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A Prospective, observational, Italian multi-center registry of self-aPposing® cOronary Stents in patients presenting with ST-segment Elevation Myocardial InfarcTION: The iPOSITION registry

Livio Giuliani, Federico Archilletti, Giuseppe Andò, Serena Rossi, Giorgio Sacchetta, Giuseppe De Iaco, Francesco Saporito, Marco Contarini, Rosario Parisi, Sabina Gallina, Marco Zimarino, Juan Luis Gutiérrez-Chico, Nicola Maddestra
DOI: 10.5603/CJ.a2021.0045
·
Pubmed: 33942280

open access

Ahead of print
Original articles
Published online: 2021-04-23

Abstract

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 (CD), 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 (ST) during the hospital stay and at 30-day follow-up. At 1 year, TLF occurred in 2.6%, CD occurred in 1.7%, TV-MI occurred in 0.4%, and TLR in 0.4% of patients. The 1-year ST 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.

Abstract

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 (CD), 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 (ST) during the hospital stay and at 30-day follow-up. At 1 year, TLF occurred in 2.6%, CD occurred in 1.7%, TV-MI occurred in 0.4%, and TLR in 0.4% of patients. The 1-year ST 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.

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Keywords

acute myocardial infarction, ST-segment elevation myocardial infarction, clinical trials, self-apposing stent, nitinol stent, interventional device/innovation, percutaneous coronary intervention (PCI), complex, primary PCI, drug-eluting stent

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Title

A Prospective, observational, Italian multi-center registry of self-aPposing® cOronary Stents in patients presenting with ST-segment Elevation Myocardial InfarcTION: The iPOSITION registry

Journal

Cardiology Journal

Issue

Ahead of print

Article type

Original Article

Published online

2021-04-23

DOI

10.5603/CJ.a2021.0045

Pubmed

33942280

Keywords

acute myocardial infarction
ST-segment elevation myocardial infarction
clinical trials
self-apposing stent
nitinol stent
interventional device/innovation
percutaneous coronary intervention (PCI)
complex
primary PCI
drug-eluting stent

Authors

Livio Giuliani
Federico Archilletti
Giuseppe Andò
Serena Rossi
Giorgio Sacchetta
Giuseppe De Iaco
Francesco Saporito
Marco Contarini
Rosario Parisi
Sabina Gallina
Marco Zimarino
Juan Luis Gutiérrez-Chico
Nicola Maddestra

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