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A Polylactide Bioresorbable Scaffold Eluting Everolimus for Treatment of Coronary Stenosis: 5-Year Follow-Up
- Source :
- Journal of the American College of Cardiology. 67(7)
- Publication Year :
- 2015
-
Abstract
- Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown.This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation.In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging.Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 ± 19 mm vs. 0.13 ± 0.33 mm; p = 0.7953; B2: 0.23 ± 0.28 mm vs. 0.18 ± 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 ± 0.20 mm versus 0.15 ± 0.24 mm (p = 0.8275) for B1 and 0.30 ± 0.37 mm versus 0.32 ± 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 ± 0.97 mm(2) at 6 months to 4.89 ± 1.81 mm(2) at 5 years (p = 0.04), but remained unchanged in B2 (4.95 ± 0.91 mm(2) at 1 year to 4.84 ± 1.28 mm(2) at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 ± 1.28 mm(2) at 6 months to 3.65 ± 1.39 mm(2) at 5 years (p = 0.01), but remained unchanged in B2, 4.35 ± 1.09 mm(2) at 1 year and 4.12 ± 1.38 mm(2) at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis.At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).
- Subjects :
- Male
Time Factors
Tissue Scaffolds
Incidence
Polyesters
Coronary Stenosis
Drug-Eluting Stents
Middle Aged
Coronary Angiography
Prosthesis Design
Coronary Vessels
Europe
Survival Rate
Postoperative Complications
Treatment Outcome
Cause of Death
Absorbable Implants
Humans
Female
Everolimus
Immunosuppressive Agents
Tomography, Optical Coherence
Ultrasonography, Interventional
Aged
Follow-Up Studies
Subjects
Details
- ISSN :
- 15583597
- Volume :
- 67
- Issue :
- 7
- Database :
- OpenAIRE
- Journal :
- Journal of the American College of Cardiology
- Accession number :
- edsair.pmid..........17d72c9863a3e1c63c43945d6e6315aa