Inhaled nitric oxide to treat intermediate risk pulmonary embolism: A multicenter randomized controlled trial.
Nitric Oxide
; 84: 60-68, 2019 03 01.
Article
em En
| MEDLINE
| ID: mdl-30633959
ABSTRACT
OBJECTIVE:
To test the hypothesis that adjunctive inhaled NO would improve RV function and viability in acute PE.METHODS:
This was a randomized, placebo-controlled, double blind trial conducted at four academic hospitals. Eligible patients had acute PE without systemic arterial hypotension but had RV dysfunction and a treatment plan of standard anticoagulation. Subjects received either oxygen plus 50â¯parts per million nitrogen (placebo) or oxygen plus 50â¯ppm NO for 24â¯h. The primary composite endpoint required a normal RV on echocardiography and a plasma troponin T concentration <14â¯pg/mL. The secondary endpoint required a blood brain natriuretic peptide concentration <90â¯pg/mL and a Borg dyspnea scoreâ¯≤â¯2. The sample size of Nâ¯=â¯76 tested if 30% more patients treated with NO would achieve the primary endpoint with 80% power and alphaâ¯=â¯5%.RESULTS:
We randomized 78 patients and after two withdrawals, 38 were treated per protocol in each group. Patients were well matched for baseline conditions. At 24â¯h, 5/38 (13%) of patients treated with placebo and 9/38 (24%) of patients treated with NO reached the primary endpoint (Pâ¯=â¯0.375). The secondary endpoint was reached in 34% with placebo and 13% of the NO (Pâ¯=â¯0.11). In a pre-planned post-hoc analysis, we examined how many patients with RV hypokinesis or dilation at enrollment resolved these abnormalities; 29% more patients treated with NO resolved both abnormalities at 24â¯h (Pâ¯=â¯0.010, Cochrane's Q test).CONCLUSIONS:
In patients with severe submassive PE, inhaled nitric oxide failed to increase the proportion of patients with a normal troponin and echocardiogram but increased the probability of eliminating RV hypokinesis and dilation on echocardiography. CLINICAL TRIAL REGISTRATION NCT01939301.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Embolia Pulmonar
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Óxido Nítrico
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Guideline
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Risk_factors_studies
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Nitric Oxide
Assunto da revista:
BIOQUIMICA
/
QUIMICA
Ano de publicação:
2019
Tipo de documento:
Article