News | Stents Bioresorbable | October 31, 2017

Thirty-Day ABSORB IV Results Demonstrate Improvements Still Needed in Bioresorbable Stents

Bioresorbable vascular scaffold proves non-inferior to metal drug-eluting stents for target lesion failure, but stent thrombosis, ischemia-driven target lesion revascularization and non-periprocedural myocardial infarction remained higher

Thirty-Day ABSORB IV Results Demonstrate Improvements Still Needed in Bioresorbable Stents

October 31, 2017 – Thirty-day results from ABSORB IV, the largest randomized everolimus-eluting bioresorbable vascular scaffold (BVS) trial to date, found BVS to be noninferior to a cobalt-chromium everolimus-eluting stent (CoCr-EES) for target lesion failure (TLF).

Findings were reported at the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, Oct. 29-Nov. 2 in Denver, sponsored by the Cardiovascular Research Foundation (CRF).

First-generation BVS have been associated with higher rates of TLF and device thrombosis than current metallic drug-eluting stents. It has been thought that this may be in part due to suboptimal implantation technique used in early studies. Therefore, the ABSORB IV trial mandated the avoidance of smaller vessels, and aggressive pre-dilatation and routine high-pressure post-dilatation were emphasized.

ABSORB IV also permitted the enrollment of more complex and higher-risk patients than ABSORB III, with inclusion of troponin-positive acute coronary syndrome (ACS) and up to three lesions in a maximum of two epicardial coronary arteries, including thrombus. Patients were randomized 1:1 to BVS or CoCr-EES after successful pre-dilatation with a 1:1 sized balloon.

Between Aug. 15, 2014 and March 31, 2017, 2,604 patients at 140 sites in five countries were randomized to BVS (N=1,296) versus CoCr-EES (N=1,308). Median age was 63 years; 28 percent of patients were female and 31.7 percent had diabetes. Among patients receiving BVS, pre-dilatation was performed in 99.8 percent of lesions, and post-dilatation was performed in 82.6 percent of lesions. The acute device success (delivery and deployment of the study scaffold/stent with residual stenosis <30 percent) was 94.6 percent for BVS compared to 99 percent for CoCr-EES (P<0.0001).

The primary endpoint of 30-day target lesion failure (TLF) was 5 percent for BVS versus 3.7 percent for CoCr-EES, a difference of 1.29 percent (Pnoninferiority=0.02; Psuperiority =0.11). As treated 30-day TLF was 4.6 percent for BVS versus 3.7 percent for CoCr-EES, a difference of 0.83 percent (Pnoninferiority=0.006). Patient-oriented major adverse cardiac events (PoCE) were 5.2 percent for BVS compared to 4.1 percent for CoCr-EES (P=0.17). However, the rate of 30-day ischemia-driven target vessel revascularization (ID-TLR) was 1.2 percent versus 0.2 percent (P=0.003), and the rate of device thrombosis was 0.6 percent in the BVS group and 0.2 percent in the CoCr-EES group (P=0.06).

“At 30 days, BVS was non-inferior to CoCr-EES for target lesion failure,” said Gregg W. Stone, M.D., professor of medicine at Columbia University Medical Center, and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital. “The rates of non-peri-procedural MI [myocardial infarction] and ID-TLR at 30 days were greater with BVS than with CoCr-EES, and a trend toward greater stent thrombosis with BVS was present. Compared to ABSORB III, reducing the number of very small vessels treated in ABSORB IV substantially reduced the device thrombosis rate in both groups. These results are largely consistent with those from earlier ABSORB trials, and highlight the need for continued advancements in device technology and standardized technique to further improve the early safety profile of BVS.”

The ABSORB IV trial was funded by Abbott Vascular. Stone reported that he is chairman of the ABSORB global clinical trial program (uncompensated) and a consultant to Reva Inc.

For more information: www.tctconference.com

Related Absorb BVS Content

FDA Investigating Increased Major Adverse Cardiac Event Rates of Absorb Bioresorbable Stent

Abbott Will End Sales of Absorb Bioresorbable Stent

Related Content

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.
Gallery | Cath Lab | October 31, 2019 | Dave Fornell, Editor
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
Overlay Init