The TAXUS(R) Stent System Shows Excellent Results In Small Vessels

Main Category: Cardiovascular / Cardiology
Also Included In: Blood / Hematology
Article Date: 13 Feb 2006 - 15:00 PDT

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Boston Scientific announced that the data from its TAXUS Clinical Trial Program, including the Meta Analysis, shows excellent efficacy and safety in treatment of small vessels (<2.5mm diameter).1

The large-scale, Johnson & Johnson-sponsored REALITY study (n=1,353 across 88 centers worldwide) directly compared the TAXUS(R) and CypherTM * Stent systems in small arteries. The REALITY study confirmed the excellent clinical outcomes with the TAXUS(R) Stent system in small vessels 2.

Recently, the de-facto single-centre ISAR SMART study compared Taxus(R) and Cypher(R) Stent systems in small vessels, which included patients with arteries similar in size to REALITY but in less complex lesions. This study, conducted by Professor Adnan Kastrati from the German Heart Centre, Technical University, Munich, Germany, failed to prove non-inferiority of the TAXUS(R) versus the Cypher Stents system in small vessels.3

Dr. Donald Baim, Brigham and Women's Hospital, Boston, MA, commented that the data from the small ISAR SMART study is at odds with the large body of evidence from the TAXUS Clinical Trial program including those data from the small vessel meta-analysis. Dr. Baim further suggested that we should therefore temper the ISAR SMART findings, in which routine angiographic follow-up led to an unheard of ~100% rate of conversion from angiographic restenosis to target lesion revascularization, in the TAXUS arm. "This pattern suggests that the "occulo-stenotic reflex" was at play, compared to the usual picture of a 50% conversion rate," said Dr. Baim.

According to the evidence-based medicine clinical trial scoring system available on TCTmd.com, the ISAR SMART study scores only 3 out of 10 points and its outcomes should therefore not be used to direct clinical practice.4 Prof. Sigmund Silber, author of the scoring system and Chairperson of the European PCI guidelines said "ISAR SMART study does not have a primary clinical endpoint, is a de-facto single-center experience without validation from an external, independent core catheter lab. Thus it is attributed a low score according to the scoring system."

Jeff Goodman, President, International for Boston Scientific commented, "The TAXUS(R) Stent system has excellent outcomes in small vessels based on the rich body of evidence from the TAXUS(R) Clinical Trial Program. The clinical outcomes in small vessels from the SIRIUS ** trial suggest some shortcomings with the Cypher(R) Stent in small vessels.5 "

Coronary Artery Disease is the major cause of premature death and disability in the Western world and most European countries. It is currently responsible for approximately 16 million deaths yearly, which represents one-third of global deaths, a burden predicted to significantly rise to 37% by 2020.6 Small vessel disease accounts for nearly 40%.7 of CAD and its treatment with bare metal stents has been particularly difficult due to problems with reclogging of the arteries.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.

REFERENCES:
1 TAXUS meta-analysis II, IV, V, VI presented by G. Stone at ACC 2005
2 REALITY study presented by M.C. Morice at ACC 2005
3 ISAR SMART is an independent study conducted by Pr Kastrati / Mehilli J, Dibra A, Kastrati A et al. Eur Heart J 2006; online.
4 Silber Score on tctmd.com.
5 SIRIUS 2.25mm - Long data abstract by Jeffrey W. Moses at TCT 2005
6 http://www.medscape.com/viewarticle/480730
7 Morice MC. Stenting for small coronary vessels. J Invasive Cardiol 2003;15:377-379.
* Cypher is a registered trademark of J&J Cordis
** SIRIUS is a trial by J&J, Cordis

http://www.bostonscientific.com

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