How T3 Labs helped Abbott Vascular, Dr. Bill Gogas, Dr. Sandeep Kumar, the core teams of Emory University lead by Dr. Habib Samady, and Georgia Tech lead by Dr. Hanjoong Jo, generate and utilize observations from a very long-term translational study toward the understanding of very late vasomotor responses and gene expression profiles in arteries treated with Abbott’s Absorb bioresorbable vascular scaffold and Xience V metallic stent.

Contemporary metallic drug-eluting stents have been employed for decades and have saved thousands of lives of patients suffering from coronary artery disease. Yet there is growing clinical evidence indicating that arteries treated with these devices develop neoatherosclerosis, hypersensitivity reactions and endothelial dysfunction leading to late (>1year) or very late (>2years) clinical events such as clinical restenosis and thrombosis. How can we prevent this vascular response? What are the changes in cells and tissues at the genetic level that lead to clinical restenosis? What type of translational evidence is needed to indicate that bioresorbable scaffolds have the potential to overcome current limitations of drug-eluting stents?

Drs. Bill Gogas, Instructor of Medicine and Sandeep Kumar, Instructor of Biomedical Engineering both at Emory University have been instrumental in bringing about an understanding of the benefits and the clinical applicability of bioresorbable scaffolds. On behalf of Emory University and Abbott Vascular, they utilized the data from a 4-year study completed at T3 Labs and generated first of its kind observations related to functional and gene expression profiles of arteries treated with bioresorbable scaffolds and metallic drug-eluting stents at 4 years after implantation.

What is needed to successfully complete a 4 year long in vivo preclinical study? Drs. Gogas and Kumar were kind enough to share their insights with us.

Interventional Precision

“All of the scaffolds in this study were placed with a very high level of accuracy,” Dr. Kumar said. “When we looked at comparisons of placement across different animals, we saw highly consistent data.”

“Interventional staff must be skilled and well trained to deliver and, appropriately size the bioresorbable scaffolds prior to deployment, utilize optimal deployment pressure to avoid strut discontinuities, and use intracoronary imaging when needed for optimization purposes. This is indicative of the high-quality work by T3 Labs.”

Excellence in veterinary care and husbandry generates reliable data

“Very few preclinical studies have such long term follow-ups,” Dr. Gogas said. “Due in large part to the T3 Labs team’s excellence in the handling, veterinary care and selection of the animals, the study did not experience a single procedure-related mortality.”

“The tissue extraction at T3 is top quality,” Dr. Kumar said. “When you run these downstream, the samples must be sterile, collected quickly and transported to the genetic testing facility in an appropriate environment that does not compromise the data. T3 accomplished this task with remarkable efficiency and accuracy.”

Imaging

The angiographic acquisitions (Philips FD10 XPer Cathlab) generated crucial QCA analysis that allowed the investigators to evaluate changes in vasomotor function following infusion of various vasoactive agents. We know well how important advancements in medical imaging are to moving efficiently through the medtech innovation process.

“The Absorb BVS vasomotion study is an important evaluation of the benefits of a bioresorbable coronary scaffold,” said Jeff Benham, staff research scientist, preclinical research and biocompatibility for Abbott Vascular. “A four-year study, such as this one, requires a lot of coordination, organization and thoughtfulness. The staff at T3 Labs was extremely helpful and adaptable over the course of this study, providing or locating the expertise needed to fulfill the complex technical requirements. T3 Labs was a great partner and collaborator.”

TCT 2016

We await with great anticipation Dr. Gogas’ Poster Presentation on Saturday, October 29th from 6:00 p.m. – 8:00 p.m. at #TCT2016. You can find the “Very Late Vasomotor Responses and Gene Expression Profiles of Porcine Coronary Arteries at 4 Years after Deployment of the Everolimus-eluting Bioresorbable Vascular Scaffold and the Everolimus-eluting Metallic Xience V stent” abstract on Dr. Gogas’ LinkedIn profile here.

To learn more about T3 Labs’ and our partner GCMI’s capability to generate robust data in long-term preclinical studies (both GLP and non-GLP), contact info@t3labs.org or call (404) 251-0600.