Inhaled Pulmonary Vasodilator Therapy in Adult Lung Transplant: A Randomized Clinical Trial.Ghadimi, K., et al.
JAMA Surgery 2021 [record in progress].
The aim of this study was to compare rates of severe/grade 3 primary graft dysfunction (PGD-3) in adult lung transplant (LT) recipients receiving inhaled epoprostenol (iEPO) versus inhaled nitric oxide (iNO).
Partcipants were randomised to receive either iNO or iEPO.
201 adult lung transplant recipients.
The primary endpoint was PGD-3 development. Secondary endpoints included duration of mechanical ventilation, acute kidney injury, early postoperative mortality, hospital and ICU lengths of stay , and mean pulmonary arterial pressure.
The blinded, equivalence randomised controlled trial evaluated whether inhaled epoprostenol (iEPO) would result in similar rates of severe/grade 3 primary graft dysfunction (PGD-3) when compared to inhaled nitric oxide (iNO) in adult lung transplant recipients. 220 lung transplant candidates were randomised according to a computer-generated sequence and 201 candidates were included in the analysis. The sample size calculation was based on a prespecified equivalence margin and showed that 200 patients were needed to provide 80% power. Patients, clinicians, data managers and statisticians were all blinded to the allocated intervention. The unadjusted and adjusted intention to treat analyses and the per-protocol analysis demonstrated equivalence for the incidence of PGD-3 within 72 hours after the arrival in the ICU. Intention to treat analysis of the secondary outcomes, including mortality up to 90 days, duration of mechanical ventilation, hospital and ICU stays, and incidence of acute kidney injury, did not show any differences. This first robust comparison iEPO and iNO in lung transplant recipients iEP and iNO showed a similar risk for the development of severe primary graft dysfunction.
ClinicalTrials.gov - NCT03081052