Abbott initiates randomized clinical trial in Japan to evaluate the Absorb™ Bioresorbable Vascular Scaffold

Abbott today announced that it has initiated the ABSORB Japan randomized controlled clinical trial to evaluate the Absorb™ Bioresorbable Vascular Scaffold (BVS) in patients with coronary artery disease (CAD), the most common form of heart disease.1 The results of this trial will support regulatory filings with the Japanese Pharmaceutical and Medical Devices Agency (PMDA) for approval of Absorb BVS in Japan.

The Absorb BVS, a drug eluting, fully bioresorbable vascular scaffold, is a small mesh tube designed to open a blocked heart vessel, restore blood flow to the heart and then dissolve into the vessel over time.2 Unlike a metallic stent that remains permanently in the body, Absorb is referred to as a scaffold to indicate that it is a temporary structure. Abbott’s Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.

CAD is the leading cause of death in the world.3 In Japan, changes in diet and lifestyle have raised concerns of a potential increase in heart disease-related deaths.4 According to the World Health Organization (WHO), cardiovascular disease is responsible for nearly one-third of all deaths in Japan.5

ABSORB Japan will enroll approximately 400 patients and compare the performance of Absorb to Abbott’s market-leading XIENCE™ family of metallic drug eluting stents. The primary endpoint is target lesion failure (TLF) at one year, a combined measure of safety and efficacy of the device. Takeshi Kimura, M.D., professor, Department of Cardiovascular Medicine, Kyoto University Hospital, is the principal investigator of the ABSORB Japan trial.

“Unlike permanent metallic stents, Absorb dissolves over time, which may allow the blood vessel to regain natural function, a unique effect that could have significant impact on the way coronary artery disease is treated in Japan,” said professor Kimura. “While the clinical outcomes of Absorb have been demonstrated in international clinical trials, we now have the opportunity to understand the impact of this technology in Japanese patients in a comparative study, and hope the results of this effort support the process to make Absorb widely available for clinical use in Japan in the future.”

The trial also will incorporate state-of-the-art imaging techniques to study the impact of treatment with Absorb in the blood vessel. The first patient in ABSORB Japan was enrolled by Shigeru Saito, M.D., director, Cardiology and Catheterization Laboratories, and vice president, Shonan Kamakura General Hospital, Kanagawa, Japan, who also enrolled the first patient in the ABSORB EXTEND trial in Japan – a prospective, single-arm trial initiated by Abbott in January 2010 in Japan and other international markets, including Europe. Data from the ABSORB EXTEND trial and other international trials have been presented at major medical meetings and continue to support the near-term safety and efficacy of Absorb across traditional measures typically used to evaluate a drug eluting stent. Ongoing evaluation will continue in randomized trials, such as ABSORB Japan, to understand the unique, long-term benefits of a device that dissolves completely over time.2

“The deliverability of this device during a procedure is similar to a best-in-class drug eluting stent, which is important for treating blockages with ease and confidence in a range of patients,” said Dr. Saito. “We anticipate continued, growing enthusiasm about Absorb from physicians and patients. By leaving no permanent implant behind, this innovative device has the potential to provide benefits never before seen with metallic stents.2”

Since the 1970s, physicians have treated patients with CAD with balloon angioplasty and metallic and drug eluting metallic stents. Nearly a decade ago, scientists at Abbott began development of Absorb. Now Abbott is the first company in the world to begin a randomized clinical trial – the third in total for the company – to test a drug eluting bioresorbable vascular scaffold in patients in Japan. Abbott recently completed enrollment for ABSORB II, a randomized trial initiated in Europe and New Zealand in November 2011.

“The initiation of ABSORB Japan represents the commitment of Abbott to invest in building the body of data for Absorb to benefit physicians and patients in Japan,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “We look forward to the knowledge gained during the course of this trial in Japan, home to many of the world’s pioneers in interventional cardiology, to learn more about the potential of Absorb – the world’s first drug eluting bioresorbable vascular scaffold.”

About the Absorb Bioresorbable Vascular Scaffold

The Absorb Bioresorbable Vascular Scaffold, similar to a small mesh tube, is designed to open a blocked heart vessel and restore blood flow to the heart. Absorb is referred to as a scaffold to indicate that it is a temporary structure, unlike a metallic stent, which is a permanent implant. The scaffold provides support to the vessel until the artery can stay open on its own, and then dissolves naturally over time.2

Abbott’s 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.

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 authorized 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.

References

1. Coronary Artery Disease. National Heart, Lung and Blood Institute. May 2011 Available at: http://www.nhlbi.nih.gov/health/health-topics/topics/cad/
2. Absorb dissolves except for two pairs of tiny metallic markers, which help guide placement and remain in the artery to enable a physician to see where the device was placed.
3. The top 10 causes of death, World Health Organization. June 2011 Available at: http://www.who.int/mediacentre/factsheets/fs310/en/index.html
4. Iso, H. (2011). Lifestyle and cardiovascular disease in Japan. Journal of Atherosclerosis and Thrombosis, Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/21307610
5. World Health Organization (n.d). The impact of chronic disease in Japan. Retrieved from http://www.who.int/chp/chronic_disease_report/japan.pdf.