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Special Edition - October 2006

This special issue of MIB NewsTips has been released in response to two important developments:

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New MedIntelliBase™ Alerts - Stay up-to-date by email on relevant industry publications and announcements as they occur

Link of the Month
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Drug-eluting stents (DES) - is there additional risk of late stent thrombosis when compared with bare metal stents?

In light of the recent controversial studies and presentations regarding the long-term safety of today's drug-eluting stents, we at The Next Phase wish to present a brief summary of this important subject:

Dr. Renu Virmani, FACC, a pathologist and medical director of CVPath, International Registry of Pathology, Maryland, has voiced the possibility of problems with widespread DES use for several years, and with her colleagues has recently published findings in the Journal of the American College of Cardiology (2006;48:193-202). She warns that in real-world practice patients are often times more complex than those observed in initial DES approval trials. In real-world patients the risk of late thrombosis resulting from DES use is increased over bare metal stents (BMS).

Several studies support the sentiments of Dr. Virmani, including the BASKET LATE trial (Late Clinical Events Related to Late Stent Thrombosis After Stopping Clopidogrel) discussed here and a second meta-analysis described below. BASKET LATE results reported at the 2006 American College of Cardiology (ACC) meeting showed that there is a significant increase in the incidence of cardiac death or MI in DES patients (n=499) as compared to BMS patients (n=244) following the discontinuation of clopidogrel (cardiac death or MI: 4.9% vs. 1.3%, p=0.01; MI: 4.1% vs. 1.3%, p=0.04). These clinical events are thought to be often related to stent thrombosis, however there was no statistically significant difference between DES and BMS patients (2.6% vs. 1.3%, p = 0.23) despite late stent thrombosis occurring twice as often in DES patients.

Results from a meta-analysis of first-generation DES versus BMS presented at the 2006 European Society of Cardiology (ESC) meeting focused on rates of death or Q-wave MI. All available data from manufacturer-supported randomized trials were evaluated including 878 sirolimus-eluting stent (SES) patients and 1,685 paclitaxel-eluting stent (PES) patients. The rate of death or Q-wave MI in SES patients was significantly higher than BMS patients (6.3% vs. 3.9%, p=0.03), and though not statistically significant a higher rate of death or Q-wave MI was observed in PES patients (2.6% vs. 2.3%, p=0.68).

On the other hand, DES manufacturers Boston Scientific and Cordis have recently emphasized data maintaining the safety and effectiveness of their respective drug-eluting stents. For example, Boston Scientific notes that the 3-year cumulative data from TAXUS pivotal trials (II and IV) demonstrate no statistically significant increase in death and MI (5.7%) versus BMS (5.3%, p=0.63) for the TAXUS Express stent. 3-year cumulative data from the RAVEL, SIRIUS, and E-SIRIUS trials also demonstrate no significant increase in death and MI (6.0%) versus BMS (4.0%, p=0.06) for the Cypher stent. These data help support the claim that the risk vs. benefit ratio are in favor of DES as very similar safety outcomes are observed with a significantly reduced rate of Target Lesion Revascularization (TLR).

On September 14, 2006 the FDA released a statement noting that it believes DES remain safe and effective when used for the FDA-approved indications. The FDA mentions in its statement that it has been closely monitoring DES since they were approved in 2003, and acknowledges that new data has recently suggested a small, significant increase in the risk of stent thrombosis following DES placement.

While important questions have been raised by the new data, the FDA states there is not enough information to draw conclusions on the rate or cause of DES thrombosis, the circumstances under which it occurs, or the risk of occurrence in a given patient. In addition to meeting with Cordis and Boston Scientific, the FDA plans to convene a public panel meeting of outside scientific experts to thoroughly review all data and consider recommendations about appropriate actions, including possible additional studies or labeling changes.

