A Cochrane review [Abstract] 1 included 22 studies with a total of 3 529 subjects in order to evaluate the efficacy and safety of antiplatelet, anticoagulant or other vasoactive agents administered in patients with peripheral arterial disease (PAD) treated by catheter intervention in the pelvic or femoropopliteal arteries. For the majority of comparisons, only one study was available so results were rarely combined in meta-analyses.
Three studies reported on drug versus placebo/control; results were consistently available for a maximum follow-up of only 6 months. A statistically significant reduction in reocclusion was found for high-dose (330 mg) acetylsalicylic acid (ASA) combined with dipyridamole (DIP) (37/66 vs. 51/67; OR 0.40, 95% CI 0.19 to 0.84; 1 study, n=133), but not for low-dose ASA (50-100 mg) combined with DIP (69/174 vs. 85/182; OR 0.69, 95% CI 0.44 to 1.10; 2 studies, n=356) nor in major amputations for lipo-ecraprost (OR 0.89, 95% CI 0.44 to 1.80).
The remaining studies compared different drugs; results were more consistently available for a longer period of 12 months. At 12 months post intervention, no statistically significant difference in reocclusion/restenosis was detected for high-dose ASA versus low-dose ASA (56/282 vs. 59/293; OR 0.98, 95% CI 0.64 to 1.48), ASA/DIP versus vitamin K antagonists (VKA), clopidogrel and aspirin versus low molecular weight heparin (LMWH) plus warfarin, suloctidil versus VKA and ticlopidine versus VKA. Treatment with cilostazol resulted in statistically significantly fewer reocclusions than ticlopidine (OR 0.32, 95% CI 0.13 to 0.76). Compared with aspirin alone, LMWH plus aspirin significantly decreased occlusion/restenosis (by up to 85%) in patients with critical limb ischaemia (OR 0.15, 95% CI 0.06 to 0.42) but not in patients with intermittent claudication (OR 1.73, 95% CI 0.97 to 3.08) and batroxobin plus aspirin reduced restenosis in diabetic patients (OR 0.28, 95% CI 0.13 to 0.60).
Data on bleeding and other potential gastrointestinal side effects were not consistently reported, although there was some evidence that high-dose ASA increased gastrointestinal side effects compared with low-dose ASA, that clopidogrel and aspirin resulted in fewer major bleeding episodes compared with LMWH plus warfarin, and that abciximab resulted in more severe bleeding episodes.
Comment: The quality of evidence is downgraded by study limitations (unclear allocation concealment and blinding), and by imprecise results (wide confidence intervals).
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