Abbott announced on 24 March, 2009 the initiation of the next phase of the ABSORB clinical trial to evaluate the safety and performance of the company’s fully bioabsorbable drug eluting coronary stent.
This second phase of the ABSORB will enrol approximately 80 patients at 10 centers in Europe, Australia and New Zealand, and will incorporate device enhancements designed to improve deliverability and vessel support. The first patient was enrolled into the second stage of the ABSORB clinical trial at Onze Lieve Vrouw Ziekenhuis Hospital in Aalst, Belgium, by Dr Bernard De Bruyne.
“Interventional cardiology has come a long way. It started with balloon angioplasty, which evolved into bare metal stents and then drug eluting metal stents were created,” said Dr Patrick W Serruys, Erasmus University Hospital, Rotterdam, The Netherlands, and principal investigator of the ABSORB trial. “Now we have the fourth revolution in interventional cardiology technology, and patient outcomes from the first stage of ABSORB clearly show that bioabsorbable devices are the future of coronary artery disease treatment.”
Results from the first stage of the ABSORB trial with 30 patients demonstrated that Abbott’s bioabsorbable everolimus-eluting stent successfully treated coronary artery disease, and that at two years, the treated vessel was able to expand and contract, without being restricted by a permanent implant – indicating that the device was absorbed. In addition, there were no cases of thrombosis out to two years of follow-up, and no new major adverse cardiac events between six months and two years, with the bioabsorbable device demonstrating a major adverse cardiac events rate of 3.6% (one patient) at two years. Major adverse cardiac events is a composite clinical measure of safety and efficacy outcomes, defined as any event that resulted in ischaemia-driven target lesion revascularisation, myocardial infarction or cardiac death.
“Based on the strong clinical outcomes from the first stage of Abbott’s bioabsorbable device trial, interventional cardiologists have been eager to enroll their patients into the second stage of the trial,” said Dr John Ormiston, Mercy Hospital in Auckland, New Zealand, and co-principal investigator in the ABSORB trial. “If the bioabsorbable stent continues to perform well in this trial and subsequent larger trials with more complex narrowings, bioabsorbable device technology may become the new standard of care for patients with coronary artery disease.”