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GUIDE-IT: NT-proBNP-guided strategy fails to improve outcomes in HFrEF
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A strategy guided by N-terminal pro-B-type natriuretic peptide did not benefit patients with HF with reduced ejection fraction more than the usual care, researchers reported in JAMA.
The GUIDE-IT study was planned for 1,100 patients but was stopped for futility by the data safety and monitoring board after 864 patients (median age, 63 years; 32% women) were enrolled.
Patients had HF with EF of 40% or less, elevated natriuretic peptide within 30 days of enrollment and history of a prior HF event.
The researchers assigned patients to a guided strategy in which HF therapy was titrated with the goal of NT-proBNP less than 1,000 pg/mL or to the usual guideline-directed care.
The primary endpoint was a composite of time to first HF hospitalization or CV mortality.
At a median of 15 months follow-up, 37% of both groups experienced the primary endpoint (adjusted HR = 0.98; 95% CI, 0.79-1.22), G. Michael Felker, MD, MHS, from Duke Clinical Research Institute, and colleagues wrote.
The groups did not differ in CV mortality (HR = 0.94; 95% CI, 0.65-1.37), all-cause mortality (HR = 0.86; 95% CI, 0.62-1.2), first HF hospitalization (HR = 1.04; 95% CI, 0.82-1.31), total HF hospitalizations (HR = 1.29; 95% CI, 0.97-1.72) and days alive and not hospitalized for CV reasons (mean difference, 19.26 days; 95% CI, –21.58 to 60.1), according to the researchers.
Despite the treatment goals for the intervention group, there was no significant difference at 12 months in achieved NT-proBNP levels; the intervention group declined 53% to a median of 1,209 pg/mL and the control group declined 48% to a median of 1,397 pg/mL. The target of less than 1,000 pg/mL was achieved in 46% of the intervention group vs. 40% of the control group (P = .21).
The results may have differed from previous trials because “patients in the control group received optimized guideline-directed medical therapy and ... substantial reductions in NT-proBNP levels [were] achieved with empirical adjustment in HFrEF medications,” Gregg C. Fonarow, MD, FACC, FAHA, FHFSA, Eliot Corday Professor of Cardiovascular Medicine and Science, director of the Ahmanson-UCLA Cardiomyopathy Center, co-chief of clinical cardiology, UCLA division of cardiology and co-director of the UCLA Preventative Cardiology Program at David Geffen School of Medicine at UCLA, wrote in a related editorial. “Perhaps the most likely explanation for the outcomes observed in the GUIDE-IT trial is that when clinical care follows guidelines and addresses the key issues, biomarkers do not make a difference and that guideline-directed care, if achieved, is more efficient and can lead to outcomes similar to biomarker-guided care.” – by Erik Swain
Disclosures: Felker reports receiving grant support from Merck and personal fees from Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, MyoKardia, Stealth Therapeutics and Trevena. Please see the study for all other authors’ relevant financial disclosures. Fonarow reports consulting for Amgen, Janssen, Medtronic, Novartis, St. Jude Medical and ZS Pharma.
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