News | Stents Bioresorbable | November 07, 2019

Bioresorbable Stent Shows Good 5-Year Outcomes in ABSORB BTK Trial

November 7, 2019 — Although the Abbott Absorb fully bioresorbable drug-eluting stent (DES) was taken off the market due to poor sales and questions on outcomes in coronary vessels compared to conventional metallic DES, it performed very well in peripheral vessels below the knee (BTK) in the ABSORB BTK Trial. The results were presented as a late-breaking trial at the 2019 Vascular Interventional Advances (VIVA) annual meeting.

This novel bioresorbable, drug-eluting scaffold has several inherent advantages over stents, related to its biological resorption. These results represent best-in-class durability for a stent-like device in this challenging vascular territory, said Ramon L. Varcoe, MBBS, MS, Ph.D., a vascular surgeon at Sydney’s Prince of Wales, who presented data at VIVA.  The trial was ended early after Abbott pulled the stent from the market, but enrolled patients continued to be tracked.

The ABSORB BTK trial is a prospective, nonrandomized, single-center study designed to evaluate a novel bioresorbable, drug-eluting scaffold used for the treatment of peripheral artery disease (PAD) below the knee. There were 71 scaffolds utilized in 55 limbs of 48 patients who fulfilled the inclusion criteria (72.7% with critical limb ischemia). Most scaffolds were implanted in arteries of the proximal half of the calf, and the mean lesion length was 20.1 mm (range, 5-50 mm). There was 100% procedural and technical success.

Over the five-year follow-up period, 38% of patients had died, all from causes unrelated to the procedure or study device; 95% of patients had sustained clinical improvement. Complete wound healing occurred in 90% of those treated for tissue loss, with no major amputations and a limb salvage rate of 100%. Primary patency (defined as freedom from peak systolic velocity ratio > 2 or target vessel occlusion) and freedom from clinically driven target lesion revascularization rates were estimated at 89.2%/80.3%/72.9% and 97.2%/90.7%/90.7% at 12, 36, and 60 months, respectively, using the Kaplan-Meier method. No late or very late scaffold thromboses were observed.


Related Absorb Stent Content:

Abbott Will End Sales of Absorb Bioresorbable Stent

VIDEO: What Went Wrong With the Absorb Stent? - interview with Ajay Kirtane, M.D., at TCT 2017

Current State of Bioresorbable Stent Technology (Update article from January 2018)

Tempering the Bioresorbable Stent Euphoria Following FDA Clearance of the Absorb

VIDEO: Bioresorbable Stent Failure Modes, Technique, Patient Selection and Future Development — a discussion with Juan Granada, M.D., executive director and chief scientific officer of the Cardiovascular Research Foundation's Skirball Center for Innovation.

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

Related Content

FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
Overlay Init