UnivTrevesV1, PascalFrancis, Corpus, bibRecord, 000397

Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study

Identifieur interne : 000397 ( PascalFrancis/Corpus ); précédent : 000396; suivant : 000398

Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study

Auteurs : Giovanni Amoroso ; Robert-Jan Van Geuns ; Christian Spaulding ; Stephane Manzo-Silberman ; Karl E. Hauptmann ; René Spaargaren ; Héctor M. Garcia-Garcia ; Patrick W. Serruys ; Stefan Verheye

Source :

EuroIntervention [ 1774-024X ] ; 2011.

RBID : Pascal:11-0361743

Descripteurs français

Pascal (Inist)
- Cardiopathie coronaire, Infarctus du myocarde, Sécurité, Complication, Evaluation performance, Performance, Extensible, Artère coronaire, Stent, Endoprothèse, Aigu, Résultat, Métal, Traitement instrumental.

English descriptors

KwdEn :
- Acute, Complication, Coronary artery, Coronary heart disease, Endoprosthesis, Expanding, Instrumentation therapy, Metal, Myocardial infarction, Performance, Performance evaluation, Result, Safety, Stent.

Abstract

Aims: In the setting of ST-elevation myocardial infarction (STEMI), epicardial vasoconstriction and thrombus load may lead to stent undersizing and malapposition after primary percutaneous coronary intervention (PPCI), which can both be responsible for stent thrombosis or restenosis. Aggressive stent deployment can, on the other hand, cause distal embolisation and the no-reflow phenomenon. The purpose of our study was to evaluate the safety and feasibility of a novel self-expanding stent by assessing the clinical, angiographic and intravascular outcomes after stent deployment at three days and at six months follow-up. Methods and results: This prospective, multicentre, non-randomised study enrolled 25 STEMI patients undergoing PPCI; a nitinol, self-expanding, coronary stent (STENTYS® stent; STENTYS, Paris, France) was used in all patients. Angiography and intravascular ultrasound (IVUS) or optical coherence tomography (OCT) were performed immediately after stent deployment, after three days and at six months. Primary safety endpoints were mortality, reinfarction, stent thrombosis and stroke at discharge and at six months. The primary feasibility endpoints were technical, device and procedural success, and stent apposition at three days and six months. Secondary endpoints included distal embolisation, binary restenosis, ischaemia-driven target lesion revascularisation (TLR) and late lumen loss (LLL). There were no adverse events at discharge or at six months. Technical, device and procedural success were 100%, 96% and 96%, respectively. IVUS showed a significant vasodilatation distal to the culprit lesion at three-day follow-up (+19%), with a concordant expansion of the implanted stent (+18%), p≤0.001 for both values. One case of distal embolisation was reported. There were no cases of late stent malapposition at six months. In-stent and in-segment LLL were 0.71±0.71 mm and 0.58±0.61 mm. Binary restenosis was 25%, ischaemia-driven TLR was 12%. Conclusions: This study shows that the use of the STENTYS® self-expanding stent is safe and feasible in STEMI patients. Three days after the procedure, the stent expanded to the same extent as the epicardial vasodilatation and appeared completely apposed to the vessel wall. This could be of benefit in preventing stent thrombosis in the setting of STEMI.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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Format Inist (serveur)

