PROTECT Halted: Event Rates Fall by Treating HF With Natriuretic-Peptide Guidance

December 14, 2009

December 14, 2009 (Basel, Switzerland) — A randomized trial of natriuretic-peptide–guided therapy for heart failure has stopped enrolling patients after an interim analysis showed that the strategy seemed to work: it led to a significant drop over one year, compared with standard management, in a composite primary end point that included worsening heart failure, HF hospitalization, and CV death, Hoffmann-La Roche (Berne, Switzerland) announced this morning in a press release [1].

The company markets the diagnostic assay for amino-terminal pro-B natriuretic peptide (NT-proBNP) used in the small single-center study, called ProBNP Outpatient Tailored CHF Therapy (PROTECT).

PROTECT enrolled 151 patients out of a projected 300, of whom 126 had been treated for at least the prespecified one year, principal investigator Dr James L Januzzi (Massachusetts General Hospital, Boston) told heartwire . The primary end-point reduction associated with natriuretic-peptide-guided therapy was significant at p=0.008, he said.

"The really significant reductions that we saw, which drove the primary end point, were in worsening heart failure and heart-failure hospitalization, along with a nonsignificant reduction in cardiovascular death," Januzzi said. Other components of the primary end point, which included acute coronary syndrome, cerebrovascular ischemia, and significant ventricular arrhythmias, were few. "They accounted for an extremely small number of the overall event rates."

The trial randomized patients in NYHA class 2–4 heart failure, an LVEF <40%, and a history of at least one admission or outpatient diuretic dose increase for heart-failure destabilization in the previous six months; those with severe renal dysfunction were excluded. Standard management consisted of state-of-the art medical therapy, with device therapy at the physician's discretion, with adjustments to treatment based as usual on clinical judgment.

Physicians treating patients in the guided-therapy group also had access to NT-proBNP levels with a mandate to intensify or add therapies to keep them below 1000 pg/mL, the company press release stated.

Januzzi said that the treatment target marks one of the ways PROTECT appears to differ from previous trials of natriuretic-peptide-guided therapy, which, as covered by heartwire , have had mixed results. "In addition to really giving both arms of the trial very aggressive heart-failure care, the goal in the study was not to use the natriuretic peptide as a signal of risk but to try specifically to suppress the natriuretic-peptide value as much as possible."

PROTECT is also looking at how the management strategies affect quality of life and echocardiographic measures of heart structure and function. The investigators expect to report the trial's full primary results in 2010.

PROTECT is sponsored by Hoffmann-La Roche. Januzzi has received grant support from Roche.

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