Abstract 4529: Platelet Inhibition And Physical Training In Peripheral Arterial Disease: Does The Choice Of Drug Matter? A Double-blind, Randomized Trial
Background: In addition to antiplatelet therapy, walking exercise is the first line therapy for intermittent claudication. Acetyl-Salicylic Acid (ASA) in contrast to Clopidogrel has been shown to reduce formation of collaterals in a rodent model after ligation of the hind limb artery. A double-blind, randomized parallel-group trial was conducted to evaluate the inhibition of collateral formation in humans with intermittent claudication by assessing pre- and post-rehabilitation walking distances.
Hypothesis: Clopidogrel compared to ASA will lead to a greater improvement in walking distance after a 3-months controlled training program.
Methods: Patients with intermittent claudication were recruited from 21 centres in Switzerland and Germany and randomized to either ASA or Clopidogrel treatment. They participated in a 3-months rehabilitation program (electronically monitored, home-based, one hour daily walking sessions at a speed of approx.120 steps/min). Walking distance was assessed by treadmill test (3.2 km/h; 12% grade) at baseline, 6 and 12 weeks.
Results: In total 229/259 patients with a mean age of 66.2 ± 7.7 years completed the study according to the protocol, 75.5% were males, 20.1% diabetics and 85.6% were active/ex-smokers. The baseline characteristics were median [interquartile range] Ankle-Brachial-Pressure-Index of 0.69 [0.57– 0.8], initial claudication distance (ICD) of 98m [70 –151m] and absolute claudication distance (ACD) of 162m [113–302m]. Training resulted in an increase of ICD by 33.3% [0 –70.2%] in the Clopidogrel group and 33.9% [1.3–90.7%] in the ASA group, the values for ACD were 34.9% [7.7– 81.1%] and 35.3% [3.9 –71.7%], respectively (pICD=0.42 and pACD=0.66).
Conclusions: Patients with intermittent claudication showed equal improvements in walking distances after a 3-months rehabilitation program in both, Clopidogrel and ASA, treatment groups.