News | Stents Bioresorbable | October 30, 2015

ABSORB China Trial Shows Bioresorbable Stent is Non-Inferior to DES

Absorb China among the late-breaking clinical data at TCT 2015

October 30, 2015 — Results from a clinical trial showed that that the Abbott Absorb everolimus-eluting bioresorbable vascular scaffold was non-inferior after one year compared to a current generation metallic drug-eluting stent (DES) in patients with coronary artery disease for the primary endpoint of angiographic in-segment late loss (LL). Findings from ABSORB China study were presented at the 2015 annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. 

ABSORB China was an angiographically based randomized trial designed to evaluate the relative effectiveness of bioresorbable vascular scaffolds (BVS) and cobalt-chromium everolimus-eluting stents (CoCr-EES); the trial was conducted for regulatory approval of BVS in China. 

A prospective, randomized, active-controlled, open-label, multicenter trial, ABSORB China randomized a total of 480 eligible patients with one or two de novo native coronary artery lesions in a 1:1 ratio at 24 sites in China. Patients were randomized to BVS (n=241) or CoCr-EES (n=239). The primary endpoint was angiographic in-segment late loss (LL), defined as the change in minimal lumen diameter from post-procedure to one year, and powered for non-inferiority with a margin of 0.15 mm.

The primary endpoint of in-segment LL at one year was 0.19 ± 0.38 mm for BVS (n=200) compared to 0.13 ± 0.38 mm for CoCr-EES (n=195); the one-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving non-inferiority of BVS compared to CoCr-EES (Pnon-inferiority=0.01). BVS and CoCr-EES also had similar one-year rates of target lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization; 3.4% vs. 4.2% respectively, P=0.62) and definite/probable scaffold/stent thrombosis (0.4% vs. 0.0% respectively, p=1.0). 

“Results from ABSORB China show that BVS was non-inferior to CoCr-EES for the primary endpoint of in-segment late loss at one year,” said lead investigator Run-Lin Gao, M.D. He is professor of medicine and chief cardiologist at Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences in Beijing, China. “Similar one-year clinical safety and effectiveness outcomes were also observed. Additional studies are needed to assess BVS outcomes in complex patients and lesions encountered in daily practice, as well as long-term clinical outcomes data to assess the ultimate safety and efficacy profile of BVS compared to CoCr-EES.”

The ABSORB China trial was funded by Abbott Vascular. Gao reported receiving a research grant from Abbott Vascular.

For more information: 

Related Content

Videos | TCT | October 03, 2018
DAIC Editor Dave Fornell takes a tour of some of the most innovative new cardiovascular technology he found on the ex
cardiologist Ted Feldman, M.D., at TCT 2017. #TCT2018 #TCT #TCT18 TCT Late breaking trials, studies.
Feature | TCT | September 21, 2018
October 4, 2018 – The Cardiovascular Research Foundation (CRF) had 15 late-breaking trials and 12 late-breaking clini
Interventional cardiology, cath lab technology, TCT, transcatheter cardiovascular therapeutics. #TCT #TCT18 #TCT2018
Feature | TCT | September 14, 2018 | Dave Fornell, Editor
The volume of information attendees receive at the annual...
Videos | TCT | November 15, 2017
DAIC Editor Dave Fornell shows some of the innovations displayed on the expo floor at the 2017 Transcatheter Cardiova
TCT 2017 late-breaking trials and studies that will be presented on the latest cardiology technology clinical trials.
Feature | TCT | November 09, 2017
November 9, 2017 — From numerous high-quality submissions, Transcatheter Cardiovascular Therapeutics (TCT) has select
Key Interventional Cardiology and structural heart Technologies to Prepare for TCT 2017.
Feature | TCT | October 26, 2017 | Dave Fornell
Here is an aggregation of DAIC content for all major cardiovascular technology news and advances this past year. These...
Videos | TCT | November 18, 2016
DAIC Editor Dave Fornell takes a video tour of some of the most innovative new interventional cardiology technologies
Videos | TCT | November 05, 2015
DAIC Editor Dave Fornell offers his choices for the most innovative new interventional cardiovascular technologies pr
Videos | TCT | November 05, 2015
Tom Watson, clinical analyst for MDBuyLine, and DAIC Dave Fornell discuss some of the technology trends at the 2015 T
Amaranth Fortitute Bioresorbable stent

The Amaranth Fortitute bioresorbable stent was among several fully bioresorbing platforms discussed in sessions, late breaking trial data presentations and on the expo floor at TCT 2015.

Feature | TCT | October 19, 2015 | Tom Watson, BS, RCVT, Clinical Analyst, MD Buyline
There were several overarching technology trends seen at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) ann
Overlay Init