Original Article
The impact of the 3-year ABSORB II trial results on my clinical practice: an Italian survey
Abstract
Background: To evaluate how the 3-year results from the “A clinical evaluation to compare the safety, efficacy and performance of ABSORB everolimus eluting bioresorbable vascular scaffold (BVS) system against XIENCE everolimus eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions” (ABSORB II) trial have influenced clinical practice among Italian interventional cardiologists.
Methods: We performed a survey among 95 interventional cardiologists sending a brief questionnaire by electronic mail. We collected 65 replies and analysed the data.
Results: The opinion of the operators regarding the two main endpoints of the study ABSORB II was conflicting. However, 66% of the operators considered at least one of the two co-primary endpoints (late lumen loss or vasomotion) unreliable and not reflecting clinical practice. Asking about an explanation for the negative results of the study, we found that the 91% of the operators considered the implantation technique the main limit of the ABSORB II. Furthermore, 74% of the operators affirmed that the results from the study did not decrease the number of scaffold implanted in their cath-lab.
Conclusions: Absorb II trial did not influence clinical practice among Italian interventional cardiologists mainly due to the overall idea that the co-primary endpoints were not adequate to provide a robust evidence on device clinical safety and also because the lack of experience on device implantation may have influenced the outcomes.
Methods: We performed a survey among 95 interventional cardiologists sending a brief questionnaire by electronic mail. We collected 65 replies and analysed the data.
Results: The opinion of the operators regarding the two main endpoints of the study ABSORB II was conflicting. However, 66% of the operators considered at least one of the two co-primary endpoints (late lumen loss or vasomotion) unreliable and not reflecting clinical practice. Asking about an explanation for the negative results of the study, we found that the 91% of the operators considered the implantation technique the main limit of the ABSORB II. Furthermore, 74% of the operators affirmed that the results from the study did not decrease the number of scaffold implanted in their cath-lab.
Conclusions: Absorb II trial did not influence clinical practice among Italian interventional cardiologists mainly due to the overall idea that the co-primary endpoints were not adequate to provide a robust evidence on device clinical safety and also because the lack of experience on device implantation may have influenced the outcomes.
