Key result
Implantation of a bioresorbable vascular scaffold resulted in a significantly higher frequency of artifactual plaque volume increase on IVUS compared to an everolimus-eluting metallic stent (53.8% vs. 39.4%, p=0.006).
Why the study?
Does everolimus-eluting bioresorbable vascular scaffold compared to everolimus-eluting metallic stent affect the immediate assessment of plaque/media volume on IVUS?
RCT (n=501)
Single-blind
2:1
Yes
Does everolimus-eluting bioresorbable vascular scaffold compared to everolimus-eluting metallic stent affect the immediate assessment of plaque/media volume on IVUS?
IVUS assessment of plaque/media volume immediately after BVS implantation is artifactually overestimated compared to EES due to differences in device volume and ultrasound backscattering, requiring specific methodological adjustments.
IVUS plaque assessments immediately post-BVS require artifact correction; extends imaging-device interaction concerns to randomized stent comparisons.
The purpose of the study to assess the comparability of immediate changes in plaque/media volume (PV) on three modalities of intravascular ultrasound (IVUS) after implantation of either bioresorbable vascular scaffold (BVS) or everolimus-eluting metallic stent (EES) in Absorb II Study. The two devices have different device volume and ultrasound backscattering that may interfere with the "plaque/media" assessed by three modalities on IVUS: grayscale, backscattering of radiofrequency and brightness function. In a multicenter randomized controlled trial, 501 patients with stable or unstable angina underwent documentary IVUS pre- and post- implantation. The change in plaque/media volume (PV) was categorized into three groups according to the relative PV change in device segment: PV "increased" >+5% (PVI), PV unchanged ±5% (PVU), and PV decreased <-5% (PVD). The change in PV was re-evaluated three times: after subtraction of theoretical device volume, after analysis of echogenicity based on brightness function. In 449 patients, 483 lesions were analyzed pre- and post-implantation. "PVI" was more frequently observed in BVS (53.8%) than EES group (39.4%), p = 0.006. After subtraction of the theoretical device volume, the frequency of "PVI" decreased in both BVS (36.2%) and EES (32.1%) groups and became comparable (p = 0.581). In addition, the percentage of "PVI" was further reduced in both device groups after correction for either radiofrequency backscattering (BVS 34.4% vs. EES 22.6%) or echogenicity (BVS 25.2% vs. EES 9.7%). PV change in device segment was differently affected by BVS and EES devices implantation due to their differences in device volume and ultrasound backscattering. It implies that the lumen volume was also artifactually affected by the type of device implanted. Comparative IVUS assessment of lumen and plaque/media volume changes following implantation of BVS and EES requires specific methodological adjustment.
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Zeng et al. (2016) conducted an RCT in Stable or unstable angina (n=501). Bioresorbable vascular scaffold (BVS) vs. Everolimus-eluting metallic stent (EES) was evaluated on Plaque volume increased >+5% (PVI) immediately after implantation (p=0.006). Implantation of a bioresorbable vascular scaffold resulted in a significantly higher frequency of artifactual plaque volume increase on IVUS compared to an everolimus-eluting metallic stent (53.8% vs. 39.4%, p=0.006).
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