The NUGGET study: NIR ultra gold‐gilded equivalency trial
Identifieur interne : 000953 ( Istex/Checkpoint ); précédent : 000952; suivant : 000954The NUGGET study: NIR ultra gold‐gilded equivalency trial
Auteurs : Nicolaus Reifart [Allemagne] ; Marie-Claude Morice [France] ; Sigmund Silber [Allemagne] ; Edouard Benit [Belgique] ; K. E. Hauptmann [Allemagne] ; Eduardo De Sousa [Brésil] ; John Webb [Canada] ; Upendra Kaul [Inde] ; Charles Chan [Singapour] ; Leif Thuesen [Danemark] ; Giulio Guagliumi [Italie] ; Michael Cobaugh [Allemagne] ; Keith Dawkins [Royaume-Uni]Source :
- Catheterization and Cardiovascular Interventions [ 1522-1946 ] ; 2004-05.
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Abstract
This study should clarify whether the gold‐coated NIROYAL stent is equivalent to the stainless steel NIR stent. Patients were randomized to either NIR stent (n = 298) or a NIROYAL stent (n = 305). The primary endpoint was the minimum lumen diameter of the target lesion at 6 months postprocedure. Secondary endpoints focused on clinical events. At 30 days, adverse events were similar in both groups. At 6 months, the minimal lumen diameter was 1.83/1.64 mm (P < 0.001; 95% CI = 0.08–0.30) and the angiographic restenosis rate was 20.6%/37.7% (P < 0.001; 95% CI = −24.7 to −9.3) for NIR/NIROYAL. The 6‐month MACE rates were NIR 7.4% and NIROYAL 10.5% (95% CI = −7.7 to 1.4). Compared to stainless steel stent, the NIROYAL stent demonstrated a smaller minimal lumen diameter, a higher late loss (i.e., higher neointimal hyperplasia in spite of a significantly better initial gain), with higher restenosis and similar MACE rates at 6 months. Catheter Cardiovasc Interv 2004;62:18–25. © 2004 Wiley‐Liss, Inc.
Url:
DOI: 10.1002/ccd.20026
Affiliations:
- Allemagne, Belgique, Brésil, Canada, Danemark, France, Inde, Italie, Royaume-Uni, Singapour
- Bavière, District de Haute-Bavière, État de São Paulo, Île-de-France
- Antony, Munich, São Paulo
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Cardiovasc. Intervent.</title><idno type="ISSN">1522-1946</idno><idno type="eISSN">1522-726X</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2004-05">2004-05</date><biblScope unit="volume">62</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="18">18</biblScope><biblScope unit="page" to="25">25</biblScope></imprint><idno type="ISSN">1522-1946</idno></series><idno type="istex">3E98A932D5F6F9DFA3D2257A763ED6880C9C002C</idno><idno type="DOI">10.1002/ccd.20026</idno><idno type="ArticleID">CCD20026</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1522-1946</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>angiography</term><term>gold</term><term>restenosis</term><term>stent</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This study should clarify whether the gold‐coated NIROYAL stent is equivalent to the stainless steel NIR stent. Patients were randomized to either NIR stent (n = 298) or a NIROYAL stent (n = 305). The primary endpoint was the minimum lumen diameter of the target lesion at 6 months postprocedure. Secondary endpoints focused on clinical events. At 30 days, adverse events were similar in both groups. At 6 months, the minimal lumen diameter was 1.83/1.64 mm (P < 0.001; 95% CI = 0.08–0.30) and the angiographic restenosis rate was 20.6%/37.7% (P < 0.001; 95% CI = −24.7 to −9.3) for NIR/NIROYAL. The 6‐month MACE rates were NIR 7.4% and NIROYAL 10.5% (95% CI = −7.7 to 1.4). Compared to stainless steel stent, the NIROYAL stent demonstrated a smaller minimal lumen diameter, a higher late loss (i.e., higher neointimal hyperplasia in spite of a significantly better initial gain), with higher restenosis and similar MACE rates at 6 months. Catheter Cardiovasc Interv 2004;62:18–25. © 2004 Wiley‐Liss, Inc.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>Brésil</li><li>Canada</li><li>Danemark</li><li>France</li><li>Inde</li><li>Italie</li><li>Royaume-Uni</li><li>Singapour</li></country><region><li>Bavière</li><li>District de Haute-Bavière</li><li>État de São Paulo</li><li>Île-de-France</li></region><settlement><li>Antony</li><li>Munich</li><li>São Paulo</li></settlement></list><tree><country name="Allemagne"><noRegion><name sortKey="Reifart, Nicolaus" sort="Reifart, Nicolaus" uniqKey="Reifart N" first="Nicolaus" last="Reifart">Nicolaus Reifart</name></noRegion><name sortKey="Cobaugh, Michael" sort="Cobaugh, Michael" uniqKey="Cobaugh M" first="Michael" last="Cobaugh">Michael Cobaugh</name><name sortKey="Hauptmann, K E" sort="Hauptmann, K E" uniqKey="Hauptmann K" first="K. E." last="Hauptmann">K. E. Hauptmann</name><name sortKey="Reifart, Nicolaus" sort="Reifart, Nicolaus" uniqKey="Reifart N" first="Nicolaus" last="Reifart">Nicolaus Reifart</name><name sortKey="Silber, Sigmund" sort="Silber, Sigmund" uniqKey="Silber S" first="Sigmund" last="Silber">Sigmund Silber</name></country><country name="France"><region name="Île-de-France"><name sortKey="Morice, Marie Laude" sort="Morice, Marie Laude" uniqKey="Morice M" first="Marie-Claude" last="Morice">Marie-Claude Morice</name></region></country><country name="Belgique"><noRegion><name sortKey="Benit, Edouard" sort="Benit, Edouard" uniqKey="Benit E" first="Edouard" last="Benit">Edouard Benit</name></noRegion></country><country name="Brésil"><region name="État de São Paulo"><name sortKey="De Sousa, Eduardo" sort="De Sousa, Eduardo" uniqKey="De Sousa E" first="Eduardo" last="De Sousa">Eduardo De Sousa</name></region></country><country name="Canada"><noRegion><name sortKey="Webb, John" sort="Webb, John" uniqKey="Webb J" first="John" last="Webb">John Webb</name></noRegion></country><country name="Inde"><noRegion><name sortKey="Kaul, Upendra" sort="Kaul, Upendra" uniqKey="Kaul U" first="Upendra" last="Kaul">Upendra Kaul</name></noRegion></country><country name="Singapour"><noRegion><name sortKey="Chan, Charles" sort="Chan, Charles" uniqKey="Chan C" first="Charles" last="Chan">Charles Chan</name></noRegion></country><country name="Danemark"><noRegion><name sortKey="Thuesen, Leif" sort="Thuesen, Leif" uniqKey="Thuesen L" first="Leif" last="Thuesen">Leif Thuesen</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Guagliumi, Giulio" sort="Guagliumi, Giulio" uniqKey="Guagliumi G" first="Giulio" last="Guagliumi">Giulio Guagliumi</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Dawkins, Keith" sort="Dawkins, Keith" uniqKey="Dawkins K" first="Keith" last="Dawkins">Keith Dawkins</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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