A Prospective, observational, Italian multi-center registry of self-aPposing® cOronary Stents in patients presenting with ST-segment Elevation Myocardial InfarcTION: The iPOSITION registry.
ST-segment elevation myocardial infarction
acute myocardial infarction
clinical trials
complex
drug-eluting stent
interventional device/innovation
nitinol stent
percutaneous coronary intervention (PCI)
primary PCI
self-apposing stent
Journal
Cardiology journal
ISSN: 1898-018X
Titre abrégé: Cardiol J
Pays: Poland
ID NLM: 101392712
Informations de publication
Date de publication:
2021
2021
Historique:
received:
20
08
2020
accepted:
24
12
2020
revised:
08
12
2020
pubmed:
5
5
2021
medline:
9
4
2022
entrez:
4
5
2021
Statut:
ppublish
Résumé
Primary percutaneous coronary intervention (pPCI) in ST-segment elevation myocardial infarction (STEMI) can be challenging for high thrombus burden and catecholamine-induced vasoconstriction. The Xposition-S stent was designed to prevent stent undersizing and minimize strut malapposition. We evaluated 1-year clinical outcomes of a nitinol, self-apposing®, sirolimus-eluting stent, pre-mounted on a novel balloon delivery system, in de novo lesions of patients presenting with STEMI undergoing pPCI. The iPOSITION is a prospective, multicenter, post-market, observational study. The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR). The study enrolled 247 STEMI patients from 7 Italian centers. Both device and procedural success occurred in 99.2% of patients, without any death, TV-MI, TLR, or stent thrombosis during the hospital stay and at 30-day follow-up. At 1 year, TLF occurred in 2.6%, cardiac death occurred in 1.7%, TV-MI occurred in 0.4%, and TLR in 0.4% of patients. The 1-year stent thrombosis rate was 0.4%. The use of an X-position S self-apposing® stent is feasible in STEMI pPCI, with excellent post-procedural results and 1-year outcomes.
Sections du résumé
BACKGROUND
Primary percutaneous coronary intervention (pPCI) in ST-segment elevation myocardial infarction (STEMI) can be challenging for high thrombus burden and catecholamine-induced vasoconstriction. The Xposition-S stent was designed to prevent stent undersizing and minimize strut malapposition. We evaluated 1-year clinical outcomes of a nitinol, self-apposing®, sirolimus-eluting stent, pre-mounted on a novel balloon delivery system, in de novo lesions of patients presenting with STEMI undergoing pPCI.
METHODS
The iPOSITION is a prospective, multicenter, post-market, observational study. The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR).
RESULTS
The study enrolled 247 STEMI patients from 7 Italian centers. Both device and procedural success occurred in 99.2% of patients, without any death, TV-MI, TLR, or stent thrombosis during the hospital stay and at 30-day follow-up. At 1 year, TLF occurred in 2.6%, cardiac death occurred in 1.7%, TV-MI occurred in 0.4%, and TLR in 0.4% of patients. The 1-year stent thrombosis rate was 0.4%.
CONCLUSIONS
The use of an X-position S self-apposing® stent is feasible in STEMI pPCI, with excellent post-procedural results and 1-year outcomes.
Identifiants
pubmed: 33942280
pii: VM/OJS/J/70466
doi: 10.5603/CJ.a2021.0045
pmc: PMC8747812
doi:
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
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