Ferenczi Emily A, Malik Iqbal S, Mayet Jamil, Foale Rodney A, Francis Darrel P
International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College and St. Mary's Hospital, 59-61 North Wharf Road, London W2 1LA, United Kingdom.
J Invasive Cardiol. 2008 Sep;20(9):437-41.
At 30 days, it is recognized that 12-hour periprocedural abciximab infusion protects against reinfarction and the need for revascularization in percutaneous coronary intervention (PCI) in acute myocardial infarction (MI). However, it is controversial whether the benefit to patients continues or fades away subsequently. We investigate whether abciximab provides a persistent advantage in terms of life-years gained in large trials of abciximab in PCI.
We identified four eligible randomized, controlled studies of PCI and adjunctive abciximab therapy in acute MI enrolling a total of 3,183 patients. Using the published time course of survival, we calculated the life-years gained at a series of time points over the following year. The weighted mean value and standard error for life-years gained at 1 year was 0.0034 +/- 0.0005. For abciximab-treated patients, life-years gained increases non-linearly for the first 90 days (gain = y = 0.003t(2) + 0.0016t - 3E-05; R(2) = 0.998; p < 0.05 for non-linear term) then linearly thereafter (gain = y = 0.004t - 0.0005; R(2) = 0.9998). The "number needed to treat" to gain 1 life-year is twenty-fold lower at the 1-year time point than at the 60-day time point.
When viewed across trials, benefit to the patient in terms of gain in life-years grows, rather than shrinks, with the passage of months. Initially, growth is significantly greater than linear, suggesting that a single periprocedural infusion continues to help prevent events from occurring up to 3 months post procedure. Evaluation of benefit at early time points may therefore underestimate the benefit of abciximab.
在30天时，人们认识到在急性心肌梗死（MI）的经皮冠状动脉介入治疗（PCI）中，围手术期12小时静脉输注阿昔单抗可预防再梗死并减少血管重建的需求。然而，这种对患者的益处随后是持续存在还是逐渐消失存在争议。我们研究了在阿昔单抗用于PCI的大型试验中，就获得的生命年数而言，阿昔单抗是否具有持续的优势。
我们确定了四项关于急性MI的PCI及辅助阿昔单抗治疗的符合条件的随机对照研究，共纳入3183例患者。利用已发表的生存时间进程，我们计算了接下来一年中一系列时间点获得的生命年数。1年时获得的生命年数的加权平均值和标准误为0.0034±0.0005。对于接受阿昔单抗治疗的患者，在最初90天内获得的生命年数呈非线性增加（增加量=y = 0.003t² + 0.0016t - 3×10⁻⁵；R² = 0.998；非线性项p < 0.05），此后呈线性增加（增加量=y = 0.004t - 0.0005；R² = 0.9998）。在1年时间点获得1个生命年的“需治疗人数”比60天时低20倍。
综合各项试验来看，从获得生命年数的角度对患者的益处随着时间推移是增加而非减少的。最初，增长显著大于线性增长，这表明围手术期单次输注在术后长达3个月仍持续有助于预防事件发生。因此，在早期时间点评估益处可能会低估阿昔单抗的益处。
