Document Detail


Twelve-month outcomes with a paclitaxel-eluting stent transitioning from controlled trials to clinical practice (the WISDOM Registry).
MedLine Citation:
PMID:  17027565     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The WISDOM Registry tracked clinical outcomes in patients receiving a slow-release, polymer-based, paclitaxel-eluting stent during the transition from randomized trials to commercial use in everyday interventional cardiology practice. Although randomized trials of drug-eluting stents have demonstrated the safety and effectiveness of these devices in less complicated, de novo lesions, observation of long-term clinical outcomes is required to monitor safety as use of this revolutionary technology expands to broader patient populations. In total, 778 patients were enrolled at 22 sites in 9 countries where the TAXUS paclitaxel-eluting stent first received market approval. Patients with de novo or restenotic coronary lesions eligible for stenting were enrolled. Clinical follow-up was conducted by telephone at 3, 6, 9, and 12 months after the procedure to capture reported stent thrombosis and major cardiac events (death, myocardial infarction, and reintervention on the target lesion). Clinical follow-up at 12 months was completed for 92% of patients. The 12-month rate of physician-reported major cardiac events was 5.2%, with a target lesion reintervention rate of 2.0%. The low overall stent thrombosis rate of 0.6% included no stent thromboses >30 days after the index procedure. Low target lesion reintervention rates were also observed in the high-risk subgroups: patients with diabetes (4.0%), vessels <2.5 mm (2.5%), lesions >20 mm (3.6%), and multiple stents in a lesion (1.4%). In conclusion, the paclitaxel-eluting TAXUS slow-release stent exhibits long-term safety and efficacy in uncomplicated and higher risk patients and lesions seen in everyday clinical practice.
Authors:
Alexandre Abizaid; Charles Chan; Yean-Teng Lim; Upendra Kaul; Nakul Sinha; Tejas Patel; Huay-Cheem Tan; Julio Lopez-Cuellar; Efrain Gaxiola; Saligram Ramesh; Alfredo Rodriguez; Mary E Russell;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2006-08-31
Journal Detail:
Title:  The American journal of cardiology     Volume:  98     ISSN:  0002-9149     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  2006 Oct 
Date Detail:
Created Date:  2006-10-09     Completed Date:  2006-11-24     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1028-32     Citation Subset:  AIM; IM    
Affiliation:
Instituto de Cardiologia Dante Pazzanese, São Paolo, Brazil. aabizaid@uol.com.br
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MeSH Terms
Descriptor/Qualifier:
Coronary Disease / complications,  mortality,  therapy*
Diabetes Complications
Female
Follow-Up Studies
Humans
Male
Middle Aged
Paclitaxel / administration & dosage*
Prospective Studies
Randomized Controlled Trials as Topic
Registries*
Stents*
Survival Rate
Treatment Outcome
Tubulin Modulators / administration & dosage*
Chemical
Reg. No./Substance:
0/Tubulin Modulators; 33069-62-4/Paclitaxel

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


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