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  • The PROXIMAL Trial: Proxima...
    Mauri, Laura, MD, MSc, FACC; Cox, David, MD, FACC; Hermiller, James, MD, FACC; Massaro, Joseph, PhD; Wahr, Joyce, MD; Tay, Sew Wah, PhD; Jonas, Michael, MD; Popma, Jeffrey J., MD, FACC; Pavliska, Jim, BS; Wahr, Dennis, MD, FACC; Rogers, Campbell, MD, FACC

    Journal of the American College of Cardiology, 10/2007, Letnik: 50, Številka: 15
    Journal Article

    The PROXIMAL Trial: Proximal Protection During Saphenous Vein Graft Intervention Using the Proxis Embolic Protection System: A Randomized, Prospective, Multicenter Clinical Trial Laura Mauri, David Cox, James Hermiller, Joseph Massaro, Joyce Wahr, Sew Wah Tay, Michael Jonas, Jeffrey J. Popma, Jim Pavliska, Dennis Wahr, Campbell Rogers We compared an embolic protection device placed proximal to the target lesion to distal embolic protection devices in 594 patients undergoing saphenous vein graft stenting. Intention-to-treat analysis showed that the composite of death, myocardial infarction, or target vessel revascularization at 30 days occurred in 9.2% of the test arm (proximal protection when possible, distal when not) and 10.0% of the control arm (distal protection when possible); noninferiority p = 0.0061. A treatment strategy that included proximal embolic protection whenever possible during treatment of saphenous vein graft lesions produced outcomes similar to those observed with a strategy using only distal embolic protection.