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

Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology, which are transcatheter devices used to seal brain aneurysms. The company said there is a risk of the delivery system’s wire and tubes fracturing and breaking off when the system is being used to place, retrieve, or move the stent inside a patient.
News | Cath Lab | September 21, 2021
September 21, 2021 — Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Devi
Feature | Cath Lab | September 14, 2021 | By Aaron Detate and Lars Thording
In the electrophysiology (EP) lab, hundreds
An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

News | Cath Lab | July 22, 2021
July 22, 2021 — Medis Medical Imaging is partnering with CORRIB Core Lab and Sinomed in randomized clinical trial of
ast End Medical announced it received U.S. Food and Drug Administration (FDA) clearance for the company's SafeCross Transseptal Radiofrequency (RF) Puncture and Steerable Balloon Introducer System. The 3-in-1 system, which includes a steerable introducer sheath with an ultra-visible positioning balloon and radiofrequency (RF) puncture dilator, aims to provide a predictable and safe solution for electrophysiology (EP) and structural heart interventions requiring left atrial access.
News | Cath Lab | July 14, 2021
July 13, 2021 — East End Medical announced it received U.S.
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone. #SCAI21 #SCAI2021 Creating a card0-renal program.

There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone.

Feature | Cath Lab | May 14, 2021 | By Dave Fornell, Editor
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal fun
Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting proc

Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting procedures.

News | Cath Lab | May 12, 2021
May 12, 2021 — Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has
SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI heart attack. #SCAI21 #SCAI2021

SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI.

Feature | Cath Lab | May 06, 2021 | By Dave Fornell, Editor
April 29, 2021 — Here is the list of late-breaking study presentations and links to articles about each of them from
Most Stable Ischemic Heart Disease Patients Did Not Meet ISCHEMIA Trial Enrollment Criteria, raising questions about its application in real-world practice. #SCAI2021 Getty Images

Getty Images

News | Cath Lab | May 03, 2021
May 3, 2021 – Results from a new study find a broad range of patients who typically undergo revascularization for sta
New study demonstrates depression, HIV, mental health, obesity, alcohol and drug abuse are risk factors on most common type of heart disease in young black patients. Photo by Dave Fornell
News | Cath Lab | April 29, 2021
April 29, 2021 – A retrospective analysis of risk factors for coronary artery disease (CAD) in young African American