Effect of a Strategy of Comprehensive Vasodilation vs Usual Care on Mortality and Heart Failure Rehospitalization Among Patients With Acute Heart Failure: The GALACTIC Randomized Clinical Trial.
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Kozhuharov Nikola, Goudev Assen, Flores Dayana, Maeder Micha T, Walter Joan, Shrestha Samyut, Gualandro Danielle Menosi, de Oliveira Junior Mucio Tavares, Sabti Zaid, Müller Beat, Noveanu Markus, Socrates Thenral, Ziller Ronny, Bayés-Genís Antoni, Sionis Alessandro, Simon Patrick, Michou Eleni, Gujer Samuel, Gori Tommaso, Wenzel Philip, Pfister Otmar, Conen David, Kapos Ioannis, Kobza Richard, Rickli Hans, Breidthardt Tobias, Münzel Thomas, Erne Paul, Mueller Christian, GALACTIC Investigators, Mueller Christian, Erne Paul, Müller Beat, Rickli Hans, Maeder Micha, Tavares de Oliveira Mucio, Münzel Thomas, Bayés-Genís Antoni, Sionis Alessandro, Goudev Assen, Dimov Bojidar, Hartwiger Sabine, Arenja Nisha, Glatz Bettina, Herr Natascha, Isenrich Rahel, Mosimann Tamina, Twerenbold Raphael, Boeddinghaus Jasper, Nestelberger Thomas, Puelacher Christian, Freese Michael, Vögele Janine, Meissner Kathrin, Martin Jasmin, Strebel Ivo, Wussler Desiree, Schumacher Carmela, Osswald Stefan, Vogt Fabian, Hilti Jonas, Barata Sara, Schneider Deborah, Schwarz Jonas, Fitze Brigitte, Hartwiger Sabine, Arenja Nisha, Glatz Bettina, Herr Natascha, Isenrich Rahel, Mosimann Tamina, Twerenbold Raphael, Boeddinghaus Jasper, Nestelberger Thomas, Puelacher Christian, Freese Michael, Vögele Janine, Meissner Kathrin, Martin Jasmin, Strebel Ivo, Wussler Desiree, Schumacher Carmela, Osswald Stefan, Vogt Fabian, Hilti Jonas, Barata Sara, Schneider Deborah, Schwarz Jonas, Fitze Brigitte, Arenja Nisha, Rentsch Katharina, Bossa Aline, Jallad Sergio, Soeiro Alexandre, Georgiev Dimitar, Jansen Thomas, Gebel Gabriele, Bossard Matthias, Christ Michael
Аннотация
OBJECTIVE: To evaluate the effect of a strategy that emphasized early intensive and sustained vasodilation using individualized up-titrated doses of established vasodilators in patients with AHF.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, open-label blinded-end-point trial enrolling 788 patients hospitalized for AHF with dyspnea, increased plasma concentrations of natriuretic peptides, systolic blood pressure of at least 100 mm Hg, and plan for treatment in a general ward in 10 tertiary and secondary hospitals in Switzerland, Bulgaria, Germany, Brazil, and Spain. Enrollment began in December 2007 and follow-up was completed in February 2019.
INTERVENTIONS: Patients were randomized 1:1 to a strategy of early intensive and sustained vasodilation throughout the hospitalization (n = 386) or usual care (n = 402). Early intensive and sustained vasodilation was a comprehensive pragmatic approach of maximal and sustained vasodilation combining individualized doses of sublingual and transdermal nitrates, low-dose oral hydralazine for 48 hours, and rapid up-titration of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or sacubitril-valsartan.
MAIN OUTCOMES AND MEASURES: The primary end point was a composite of all-cause mortality or rehospitalization for AHF at 180 days.
RESULTS: Among 788 patients randomized, 781 (99.1%; median age, 78 years; 36.9% women) completed the trial and were eligible for primary end point analysis. Follow-up at 180 days was completed for 779 patients (99.7%). The primary end point, a composite of all-cause mortality or rehospitalization for AHF at 180 days, occurred in 117 patients (30.6%) in the intervention group (including 55 deaths [14.4%]) and in 111 patients (27.8%) in the usual care group (including 61 deaths [15.3%]) (absolute difference for the primary end point, 2.8% [95% CI, -3.7% to 9.3%]; adjusted hazard ratio, 1.07 [95% CI, 0.83-1.39]; P = .59). The most common clinically significant adverse events with early intensive and sustained vasodilation vs usual care were hypokalemia (23% vs 25%), worsening renal function (21% vs 20%), headache (26% vs 10%), dizziness (15% vs 10%), and hypotension (8% vs 2%).
CONCLUSIONS AND RELEVANCE: Among patients with AHF, a strategy of early intensive and sustained vasodilation, compared with usual care, did not significantly improve a composite outcome of all-cause mortality and AHF rehospitalization at 180 days.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00512759.