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ABSORB: Second-generation bioresorbable vascular scaffold safe, efficacious
A second-generation everolimus-eluting bioresorbable vascular scaffold was safe and efficacious from 6 to 24 months, according to results of the ABSORB trial.
The multicenter, single-arm trial found that serial observations at 6 months and 2 years confirmed no late restenosis or unfavorable imaging outcomes.
The study enrolled 45 patients and assessed the bioresorbable vascular scaffold (Absorb, Abbott Vascular) via serial invasive imaging methods of quantitative coronary angiography, IVUS and optical coherence tomography.
Researchers reported that late luminal loss increased from 0.16 ± 0.18 mm to 0.27 ± 0.20 mm as assessed by quantitative coronary angiography, with an increase in neointima of 0.68 ± 0.43 mm2 found by OCT and 0.17 ± 0.26 mm2 found by IVUS. Researchers also emphasized that another cohort study showed a 1-year late loss of 0.27 mm, “potentially suggesting very little progression of neointima during the second year,” they wrote.
Struts that were still recognizable on OCT at 2 years showed 99% of neointimal coverage. There was an increase in mean scaffold area compared with baseline (0.54 ± 1.09 mm2 as detected by IVUS, P=.003; and 0.77 ± 1.33 m2 as detected by OCT, P=.016). The 2-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis.
“At 2 years, the scaffold is still detectable by various imaging modalities,” researchers wrote. “However, its mechanical integrity must have subsided, as indicated by the dynamic vasomotion, and the structural increase in the [scaffold area] is demonstrated by IVUS and OCT. Tissue growth on OCT and IVUS increased between 6 months and 2 years, suggesting an ongoing biological proliferative healing process.”
Disclosure: Ormiston reports no relevant financial disclosures. The trial was funded by Abbott Vascular.