The prevention of progression of arterial disease and diabetes (POPADAD) trial: factorial randomised placebo controlled trial of aspirin and antioxidants in patients with diabetes and asymptomatic peripheral arterial disease

Abstract

Objective

Efficacy and Safety of Aspirin in Patients With Peripheral Vascular Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…Nine trials reported the outcome of all-cause mortality [10,[21][22][23][24][27][28][29][30]. At a weighted mean follow up duration of 6.1 (SD = 2.9) years, the incidence of all-cause mortality was similar in both the aspirin and control groups, 7.7% (95% CI 4.3-11.1%) versus 8.5% (95% CI 4.6-12.5%) (RR = 0.93, 95% CI 0.8-1.1, P = 0.33, I 2 = 0%) (Fig 2).…”

“…Three trials had multiple comparison arms and thus only the aspirin and placebo arms were included [23,25,26]. Three trials were multicenter and reported outcomes exclusively in patients without prior history of an ischemic event (including prior stroke or MI) [10,21,22], and 4 trials included low-dose aspirin ( 325mg per day) [10,21,22,24]. All of the trials included chronic stable PVD patients except one trial [25] that assessed the use of aspirin in setting of acute lower limb ischemia.…”

“…At the individual study level, two trials were considered to have low risk of bias assessed with use of the Cochrane risk of bias tool [10,21]. One trial was considered to have high risk of bias [22], and the remaining trials had unclear risk due to lack of reporting of detailed methods (S4 Table).…”

“…Two of the included trials employed factorial design and thus each trial was divided into two sub-studies for analysis purposes. The Critical Leg Ischaemia Prevention Study (CLIPS) trial randomized patients to aspirin versus placebo and aspirin plus vitamin E versus vitamin E only, while the Prevention Of Progression of Arterial Disease And Diabetes (POPADAD) trial randomized patients to aspirin versus placebo and aspirin plus antioxidant versus antioxidant only [21,22]. Three trials had multiple comparison arms and thus only the aspirin and placebo arms were included [23,25,26].…”

“…A final number of 11 trials reporting outcomes in patients with PDV were included in the analysis [10,[21][22][23][24][25][26][27][28][29][30] (Fig 1).…”