News | November 08, 2019

One-Year Results of the DISAPEAR Registry Positive for Absorb Stent

The Absorb bioresorbable stent (BVS) demonstrated good patency and clinical outcomes in patients with chronic limb-threatening ischemia (CLTI) in the DISAPEAR Registry

 Bioresorbable stent Abbott Absorb stent

November 8, 2019 — The Absorb bioresorbable stent (BVS) demonstrated good patency and clinical outcomes in patients with chronic limb-threatening ischemia (CLTI) in the DISAPEAR Registry. This included complex infrapopliteal disease and comorbidities such as diabetes and renal failure, said Steven Kum, M.D., who presented the trial at the 2019 Vascular Interventional Advances (VIVA) annual meeting.

Future prospective controlled studies can further help corroborate the significance of these findings, Kum said.

The Abbott Absorb BVS has demonstrated favorable short- and medium-term results in below-the-knee vessels in patients with CLTI or claudication. The DISAPEAR registry aimed to evaluate the safety and effectiveness of the Absorb BVS in an Asian cohort exclusively with CLTI.

A retrospective analysis was performed in patients with Rutherford class 4 to 6 CLTI with de novo infrapopliteal lesions with angiographic stenosis > 50 percent who were treated with Absorb BVS between August 2012 and June 2017 at Changi General Hospital, Singapore. Assessments included technical success, primary patency (duplex ultrasound peak systolic velocity ratio < 2.0), freedom from clinically driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, and wound healing at 6 and 12 months after the index intervention.

Forty-one patients (41 limbs) with 53 lesions were treated with 69 scaffolds during the study period. About 90 percent of the patients had diabetes, 59 percent had ischemic heart disease, 12 percent had dialysis-dependent renal failure, and 93 percent had Rutherford category 5/6 ischemia with tissue loss.

Technical success was achieved in all patients. The mean lesion length was 22.7 ± 17.2 mm. Twenty-four percent of lesions were classified as severely calcified according to the PARC classification. The primary patency rates at 6 and 12 months were 95 percent and 86 percent, respectively. The corresponding rates of freedom from CD-TLR were 98 percent and 93 percent. Freedom from major amputation was 98 percent at both time points and amputation-free survival was 93 percent and 85 percent at 6 months and 1 year after the index procedure. Complete wound healing occurred in 79.5 percent of patients with Rutherford 5 and 6 ischemia by the end of 12 months after the index procedure. There were no deaths within 30 days of the index intervention.

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

Related Content

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
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
Overlay Init