NO :	PASCAL 11-0361743 INIST
ET :	Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study
AU :	AMOROSO (Giovanni); GEUNS (Robert-Jan Van); SPAULDING (Christian); MANZO-SILBERMAN (Stephane); HAUPTMANN (Karl E.); SPAARGAREN (René); GARCIA-GARCIA (Héctor M.); SERRUYS (Patrick W.); VERHEYE (Stefan)
AF :	Onze Lieve Vrouwe Gasthuis/Amsterdam/Pays-Bas (1 aut.); Erasmus MC/Rotterdam/Pays-Bas (2 aut., 7 aut., 8 aut.); Cochin Hospital, Assistance Publique Hôpitaux de Paris, France and Paris Descartes University and INSERM U 970/Paris/France (3 aut., 4 aut.); Krankenhaus der Barmherzigen Brüder/Trier/Allemagne (5 aut.); STENTYS SA/Paris/France (6 aut.); ZNA Middelheim/Antwerp/Belgique (9 aut.)
DT :	Publication en série; Niveau analytique
SO :	EuroIntervention; ISSN 1774-024X; France; Da. 2011; Vol. 7; No. 4; Pp. 428-436; Bibl. 29 ref.
LA :	Anglais
EA :	Aims: In the setting of ST-elevation myocardial infarction (STEMI), epicardial vasoconstriction and thrombus load may lead to stent undersizing and malapposition after primary percutaneous coronary intervention (PPCI), which can both be responsible for stent thrombosis or restenosis. Aggressive stent deployment can, on the other hand, cause distal embolisation and the no-reflow phenomenon. The purpose of our study was to evaluate the safety and feasibility of a novel self-expanding stent by assessing the clinical, angiographic and intravascular outcomes after stent deployment at three days and at six months follow-up. Methods and results: This prospective, multicentre, non-randomised study enrolled 25 STEMI patients undergoing PPCI; a nitinol, self-expanding, coronary stent (STENTYS® stent; STENTYS, Paris, France) was used in all patients. Angiography and intravascular ultrasound (IVUS) or optical coherence tomography (OCT) were performed immediately after stent deployment, after three days and at six months. Primary safety endpoints were mortality, reinfarction, stent thrombosis and stroke at discharge and at six months. The primary feasibility endpoints were technical, device and procedural success, and stent apposition at three days and six months. Secondary endpoints included distal embolisation, binary restenosis, ischaemia-driven target lesion revascularisation (TLR) and late lumen loss (LLL). There were no adverse events at discharge or at six months. Technical, device and procedural success were 100%, 96% and 96%, respectively. IVUS showed a significant vasodilatation distal to the culprit lesion at three-day follow-up (+19%), with a concordant expansion of the implanted stent (+18%), p≤0.001 for both values. One case of distal embolisation was reported. There were no cases of late stent malapposition at six months. In-stent and in-segment LLL were 0.71±0.71 mm and 0.58±0.61 mm. Binary restenosis was 25%, ischaemia-driven TLR was 12%. Conclusions: This study shows that the use of the STENTYS® self-expanding stent is safe and feasible in STEMI patients. Three days after the procedure, the stent expanded to the same extent as the epicardial vasodilatation and appeared completely apposed to the vessel wall. This could be of benefit in preventing stent thrombosis in the setting of STEMI.
CC :	002B25; 002B12A03; 002B26; 002B12A05
FD :	Cardiopathie coronaire; Infarctus du myocarde; Sécurité; Complication; Evaluation performance; Performance; Extensible; Artère coronaire; Stent; Endoprothèse; Aigu; Résultat; Métal; Traitement instrumental
FG :	Pathologie de l'appareil circulatoire; Pathologie du myocarde
ED :	Coronary heart disease; Myocardial infarction; Safety; Complication; Performance evaluation; Performance; Expanding; Coronary artery; Stent; Endoprosthesis; Acute; Result; Metal; Instrumentation therapy
EG :	Cardiovascular disease; Myocardial disease
SD :	Cardiopatía coronaria; Infarto miocardio; Seguridad; Complicación; Evaluación prestación; Rendimiento; Extensible; Arteria coronaria; Stent; Endoprotesis; Agudo; Resultado; Metal; Tratamiento instrumental
LO :	INIST-27659.354000508560620050
ID :	11-0361743

