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Left Main & Coronary Bifurcation Summit (CBS) was founded in 2006 as a think tank dedicated to the treatment of left main and coronary bifurcation lesions. CBS aims to improve cardiological care by refreshing fundamental researches, clinical trials, yearly published guidelines, emerged ideas and case-based discussion.

Association and Affiliations
- Organized by
  
  Nanjing Heart Center
  
  Asian Bifurcation Club (ABC)
  
  Nanjing First Hospital, Nanjing Medical University
- Co-organized by
  
  Chinese Society of Cardiology (CSC)
  
  Capacity Building and Continuing Education Center,National Health and Family Planning Commission (CBCEC)
  
  American Society for Cardiovascular Angiography and Interventions (SCAI)
  
  Asian Heart Society (AHS)
Contact Us
- Registration Administration of Domestic Representatives
  
  Hongjuan Peng : +86-13913895477
  
  Haimei Xu +86-13914736846
  
  cbsnj@cbsmd.cn
- Registration Administration of Overseas Representatives
  
  Ling Lin : +86 (25) 52271398
  
  +86-13951884596
  
  cbs@cbsmd.cn
- Management of Challenging Cases
  
  Yingying Zhao :+86-13815408517
  
  sub@cbsmd.cn
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CBS2019 Congress Secretariat, Nanjing First Hospital, Building No.9 68# Changle Road, Nanjing, China

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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.

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