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GALACTIC: Vasodilation may not improve mortality, rehospitalization for acute HF
PARIS — Early intensive and sustained vasodilation was well tolerated among patients with acute HF, but it did not improve all-cause mortality and acute HF rehospitalizations at 180 days, according to data from the GALACTIC trial presented at the European Society of Cardiology Congress.
Christian Eugen Mueller, MD, director of the Cardiovascular Research Institute Basel and professor at University Hospital Basel in Switzerland, and colleagues analyzed data from 788 patients who presented to the ED with acute HF, had acute dyspnea NYHA class III or IV, and had B-type natriuretic peptide levels greater than 500 ng/L or N-terminal pro-B-type natriuretic peptide levels greater than 2,000 ng/L.
Patients were assigned the intervention (n = 382; median age, 78 years; 37% women), which included early intensive and sustained vasodilation, or standard of care (n = 399; median age, 77 years; 37% women). The use of other therapies such as beta-blockers and cardiac devices were left to the discretion of the treating physician in both groups.
“We used, in a scheme, drugs in an application that optimizes the safety in the emergency department,” Mueller said during the presentation.
Patients in the treatment arm first received sublingual and transdermal nitrates, which were then complemented by hydralazine. Patients were then given ACE inhibitors on the second day of hospitalization and, if ideal, was uptitrated aggressively on a daily basis.
“This is unique that it used individualized doses of well-characterized, widely available and mostly inexpensive drugs,” Mueller said during the presentation. “This would have the beauty that if it has a positive finding, you in whatever country you come from would be immediately able to apply it once you’re back home in your institution.”
This approach may also help with achieving target doses, Mueller added
“In a patient that would tolerate this perfectly, we would achieve the target dose already on day 7,” Mueller said during the presentation. “However, uptitration to a target dose is sometimes wishful thinking in this frail population, so the protocol also had a predefined deescalation scheme, what to do in case of hypotension, renal function deterioration or hyperkalemia. If that would occur on day 5, then of course the next step is to deescalate the dose as much as necessary.”
The primary endpoint was all-cause mortality or acute HF rehospitalization within 180 days. The primary analysis of the primary endpoint was adjusted for four predefined strong predictors: acute HF hospitalization in the last year, age, serum creatinine and systolic BP. Secondary endpoints included time to discharge, adverse events and quantitative assessment of dyspnea at day 2 and day 6 in sitting and lying positions.
For the primary endpoint, there were comparable rates in the intervention and standard of care groups at 180 days (30.6% vs. 27.8%; adjusted HR = 1.07; 95% CI, 0.83-1.39). A statistically significant interaction was seen between sex and the effect of therapy, which indicated a possible effect of harm in the intervention group, Mueller said during the presentation.
Both groups also had similar rates of improvement in dyspnea, and both groups had a median length of stay of 9 days.
The adverse events in the intervention group were mainly headache from nitrates, which occurred in 26% of patients assigned the intervention and 10% in those assigned standard of care (P < .001). Systolic arterial hypertension occurred in 8% of patients in the intervention arm and 2% of those in the standard of care arm (P = .001). Death occurred in 14% of patients assigned the intervention and 15% of those assigned standard of care (P = .803), according to the presentation. – by Darlene Dobkowski
Reference:
Mueller CE. Hot Line Session 3. Presented at: European Society of Cardiology Congress; Aug. 31-Sept. 4, 2019; Paris.
Disclosure: Cardiology Today could not confirm relevant financial disclosures at the time of publication.