PROTECT in Print: A Success for Biomarker-Guided HF Therapy

October 17, 2011

October 17, 2011 (Washington, DC) — Attentive management of patients with chronic systolic heart failure using natriuretic-peptide levels to guide drug-therapy adjustments significantly cut the risk of cardiovascular events in a small, single-center randomized trial [1].

Such guided therapy has been long studied, with mixed results. But natriuretic-peptide levels in the Pro-BNP Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) trial may have been monitored and addressed more diligently than in previous studies.

The result: the adjusted hazard ratio for the primary end point (a composite of cardiovascular events) at a mean of 10 months was 0.44 (95% CI 0.22–0.84; p=0.02) for patients under guided therapy vs those managed conventionally, according to authors led by Dr James Januzzi (Massachusetts General Hospital, Boston). The end point included worsening HF, hospitalization for HF, acute coronary syndromes, ventricular arrhythmias, cerebral ischemia, and CV death.

Guided therapy (n=75 vs n=76 for standard management alone) consisted of standard care plus treating to an N-terminal pro-B-type natriuretic-peptide (NT-proBNP) goal of <1000 pg/mL.

The findings, which Januzzi previously presented at the American Heart Association 2010 Scientific Sessions, as covered by heartwire , are published online today in the Journal of the American College of Cardiology.

The NT-proBNP-guided approach was also well tolerated, "with favorable effects on quality of life and significant improvements in LV volumes on echocardiography," Januzzi et al write.

"Our results thus suggest that in patients with HF due to LV systolic dysfunction, NT-proBNP monitoring with aggressive care to lower concentrations below a threshold value may be a useful tool to assist in standard HF care."

Generalizability of PROTECT to clinical practice is limited in that the trial is small and showcases efforts at a single experienced heart-failure center. Still, writes Dr Alan Maisel (University of California, San Diego) in an accompanying editorial [2], "We can now be confident that lowering natriuretic peptide levels is indeed possible . . . , is safe (the kidneys still work, the blood pressure is fine), and may lead to more benefits compared with simple [symptom-guided] uptitration of therapies. PROTECT demonstrates the most robust lowering of NT-proBNP concentrations reported to date in any trial."

This study was supported in part by Roche Diagnostics. Januzzi discloses support from the Balson Cardiac Scholar Fund; receiving research grants and consultancy fees from Roche Diagnostics, Siemens Diagnostics, and Critical Diagnostics; and receiving speaking fees from Roche Diagnostics and Siemens Diagnostics. Disclosures for the coauthors are listed in the paper. Maisel discloses consulting for Alere; receiving speaking honoraria from Alere and Abbott and research support from Alere, Brahms-Thermo Fishe, Abbott Laboratories, Critical Diagnostics, and Nanosphere; and serving on the advisory board for Critical Diagnostics.

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