- The NUGGET trial (NIR Ultimate Gold-Gilded Equivalency
Trial): 6 months post-procedure safety and efficacy results
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- Sigmund Silber, Klinik Dr. H. Müller, Munchen Germany;
- Nikolaus Reifart, Kardiologisches Institut, Bad Soden Germany;
- Marie-Claude Morice, Institut Cardiovasculaire Paris Sud,
Massy France;
- Jurgen Vom Dahl, Rheinisch-Westfalische Hochschule, Aachen
Germany;
- Edouard Benit, UZ Virga Jesse, Hasselt Belgium; Karl-Eugen
Hauptmann, Krankenhaus der Barmherzigen Brüder, Trier Germany;
Eduardo Sousa, Instituto Dante Pazzanese de Cardiologia, Sao
Paolo Brazil; John Webb, St. Paul's Hospital, Vancouver Canada;
Upendra Kaul, Batra Hospital and Medical Research Center, New
Dehli India; Charles Chan, Singapore General Hospital, Singapore
Singapore
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- Circulation, 104, II-623 (2001)
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| Background: Gold
coated stents are radiodense and have been shown to reduce platelet
activation and intimal hyperplasia in animals. Two randomised
trials however revealed inferior outcomes compared with stainless
steel implants and thus these two stents (Devon® and InFlow®)
were taken off the market. The NIROYALä stent was manufactured
with an improved plating process to avoid cracking or peeling
of the gold layer during the stent-expansion, which results in
a bimetallic "battery" and most likely has been the
reason for increased proliferation with the other gold stents.
Objectives: Demonstrate equivalency in the Minimal Lumen Diameter
(MLD) measured by QCA at 6 months post-procedure between NIRä
Stent and the NIROYALä Stent Methods: This is a prospective,
multicentre, randomised, controlled clinical study conducted
in 21 sites in 13 countries worldwide. A total of 603 patients
with ischemic coronary artery disease eligible for a planned
stenting procedure of a single lesion £30mm within a native
coronary artery ^(3)2.5-£ 4.0 mm in lumen diameter were
included. The primary endpoint is the MLD of the target lesion
at 6 months post- procedure. Preliminary results: Between 02
November 1999 and 05 December 2000, 603 patients were enrolled.
Mean age was 61 years, 76% of patients were male, 38% had prior
MI and 18% were diabetic. Mean lesion lengths were 8.9mm±3.6mm
(NIR) and 8.7±3.4mm (NIROYAL). Lesion types in NIR vs.
NIROYAL group: type A: 5.0% vs. 7%, type B1: 41% vs. 38%, type
B2: 54% vs. 55% and type C: 0% vs. 0.4%. Reference diameter pre
2.79mm±0.51mm (NIR) and 2.87mm±0.52mm (NIROYAL).
Minimal Lumen diameter (MLD) pre 0.96mm±0.34mm (NIR) and
1.00mm±0.30mm (NIROYAL), Diameter Stenosis (DS) pre 65%±11%
(NIR) and 65%±9% (NIROYAL). MLD post 2.50mm±0.37mm
(NIR) and 2.69mm±0.40mm (NIROYAL), DS post 16%±6%
(NIR) and 14%±6% (NIROYAL). The 6 months post procedure
safety and efficacy results will be presented at the meeting |
