The effect of prophylactic extracorporeal photopheresis on cardiac allograft vasculopathy during the first post-transplant year in de novo heart transplant recipients: ECP-OCT2019 study design

    Authors

    Keywords

    cardiac allograft vasculopathy, intimal thickening, extracorporeal photopheresis, optical coherence tomography

    DOI

    https://doi.org/10.15836/ccar2024.419

    Full Text

    **Introduction:** Cardiac allograft vasculopathy (CAV) remains a major cause of long-term morbidity and mortality after heart transplantation (HTx). Coronary intimal thickening that occurs during the first post-HTx year is an early sign of CAV. (1) To the best of our knowledge, only one study has reported of decreased intimal thickening in HTx recipients who received prophylactic extracorporeal photopheresis (ECP) in addition to maintenance immunosuppressive therapy (IST) consisting of cyclosporine, azathioprine, and steroid. (2) The ECP-OCT2019 trial is designed to evaluate the effect of prophylactic ECP on intimal thickening during the first post-HTx year, as assessed by optical coherence tomography (OCT), in light of modern IST which includes mycophenolate mofetil, proven to have advantages over azathioprine in CAV prevention. **Study design:** ECP-OCT2019 is a pilot, interventional, prospective, randomized, open-label study. A total of 38 patients were randomized into two arms to receive either 10 cycles of ECP treatment in addition to standard IST or standard IST alone. In all patients, coronary angiography with OCT imaging was performed within the first three months after HTx and repeated one year after HTx to detect progression of intimal thickening. The primary endpoint was defined as the change in intimal volume from baseline to one-year follow-up. Secondary endpoints included changes in maximal and mean intimal thickness, maximal and mean intimal layer area, as well as minimal and mean lumen area. **Conclusion:** ECP-OCT2019 is the first prospective study to evaluate the effect of prophylactic ECP on intimal thickening in HTx recipients in the context of modern IST. Our results may influence current clinical practice in CAV prevention and diagnostics.

    Literature

    1. Khush KK, Cherikh WS, Chambers DC, Harhay MO, Hayes D, Hsich E, et al. International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-sixth adult heart transplantation report - 2019; focus theme: Donor and recipient size match. J Heart Lung Transplant. 2019 October;38(10):1056–66. https://doi.org/10.1016/j.healun.2019.08.004
    2. Barr ML, Baker CJ, Schenkel FA, McLaughlin SN, Stouch BC, Starnes VA, et al. Prophylactic photopheresis and chronic rejection: effects on graft intimal hyperplasia in cardiac transplantation. Clin Transplant. 2000;14(2):162–6. https://doi.org/10.1034/j.1399-0012.2000.140211.x
    Cardiologia Croatica
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    The effect of prophylactic extracorporeal photopheresis on cardiac allograft vasculopathy during the first post-transplant year in de novo heart transplant recipients: ECP-OCT2019 study design

    Extended Abstract
    Issue11-12
    Published
    Pages419
    PDF via DOIhttps://doi.org/10.15836/ccar2024.419
    cardiac allograft vasculopathy
    intimal thickening
    extracorporeal photopheresis
    optical coherence tomography

    Authors

    Mia Dubravčić Došen*ORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Hrvoje JurinORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Marijan PašalićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Branka Golubić ĆepulićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Ines BojanićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Sanja MazićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Dora FabijanovićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Nina JakušORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Ivo PlanincORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Jure SamardžićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Maja ČikešORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Daniel LovrićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Kristina Marić BešićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Joško BulumORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Hrvoje GašparovićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Davor MiličićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Boško SkorićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia

    *Correspondence email: dubravcic.mia@gmail.com

    Full Text

    Introduction: Cardiac allograft vasculopathy (CAV) remains a major cause of long-term morbidity and mortality after heart transplantation (HTx). Coronary intimal thickening that occurs during the first post-HTx year is an early sign of CAV. (1) To the best of our knowledge, only one study has reported of decreased intimal thickening in HTx recipients who received prophylactic extracorporeal photopheresis (ECP) in addition to maintenance immunosuppressive therapy (IST) consisting of cyclosporine, azathioprine, and steroid. (2) The ECP-OCT2019 trial is designed to evaluate the effect of prophylactic ECP on intimal thickening during the first post-HTx year, as assessed by optical coherence tomography (OCT), in light of modern IST which includes mycophenolate mofetil, proven to have advantages over azathioprine in CAV prevention.

    Study design: ECP-OCT2019 is a pilot, interventional, prospective, randomized, open-label study. A total of 38 patients were randomized into two arms to receive either 10 cycles of ECP treatment in addition to standard IST or standard IST alone. In all patients, coronary angiography with OCT imaging was performed within the first three months after HTx and repeated one year after HTx to detect progression of intimal thickening. The primary endpoint was defined as the change in intimal volume from baseline to one-year follow-up. Secondary endpoints included changes in maximal and mean intimal thickness, maximal and mean intimal layer area, as well as minimal and mean lumen area.

    Conclusion: ECP-OCT2019 is the first prospective study to evaluate the effect of prophylactic ECP on intimal thickening in HTx recipients in the context of modern IST. Our results may influence current clinical practice in CAV prevention and diagnostics.

    Literature

    1. 1.
      Khush KK, Cherikh WS, Chambers DC, Harhay MO, Hayes D, Hsich E, et al. International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-sixth adult heart transplantation report - 2019; focus theme: Donor and recipient size match. J Heart Lung Transplant. 2019 October;38(10):1056–66.DOI
    2. 2.
      Barr ML, Baker CJ, Schenkel FA, McLaughlin SN, Stouch BC, Starnes VA, et al. Prophylactic photopheresis and chronic rejection: effects on graft intimal hyperplasia in cardiac transplantation. Clin Transplant. 2000;14(2):162–6.DOI