LAPTOP-HF: Left atrial pressure-guided therapy may benefit patients with HF
ORLANDO, Fla. — Left atrial pressure-guided therapy combined with physician-directed patient self-management was safe and appears reduced HF hospitalization rates, according to late-breaking clinical trial results presented at the Heart Failure Society of America Scientific Assembly.
William T. Abraham, MD, FACP, FACC, FAHA, FESC, director of the division of cardiovascular medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Wexner Medical Center, Columbus, presented the results of the randomized, unblinded trial.
The cohort consisted of 486 patients (mean age, 62 years; 25% women) with NYHA class III HF and prior HF hospitalization or consistent elevated levels of N-terminal pro-B natriuretic peptide. Patients were randomly assigned to receive left atrial pressure-guided therapy or standard of care with daily medication reminders.
For the left atrial pressure-guided therapy, patients took left atrial pressure readings at least once a day and followed subsequent instructions, which were programmed by a physician to display advice based on that day’s reading.
Abraham said the researchers planned to enroll 730 patients, but the study was stopped early at the recommendation of the Data Safety Monitoring Board after 486 patients were randomized.
The primary safety endpoint of the trial was freedom from safety-related major adverse CV and neurological events (MACNE) in the treatment group at 12 months, with a goal of a 95% lower confidence bound for the freedom of MACNE greater than 80% in the treatment group.
The original efficacy endpoint was reduction in relative risk for HF-related MACNE, defined as adjudicated events of acute decompensated HF and severe complications from HF therapy requiring hospitalization, compared with the control group over the course of the study.
Abraham said the efficacy endpoint was revised to track relative risk reduction over 12 months, and to adjust the definition of HF hospitalization to adjudicated events of acute decompensated HF requiring the patient to be hospitalized.
Also, the revised efficacy endpoint was considered exploratory and was intended to enable comparison with the primary efficacy endpoint of the CHAMPION trial, Abraham said.
In the as-treated population, the primary safety endpoint was met, with a 12-month rate of event-free probability of 92.4% and a lower 95% CI bound at 12 months of 89.1%, but the sample size was not large enough to draw a definitive conclusion, according to Abraham, who noted that most MACNE events occurred early and the rate did not increase over time.
The original primary efficacy endpoint was not met (RR = 0.91; P = .488; RR reduction = 9%), but the revised endpoint was (RR = 0.57; P = .003; RR reduction = 43%), he said.
The cumulative 12-month HRs for HF hospitalization were similar in LAPTOP-HF and CHAMPION, he said.
“While hypothesis-generating and not definitive, LAPTOP-HF findings support the results of the CHAMPION trial and the potential efficacy of pressure-guided, physician-directed, patient self-management in NYHA Class III HF patients at risk for HF re-hospitalization,” Abraham said. – by Dave Quaile
Abraham WT, et al. Late-Breaking Clinical Trials. Presented at: Heart Failure Society of America Scientific Assembly; Sept. 17-20, 2016; Orlando, Fla.
Disclosure: Abraham reports consulting for St. Jude Medical.