ACC.17: ABSORB III trial shows stent associated with increased risk of adverse outcomes

New results on Abbott Vascular’s Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) were revealed at this year’s American College of Cardiology (ACC)’s Scientific Session, providing disappointing results for the stent that are consistent with a trend set by previous studies.

The results were presented at ACC on March 18 by Stephen Ellis, MD, the study’s lead author and a cardiologist at the Cleveland Clinic.

The randomized, multicenter trial that included 2,000 patients showed that those who received the Absorb BVS faced an overall elevated risk of adverse outcomes at two years compared to patients that had metal stents when they were placed in smaller vessels.

The results showed that non-inferiority was retained for the span between one and two years, but at 25 months, target lesion failure occurred in 11 percent of patients who had the Absorb BVS compared to 7.9 percent of patient who had the Xience drug-eluting stent.

The morning of the presentation, the U.S. Food and Drug Administration (FDA) published a statement in line with the findings, saying that there is indeed an elevated risk of major adverse cardiac events in patients who received the Absorb BVS compared to those who received the metallic Xience.

Trials on the Absorb BVS have always been high profile for cardiologists in the field because of the major benefits bioresorbable stents offer. They fully dissolve over approximately three years, restore vasomotor function and pulsatility, and allow the heart to function more naturally than it would with a metallic stent, which remains in the body permanently.

Previous trials have been lukewarm in proving that the Absorb BVS works better than a metal stent, but this latest trial suggests that if it used according to FDA guidelines that suggest it only be used in appropriately sized vessels, it should work just as well.

“These results show that this device is generally comparable with the drug-eluting metal stent when the device is placed in appropriately sized vessels and placed using appropriate procedural techniques,” Ellis said.

Though the results are encouraging, Ellis said these results cannot definitively show whether the dissolving scaffold reduces long-term adverse events compared to a permanent metal because the scaffold has not dissolved in most patients yet. It takes about three years.