TCT (Transcatheter Cardiovascular Therapeutics) 2014 is the focal point for many news releases, one such announcement coming from Abbott. The company has announced positive one-year clinical results from ABSORB II, the world’s first prospective, randomized, controlled trial comparing the safety and effectiveness of the dissolving Absorb heart device to Abbott’s market-leading metallic XIENCE family of Drug Eluting Stents (DES).
Background
Unlike a metallic stent, which effectively cages the vessel open on a permanent basis, Abbott’s Absorb is more flexible and dissolves over time, leaving behind a treated vessel free of indwelling implant with the potential to flex, pulse and dilate in response to various demands on the heart, based on people’s lifestyle and activities, such as exercise.
The ABSORB II trial, conducted primarily in Europe, included 501 people with coronary artery disease (CAD), the most common form of heart disease. The results were featured at a late-breaking session at the 26th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in Washington D.C.
At one year, overall clinical outcomes for Absorb were comparable to Abbott’s XIENCE metallic DES. Moreover people treated with Absorb experienced a significantly lower rate of angina, a novel and important finding given the impact of angina on people’s quality of life and its cost burden on healthcare systems.
Investigator comments
“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 one year to a best-in-class metallic drug eluting stent in traditional endpoints,” said Patrick W. Serruys, M.D., Ph.D., 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.”
Company comments
“The excitement about a heart device that dissolves after doing its job will continue to increase with these positive results from a randomized, controlled trial showing comparable outcomes between Absorb and XIENCE,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “These data represent a significant milestone for Absorb and show how this unique technology can potentially benefit people with heart disease.”
Source: Abbott Vascular
published: September 15, 2014 in: Abbott, Cardio, Clinical Studies/Trials, Congresses and Meetings