TCT 2016: Three-Year ABSORB II Data Fail To Show The Hoped-For Long-Term Benefit Of Bioresorbable Stent
The data, presented Oct. 30 at the TCT Conference in Washington, DC, also showed higher rates of device-related adverse events including myocardial infarction with Abbott’s Absorb bioresorbable stent than a metallic drug-eluting stent, but the study was not powered to show differences in clinical endpoints, so this adverse safety signal must be evaluated in future clinical trials.
You may also be interested in...
A letter to Abbott's customers states that the company will restrict its Absorb bioresorbable stent to registries in Europe while it investigates possible safety issues flagged in clinical trials.
Preliminary two-year results from the randomized AIDA trial comparing Abbott's Absorb GT1 BVS and Abbott's Xience Prime drug-eluting stent found patients treated with Absorb were almost four times as likely to develop a stent thrombosis. The results are the latest in disappointing clinical news for the bioabsorbable scaffold.
Two-year results of the ABSORB III trial, comparing Abbott's Absorb bioresorbable stent to its Xience metal drug-eluting stent, showed a higher risk of target vessel failure with Absorb, prompting the US FDA to send-out a "Dear Doctor" letter reiterating the importance of following the recommended implantation technique.