One-Year ABSORB II Data Support Abbott's Absorb Bioresorbable Vascular Scaffold

September 14, 2014—Abbott Vascular announced 1-year clinical results from the ABSORB II prospective randomized controlled trial comparing the safety and effectiveness of Abbott’s Absorb coronary bioresorbable vascular scaffold (BVS) to the company’s Xience family of drug-eluting stents. Principal Investigator Patrick W. Serruys, MD, presented the results at a late-breaking trial session at the 26th Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

The trial, which was primarily conducted in Europe, included 501 patients with coronary artery disease.

According to Abbott Vascular, the overall clinical outcomes at 1 year for Absorb were comparable to Xience. Patients treated with Absorb experienced a significantly lower rate of angina, a novel finding given the impact of angina on quality of life and its cost burden on health care systems. 

Abbott Vascular advised that the primary endpoint of the ABSORB II trial was vessel motion at 3 years, at which time, Absorb has fully dissolved. Without a permanent stent caging the vessel, the vessel has the potential to return to a more natural state. Clinical endpoints and quality of life measures will be assessed annually for up to 3 years. Imaging endpoints, or specialized pictures inside the blood vessel, will be assessed at 3 years. 
 
Prof. Serruys, who is Professor of Interventional Cardiology at the Thoraxcentre, Erasmus University Hospital in Rotterdam, the Netherlands, commented in Abbott’s press release, “The results of ABSORB II provide international doctors with additional confidence to use Absorb to treat their patients based on randomized clinical data showing that Absorb provides comparable results at 1 year to a best-in-class metallic drug-eluting stent in traditional endpoints. Additionally, the lower rate of chest pain observed in people treated with Absorb is a promising finding that shows that Absorb may offer people unique quality of life benefits beyond the excellent clinical outcomes already offered with drug eluting stents.”
 
As summarized by Abbott Vascular, the patient-oriented clinical endpoint of all death, all heart attacks, and all revascularization was 7.3% for Absorb and 9.1% for Xience (P = .47) at 1 year. The device-oriented clinical endpoint of target lesion failure was 4.8% for Absorb and 3% for Xience (P = .35) at 1 year. The individual components of these composite endpoints were also comparable between the two treatment groups. The rates of stent thrombosis observed for Absorb at 1 year were low at 0.6% for definite stent thrombosis and 0.9% for definite/probable stent thrombosis.  

The data also showed that during the 1 year follow-up, patients treated with Absorb were less likely to experience angina once they left the hospital than those treated with Xience (16.4% vs 25.6%; P = .01).

The company noted that angina has a significant impact on quality of life and health care costs. Patients who have angina after a coronary stenting procedure use more health care resources, including additional diagnostic and treatment tools to try to identify the source of angina, than those without angina. In addition, they typically have a lower quality of life because they are less likely to lead active lifestyles than those without angina. Therefore, reducing the burden of angina could help people live healthier lives and reduce costs to the health care system, stated Abbott Vascular. 

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. In January 2011, Abbott announced European CE Mark approval for the Absorb BVS, which is available in more than 60 countries worldwide.