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Long-term outcomes of routine versus provisional T-stenting for de novo coronary bifurcation lesions: five-year results of the Bifurcations Bad Krozingen I study Comparison of Coronary Intimal Plaques by Optical Coherence Tomography in Arteries With Versus Without Internal Running Vasa Vasorum Volumetric characterization of human coronary calcification by frequency-domain optical coherence tomography The Relation Between Optical Coherence Tomography-Detected Layered Pattern and Acute Side Branch Occlusion After Provisional Stenting of Coronary Bifurcation Lesions Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data Reply: Will Pulmonary Artery Denervation Really Have a Place in the Armamentarium of the Pulmonary Hypertension Specialist? Two-year outcomes of everolimus vs. paclitaxel-eluting stent for the treatment of unprotected left main lesions: a propensity score matching comparison of patients included in the French Left Main Taxus (FLM Taxus) and the LEft MAin Xience (LEMAX) registries Left main coronary artery disease: importance, diagnosis, assessment, and management Histopathological validation of optical coherence tomography findings of the coronary arteries Diagnostic accuracy of fractional flow reserve from anatomic CT angiography

Clinical TrialJune 2018

JOURNAL:JACC Clin Electrophysiol. Article Link

Improving the Use of Primary Prevention Implantable Cardioverter-Defibrillators Therapy With Validated Patient-Centric Risk Estimates

WC Levy, AS Hellkamp, DB Mark et al. Keywords: heart failure; ICD; non-sudden death; prognosis; proportional risk; regression analysis; risk prediction model; sudden death

ABSTRACT


OBJECTIVES - The authors previously developed the Seattle Proportional Risk Model (SPRM) in systolic heart failure patients without implantable cardioverter-defibrillators (ICDs)to predict the proportion of deaths that were sudden. They subsequently validated the SPRM in 2 observational ICD data sets. The objectives in the present study were to determine whether this validated model could improve identification of clinically important variations in the expected magnitude of ICD survival benefit by using a pivotal randomized trial of primary prevention ICD therapy.


BACKGROUND - Recent data show that <50% of nominally eligible subjects receive guideline- recommended primary prevention ICDs.

METHODS - In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), a placebo-controlled ICD trial in 2,521 patients with an ejection fraction ≤35% and symptomatic heart failure, we tested the use of patient-level SPRM-predicted probability of sudden death (relative to that of non-sudden death) as a summary measurement of the potential for ICD benefit. A Cox proportional hazards model was used to estimate variations in the relationship between patient-level SPRM predictions and ICD benefit.

RESULTS - Relative to use of mortality predictions with the Seattle Heart Failure Model, the SPRM was much better at partitioning treatment benefit from ICD therapy (effect size was 2- to 3.6-fold larger for the ICD×SPRM interaction). ICD benefit varied significantly across SPRM-predicted risk quartiles: for all-cause mortality, a +10% increase with ICD therapy in the first quartile (highest risk of death, lowest proportion of sudden death) to a decrease of 66% in the fourth quartile (lowest risk of death, highest proportion of sudden death; p = 0.0013); for sudden death mortality, a 19% reduction in SPRM quartile 1 to 95% reduction in SPRM quartile 4 (p < 0.0001).

CONCLUSIONS - In symptomatic systolic heart failure patients with a Class I recommendation for primary prevention ICD therapy, the SPRM offers a useful patient-centric tool for guiding shared decision making.