Abbott Completes Enrollment for Bioresorbable Vascular Scaffold Trials

Abbott Park, Ill.-based Abbott Laboratories has completed enrollment in three clinical trials to support approvals of the company’s Absorb bioresorbable vascular scaffold (BVS) in the United States, Japan and China. Combined, the U.S., Japan and China account for more than 50 percent of the world’s heart stent market. Absorb received CE mark in 2011 for commercialization in the European Union and is available in more than 60 countries around the world.

“The randomized clinical trials for Absorb demonstrate Abbott’s commitment to provide the highest level of clinical evidence possible to assess Absorb compared to metallic drug eluting stents—the current standard of care,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president of medical affairs and chief medical officer of Abbott Vascular. “We look forward to evaluating the results of these trials, which we intend to submit to support regulatory approvals of the device.”

Absorb works by opening a blocked vessel and restoring blood flow to the heart similar to a metallic stent; however, unlike a metallic stent, Absorb dissolves over time, potentially leaving behind a more flexible vessel because it is free from a permanent metallic stent which cages the vessel. Absorb is referred to as a scaffold to indicate that it is a temporary structure, unlike a metallic stent, which is a permanent implant. Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures. The Absorb BVS delivers everolimus, an anti-proliferative drug used in Abbott’s Xience coronary stent systems. Everolimus was developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent or scaffold implantation.

The ABSORB III clinical trial, which has enrolled approximately 2,000 people in the United States, will evaluate the potential benefits of Absorb in people with coronary artery disease, a narrowing of one or more arteries that supply blood to the heart. The primary endpoint of ABSORB III is target lesion failure (TLF), a combined measure of the safety and effectiveness of Absorb in comparison to the company’s Xience family of drug eluting stents at one year.

“The rapid completion of enrollment in the Absorb randomized trials is a testament to the interest among doctors and patients in advancing new options to treat heart disease,” said Gregg Stone, M.D., FACC, FSCAI, director of cardiovascular research and education at the Center for Interventional Vascular Therapy, Columbia University Medical Center, New York-Presbyterian Hospital. “Absorb represents an entirely new approach to helping people with heart disease by doing the job of a metallic stent, but then disappearing after its work is done, giving people the opportunity to live their lives free of a permanent metallic device implanted in their arteries.”

The ABSORB Japan and ABSORB China trials enrolled approximately 400 people each, and the primary endpoint is TLF at one year and late loss at one year, respectively, in comparison to the Xience family of drug eluting stents. The ABSORB II trial enrolled approximately 500 people, mostly in Europe, and one-year clinical results are anticipated later this year.

“The medical community eagerly awaits the results of the randomized trials for Absorb,” said Dean Kereiakes, M.D., FACC, FSCAI, medical director of The Christ Hospital Heart & Vascular Center and the Lindner Research Center in Cincinnati, Ohio, and professor of clinical medicine at Ohio State University. “We have made tremendous progress in interventional cardiology with the advances in metallic stents. A device that could provide similar benefits but not leave behind a permanent implant has the potential to transform the way coronary artery disease is treated.”

Abbott Vascular Inc. is a subsidiary of Abbot Laboratories, a pharmaceuticals and health care products company.