Abbott initiates clinical trial to evaluate the Absorb™ bioresorbable vascular scaffold compared to a metallic drug eluting stent

Abbott today announced the initiation of ABSORB II, the first randomized, controlled, multi-center clinical trial to evaluate the safety, efficacy and performance of the Absorb™ bioresorbable vascular scaffold (BVS) compared to the company’s XIENCE PRIME™ Everolimus Eluting Coronary Stent System. Approximately 500 patients with coronary artery disease will be enrolled at about 40 investigational sites in Europe andNew Zealand. The first patient was enrolled by Philip MacCarthy, M.D., consultant cardiologist and clinical lead, and Jonathan Hill, M.D., consultant cardiologist, at King’sCollegeHospital inLondon.

Absorb is a bioresorbable scaffold designed to treat a patient’s blocked vessel and then fully dissolve, leaving the vessel free of a permanent metallic implant. Because a permanent implant is not left behind, naturally occurring vessel functions may be restored. Absorb has CE Mark and is authorized for sale inEuropefor the treatment of coronary artery disease. In theUnited States, Absorb currently is investigational and is not available for sale.

“Absorb has the potential to be an important advancement in the field of interventional cardiology, as clinical trials of this dissolvable device to date suggest that a permanent implant may not be needed to restore and maintain blood flow to the heart,” said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands and primary investigator for the ABSORB II clinical trial. “The ABSORB II trial is designed to test unique endpoints to determine the differences between Absorb and a permanent metallic implant, which may provide us with valuable insight into the potential uses of bioresorbable technology in patients with coronary artery disease.”

The ABSORB II clinical trial will enroll approximately 500 patients at about 40 investigational sites in Europe andNew Zealand. Patients will be randomized at a ratio of 2-to-1 (Absorb to XIENCE PRIME). The primary endpoints of the trial are change in dimension of the lumen (interior of the vessel) over time and vasomotion (vessel movement) at the treated vessel segment, which will be assessed based on changes in the vessel diameter in response to a stimulus. Clinical endpoints, including death, myocardial infarction (heart attack), target lesion revascularization, and scaffold/stent thrombosis, will be assessed at 30 and 180 days and at one, two and three years post-treatment. Quality-of-life measures will be assessed prior to treatment, at 180 days and at one, two and three years post-treatment.

“ABSORB II is the first head-to-head study to test our Absorb device compared to XIENCE PRIME, a drug eluting metallic stent, in patients with coronary artery disease,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “This is also the first trial to evaluate clinical endpoints that may be unique to a bioresorbable device, such as measuring the ability of the vessel to respond to normal blood pressure changes. The potential to restore a treated vessel back to a more natural state will also be assessed in this trial.”

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. Studies to date have shown that the Absorb device restores blood flow by opening a blocked vessel and providing support to the vessel until the device dissolves after approximately two years. In January 2011, Abbott announced that Absorb received CE Mark and is authorized for sale inEuropefor the treatment of coronary artery disease. In theU.S., Absorb currently is investigational and is not available for sale.

Abbott has completed one clinical trial called ABSORB and currently is conducting a second trial called ABSORB EXTEND to evaluate the company’s bioresorbable device for the treatment of coronary artery disease. The ABSORB clinical trial, which is the first to evaluate a drug eluting BVS for the treatment of coronary artery disease, is a prospective, non-randomized (open label), two-stage study that was conducted in Europe andNew Zealand.

In the first stage of the trial, 30 patients were enrolled. The five-year results showed no reports of cardiac death, blood clots or ischemia-driven target lesion revascularization. The major adverse cardiac event (MACE) rate at five years was 3.4 percent, with no new events reported between six months and five years. In the second stage of the trial, 101 patients were enrolled. Eighteen-month data from all 101 patients showed no reports of cardiac death or blood clots. Two-year results in 44 patients showed no reports of blood clots and a MACE rate of 6.8 percent. Imaging data at two years showed a late loss of 0.27 mm, which is comparable to the one-year result. Of the patients’ vessels that were assessed for vasomotor function at two years, the majority showed signs of vasomotion, suggesting that vessel movement was observed in the arteries of these patients as their vessels were no longer constrained by the scaffold.

The ABSORB EXTEND trial is a large-scale, single-arm study that will evaluate Absorb in patients at up to 100 centers in Europe, Asia Pacific,CanadaandLatin America. The trial will enroll approximately 1,000 patients with complex coronary artery disease.

Abbott’s BVS 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 XIENCE PRIME

XIENCE PRIME received CE Mark in 2009 and FDA approval in 2011. XIENCE PRIME is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions ≤32 mm) with reference vessel diameters of ≥2.25 mm to ≤4.25 mm. Additional information about XIENCE PRIME, including important safety information, is available at www.xiencestent.com or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_PRIME_Everolimus_Eluting_Coronary_Stent_System.pdf.