P Lechat1, P Priollet. 1. Service de Pharmacologie, Hôpital de la Salpêtrière, 47-83, boulevard de l'Hôpital, 75651 Paris Cedex 13.
Abstract
OBJECTIVE: To determine the effect of aspirin among patients with lower limb occlusive arterial disease. DESIGN: Meta-analysis of trials issuing from a collaborative meta-analysis of randomized trials of anti-platelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. Five trials were identified as comparing aspirin (with or without dipyridamole) to placebo, in 1 029 patients with lower limb occlusive arterial disease. There was no new publication found comparing aspirin and placebo in lower limb occlusive arterial disease. MAIN OUTCOME MEASURE: As in the main meta-analysis, "serious vascular event": non fatal myocardial infarction, non fatal stroke or vascular death. RESULTS: Among these 1 029 patients, allocation to aspirin did not reduce the outcome of serious vascular event, nor of any of the individual events. This result, as opposed to the enhancement of 23% +/- 8% announced in the main meta-analysis, clearly demonstrate that the beneficial effect cannot be attributable to aspirin. DISCUSSION: In the collaborative meta-analysis, aspirin was the most widely used product (75% of the trials) and it showed its beneficial effect when administered at doses ranging from 75 to 150 mg/day, as compared to placebo. Among the other anti-platelet treatments analyzed, clopidogrel was the only product for which large scale randomized evidence versus aspirin was available. Various national health institutions, in the United States as well as in Europe, show a major concern regarding the use of anti-platelet treatments, in peripheral arterial occlusive disease as well as in other manifestations of cardiovascular disease. Their guidelines take of course the patient's health into account but the economical aspect of this prevention is increasingly hard to circumvent. Based on the results of the collaborative meta-analysis, these guidelines all recommend a lifetime use of low doses of aspirin, reserving clopidogrel for patients intolerant to aspirin, mainly because they do not consider the additional benefit recognized with clopidogrel as important enough to counterbalance the cost of the treatment. While aspirin as a first choice antiplatelet therapy cannot be discussed in coronary disease, after a myocardial infarction, or in cerebrovascular disease, its use in lower limb occlusive arterial disease does not enable a reduction in morbi-mortality. From an economical point of view, the use of a cheap but inefficient preventive treatment could also lead to an increased cost for curing the complications expected with an uncontrolled widely spread disease as chronic lower limb ischemia.
OBJECTIVE: To determine the effect of aspirin among patients with lower limb occlusive arterial disease. DESIGN: Meta-analysis of trials issuing from a collaborative meta-analysis of randomized trials of anti-platelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. Five trials were identified as comparing aspirin (with or without dipyridamole) to placebo, in 1 029 patients with lower limb occlusive arterial disease. There was no new publication found comparing aspirin and placebo in lower limb occlusive arterial disease. MAIN OUTCOME MEASURE: As in the main meta-analysis, "serious vascular event": non fatal myocardial infarction, non fatal stroke or vascular death. RESULTS: Among these 1 029 patients, allocation to aspirin did not reduce the outcome of serious vascular event, nor of any of the individual events. This result, as opposed to the enhancement of 23% +/- 8% announced in the main meta-analysis, clearly demonstrate that the beneficial effect cannot be attributable to aspirin. DISCUSSION: In the collaborative meta-analysis, aspirin was the most widely used product (75% of the trials) and it showed its beneficial effect when administered at doses ranging from 75 to 150 mg/day, as compared to placebo. Among the other anti-platelet treatments analyzed, clopidogrel was the only product for which large scale randomized evidence versus aspirin was available. Various national health institutions, in the United States as well as in Europe, show a major concern regarding the use of anti-platelet treatments, in peripheral arterial occlusive disease as well as in other manifestations of cardiovascular disease. Their guidelines take of course the patient's health into account but the economical aspect of this prevention is increasingly hard to circumvent. Based on the results of the collaborative meta-analysis, these guidelines all recommend a lifetime use of low doses of aspirin, reserving clopidogrel for patients intolerant to aspirin, mainly because they do not consider the additional benefit recognized with clopidogrel as important enough to counterbalance the cost of the treatment. While aspirin as a first choice antiplatelet therapy cannot be discussed in coronary disease, after a myocardial infarction, or in cerebrovascular disease, its use in lower limb occlusive arterial disease does not enable a reduction in morbi-mortality. From an economical point of view, the use of a cheap but inefficient preventive treatment could also lead to an increased cost for curing the complications expected with an uncontrolled widely spread disease as chronic lower limb ischemia.