Links to Exploration step

Pascal:11-0361743

Le document en format XML

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<term>Complication</term>
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<term>Coronary heart disease</term>
<term>Endoprosthesis</term>
<term>Expanding</term>
<term>Instrumentation therapy</term>
<term>Metal</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Cardiopathie coronaire</term>
<term>Infarctus du myocarde</term>
<term>Sécurité</term>
<term>Complication</term>
<term>Evaluation performance</term>
<term>Performance</term>
<term>Extensible</term>
<term>Artère coronaire</term>
<term>Stent</term>
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<front><div type="abstract" xml:lang="en">Aims: In the setting of ST-elevation myocardial infarction (STEMI), epicardial vasoconstriction and thrombus load may lead to stent undersizing and malapposition after primary percutaneous coronary intervention (PPCI), which can both be responsible for stent thrombosis or restenosis. Aggressive stent deployment can, on the other hand, cause distal embolisation and the no-reflow phenomenon. The purpose of our study was to evaluate the safety and feasibility of a novel self-expanding stent by assessing the clinical, angiographic and intravascular outcomes after stent deployment at three days and at six months follow-up. Methods and results: This prospective, multicentre, non-randomised study enrolled 25 STEMI patients undergoing PPCI; a nitinol, self-expanding, coronary stent (STENTYS® stent; STENTYS, Paris, France) was used in all patients. Angiography and intravascular ultrasound (IVUS) or optical coherence tomography (OCT) were performed immediately after stent deployment, after three days and at six months. Primary safety endpoints were mortality, reinfarction, stent thrombosis and stroke at discharge and at six months. The primary feasibility endpoints were technical, device and procedural success, and stent apposition at three days and six months. Secondary endpoints included distal embolisation, binary restenosis, ischaemia-driven target lesion revascularisation (TLR) and late lumen loss (LLL). There were no adverse events at discharge or at six months. Technical, device and procedural success were 100%, 96% and 96%, respectively. IVUS showed a significant vasodilatation distal to the culprit lesion at three-day follow-up (+19%), with a concordant expansion of the implanted stent (+18%), p≤0.001 for both values. One case of distal embolisation was reported. There were no cases of late stent malapposition at six months. In-stent and in-segment LLL were 0.71±0.71 mm and 0.58±0.61 mm. Binary restenosis was 25%, ischaemia-driven TLR was 12%. Conclusions: This study shows that the use of the STENTYS® self-expanding stent is safe and feasible in STEMI patients. Three days after the procedure, the stent expanded to the same extent as the epicardial vasodilatation and appeared completely apposed to the vessel wall. This could be of benefit in preventing stent thrombosis in the setting of STEMI.</div>
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<server><NO>PASCAL 11-0361743 INIST</NO>
<ET>Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study</ET>
<AU>AMOROSO (Giovanni); GEUNS (Robert-Jan Van); SPAULDING (Christian); MANZO-SILBERMAN (Stephane); HAUPTMANN (Karl E.); SPAARGAREN (René); GARCIA-GARCIA (Héctor M.); SERRUYS (Patrick W.); VERHEYE (Stefan)</AU>
<AF>Onze Lieve Vrouwe Gasthuis/Amsterdam/Pays-Bas (1 aut.); Erasmus MC/Rotterdam/Pays-Bas (2 aut., 7 aut., 8 aut.); Cochin Hospital, Assistance Publique Hôpitaux de Paris, France and Paris Descartes University and INSERM U 970/Paris/France (3 aut., 4 aut.); Krankenhaus der Barmherzigen Brüder/Trier/Allemagne (5 aut.); STENTYS SA/Paris/France (6 aut.); ZNA Middelheim/Antwerp/Belgique (9 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>EuroIntervention; ISSN 1774-024X; France; Da. 2011; Vol. 7; No. 4; Pp. 428-436; Bibl. 29 ref.</SO>
<LA>Anglais</LA>
<EA>Aims: In the setting of ST-elevation myocardial infarction (STEMI), epicardial vasoconstriction and thrombus load may lead to stent undersizing and malapposition after primary percutaneous coronary intervention (PPCI), which can both be responsible for stent thrombosis or restenosis. Aggressive stent deployment can, on the other hand, cause distal embolisation and the no-reflow phenomenon. The purpose of our study was to evaluate the safety and feasibility of a novel self-expanding stent by assessing the clinical, angiographic and intravascular outcomes after stent deployment at three days and at six months follow-up. Methods and results: This prospective, multicentre, non-randomised study enrolled 25 STEMI patients undergoing PPCI; a nitinol, self-expanding, coronary stent (STENTYS® stent; STENTYS, Paris, France) was used in all patients. Angiography and intravascular ultrasound (IVUS) or optical coherence tomography (OCT) were performed immediately after stent deployment, after three days and at six months. Primary safety endpoints were mortality, reinfarction, stent thrombosis and stroke at discharge and at six months. The primary feasibility endpoints were technical, device and procedural success, and stent apposition at three days and six months. Secondary endpoints included distal embolisation, binary restenosis, ischaemia-driven target lesion revascularisation (TLR) and late lumen loss (LLL). There were no adverse events at discharge or at six months. Technical, device and procedural success were 100%, 96% and 96%, respectively. IVUS showed a significant vasodilatation distal to the culprit lesion at three-day follow-up (+19%), with a concordant expansion of the implanted stent (+18%), p≤0.001 for both values. One case of distal embolisation was reported. There were no cases of late stent malapposition at six months. In-stent and in-segment LLL were 0.71±0.71 mm and 0.58±0.61 mm. Binary restenosis was 25%, ischaemia-driven TLR was 12%. Conclusions: This study shows that the use of the STENTYS® self-expanding stent is safe and feasible in STEMI patients. Three days after the procedure, the stent expanded to the same extent as the epicardial vasodilatation and appeared completely apposed to the vessel wall. This could be of benefit in preventing stent thrombosis in the setting of STEMI.</EA>
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<FD>Cardiopathie coronaire; Infarctus du myocarde; Sécurité; Complication; Evaluation performance; Performance; Extensible; Artère coronaire; Stent; Endoprothèse; Aigu; Résultat; Métal; Traitement instrumental</FD>
<FG>Pathologie de l'appareil circulatoire; Pathologie du myocarde</FG>
<ED>Coronary heart disease; Myocardial infarction; Safety; Complication; Performance evaluation; Performance; Expanding; Coronary artery; Stent; Endoprosthesis; Acute; Result; Metal; Instrumentation therapy</ED>
<EG>Cardiovascular disease; Myocardial disease</EG>
<SD>Cardiopatía coronaria; Infarto miocardio; Seguridad; Complicación; Evaluación prestación; Rendimiento; Extensible; Arteria coronaria; Stent; Endoprotesis; Agudo; Resultado; Metal; Tratamiento instrumental</SD>
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Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study

Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study

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