The IN.PACT Arteriovenous (AV) Access randomized trial evaluating the safety and effectiveness of the Medtronic IN.PACT AV Access drug-coated balloon (DCB) met both of its endpoints, in data presented at the 2019 Vascular Interventional Advances (VIVA) annual meeting.
November 7, 2019 — The IN.PACT Arteriovenous (AV) Access randomized trial evaluating the safety and effectiveness of the Medtronic IN.PACT AV Access drug-coated balloon (DCB) met both of its endpoints, in data presented at the 2019 Vascular Interventional Advances (VIVA) annual meeting.
The study compared the DCB to percutaneous transluminal angioplasty (PTA) for the treatment of 330 patients with obstructive lesions (de novo or restenotic) of the native arteriovenous dialysis fistulae (AVF) in the upper extremity. Target lesion primary patency was 81.4% in the DCB group compared to 59% in the PTA group (P < .001) and there was a 56% reduction in the total number of reinterventions required to maintain patency, explained Robert Lookstein, M.D., MHCDL, executive vice chairman in the Department of Diagnostic, Molecular and Interventioal Radiology, Mount Sinai Health System.
He said 12-month, all-cause mortality was 90.6% in the DCB group compared to 90.4% in the PTA group. The results were first presented at the CIRSE 2019 meeting.
The trial was is an independently adjudicated, prospective, global, multicenter, single-blinded study.
The primary effectiveness endpoint was the target lesion primary patency rate, defined as freedom from clinically driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through six months (210 days) post-procedure. The primary safety endpoint was defined as the serious adverse event rate involving the AV access circuit through 30 days post-procedure.
Distribution of lesion location, AVF type, and lesion type among patients in the DCB and PTA groups was similar (P=0.310, P=0.918, and P=0.905, respectively). Six-month primary patency of restenotic lesions was 78.9% in the DCB group compared to 52.4% in the PTA group (difference, 26.5%). Primary patency of radiocephalic fistulas was 81.7% in the DCB group compared to 60% in the PTA group (difference, 21.7%). Primary patency of brachiocephalic fistulas was 80.8% in the DCB group compared to 57.4% in the PTA group (difference, 23.4%). Primary patency of anastomotic lesions was 84.6% in the DCB group compared to 50.0% in the PTA group (difference, 34.6%). Primary patency of cephalic arch lesions was 84.0% in the DCB group compared to 50.0% in the PTA group (difference, 34%).
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