Key result
Absorb BVS yields similar 2-year target vessel failure rates compared to Xience EES.
Why the study?
Patients with acute coronary syndrome might represent a specific subgroup in which bioresorbable scaffold implantation could lead to better outcomes compared to metallic drug eluting stents.
Does the Absorb bioresorbable vascular scaffold improve 2-year clinical outcomes compared to the Xience everolimus-eluting stent in patients presenting with or without acute coronary syndrome?
RCT (n=1,845)
Single-blind
Centralized web-based system in random block sizes
Yes
Does the Absorb bioresorbable vascular scaffold improve 2-year clinical outcomes compared to the Xience everolimus-eluting stent in patients presenting with or without acute coronary syndrome?
The Absorb bioresorbable vascular scaffold does not improve target vessel failure compared to the Xience everolimus-eluting stent and is associated with a higher risk of device thrombosis, regardless of whether patients present with or without acute coronary syndrome.
BACKGROUND: Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI), might lead to better outcomes when compared to conventional treatment with metallic drug eluting stents. In this prespecified subgroup analysis of the Amsterdam Investigator-Initiated Absorb Strategy All-Comers (AIDA) trial, we evaluated the clinical outcomes of Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES) treated patients presenting either with or without ACS. METHODS AND RESULTS: We classified AIDA patients on the basis of clinical presentation of ACS or of no-ACS. The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; P = 0.49) and in no-ACS patients (11.7% versus 10.7%, respectively; P = 0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7%, respectively, P = 0.03) as well as in no-ACS patients (2.4% versus 0.2%, respectively; P = 0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17). CONCLUSION: In the AIDA trial, the 2-year outcomes of PCI with Absorb BVS versus Xience EES were consistent in ACS and no-ACS patients: similar rates for TVF and consistently higher rates of definite or probable stent thrombosis under Absorb BVS versus Xience EES. There were no statistically significant interactions between clinical presentation and randomized device modality.
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Tijssen et al. (2019) conducted an RCT in Coronary artery disease (n=1,845). Absorb bioresorbable vascular scaffold vs. Xience everolimus-eluting stent was evaluated on Target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization) at 2 years in patients with acute coronary syndrome (p=0.49). The Absorb bioresorbable vascular scaffold resulted in similar 2-year rates of target vessel failure compared to the Xience everolimus-eluting stent in both acute coronary syndrome (10.2% vs 9.0%) and stable coronary disease patients (11.7% vs 10.7%).
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