A related editorial notes that results from a previous study (ABSORB III) have also shown a higher rate of device thrombosis with the Absorb everolimus-eluting bioresorbable vascular scaffold, when compared to an everolimus-eluting metallic stent. The FDA issued a safety alert based on these findings.
The current report is a preliminary analysis from the AIDA trial, which the data and safety monitoring board recommended due to the identified safety concerns. The bioresorbable scaffold was associated with an increased incidence of device thrombosis throughout the 2 years of follow-up (3.5% vs. 0.9%; HR 3.87; 95% CI 1.78 to 8.42; P<0.001).
The author of the editorial says that the results of this study have ‘major implications for the practitioner’. It extends concerns to a broader population of patients and they suggest that ‘there is little justification for routine use of the everolimus-eluting bioresorbable scaffold over the everolimus-eluting metallic stent’. If it is to be used, they suggest that it only be used in patients who can adhere to dual antiplatelet therapy for an extended period, possibly up to 3 years, without unacceptable side effects. This however will come at the cost of a higher risk of bleeding, which will further attenuate any potential longer-term benefits of currently available bioresorbable scaffolds.