With these issues in mind, recall the independent predictors of cumulative stent thrombosis as reported in the Journal of the American Medical Association (2005;293:2126-30). They include:
  • Premature discontinuation of antiplatelet therapy
  • Renal failure
  • Bifurcation lesion
  • Diabetes
  • Low LVEF

More specifically, stent length is a predictor of subacute stent thrombosis, while neither renal failure nor diabetes predicts late stent thrombosis. It is also speculated by Dr. Virmani and others that late stent thrombosis could be linked to local over-effectiveness of drugs at specific sites where endothelialization does not occur. She has stated that compared to variables such as stent length, the number of uncovered struts is the best predictor of thrombosis in her studies.

These recent findings suggest that today's DES may not be the ideal solution for the wide variety of cases originally envisioned. As an example, the BASKET trial results suggested that BMS should be used in patients with vessels larger than 3.0mm. Further studies with large patient populations are being conducted to help answer the numerous questions being raised today.

On a final note, many of the factors thought to cause stent thrombosis are being considered by manufacturers of second generation of DES such as Conor, Biotronik, and Medtronic. For example, absorbable polymers and fully absorbable stents are being developed to address the issue of endothelialization.

Interested in keeping up to date on this issue? Is there another specific area of interest where you need current, timely information? Click here to learn more about our MIB Alerts and MarketTracks - A Better Way to stay up to date.

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New Carotid Artery Disease (CAD) treatment for high-risk patients

Cordis Endovascular announced on September 27, 2006 that it has received approval from the FDA to market its Precise® Nitinol Stent and Angioguard™ Emboli Capture Guidewire to treat carotid artery disease (CAD). FDA approval of the Cordis carotid system was announced at the 2006 Vascular Interventional Advances (VIVA) meeting in Las Vegas. Precise and Angioguard are approved to treat carotid artery disease in patients at high risk for adverse events from carotid endarterectomy (CEA).

Carotid Artery Stenting (CAS) is a minimally-invasive procedure intended to improve circulation to the brain while helping prevent debris from entering cerebral blood flow.  CAS is an important alternative for patients who are ineligible, or at high risk, for the invasive procedure CEA. The Precise/Angioguard combination is the only carotid system currently backed by a large, randomized clinical trial (SAPPHIRE) to support the potential benefits of CAS in patients at high-risk for CEA. The Cordis carotid system has been studied in over 3,000 patients across both SAPPHIRE and the Carotid Artery Stent Education System Post-Marketing Study (CASES-PMS). Low rates of stroke were demonstrated in both studies.

The AHA estimates that 20% to 30% of strokes are associated with CAD, caused by particles of atherosclerotic plaque traveling into the neurovasculature. As of 2005, the CDC estimates that stroke affects an estimated 700,000 Americans each year, making it a leading cause of serious, long-term disability, and the nation's third leading cause of death.

Interested in keeping up to date on this issue? Is there another specific area of interest where you need current, timely information? Click here to learn more about our MIB Alerts and MarketTracks - A Better Way to stay up to date.

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MedIntelliBase at TCT 2006

MedIntelliBase is attending the Transcatheter Cardiovascular Therapeutics (TCT) 2006 meeting in Washington, D.C. to keep current with the latest industry developments and to demonstrate MIB Alerts and MIB MarketTracks.

Dates available for meetings include Monday, October 23 and Tuesday, October 24.

To arrange a meeting, please contact:

Vicky Hunsicker Sanko
Office Phone - 1-425-869-8724
Cell Phone - 1-206-669-3053

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Link of the Month
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Fun Fact of the Month
  • Dance... for the rhythm of your heart - Physical fitness doesn't always have to be strenuous or boring - ballroom dancing can be fun, social, and an effective way to improve physical fitness in patients with heart disease...[Sun.Star - Philippines]
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Editor: Vicky Hunsicker Sanko
The Next Phase Publishing**
Mobile - 206/669-3053
Phone - 425/869-8724
Toll Free - 800/390-2756
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Assistant Editor & Market Research Analyst: Tyler Mittleider
The Next Phase Publishing**
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Market Research Analyst: Jordan Zornes
The Next Phase Publishing**
Phone - 425/894-4147
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© The Next Phase® Consultancy, Inc. 2006. All rights reserved.

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