerebral ischaemic attack, thrombosis and decline in ABPI in patients with an established diagnosis of PAD.