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ABSORB: Second generation bioresorbable stent demonstrates improvement
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Coverage from the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting
The first generation of the bioresorbable everolimus-eluting coronary stent, which showed signs of shrinkage at 6 months, ultimately led to late luminal loss. Alterations in the manufacturing process and new design modifications have resulted in improvements in results reported from a second cohort of the ABSORB trial.
The updated results were reported by John A. Ormiston, MB, ChB, of Green Lane and Mercy Hospital in Auckland, New Zealand, and Patrick W. Serruys, MD, PhD, of Erasmus Medical Center in Rotterdam, the Netherlands.
Cohort A, a prospective, open-label, first-in-man registry, consisted of 30 patients with single de novo native lesions who received either a 3 × 12 mm or a 3 × 18 mm bioresorbable everolimus-eluting coronary stent (BVS, Abbott Vascular). The intent-to-treat population included 29 patients who were followed for 3 years.
2-year outcomes
Ormiston said that at 2 years, one ischemia-driven major adverse CV event occurred in the intent-to-treat population, and this number remained the same through year 3. There were no cardiac deaths or ischemia-driven target lesion revascularizations at 3 years, but there was one non-Q-wave MI. Two non-cardiac deaths occurred at year 3.
Late lumen loss, attributed mainly to scaffold shrinkage, was 0.43 mm, accompanied by an analysis by IVUS showed significant decreases in lumen area and minimal lumen area, and an increase in plaque area at 6 months. The researchers reported increases in lumen area and minimal lumen area and a decrease in plaque area at the 2-year time point.
Generation 2.0
Alterations in the manufacturing process of the stent polymer, coupled with geometric modifications in the platform design of the everolimus-eluting
stent, were associated with favorable results among patients in cohort B, according to Serruys. In-stent proximal late lumen loss was 0.07 mm, distal late lumen loss was 0.07 mm and in-scaffold late lumen loss was 0.19 mm, according to the researchers.
The cohort was split into two groups: group B1 consisted of 45 patients followed from baseline to 6 and 24 months; group B2 consisted of 56 patients followed from baseline to 12 and 24 months. Data presented at TCT 2010 were collected through 6 months for patients in the intent-to-treat group of cohort B1.
Data from quantitative optical coherence tomography were available for 25 patients and showed a 2.67% increase in mean scaffold area and an increase in percentage area of stenosis (from 19% to 24%; P=.03) from the time of intervention out to 180 days.
Quantitative IVUS data were available for 37 patients, among whom the mean scaffold area decreased by 2% from intervention to 180 days. Percentage lumen area of stenosis also increased from 17% to 19% during the same time period, although the difference did not attain statistical significance (P=.24).
“The current promising results … certainly justifies the prospect of a randomized trial comparing a metallic DES [drug-eluting stent] with this drug-eluting bioresorbable scaffold,” Serruys concluded.
Disclosures:
- Dr. Ormiston reports being on an advisory board of and receiving honoraria from Abbott Vascular and Boston Scientific.