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

Gallery | Cath Lab | October 31, 2019
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t
OmniVision Announces Guinness World Record for Smallest Image Sensor

OmniVision's OVM6948 CameraCubeChip, a fully packaged, wafer-level camera module measuring 0.65mm x 0.65mm x 1.158mm, built on OmniVision's OV6948, winner of the Guinness World Record for “The Smallest Image Sensor Commercially Available.”

News | Cath Lab | October 22, 2019
October 22, 2019 — OmniVision Technologies Inc.
People watch the presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., live in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long term surgical outcomes. #TCT2019

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. 

Feature | Cath Lab | October 03, 2019
October 3, 2019 – Five-year data from the EXCEL Trial showed patients with left main coronary disease treated with pe
Two Stents Implanted in Democratic Presidential Candidate Bernie Sanders, suffers chest pain
News | Cath Lab | October 02, 2019 | Dave Fornell, Editor
October 2, 2019 — Democratic presidential candidate Sen.
Bypass Surgery and Coronary Stenting Yield Comparable 10-Year Survival
News | Cath Lab | September 25, 2019
Ten-year survival rates are similar for bypass surgery and coronary stenting with drug-eluting stents in randomized...
Complete Revascularization Superior to Culprit Lesion-only Intervention
News | Cath Lab | September 10, 2019
An international randomized trial has shown that complete revascularization reduces major cardiovascular events...
The cath lab staff UH Portage Medical Center.

The cath lab staff UH Portage Medical Center.

Feature | Cath Lab | September 09, 2019 | Anjan Gupta, M.D., FACC, FSCAI
Primary percutaneous coronary intervention (PCI) is the preferred treatment for acute...
Overlay Init