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Is the PARADIGM-HF cohort representative of the real-world heart failure patient population?

Gustavo Rodrigues1, António Tralhão1, Carlos Aguiar1

  • 1Hospital de Santa Cruz, CHLO, Lisbon, Portugal.

Revista Portuguesa De Cardiologia
|May 22, 2018
PubMed

Insights

Only 24.3% of heart failure patients met the criteria for sacubitril/valsartan in the PARADIGM-HF trial. Real-world data show limited eligibility for this new heart failure drug.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Pharmacology

Background:

  • Sacubitril/valsartan is a new drug with significant prognostic impact in heart failure, now included in clinical guidelines.
  • Randomized controlled trial (RCT) results may not fully represent real-world patient populations.
  • Assessing the generalizability of RCT findings to routine clinical practice is crucial for effective treatment implementation.

Purpose of the Study:

  • To evaluate the representativeness of the PARADIGM-HF trial patient selection criteria within a real-world heart failure cohort.
  • To determine the proportion of heart failure patients in a typical clinic who would meet the eligibility criteria for sacubitril/valsartan based on the PARADIGM-HF trial.

Main Methods:

  • Retrospective review of 196 heart failure outpatient records (January 2013 - December 2014).
  • Exclusion of patients with preserved ejection fraction.
  • Application of the inclusion and exclusion criteria from the PARADIGM-HF trial to the remaining patient cohort.

Main Results:

  • After exclusions, 152 patients with systolic heart failure were analyzed.
  • A significant proportion of patients did not meet trial criteria: 106 lacked inclusion criteria, and 45 had exclusion criteria.
  • Only 24.3% of all systolic heart failure patients (ejection fraction ≤50%) and 42% of heart failure with reduced ejection fraction (HFrEF) patients (ejection fraction ≤35%) met the PARADIGM-HF eligibility criteria.

Conclusions:

  • The study indicates that a substantial majority of heart failure patients in a real-world setting do not meet the strict eligibility criteria of the pivotal PARADIGM-HF trial.
  • Findings suggest a potential gap between the generalizability of RCT results and the applicability of sacubitril/valsartan in routine clinical practice.
  • Further research may be needed to understand treatment patterns and outcomes in the broader heart failure population not represented in the trial.
Abstract

Keywords:
Fração de ejeção reduzidaHeart failureInsuficiência cardíacaMedical therapyReduced ejection fractionSacubitril-valsartanSacubitril/valsartanTerapêutica médica

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