MedIntelliBase® NewsTips  
September 2006

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Late-Breaking Updates
  • World Congress of Cardiology (WCC) 2006 - Clinical trial and emerging technology updates from the mid-September WCC 2006 conference in Barcelona, Spain.
  • All updates expand your access to our extensive archives of pivotal trials and registries as well as emerging and established technologies.
These MedIntelliBase™ MarketTracks titles are newly updated:

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

Coming in early October

A special issue of MIB NewsTips will be released in early October covering two important topics:

  • Recent developments concerning drug-eluting stents (DES) and the increased risk of late stent thrombosis
  • FDA approval on September 27, 2006 for the combination of a J&J Cordis stent and embolic protection device to treat carotid artery disease

Stay tuned...

Table of Contents

Late Breaking News from the World Congress of Cardiology (WCC) 2006 -- Cardiovascular & Endovascular Therapeutics MIB MarketTracks
Link of the Month
Fun Fact of the Month
  • It was in his genes - A California man lived to the "supercentenarian" age of 112 years despite his bad habits and diet of junk foods

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Cardiovascular & Endovascular Therapeutics MarketTracks -

The Next Phase is pleased to present our NewsTips subscribers two thought-provoking excerpts from its coverage of the World Congress of Cardiology (WCC) 2006 conference in Barcelona, Spain from September 2-6, 2006:

BASKET Study More details available to our subscribers

Dr. Christoph Kaiser of Basel, Switzerland presented 18-month results from the Basel Stent Cost-effectiveness Trial--Late Thrombotic Events (BASKET), which suggest that using drug-eluting stents may not lead to optimal benefits in vessels with a diameter larger than 3mm.

The study randomized 826 consecutive patients in a 2:1 manner respectively to drug-eluting stents (DES) or bare metal stents (BMS). 18-month follow-up was conducted and documented the occurrence of major adverse cardiac events (MACE). Dr. Kaiser reported that overall event rates were low including death/MI, non-infarct related target vessel revascularization, and MACE.

In an analysis of patients with and without bypass graft interventions and small vessel stenting (<3.0mm), a highly significant benefit was observed with the use of DES compared to BMS. For the remainder of patients with vessels larger than 3.0mm, no benefits were observed when using DES versus BMS. According to Dr. Kaiser these findings challenge the popular idea that, regardless of baseline characteristics, all patients should receive DES.

WAVE Study More details available to our subscribers

The addition of warfarin to aspirin therapy in the treatment of peripheral arterial disease (PAD) did not benefit patients in the Warfarin Antiplatelet Vascular Evaluation (WAVE) study. According to Dr. Sonia Anand (McMaster University, Hamilton, ON), bleeding complications associated with the use of warfarin in addition to aspirin neutralized any potential benefits. Patients who received warfarin plus aspirin were at a significantly higher risk of life-threatening bleeds than those who received aspirin therapy alone.

The WAVE study was conducted in 80 centers and seven countries. Nearly 2000 PAD patients were randomized to aspirin plus warfarin or aspirin alone. In both groups, therapy was titrated to reach INR levels of 1.8 to 3.5.  The two primary endpoints included cardiovascular death, MI, and stroke; and CV death, MI, stroke, and severe ischemia in the coronary or peripheral arteries. Life-threatening bleeding and moderate bleeding were the two safety endpoints.

No significant benefit in favor of the two-drug regimen was observed in either of the efficacy endpoints. Furthermore, the combination of warfarin and aspirin was associated with a significantly increased risk of moderate and life-threatening bleeds, and a 15-fold risk of hemorrhagic stroke. These results demonstrate the need for further studies with better antithrombotics in PAD, such as aspirin plus oral factor Xa inhibitors or thrombin blockers.

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Link of the Month
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Fun Fact of the Month
  • It was in his genes - A World War I veteran lived to the "supercentenarian" age of 112 years despite his bad habits and diet of sausage and waffles, and had the organs of a 50 to 60 year old...
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