First Patient in Japan Treated With Abbott's Bioresorbable Stent in Global Clinical Trial
August 17, 2011 – Abbott announced today that the first patient in Japan has been treated with the Absorb bioresorbable vascular scaffold (BVS) as part of the ABSORB EXTEND clinical trial. Abbott's BVS stent restores blood flow by opening a clogged vessel and providing support to the vessel until the device dissolves within two years, leaving patients with a treated vessel free of a permanent metallic implant. The device received CE mark approval in the European Union (EU) for the treatment of coronary artery disease and is under clinical investigation in several countries around the world. The first patient in Japan was treated in the ABSORB EXTEND clinical trial by Shigeru Saito, M.D., director, cardiology and catheterization laboratories, and vice president, Shonan Kamakura Hospital, Kanagawa, Japan.
"Abbott's BVS technology has the potential to open up a new therapy option for physicians treating patients with coronary artery disease in Japan," said Saito. "For Japanese patients, this technology will hold tremendous appeal, as it is designed to treat a clogged blood vessel like a drug-eluting stent and then dissolve, thereby restoring a more natural vessel function without leaving a permanent metallic implant behind in the body. Our hope is that our participation in the ABSORB EXTEND trial will be a meaningful contribution toward making this innovative technology available to patients in Japan."
Abbott's BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. Because a permanent metallic implant is not left behind, a vessel treated with the BVS device may ultimately have the ability to move, flex, pulsate and dilate. Restoration of these naturally occurring vessel functions is one of the features that makes Abbott's BVS a significant innovation for patients in the evaluation and treatment of coronary artery disease. In addition, continuing research will show whether the need to administer long-term dual anti-platelet therapy to patients is necessary once the temporary scaffold is metabolized.
About the ABSORB EXTEND Clinical Trial
The ABSORB EXTEND trial is a large-scale, single-arm trial that will enroll approximately 1,000 patients at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The ABSORB EXTEND trial will enroll patients with complex coronary artery disease. Data from this trial may be used to support approval in various markets around the world. Key endpoints of the study include assessments of safety – major adverse cardiac events (MACE) and treated-site thrombosis rates – at 30 days and at six, 12, 24 and 36 months, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints in a sub-group study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other imaging modalities.
To date, more than 300 patients in Europe, Latin America and Asia Pacific have been enrolled in the ABSORB EXTEND trial.
About the ABSORB Clinical Trial
The ABSORB trial is the first clinical trial evaluating a drug eluting bioresorbable vascular scaffold for the treatment of coronary artery disease. Abbott is the only company with four-year clinical data on a complete patient set evaluating the safety and performance of this technology. The ABSORB trial is a prospective, non-randomized (open label), two-stage study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety – MACE and treated-site thrombosis rates – at 30 days and at six, nine, 12 and 24 months, with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the device. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other imaging modalities at six, 12, 18, 24, 36 and 60 months.
Results from the first stage of the ABSORB trial with 30 patients demonstrated that Abbott’s BVS successfully treated coronary artery disease and dissolved within approximately two years. Patients in this first stage of the ABSORB trial experienced no blood clots (thromboses) and no cardiac deaths out to four years and no new MACE between six months and four years.
Twelve-month results from the 101 patients enrolled in the second stage of the ABSORB trial showed a MACE rate of 6.9 percent. There were no reports of blood clots in any of the 101 patients at 12 months.
Abbott’s bioresorbable vascular scaffold delivers everolimus, an anti-proliferative drug. Everolimus is 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 treated-site neointimal growth in the coronary vessels following vascular device implantations, due to its anti-proliferative properties.
For more information: www.abbott.com