Key result
Optimal PSP implantation technique fails to reduce definite scaffold thrombosis with Absorb BVS.
Why the study?
Specific implantation strategies based on predilatation, sizing, and post-dilatation have been proposed for the Absorb bioresorbable vascular scaffold to optimise outcomes, and whether these techniques influence definite scaffold thrombosis and target lesion revascularisation in AIDA trial patients needed evaluation.
Does optimal scaffold implantation technique according to predilatation, sizing, and post-dilatation (PSP) criteria reduce the incidence of definite scaffold thrombosis and target lesion revascularisation in coronary lesions treated with the everolimus-eluting Absorb bioresorbable vascular scaffold?
Cohort (n=869)
QCA readers blinded to events; outcomes adjudicated by an independent clinical events committee
Does optimal scaffold implantation technique according to predilatation, sizing, and post-dilatation (PSP) criteria reduce the incidence of definite scaffold thrombosis and target lesion revascularisation in coronary lesions treated with the everolimus-eluting Absorb bioresorbable vascular scaffold?
In this lesion-level analysis of the AIDA trial, optimal PSP implantation technique did not reduce scaffold thrombosis or target lesion revascularisation with the Absorb bioresorbable vascular scaffold, suggesting operator technique cannot overcome device expansion limits.
PSP implantation did not reduce ScT or TLR in AIDA; challenges prior retrospective data and leaves optimal technique open for prospective evaluation.
AIMS: Specific implantation strategies have been proposed for the Absorb bioresorbable vascular scaffold (Absorb BVS) to optimise outcomes. We aimed to analyse whether the occurrence of definite scaffold thrombosis (ScT) and target lesion revascularisation (TLR) in Absorb-treated AIDA patients was influenced by scaffold implantation techniques. METHODS AND RESULTS: Absorb BVS implantation in 1,074 lesions was graded according to definitions of optimal implantation based on predilatation, sizing, and post-dilatation (PSP). Lesion-oriented outcomes (definite ScT and TLR) that occurred during a median follow-up of 707 days were related to the presence or absence of PSP. Of 1,074 lesions, 158 (14.7%) lesions met PSP criteria. The most prevalent reason for not meeting PSP criteria was inadequate sizing: 863 (94.2%). Definite ScT occurred in four of 158 PSP-treated lesions compared with 27 of 916 non PSP-treated lesions, with two-year KM estimates of 3.0% vs. 4.1% and an HR of 1.14 (p=0.811). TLR occurred in eight of 158 PSP-treated lesions compared with 61 of 916 non PSP-treated lesions, with KM estimates of 5.6% vs. 7.1% and an HR of 1.29 (p=0.492). CONCLUSIONS: In AIDA, lesions that underwent scaffold implantation according to an optimised Absorb BVS implantation technique did not have lower rates of ScT and TLR compared to scaffold-treated lesions that did not meet PSP criteria.
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Kraak et al. (2018) conducted a cohort in Coronary artery disease undergoing PCI with everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) (n=869). Optimal PSP (predilatation, sizing, and post-dilatation) scaffold implantation technique vs. Non-PSP scaffold implantation technique (not meeting PSP criteria) was evaluated on Definite scaffold thrombosis (ScT) at 2 years (PSP-A definition) (HR 1.14, 95% CI 0.40-3.25, p=0.811). Optimal PSP (predilatation, sizing, post-dilatation) implantation of Absorb BVS did not reduce 2-year definite scaffold thrombosis compared to non-PSP implantation (3.0% vs 4.1%; HR 1.14, p=0.811).
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