Abbott Initiates U.S. Mega Study On Absorb™ Stent

In short

At 2250 patients Abbott’s newly announced absorbable stent trial is one of the largest studies we’ve come across. The huge number is probably driven by a combination of the quest for significant results and the additional study end points identified in the protocol. Data from the so-called ABSORB III trial will support U.S. regulatory filings for the Absorb™ bioresorbable stent.

Background

The ABSORB III  randomised, controlled trial will compare the performance of Abbott’s drug eluting Absorb™ Bioresorbable Vascular Scaffold (BVS) device to the company’s XIENCE™ family of drug eluting stents. Unlike a permanent metallic stent, treatment with an Absorb BVS could provide important clinical benefits as the device ultimately disappears, leaving the patient with a vessel able to resume more natural function and movement. Distilling subtle differences in clinical outcome is likely to be a tricky affair however, which dictates a significant data set. Companies don’t do big studies for the sake of it!  Indeed approximately 1,000 patients from more than 20 countries have already been treated with the Absorb BVS device across multiple clinical trials, with data out to five years on the first patients treated.

The start of this trial in the United States follows the recent international commercial launch of Absorb in Europe and parts of Latin America and Asia, including the recent regulatory approval and launch in India – a country with a significant and growing prevalence of heart disease.

Abbott refers to Absorb as a scaffold to indicate that it is a temporary structure, unlike a metallic stent, which is a permanent implant. Like the non-absorbable Xience stent, Absorb delivers everolimus, an anti-proliferative drug used in Abbott’s XIENCE coronary stent systems.

The primary endpoint of ABSORB III is target lesion failure, a combined measure of safety and efficacy, at one year. In addition, a subset of patients within the trial will be evaluated for novel endpoints such as vasomotion, a measure of how much natural motion returns to the vessel as Absorb dissolves into the arterial tissue.

Physician comments

Dean Kereiakes, M.D., FACC, FSCAI, medical director of The Christ Hospital Heart & Vascular Center and the Lindner Research Center in Cincinnati, and professor of clinical medicine at Ohio State University, was one of the first physicians to enroll a patient into the ABSORB III trial. “The deliverability of the Absorb device is impressive and similar to a best-in-class drug eluting stent,” said Dr. Kereiakes, who is a co-primary investigator of the ABSORB III trial. “Absorb combines the unique attributes of a dissolvable material with the established MULTI-LINK stent design, making the scaffold flexible and conformable to the vessel.”

“With the introduction of balloon angioplasty in the 1970s, cardiologists wanted to open a blocked vessel without leaving anything behind. Absorb represents the latest innovation that may help us reach this goal, which could result in important long-term benefits related to the restoration of natural vessel function,” said Stephen Ellis, M.D., section head of Interventional Cardiology at the Cleveland Clinic and co-primary investigator of the ABSORB III trial. “The data collected on Absorb from the ABSORB III trial could have the potential to drive significant changes in how cardiologists treat patients with coronary artery disease.”

Company comments

“Absorb is an excellent demonstration of Abbott’s continued global leadership and innovation. The ABSORB III trial will provide important insight about the benefits of Absorb in U.S. patients with heart disease and will supplement the knowledge gained about this technology since the start of international clinical trials of Absorb in 2006,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “The advancement of Absorb into clinical trials in the United States represents an important step in the process of filing for U.S. regulatory approval – with the goal of establishing Absorb as a new therapeutic option to treat U.S. patients with heart disease, the number one killer of men and women.”

Regulatory status 

Absorb is an investigational device, limited by United States law to investigational use and is not approved or available for sale in the United States. Absorb is authorised for sale in CE Mark countries. Absorb is available in Europe, the Middle East, parts of Latin America, and parts of Asia Pacific, including India, Hong Kong, Malaysia and New Zealand.

Source: Abbott Vascular, Business Wire