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Stenting Left Main

科研文章

荐读文献

Sirolimus-eluting stent implantation for unprotected left main coronary artery stenosis: comparison with bare metal stent implantation Percutaneous coronary intervention for the left main stem and other bifurcation lesions: 12th consensus document from the European Bifurcation Club Intravascular ultrasound in the evaluation and treatment of left main coronary artery disease: a consensus statement from the European Bifurcation Club Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients With Diabetes Left Main Revascularization in 2017 Coronary Artery Bypass Grafting or Percutaneous Coronary Intervention? Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial Differences between the left main and other bifurcations Left-main restenosis in the DES era-a call for action Percutaneous coronary intervention in left main coronary artery disease: the 13th consensus document from the European Bifurcation Club Meta-Analysis of Comparison of 5-Year Outcomes of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Unprotected Left Main Coronary Artery in the Era of Drug-eluting Stents

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.