Effect of a Strategy of Comprehensive Vasodilation vs Usual Care on Mortality and Heart Failure Rehospitalization Among Patients With Acute Heart Failure
| Autor: | Nikola, Kozhuharov, Assen, Goudev, Dayana, Flores, Micha T, Maeder, Joan, Walter, Samyut, Shrestha, Danielle Menosi, Gualandro, Mucio Tavares, de Oliveira Junior, Zaid, Sabti, Beat, Müller, Markus, Noveanu, Thenral, Socrates, Ronny, Ziller, Antoni, Bayés-Genís, Alessandro, Sionis, Patrick, Simon, Eleni, Michou, Samuel, Gujer, Tommaso, Gori, Philip, Wenzel, Otmar, Pfister, David, Conen, Ioannis, Kapos, Richard, Kobza, Hans, Rickli, Tobias, Breidthardt, Thomas, Münzel, Paul, Erne, Christian, Mueller, Micha, Maeder, Mucio, Tavares de Oliveira, Bojidar, Dimov, Sabine, Hartwiger, Nisha, Arenja, Bettina, Glatz, Natascha, Herr, Rahel, Isenrich, Tamina, Mosimann, Raphael, Twerenbold, Jasper, Boeddinghaus, Thomas, Nestelberger, Christian, Puelacher, Michael, Freese, Janine, Vögele, Kathrin, Meissner, Jasmin, Martin, Ivo, Strebel, Desiree, Wussler, Carmela, Schumacher, Stefan, Osswald, Fabian, Vogt, Jonas, Hilti, Sara, Barata, Deborah, Schneider, Jonas, Schwarz, Brigitte, Fitze, Katharina, Rentsch, Aline, Bossa, Sergio, Jallad, Alexandre, Soeiro, Dimitar, Georgiev, Thomas, Jansen, Gabriele, Gebel, Matthias, Bossard, Michael, Christ |
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| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Vasodilator Agents Comorbidity Patient Readmission 01 natural sciences Drug Administration Schedule law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Cause of Death Internal medicine Clinical endpoint Humans Medicine 030212 general & internal medicine 0101 mathematics Adverse effect Aged Cause of death Aged 80 and over Heart Failure business.industry 010102 general mathematics Hazard ratio General Medicine medicine.disease Hospitalization Blood pressure Heart failure Acute Disease Female business Sacubitril Valsartan |
| Zdroj: | JAMA. 322:2292 |
| ISSN: | 0098-7484 |
| Popis: | Importance Short-term infusions of single vasodilators, usually given in a fixed dose, have not improved outcomes in patients with acute heart failure (AHF). 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 |
| Databáze: | OpenAIRE |
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