Abbott's ABSORB Bioresorbable Vascular Scaffold Demonstrates Positive One-Year Safety and Efficacy Results
- Clinical Results from 101 Patients Show Low MACE Rate, No
Blood Clots and Low Late Loss
- In a Sub-Analysis, Nearly All Patients' Vessels Assessed for Vasomotor Function Showed Signs of Vasomotion at One Year
NEW ORLEANS, April 3, 2011 /PRNewswire/ -- Abbott (NYSE: ABT) today announced positive one-year results from 101 patients enrolled in the second phase of the ABSORB trial evaluating the world's first drug eluting Bioresorbable Vascular Scaffold (BVS) for the treatment of coronary artery disease. These results were presented during the American College of Cardiology's (ACC) 60th Annual Scientific Session and i2 Summit 2011 in New Orleans.
At one year, Abbott's ABSORB device demonstrated a low 6.9 percent rate of major adverse cardiac events(1) (MACE) and no reports of blood clots (thromboses). In an analysis of 56 of the 101 patients, imaging results showed a late loss of 0.27 mm, which is comparable to past data on drug eluting stents. Importantly, of the patients' vessels that were assessed for vasomotor function, nearly all showed signs of vasomotion (constriction or dilation of the vessel) at one year, indicating that vessel movement was observed in the arteries of these patients as their vessels were no longer constrained by the scaffold, which had begun to be metabolized.
"The one-year data in these patients confirm earlier results seen at the six- and nine-month periods – that the ABSORB device has the potential to effectively treat coronary artery disease with the possibility of restoring natural vessel function in a way not possible with permanent metallic implants," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands. "In addition, the one-year late loss seen with ABSORB is similar to what has been seen in a historical series of drug eluting stents, which is an encouraging indication that a bioresorbable scaffold like ABSORB might be able to offer the performance capabilities of a metallic drug eluting stent but with the added benefit of eventually dissolving away."
ABSORB is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. The device is designed to slowly metabolize and eventually be resorbed by the body after providing support to the vessel during the healing process. ABSORB received CE Mark in Europe earlier this year and is not approved or available for sale in the United States.
Since a permanent metallic implant is not left behind, a patient's vessel treated with ABSORB may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. Restoration of these naturally occurring vessel functions, or vascular restoration therapy (VRT), is one of the features that makes ABSORB a significant innovation for patients in the 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.
"The positive one-year clinical results from the ABSORB trial provide support for the clinical performance of the device and its potential to change the way coronary artery disease is treated," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "Abbott is committed to continuing to build the body of clinical evidence supporting this novel therapy, and we are planning additional clinical trials this year."
About the ABSORB Clinical Trials
The ABSORB trial is the first clinical trial evaluating a drug eluting BVS for coronary artery disease, and Abbott is the only company with long-term, four-year clinical data on a complete patient set evaluating the safety and performance of a drug eluting BVS. The ABSORB trial is a prospective, non-randomized (open label), two-phase 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 – major adverse cardiac events (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 BVS device, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12, 18 and 24 months.
Results from the first stage of the ABSORB trial with 30 patients demonstrated that Abbott's BVS successfully treated coronary artery disease and was resorbed into the walls of treated arteries after approximately two years. Patients in this first stage of the ABSORB trial experienced no blood clots (thromboses) out to four years and no new MACE between six months and four years (3.4 percent at four years).
The ABSORB EXTEND trial is a single-arm study that will evaluate patients at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The trial will enroll approximately 1,000 patients with more complex coronary artery disease.
About the ABSORB Bioresorbable Vascular Scaffold
ABSORB is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. The device is designed to restore blood flow by opening a clogged vessel and providing support to the vessel. Once the vessel can remain open without the extra support, ABSORB is designed to slowly metabolize and eventually be resorbed by the body. Since a permanent implant is not left behind, a vessel treated with ABSORB may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. Restoration of these naturally occurring vessel functions is one of the features that makes ABSORB a significant innovation for patients in the treatment of coronary artery disease. ABSORB is currently under development and is not available for sale in the United States.
Abbott's bioresorbable technology 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.
About Abbott Vascular
Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com.
(1) MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction or MI), or retreatment of a lesion (ischemia-driven target lesion revascularization, or ID-TLR).
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Posted: April 2011