Erasmus MC, Rotterdam, The Netherlands.
Am Heart J. 2011 Mar;161(3):500-507.e1. doi: 10.1016/j.ahj.2010.11.022.
Meta-analyses of randomized trials show that primary percutaneous coronary intervention (PPCI) results in lower mortality than fibrinolytic therapy in patients with myocardial infarction. We investigated which categories of patients with myocardial infarction would benefit most from the strategy of PPCI and, thus, have lowest numbers needed to treat to prevent a death.
Individual patient data were obtained from 22 (n = 6,763) randomized trials evaluating efficacy and safety of PPCI versus fibrinolysis. A risk score was developed and validated to estimate the probability of 30-day death in individuals. Patients were then divided in quartiles according to risk. Subsequent analyses were performed to evaluate if the treatment effect was modified by estimated risk.
Overall, 446 patients (6.6%) died within 30 days after randomization. The mortality risk score contained clinical characteristics, including the time from symptom onset to randomization. The c-index was 0.76, and the Hosmer-Lemeshow test was nonsignificant, reflecting adequate discrimination and calibration. Patients randomized to PPCI had lower mortality than did patients randomized to fibrinolysis (5.3% vs 7.9%, adjusted odds ratio 0.63, 95% CI 0.42-0.84, P < .001). The interaction between risk score and allocated treatment interaction term had no significant contribution (P = .52) to the model, indicating that the relative mortality reduction by PPCI was similar at all levels of estimated risk. In contrast, the absolute risk reduction was strongly related to estimated risk at baseline: the numbers needed to treat to prevent a death by PPCI versus fibrinolysis was 516 in the lowest quartile of estimated risk compared with only 17 in the highest quartile.
Primary percutaneous coronary intervention is consistently associated with a strong relative reduction in 30-day mortality, irrespective of patient baseline risk, and should therefore be considered as the first choice reperfusion strategy whenever feasible. If access to percutaneous coronary intervention is >2 hours, fibrinolysis remains a legitimate option in low-risk patients because of the small absolute risk reduction by PPCI in this particular cohort.
随机试验的荟萃分析显示,与溶栓治疗相比,急性心肌梗死患者行直接经皮冠状动脉介入治疗(PPCI)的死亡率更低。我们研究了哪类心肌梗死患者从 PPCI 策略中获益最大,从而可以预防死亡的治疗人数最少。
从 22 项评估 PPCI 与溶栓治疗疗效和安全性的随机试验中获得了个体患者数据。制定并验证了风险评分以评估个体 30 天死亡的概率。然后根据风险将患者分为四分位数。进行后续分析以评估治疗效果是否受估计风险的影响。
共有 6763 例患者随机分为 22 项试验,6.6%的患者在随机分组后 30 天内死亡。死亡率风险评分包含了临床特征,包括从症状发作到随机分组的时间。C 指数为 0.76,Hosmer-Lemeshow 检验无统计学意义,表明具有良好的区分度和校准度。与溶栓治疗相比,PPCI 治疗的患者死亡率更低(5.3%比 7.9%,调整后的比值比为 0.63,95%CI 为 0.42-0.84,P<0.001)。风险评分与分配治疗的交互项对模型没有显著贡献(P=0.52),这表明 PPCI 的相对死亡率降低在所有估计风险水平上是相似的。相反,绝对风险降低与基线时的估计风险密切相关:与溶栓治疗相比,PPCI 预防死亡的治疗人数需要治疗人数为 516 例,而在估计风险最高的四分位数中仅为 17 例。
直接经皮冠状动脉介入治疗与 30 天死亡率的显著相对降低相关,无论患者的基线风险如何,均应作为可行时的首选再灌注策略。如果经皮冠状动脉介入治疗的时间>2 小时,由于在这一特定人群中 PPCI 的绝对风险降低较小,低风险患者仍可选择溶栓治疗。