1 Dolmatch B, Waheed U, Balamuthusamy S, Hoggard J, Settlage R; AVeVA Trial Investigators. Prospective, Multicenter Clinical Study of the Covera Vascular Covered Stent in the Treatment of Stenosis at the Graft-Vein Anastomosis of Dysfunctional Hemodialysis Access Grafts. J Vasc Interv Radiol. 2022;33(5):479-488.e3. doi:10.1016/j. jvir.2022.02.008. AVeNEW Clinical Studies data on file. At 6 months in AVeVA target lesion primary patency (TLPP) was 70.3% (proportional analysis). At 6 months in AVeNEW, TLPP was 78.7% for Covera™ Vascular Covered Stent vs. 47.9% for PTA alone, P < .001. 130 of the 142 (91.5%) subjects randomized to the Covera™ Vascular Stent group and 123 of the 138 (89.1%) randomized to PTA completed their 6-month follow-up. TLPP defined as the interval following the index intervention until the next clinically-driven reintervention at or adjacent to the original treatment site or until the extremity was abandoned for permanent access. In AVeNEW, TLPP at 6 Months – Subgroup Analysis is provided as observational data without P values. In AVeNEW, patients who received the Covera™ Vascular Covered Stent had 103 reinterventions involving a new lesion compared to 72 reinterventions in the PTA only group at 24 months. At 30 days, freedom from primary safety events was 96.4% in AVeVa and 95.0% (Covera™ Vascular Covered Stent) vs. 96.4% (PTA alone) in AVeNEW (P < .0022). Freedom from primary safety events was defined as freedom from an adverse event involving the access circuit resulting in additional intervention, surgery, hospitalization, or death.
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BD-23522v2
