News | Drug-Eluting Balloons | November 14, 2019

IN.PACT AV Access 6-Month Data Show Increased Vessel Patency

Trial showed drug-coated balloon had a 56 percent reduction in reinterventions

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. #VIVA #VIVA19 #VIVA2019

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%).

Find information on all the VIVA 2019 Late-breaking Clinical Trials
 

Related Content

Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
htisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...
News | Cath Lab | December 18, 2019
December 18, 2019 — Cook Medical initiated a recall of its CrossCath Support Catheters in November, which the U.S.