Antiplatelet Therapy for Ischemic Heart Disease
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《新英格兰医药杂志》
To the Editor: In their editorial on antiplatelet therapy for ischemic heart disease, Lange and Hillis (Jan. 15 issue)1 assert that in all patients who undergo percutaneous coronary intervention, clopidogrel should be added to aspirin for 9 to 12 months after the procedure, citing the CREDO (Clopidogrel for the Reduction of Events during Observation)2 and PCI-CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events)3 trials. However, in these trials the benefits of dual antiplatelet therapy after one month were marginal. In the CREDO trial, treatment of 1053 patients with clopidogrel from day 29 until one year after percutaneous coronary intervention prevented about two deaths and 11 myocardial infarctions and caused 11 major bleeding events. In PCI-CURE, treatment with clopidogrel from day 30 until eight months after percutaneous coronary intervention reduced the rate of myocardial infarction or death from cardiovascular causes by 0.8 percentage point (although the rate of death from cardiovascular causes was not reduced). Clopidogrel costs $4 per day. If only medication costs are considered, prolonged clopidogrel therapy after percutaneous coronary intervention in the CREDO trial cost about $700,000 per life saved and $100,000 per event prevented; in the PCI-CURE trial, the cost was about $120,000 per myocardial infarction prevented. Formal cost-effectiveness analysis would yield somewhat different numbers, but the bottom line would be similar. At a time when many patients pay for all or part of their medications, we must ask whether this is the best use of their health care dollars.
Anthony E. Steimle, M.D.
Kaiser Permanente Northern California
Santa Clara, CA 95051
References
Lange RA, Hillis LD. Antiplatelet therapy for ischemic heart disease. N Engl J Med 2004;350:277-280.
Steinhubl SR, Berger PB, Mann JT III, et al. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 2002;288:2411-2420.
Mehta SR, Yusuf S, Peters RJG, et al. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001;358:527-533.
The editorialists reply: In the CREDO study, clopidogrel therapy for one year after percutaneous coronary intervention reduced the risk of ischemic events as compared with placebo. Although the relative benefit of clopidogrel was greatest during the first 28 days after percutaneous coronary intervention (a 19 percent reduction in the combined end point of death or myocardial infarction), the continuation of clopidogrel for one year led to a further reduction in such events. Specifically, clopidogrel therapy, in comparison with placebo, was associated with 12 fewer deaths or myocardial infarctions during the first 28 days after percutaneous coronary intervention and an additional reduction of 15 deaths or myocardial infarctions when it was continued for 1 year. The subjects who received clopidogrel for one year were not more likely than those who received placebo to have major bleeding.
As Dr. Steimle notes, the results of a formal analysis that assesses the cost of clopidogrel therapy in relation to an accepted measure of outcome (e.g., so-called disability-adjusted life-years) will allow a health maintenance organization to decide whether such treatment is truly cost effective. If a health maintenance organization decides that such treatment is not cost effective, it has a responsibility to inform its members that it has decided not to offer a treatment with proven efficacy. Individual members can then decide whether they want to purchase such treatment out of pocket.
Richard A. Lange, M.D.
L. David Hillis, M.D.
University of Texas Southwestern Medical Center
Dallas, TX 75390-9030
Anthony E. Steimle, M.D.
Kaiser Permanente Northern California
Santa Clara, CA 95051
References
Lange RA, Hillis LD. Antiplatelet therapy for ischemic heart disease. N Engl J Med 2004;350:277-280.
Steinhubl SR, Berger PB, Mann JT III, et al. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 2002;288:2411-2420.
Mehta SR, Yusuf S, Peters RJG, et al. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001;358:527-533.
The editorialists reply: In the CREDO study, clopidogrel therapy for one year after percutaneous coronary intervention reduced the risk of ischemic events as compared with placebo. Although the relative benefit of clopidogrel was greatest during the first 28 days after percutaneous coronary intervention (a 19 percent reduction in the combined end point of death or myocardial infarction), the continuation of clopidogrel for one year led to a further reduction in such events. Specifically, clopidogrel therapy, in comparison with placebo, was associated with 12 fewer deaths or myocardial infarctions during the first 28 days after percutaneous coronary intervention and an additional reduction of 15 deaths or myocardial infarctions when it was continued for 1 year. The subjects who received clopidogrel for one year were not more likely than those who received placebo to have major bleeding.
As Dr. Steimle notes, the results of a formal analysis that assesses the cost of clopidogrel therapy in relation to an accepted measure of outcome (e.g., so-called disability-adjusted life-years) will allow a health maintenance organization to decide whether such treatment is truly cost effective. If a health maintenance organization decides that such treatment is not cost effective, it has a responsibility to inform its members that it has decided not to offer a treatment with proven efficacy. Individual members can then decide whether they want to purchase such treatment out of pocket.
Richard A. Lange, M.D.
L. David Hillis, M.D.
University of Texas Southwestern Medical Center
Dallas, TX 75390-9030