CBS 2019
CBSMD教育中心
中 文

Other Relevant Articles

Abstract

Recommended Article

2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC) Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years Derivation and Validation of a Chronic Total Coronary Occlusion Intervention Procedural Success Score From the 20,000-Patient EuroCTO Registry:The EuroCTO (CASTLE) Score Large-Bore Radial Access for Complex PCI: A Flash of COLOR With Some Shades of Grey Major infections after bypass surgery and stenting: an overlooked but fatal complication Know Diabetes by Heart: A Partnership to Improve Cardiovascular Outcomes in Type 2 Diabetes Mellitus PCI and CABG for Treating Stable Coronary Artery Disease Management of Patients With NSTE-ACS: A Comparison of the Recent AHA/ACC and ESC Guidelines

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.