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Stenting Left Main

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Outcomes Among Patients Undergoing Distal Left Main Percutaneous Coronary Intervention Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial Successful bailout stenting strategy against lethal coronary dissection involving left main bifurcation Left Main Revascularization With PCI or CABG in Patients With Chronic Kidney Disease: EXCEL Trial Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease Contemporary Approach to Coronary Bifurcation Lesion Treatment Second vs. First generation drug eluting stents in multiple vessel disease and left main stenosis: Two-year follow-up of the observational, prospective, controlled, and multicenter ERACI IV registry Predictors of Left Main Coronary Artery Disease in the ISCHEMIA Trial Radial versus femoral artery access in patients undergoing PCI for left main coronary artery disease: analysis from the EXCEL trial Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial
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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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