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AIDA: BVS linked to similar rate of TVF, higher rate of device thrombosis vs. metallic stent
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In the investigator-initiated AIDA trial, a bioresorbable vascular scaffold conferred similar risk for target vessel failure but higher risk for device thrombosis compared with a cobalt-chromium everolimus-eluting metallic stent at 2 years.
To assess the performance of the BVS (Absorb, Abbott Vascular) vs. the EES (Xience, Abbott Vascular), the researchers randomly assigned 1,845 patients undergoing PCI representative of those seen in real-world clinical practice (mean age, 64 years; 74% men) to one or the other.
All patients had CAD and at least one target lesion deemed suitable for PCI. Those with target lesions > 70 mm, visually estimated reference vessel diameter < 2.5 mm or > 4 mm, bifurcation lesions or in-stent restenosis were excluded.
The primary outcome was TVF, defined as cardiac death, target vessel MI or target vessel revascularization. Median follow-up was 707 days. The researchers estimated 2-year event rates based on Kaplan-Meier estimates in time-to-event analyses.
Joanna J. Wykrzykowska, MD, PhD, from Heartcenter, Academic Medical Center, University of Amsterdam, and colleagues reported in The New England Journal of Medicine that the primary outcome occurred in 105 patients in the BVS group (2-year cumulative event rate, 11.7%) and in 94 patients in the EES group (2-year cumulative event rate, 10.7%; HR = 1.12; 95% CI, 0.85-1.43).
Two-year cumulative event rates for cardiac death were 2% in the BVS group and 2.7% in the EES group (HR = 0.78; 95% CI, 0.42-1.44); for target vessel MI, they were 5.5% in the BVS group and 3.2% in the EES group (HR = 1.6; 95% CI, 1.01-2.53); and for TVR they were 8.7% in the BVS group and 7.5% in the EES group (HR = 1.16; 95% CI, 0.84-1.62), according to the researchers.
Definite or probable device thrombosis occurred in 31 patients assigned BVS (2-year cumulative event rate, 3.5%) and nine of those assigned EES (2-year cumulative event rate, 0.9%; HR = 3.87; 95% CI, 1.78-8.42).
In a related editorial, Debabrata Mukherjee, MD, from the division of cardiovascular medicine at Texas Tech University Health Sciences Center, El Paso, wrote that the results are consistent with previous meta-analyses, but limitations include that predilation with an appropriately sized balloon and use of IVUS during implantation were not routinely performed.
“The current study extends the concern regarding [BVS] thrombosis to a broader population of patients,” Mukherjee wrote. “Given the lack of an advantage with respect to clinical efficacy, the challenges in delivering the device (including longer procedural times) and the higher rate of device thrombosis with the [BVS], there is little justification for routine use of the everolimus-eluting [BVS] over the [metallic EES].” – by Erik Swain
Disclosure : The study was funded by an unrestricted educational grant from Abbott Vascular. Mukherjee reports no relevant financial disclosures. Wykrzykowska reports receiving a grant and personal fees from Abbott Vascular. Please see the full study for a list of the other researchers’ relevant financial disclosures.
Perspective
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Ajay J. Kirtane, MD, SM
This study is confirmatory to the data that has been presented from the ABSORB series of trials. The fact that these findings remained despite the inclusion criteria is sobering. However, despite these criteria, there were still vessels < 2.5 mm in diameter enrolled in the study, as indicated in the supplementary appendix. That having been said, these findings in some respects are consistent with the overall ABSORB experience, in which the absolute difference in outcomes between stents was greater in the smaller-vessel subset, but the relative differences are similar.
These data, in conjunction with the recently presented ABSORB III results, will certainly give physicians pause. The promise of bioabsorbable stent technologies is in the prevention of late events. At present, we have not followed patients for long enough to see these possible benefits. However, there seems to be enough of an early safety signal to signify that we ought to be fully optimizing implantation techniques with these devices, if we elect to use them.
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