CBS 2019
CBSMD教育中心
中 文

推荐文献

Abstract

Recommended Article

2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC) Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial Volume brings value Predicting lifetime risk for developing atherosclerotic cardiovascular disease in Chinese population: the China-PAR project Obesity, Diabetes, and Acute Coronary Syndrome: Differences Between Asians and Whites Clinical Implications of Periprocedural Myocardial Injury in Patients Undergoing Percutaneous Coronary Intervention for Chronic Total Occlusion: Role of Antegrade and Retrograde Crossing Techniques

Volume 74, Issue 16, October 2019

JOURNAL:J Am Coll Cardiol. Article Link

Nonproportional Hazards for Time-to-Event Outcomes in Clinical Trials: JACC Review Topic of the Week

J Gregson, L Sharples, GW Stone et al. Keywords: clinical trials; Cox proportional hazards; nonproportional hazards; statistics; time-to-event outcomes; trial design

ABSTRACT


Most major clinical trials in cardiology report time-to-event outcomes using the Cox proportional hazards model so that a treatment effect is estimated as the hazard ratio between groups, accompanied by its 95% confidence interval and a log-rank p value. But nonproportionality of hazards (non-PH) over time occurs quite often, making alternative analysis strategies appropriate. This review presents real examples of cardiology trials with different types of non-PH: an early treatment effect, a late treatment effect, and a diminishing treatment effect. In such scenarios, the relative merits of a Cox model, an accelerated failure time model, a milestone analysis, and restricted mean survival time are examined. Some post hoc analyses for exploring any specific pattern of non-PH are also presented. Recommendations are made, particularly regarding how to handle non-PH in pre-defined Statistical Analysis Plans, trial publications, and regulatory submissions.