Procedural findings and early healing response after implantation of a self-apposing bioresorbable scaffold in coronary bifurcation lesions.
Absorbable Implants
Aged
Angina, Stable
/ diagnostic imaging
Coronary Artery Disease
/ diagnostic imaging
Coronary Stenosis
/ diagnostic imaging
Coronary Vessels
/ diagnostic imaging
Feasibility Studies
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention
/ adverse effects
Pilot Projects
Proof of Concept Study
Prospective Studies
Prosthesis Design
Risk Factors
Time Factors
Tomography, Optical Coherence
Treatment Outcome
Wound Healing
Bioresorbable stent
Coronary bifurcations
Optical coherence tomography
Stent fracture
Journal
The international journal of cardiovascular imaging
ISSN: 1875-8312
Titre abrégé: Int J Cardiovasc Imaging
Pays: United States
ID NLM: 100969716
Informations de publication
Date de publication:
Jul 2019
Jul 2019
Historique:
received:
12
02
2018
accepted:
16
01
2019
pubmed:
6
5
2019
medline:
23
7
2019
entrez:
5
5
2019
Statut:
ppublish
Résumé
We aimed to evaluate feasibility, early healing and self-correcting properties of the Desolve 150 bioresorbable scaffold (BRS) implanted in bifurcation lesions, using the simple, provisional side branch (SB) stenting technique. BIFSORB pilot was a proof-of-concept study enrolling 10 patients with stable angina pectoris and a bifurcation lesion with SB ≥ 2.5 mm and less than 50% diameter stenosis. Procedure and 1-month outcome was evaluated by optical coherence tomography (OCT) to assess scaffold performance and healing patterns. Nine patients were treated with Desolve 150 BRS and one delivery to the target bifurcation failed. Thrombus formation in the jailed SB ostium was seen in three cases, but was completely resolved at 1-month. OCT confirmed acute self-correcting properties. No clinical events were reported after six months. Scaffold diameter by OCT increased in the proximal main vessel from 3.09 ± 0.16 mm to 3.34 ± 0.18 mm (p = 0.01) and in distal main vessel from 2.82 ± 0.26 mm to 3.02 ± 0.29 mm (p < 0.01) at one-month follow-up. SB ostial diameter stenosis improved from 42 ± 15% to 34 ± 12% (p = 0.01). Malapposition was effectively reduced after 1 month from 4.1 (1.4; 6.1)% to 0.1 (0; 0.6)% (p = 0.002). Treatment of bifurcation lesions using Desolve 150 BRS was feasible except for a delivery failure and unsettling thrombus formation behind jailing SB struts, which was completely resolved at 1-month. Self-correcting and even self-expanding properties were confirmed.
Identifiants
pubmed: 31053981
doi: 10.1007/s10554-019-01537-5
pii: 10.1007/s10554-019-01537-5
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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