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Stenting Left Main

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Randomized Trial of Stents Versus Bypass Surgery for Left Main Coronary Artery Disease: 5-Year Outcomes of the PRECOMBAT Study Long-Term Outcomes of Different Two-Stent Techniques With Second-Generation Drug-Eluting Stents for Unprotected Left Main Bifurcation Disease: Insights From the FAILS-2 Study Complex PCI procedures: challenges for the interventional cardiologist EXCELling in Left Main Intervention Long-term outcomes following mini-crush versus culotte stenting for the treatment of unprotected left main disease: insights from the Milan and New-Tokyo (MITO) registry Operator Experience and Outcomes After Left Main Percutaneous Coronary Intervention Long-term safety and effectiveness of unprotected left main coronary stenting with drug-eluting stents compared with bare-metal stents Left Main Revascularization in 2017: Coronary Artery Bypass Grafting or Percutaneous Coronary Intervention? Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data Clinical and angiographic outcomes of patients treated with everolimus-eluting stents or first-generation Paclitaxel-eluting stents for unprotected left main disease
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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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