Abbott has announced positive one-year clinical results from ABSORB II, the world’s first prospective, randomised, controlled trial comparing the safety and effectiveness of the dissolving Absorb heart device to Abbott’s metallic Xience family of drug-eluting stents.
The trial, conducted primarily in Europe, included 501 people with coronary artery disease. The results were presented at a late-breaking session at the 26th Transcatheter Cardiovascular Therapeutics (TCT; 13–17 September, Washington, USA).
At one year, overall clinical outcomes for Absorb were comparable to Xience, and people treated with Absorb experienced a significantly lower rate of angina.
“The results of ABSORB II provide international doctors with additional confidence to use Absorb to treat their patients based on randomised clinical data showing that Absorb provides comparable results at one year to a best-in-class metallic drug eluting stent in traditional endpoints,” says Patrick W Serruys, professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, The Netherlands, and principal investigator of the ABSORB II trial. “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.”
At one year, the patient-oriented clinical endpoint of all death, all heart attacks and all revascularisation was 7.3% for Absorb and 9.1% for Xience (p=0.47). The device-oriented clinical endpoint of target lesion failure (TLF) was 4.8% for Absorb and 3.0% for Xience (p=0.35) at one 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 one 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 course of one year, people treated with Absorb were less likely to experience angina once they left the hospital than those treated with Xience, at a rate of 16.4% versus 25.6% (p=0.01), respectively.
The primary endpoint of the ABSORB II trial is vessel motion at three 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 three years. Imaging endpoints, or specialised pictures inside the blood vessel, will be assessed at three years.