McGregor M, Brophy J M
McGill University Health Centre, Montréal, Québec.
Can J Cardiol. 1999 Feb;15(2):201-7.
To estimate the magnitude of the clinical benefits that may result from use of abciximab at the time of angioplasty and the cost of achieving them.
Four published randomized control trials.
Meta-analysis of outcomes at six months.
Use of abciximab in comparable high risk populations, in the manner described in these trials, is estimated to have the following effects: It does nto influence mortality within the first six months. It reduces the rate of myocardial infarction (MI) by 3.3/100 treatments with a 95% CI of 1.6 to 5.2. It may reduce the need for revascularization (angioplasty or coronary artery bypass graft) by 2.1/100 treatments (95% CI -1.0 to 5.0). It does not cause any significant increase in major hemorrhagic events. There is no evidence that it influences restenosis rates. The net cost per MI prevented would be approximately $44,000, ranging from approximately $29,000 to $71,000 on sensitivity analysis. The net cost per adverse event prevented (MI plus revascularization procedure) would be approximately $27,000 (sensitivity analysis $16,000 to $57,000). Use of abciximab for all of the approximately 17,487 angioplasties carried out in Canada each year may prevent 395 myocardial infarcts and 186 revascularization procedures, at an overall cost of approximately $29 million and a cost effectiveness of approximately $50,000 per adverse event prevented. (This assumes the same proportional reduction in events as in these four studies, and that 35% of procedures are high risk).
Possible eventual prolongation of life due to fewer periprocedural MIs with abciximab use cannot be quantified. Thus, these estimates of cost effectiveness cannot be used to compare this intervention directly with others in terms of dollars per life year saved. The field is evolving rapidly and these conclusions may soon have to be modified. Increasing use of stents will probably slightly reduce, but not abolish, the health benefits of abciximab use. These estimates are based on only four trials. However, until more trials are completed they provide the best available evidence on which to base policy decisions.
评估血管成形术时使用阿昔单抗可能带来的临床益处程度及其实现成本。
四项已发表的随机对照试验。
对六个月时的结果进行荟萃分析。
在这些试验中所描述的方式下，在具有可比性的高风险人群中使用阿昔单抗估计有以下效果：它不影响前六个月内的死亡率。每100次治疗可使心肌梗死（MI）发生率降低3.3，95%可信区间为1.6至5.2。每100次治疗可能使血运重建（血管成形术或冠状动脉搭桥术）需求降低2.1（95%可信区间为-1.0至5.0）。它不会导致重大出血事件显著增加。没有证据表明它会影响再狭窄率。预防每例心肌梗死的净成本约为44,000美元，敏感性分析显示范围约为29,000美元至71,000美元。预防每例不良事件（心肌梗死加血管重建手术）的净成本约为27,000美元（敏感性分析为16,000美元至57,000美元）。每年在加拿大进行的约17,487例血管成形术中全部使用阿昔单抗可能预防395例心肌梗死和186例血管重建手术，总成本约为2900万美元，预防每例不良事件的成本效益约为50,000美元。（这假设事件减少的比例与这四项研究相同，且35%的手术为高风险）。
由于使用阿昔单抗减少围手术期心肌梗死而可能最终延长的寿命无法量化。因此，这些成本效益估计不能用于直接将这种干预措施与其他措施按每挽救生命年的美元数进行比较。该领域发展迅速，这些结论可能很快就得修改。支架使用的增加可能会略微降低但不会消除使用阿昔单抗的健康益处。这些估计仅基于四项试验。然而，在更多试验完成之前，它们提供了可用于制定政策决策的最佳现有证据。
