Aims:

The VALIDATE-SWEDEHEART trial was a registry-based randomized trial comparing bivalirudin and heparin in patients with acute myocardial infarction undergoing percutaneous coronary intervention. It showed no differences in mortality at 30 or 180 days. This study examines how well the trial population results may generalize to the population of all screened patients with fulfilled inclusion criteria in regard to mortality at 30 and 180 days.

Methods:

The standardized difference in the mean propensity score for trial inclusion between trial population and the screened not-enrolled with fulfilled inclusion criteria was calculated as a metric of similarity. Propensity scores were then used in an inverse-probability weighted Cox regression analysis using the trial population only to estimate the difference in mortality as it would have been had the trial included all screened patients with fulfilled inclusion criteria. Patients who were very likely to be included were weighted down and those who had a very low probability of being in the trial were weighted up.

Results:

The propensity score difference was 0.61. There were no significant differences in mortality between bivalirudin and heparin in the inverse-probability weighted analysis (hazard ratio 1.11, 95% confidence interval (0.73, 1.68)) at 30 days or 180 days (hazard ratio 0.98, 95% confidence interval (0.70, 1.36)).

Conclusion:

The propensity score difference demonstrated that the screened not-enrolled with fulfilled inclusion criteria and trial population were not similar. The inverse-probability weighted analysis showed no significant differences in mortality. From this, we conclude that the VALIDATE results may be generalized to the screened not-enrolled with fulfilled inclusion criteria.

中文翻译：

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评估 VALIDATE-SWEDEHEART 试验的外部有效性

目标：

VALIDATE-SWEDEHEART 试验是一项基于注册的随机试验，在接受经皮冠状动脉介入治疗的急性心肌梗死患者中比较比伐卢定和肝素。它显示 30 天或 180 天死亡率没有差异。本研究检验了试验人群的结果如何适用于所有符合纳入标准的筛查患者的 30 天和 180 天死亡率。

方法：

试验人群与未纳入符合纳入标准的筛选人群之间的试验纳入平均倾向评分的标准化差异被计算为相似性度量。然后在使用试验人群的逆概率加权 Cox 回归分析中使用倾向评分，仅用于估计死亡率的差异，因为如果试验包括所有符合纳入标准的筛选患者，本应如此。很可能被纳入的患者被加权，而那些参加试验的可能性非常低的患者被加权。

结果：

倾向得分差异为 0.61。比伐卢定和肝素在 30 天或 180 天（风险比 0.98，95% 置信区间（0.70 , 1.36))。

结论：

倾向得分差异表明，符合纳入标准的未登记筛选和试验人群并不相似。逆概率加权分析显示死亡率没有显着差异。由此，我们得出结论，VALIDATE 结果可以推广到筛选出的未登记符合纳入标准的人群。