#ESC20 PARALLAX Trial 🧵
-2,566 HF patients (LVEF >40%)
-Sacubitril-Valsartan vs Active-controlled treatment (Enalapril, Valsartan or Placebo)
-Primary endpoint: NTproBNP at 12 weeks and 6MWD at 24 weeks
-Exploratory endpoints: eGFR change, HF hospitalization and HF death
-2,566 HF patients (LVEF >40%)
-Sacubitril-Valsartan vs Active-controlled treatment (Enalapril, Valsartan or Placebo)
-Primary endpoint: NTproBNP at 12 weeks and 6MWD at 24 weeks
-Exploratory endpoints: eGFR change, HF hospitalization and HF death
Demographics:
-Age mean 73 y
-Female 50%
-Latin and Central America 14%
-LVEF mean 57%
-NYHA class II-III 99%
-NTproBNP mean 786 pg/mL
-Age mean 73 y
-Female 50%
-Latin and Central America 14%
-LVEF mean 57%
-NYHA class II-III 99%
-NTproBNP mean 786 pg/mL
Primary endpoints
-Sacubitril-Valsartan achieved a significant change in NTproBNP at 12 weeks (HR 0.84, 0.80-0.88)
-Without difference in 6MWD at 24 weeks (mean difference - 2.5, (-8.5 to 3.5)
-Without difference in quality of life (KCCQ and NYHA class)
-Sacubitril-Valsartan achieved a significant change in NTproBNP at 12 weeks (HR 0.84, 0.80-0.88)
-Without difference in 6MWD at 24 weeks (mean difference - 2.5, (-8.5 to 3.5)
-Without difference in quality of life (KCCQ and NYHA class)
Exploratory endpoints
Sacubitril-Valsartan achieved:
-Lower eGFR decline
-Lower HF hospitalization (HR 0.49, 0.30-0.81)
-Lower HF death and HF hospitalization (HR 0.64, 0.42-0.97)
Sacubitril-Valsartan achieved:
-Lower eGFR decline
-Lower HF hospitalization (HR 0.49, 0.30-0.81)
-Lower HF death and HF hospitalization (HR 0.64, 0.42-0.97)
Conclusions
-Trial with mixed results
-Without difference in quality of life
-Significant difference in "soft" primary endpoint (NTproBNP at 12 w)
-Significant difference in "hard" exploratory endpoints (HF outcomes)
-Confirms PARAGON-HF trends
-Finally a treatment for HFpEF?
-Trial with mixed results
-Without difference in quality of life
-Significant difference in "soft" primary endpoint (NTproBNP at 12 w)
-Significant difference in "hard" exploratory endpoints (HF outcomes)
-Confirms PARAGON-HF trends
-Finally a treatment for HFpEF?
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