Extracorporeal photopheresis for the prevention of rejection after lung transplantation: a prospective randomised controlled trial
Alberto Benazzo, A. Cho, S. Auner, Stefan Schwarz, Zsófia Kovács, Dariga Ramazanova, Vera Kolovratova, Manuela Branka, Gabriela Muraközy, E. Hielle-Wittmann, Clemens Aigner, Konrad Höetzenecker, Thomas Wekerle, Nina Worel, Robert Knobler, Péter Jaksch
Abstract
Background Lung transplant recipients have the worst long-term outcomes of all solid organs due to acute rejection and chronic lung allograft dysfunction (CLAD). Our objective was to investigate the efficacy of extracorporeal photopheresis (ECP) as a prophylactic treatment to prevent acute cellular rejection (ACR), cytomegalovirus (CMV) infections and reduce the risk of CLAD. Methods This was a single-centre prospective randomised controlled trial conducted at the Medical University of Vienna (Vienna, Austria) between 2018 and 2020. It included 31 COPD recipients per group. The treatment group underwent ECP in addition to a standard triple-drug immunosuppression protocol after lung transplantation. The control group received standard triple-drug immunosuppressive therapy. The primary outcome was a composite outcome defined as incidence of high-grade ACR, CMV infection or CLAD within 24 months after lung transplantation. Results In the control group, 19 patients (61.3%) achieved the primary combined end-point compared with only six patients (19.4%) in the treatment group (p<0.001). Freedom from high-grade ACR was significantly greater in the ECP group (p=0.045). Cumulative A scores were significantly lower in the ECP group than in the control group at 3 months (0.18±0.44 versus 0.56±0.94; p<0.05) and at 12 months (0.25±0.48 versus 1.0±1.45; p=0.002). The rate of infections was lower in the ECP group with five cases and 67 cumulative hospital days compared with 22 cases and 309 days in the control group (p=0.002). Freedom from CLAD at 3 years was significantly greater in the ECP group (p=0.015). Conclusion Adding ECP to standard triple immunosuppression resulted in a significant reduction of the number of ACR episodes and significantly lower incidence of CLAD.