Document Detail


First human use of the TAXUS Petal paclitaxel-eluting bifurcation stent.
MedLine Citation:
PMID:  20542797     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: This first human use (FHU) study in bifurcation lesions evaluated safety and feasibility of the TAXUS Petal paclitaxel-eluting dedicated bifurcation stent. METHODS AND RESULTS: This prospective, single-arm, multicentre study had a composite primary endpoint of 30-day death, myocardial infarction (MI), and target vessel revascularisation (TVR). Angiographic and intravascular ultrasound follow-up was at six months with clinical follow-up through five years. Mean age (N=28) was 60.9 + or - 9.3 years and 17.9% of patients had medically treated diabetes. Main branch (MB) lesion length was 13.8 + or - 5.9 mm with 4.4 + or - 2.5 mm in the side branch (SB). TAXUS Petal was successfully implanted in 89.3% of patients (25/28). On a per device basis, 73.5% (25/34) of Petal deployments were successful. The primary endpoint occurred in one patient (3.7%, in-hospital non-Q-wave MI). Through one year, TVR was 11.1%, target lesion revascularisation was 7.4%, and there were no deaths, Q-wave MIs, or stent thromboses. In-segment late loss (n=21) was 0.47 + or - 0.45 mm (proximal MB), 0.41 + or - 0.57 mm (distal MB), and 0.18 + or - 0.39 mm (SB). CONCLUSIONS: The requirement for rotational alignment made delivery of this first generation TAXUS Petal stent challenging and accounted for the relatively low device delivery success. Clinical and angiographic outcomes were satisfactory when successful delivery was achieved.
Authors:
John A Ormiston; Thierry Lefèvre; Eberhard Grube; Dominic J Allocco; Keith D Dawkins
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology     Volume:  6     ISSN:  1969-6213     ISO Abbreviation:  EuroIntervention     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-06-14     Completed Date:  2010-09-28     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  France    
Other Details:
Languages:  eng     Pagination:  46-53     Citation Subset:  IM    
Affiliation:
Mercy Angiography, Mercy Hospital, Auckland, New Zealand. johno@mercyangiography.co.nz
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00497367
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MeSH Terms
Descriptor/Qualifier:
Aged
Angioplasty, Transluminal, Percutaneous Coronary / adverse effects,  instrumentation*,  mortality
Cardiovascular Agents / administration & dosage*
Coronary Angiography
Coronary Artery Disease / diagnosis,  mortality,  therapy*
Drug-Eluting Stents*
Europe
Feasibility Studies
Female
Humans
Male
Middle Aged
Myocardial Infarction
New Zealand
Paclitaxel / administration & dosage*
Prospective Studies
Prosthesis Design
Time Factors
Treatment Outcome
Ultrasonography, Interventional
Chemical
Reg. No./Substance:
0/Cardiovascular Agents; 33069-62-4/Paclitaxel

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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