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Antithrombotic drugs in the primary medical management of intermittent claudication: a meta-analysis
B Girolami1, E Bernardi, M H Prins
1Institute of Medical Semeiotics, University Hospital of Padua, Italy. girolami@uxl.unipd.it
Insights
Clopidogrel and ticlopidine effectively reduce major vascular events in intermittent claudication patients. Aspirin
Area of Science:
- Vascular Medicine
- Pharmacology
Background:
- Efficacy of antithrombotic drugs for intermittent claudication lacks consensus.
- Primary medical treatment needs evidence-based antithrombotic options.
Purpose of the Study:
- To evaluate the efficacy of antithrombotic drugs in patients with intermittent claudication.
- To identify drugs that reduce clinical events and improve walking distance.
Main Methods:
- Systematic review and meta-analysis of randomized controlled trials (RCTs) and comparative studies.
- Studies were graded by level of evidence (1-3).
- Outcomes included mortality, vascular events, amputations, walking distance, and arterial flow.
Main Results:
- Ticlopidine significantly decreased mortality versus placebo.
- Clopidogrel reduced vascular events compared to aspirin in Level 1 studies.
- Aspirin and ticlopidine decreased arterial occlusions and revascularization procedures, respectively.
- Several agents showed small improvements in pain-free walking distance.
Conclusions:
- Clopidogrel and ticlopidine are effective in reducing clinical events for intermittent claudication.
- These drugs may be valuable additions to primary medical therapy.
- Aspirin's use is extrapolated from other atherosclerotic conditions; direct evidence is lacking.
- Further evaluation of other antithrombotics in this patient group is needed.
Background:
There is no consensus on the efficacy of the antithrombotic drugs available for patients with intermittent claudication.
Methods:
A Medline and manual search was used to identify relevant publications. Uncontrolled or retrospective studies, double reports or trials without clinical outcomes were excluded. Included studies were graded as level 1 (randomised and double- or assessor-blind), level 2 (open randomised), or level 3 (non-randomised comparative). Mortality, cerebro- or cardiovascular events, amputations, arterial occlusions or number of revascularization procedures performed in the lower limbs, pain-free and total walking distance, ankle brachial index and calf blood flow, were the main outcomes considered. When feasible, end of treatment results, either continuous or binary, were combined with appropriate statistical methods.
Results:
Mortality was significantly decreased by ticlopidine compared to placebo (common odds ratio 0.68, 95% C.I., 0.49 - 0.95); clopidogrel decreased vascular events in comparison to aspirin (odds ratio 0.76, 95% C.I., 0.63 - 0.92) in level 1 studies. Arterial occlusions and the number of revascularization procedures performed were statistically significantly decreased by aspirin and ticlopidine, respectively. A small but statistically significant improvement in pain-free walking distance was determined by picotamide, indobufen, low molecular weight heparins, sulodexide and defibrotide, in small studies.
Conclusions:
Clopidogrel and ticlopidine do reduce clinically important events in patients with intermittent claudication and could be added to the primary medical treatment of these patients. The use of aspirin in these patients cannot be based on direct evidence, but only on analogy with coronary and cerebral atherosclerosis, where it has documented efficacy. Other antithrombotic drugs were not properly evaluated in patients with intermittent claudication.