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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

Identifieur interne : 000952 ( PascalFrancis/Curation ); précédent : 000951; suivant : 000953

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 [Pays-Bas] ; Robert-Jan Van Geuns [Pays-Bas] ; Christian Spaulding [France] ; Stephane Manzo-Silberman [France] ; Karl E. Hauptmann [Allemagne] ; René Spaargaren [France] ; Héctor M. Garcia-Garcia [Pays-Bas] ; Patrick W. Serruys [Pays-Bas] ; Stefan Verheye [Belgique]

Source :

RBID : Pascal:11-0361743

Descripteurs français

English descriptors

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.
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A11 02  1    @1 GEUNS (Robert-Jan Van)
A11 03  1    @1 SPAULDING (Christian)
A11 04  1    @1 MANZO-SILBERMAN (Stephane)
A11 05  1    @1 HAUPTMANN (Karl E.)
A11 06  1    @1 SPAARGAREN (René)
A11 07  1    @1 GARCIA-GARCIA (Héctor M.)
A11 08  1    @1 SERRUYS (Patrick W.)
A11 09  1    @1 VERHEYE (Stefan)
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A14 02      @1 Erasmus MC @2 Rotterdam @3 NLD @Z 2 aut. @Z 7 aut. @Z 8 aut.
A14 03      @1 Cochin Hospital, Assistance Publique Hôpitaux de Paris, France and Paris Descartes University and INSERM U 970 @2 Paris @3 FRA @Z 3 aut. @Z 4 aut.
A14 04      @1 Krankenhaus der Barmherzigen Brüder @2 Trier @3 DEU @Z 5 aut.
A14 05      @1 STENTYS SA @2 Paris @3 FRA @Z 6 aut.
A14 06      @1 ZNA Middelheim @2 Antwerp @3 BEL @Z 9 aut.
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N21       @1 249
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Pascal:11-0361743

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<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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</fA06>
<fA08 i1="01" i2="1" l="ENG">
<s1>Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study</s1>
</fA08>
<fA11 i1="01" i2="1">
<s1>AMOROSO (Giovanni)</s1>
</fA11>
<fA11 i1="02" i2="1">
<s1>GEUNS (Robert-Jan Van)</s1>
</fA11>
<fA11 i1="03" i2="1">
<s1>SPAULDING (Christian)</s1>
</fA11>
<fA11 i1="04" i2="1">
<s1>MANZO-SILBERMAN (Stephane)</s1>
</fA11>
<fA11 i1="05" i2="1">
<s1>HAUPTMANN (Karl E.)</s1>
</fA11>
<fA11 i1="06" i2="1">
<s1>SPAARGAREN (René)</s1>
</fA11>
<fA11 i1="07" i2="1">
<s1>GARCIA-GARCIA (Héctor M.)</s1>
</fA11>
<fA11 i1="08" i2="1">
<s1>SERRUYS (Patrick W.)</s1>
</fA11>
<fA11 i1="09" i2="1">
<s1>VERHEYE (Stefan)</s1>
</fA11>
<fA14 i1="01">
<s1>Onze Lieve Vrouwe Gasthuis</s1>
<s2>Amsterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02">
<s1>Erasmus MC</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>2 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="03">
<s1>Cochin Hospital, Assistance Publique Hôpitaux de Paris, France and Paris Descartes University and INSERM U 970</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="04">
<s1>Krankenhaus der Barmherzigen Brüder</s1>
<s2>Trier</s2>
<s3>DEU</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="05">
<s1>STENTYS SA</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="06">
<s1>ZNA Middelheim</s1>
<s2>Antwerp</s2>
<s3>BEL</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA20>
<s1>428-436</s1>
</fA20>
<fA21>
<s1>2011</s1>
</fA21>
<fA23 i1="01">
<s0>ENG</s0>
</fA23>
<fA43 i1="01">
<s1>INIST</s1>
<s2>27659</s2>
<s5>354000508560620050</s5>
</fA43>
<fA44>
<s0>0000</s0>
<s1>© 2011 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>29 ref.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>11-0361743</s0>
</fA47>
<fA60>
<s1>P</s1>
</fA60>
<fA61>
<s0>A</s0>
</fA61>
<fA64 i1="01" i2="1">
<s0>EuroIntervention</s0>
</fA64>
<fA66 i1="01">
<s0>FRA</s0>
</fA66>
<fC01 i1="01" l="ENG">
<s0>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.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B25</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002B12A03</s0>
</fC02>
<fC02 i1="03" i2="X">
<s0>002B26</s0>
</fC02>
<fC02 i1="04" i2="X">
<s0>002B12A05</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Cardiopathie coronaire</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Coronary heart disease</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Cardiopatía coronaria</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Infarctus du myocarde</s0>
<s2>NM</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Myocardial infarction</s0>
<s2>NM</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Infarto miocardio</s0>
<s2>NM</s2>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Sécurité</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Safety</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Seguridad</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Complication</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Complication</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Complicación</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Evaluation performance</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Performance evaluation</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Evaluación prestación</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Performance</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Performance</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Rendimiento</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Extensible</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Expanding</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Extensible</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Artère coronaire</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Coronary artery</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Arteria coronaria</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Stent</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Stent</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Stent</s0>
<s5>15</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Endoprothèse</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Endoprosthesis</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Endoprotesis</s0>
<s5>16</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Aigu</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>Acute</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA">
<s0>Agudo</s0>
<s5>17</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE">
<s0>Résultat</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG">
<s0>Result</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA">
<s0>Resultado</s0>
<s5>18</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE">
<s0>Métal</s0>
<s2>NC</s2>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG">
<s0>Metal</s0>
<s2>NC</s2>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA">
<s0>Metal</s0>
<s2>NC</s2>
<s5>19</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE">
<s0>Traitement instrumental</s0>
<s5>78</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG">
<s0>Instrumentation therapy</s0>
<s5>78</s5>
</fC03>
<fC03 i1="14" i2="X" l="SPA">
<s0>Tratamiento instrumental</s0>
<s5>78</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Pathologie de l'appareil circulatoire</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Cardiovascular disease</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Aparato circulatorio patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Pathologie du myocarde</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Myocardial disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Miocardio patología</s0>
<s5>38</s5>
</fC07>
<fN21>
<s1>249</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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