PRESERVE II trial shows robust five-year outcomes

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W. Anthony Lee at VAM 2024

Five-year outcomes the PRESERVE II pivotal trial of Cook Medical’s Zenith branch iliac graft (ZBIS) demonstrate “sustained safety and effectiveness” when combined with the iCast (Getinge) covered stent for the treatment of aortoiliac aneurysms and preservation of hypogastric artery perfusion, new data show.

W. Anthony Lee, MD, chief of vascular surgery at Boca Raton Regional Hospital in Boca Raton, Florida, delivered the results during the 2024 Vascular Annual Meeting (VAM 2024) in Chicago (June 19–22). Five-year outcomes were completed among 75% of the 40-patient cohort across 18 U.S. medical centers. Lee reported no aneurysm-related mortality, rupture, type III endoleaks, migrations or device integrity issues. Five-year freedom from all-cause mortality was 88.9%; hypogastric artery primary and secondary patency were 91% and 94%, respectively; and external iliac artery primary patency was at 95%, he told VAM 2024.

Nine patients underwent 15 secondary interventions, six ipsilateral to the ZBIS, Lee said. Freedom from type I and II endoleaks was 97.3% at five years, while aneurysm shrinkage was about 25%, he added.

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