The Summit Score Stratifies Mortality and Morbidity in Chronic Obstructive Pulmonary Disease

Int J Chron Obstruct Pulmon Dis. 2020 Jul 20;15:1741-1750. doi: 10.2147/COPD.S254437. eCollection 2020.

Abstract

Introduction: Tobacco use and other cardiovascular risk factors often accompany chronic obstructive pulmonary disease (COPD). This study derived and validated the Summit Score to predict mortality in people with COPD and cardiovascular risks.

Methods: SUMMIT trial subjects (N=16,485) ages 40-80 years with COPD were randomly assigned 50%/50% to derivation (N=8181) and internal validation (N=8304). Three external COPD validations from Intermountain Healthcare included outpatients with cardiovascular risks (N=9251), outpatients without cardiovascular risks (N=8551), and inpatients (N=26,170). Cox regression evaluated 40 predictors of all-cause mortality. SUMMIT treatments including combined fluticasone furoate (FF) 100μg/vilanterol 25μg (VI) were not included in the score.

Results: Mortality predictors were FEV1, heart rate, systolic blood pressure, body mass index, age, smoking pack-years, prior COPD hospitalizations, myocardial infarction, heart failure, diabetes, anti-thrombotics, anti-arrhythmics, and xanthines. Combined in the Summit Score (derivation: c=0.668), quartile 4 vs 1 had HR=4.43 in SUMMIT validation (p<0.001, 95% CI=3.27, 6.01, c=0.662) and HR=8.15 in Intermountain cardiovascular risk COPD outpatients (p<0.001, 95% CI=5.86, 11.34, c=0.736), and strongly predicted mortality in the other Intermountain COPD populations. Among all SUMMIT subjects with scores 14-19, FF 100μg/VI 25μg vs placebo had HR=0.76 (p=0.0158, 95% CI=0.61, 0.95), but FF 100μg/VI 25μg was not different from placebo for scores <14 or >19.

Conclusion: In this post hoc analysis of SUMMIT trial data, the Summit Score was derived and validated in multiple Intermountain COPD populations. The score was used to identify a subpopulation in which mortality risk was lower for FF 100μg/VI 25μg treatment.

Trial registration: The SUMMIT trial is registered at ClinicalTrials.gov as number NCT01313676.

Keywords: IMRS; Intermountain risk score; clinical decision tool; randomized controlled trial; risk score.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Adult
  • Aged
  • Aged, 80 and over
  • Androstadienes / therapeutic use
  • Chlorobenzenes / therapeutic use
  • Double-Blind Method
  • Drug Combinations
  • Forced Expiratory Volume
  • Humans
  • Middle Aged
  • Morbidity
  • Pulmonary Disease, Chronic Obstructive* / diagnosis
  • Pulmonary Disease, Chronic Obstructive* / drug therapy

Substances

  • Androstadienes
  • Chlorobenzenes
  • Drug Combinations

Associated data

  • ClinicalTrials.gov/NCT01313676

Grant support

This study was funded by an in-kind grant from GlaxoSmithKline and by a grant from the Intermountain Healthcare Foundry innovation program. The funding sources had no role in the design of the study, the data analysis, the interpretation of the findings, or the writing or publication of the study manuscript.