Study Reports Taxus Stent Twice As Effective As Bare-Metal Stents In Diabetics

Main Category: Cardiovascular / Cardiology
Also Included In: Diabetes
Article Date: 10 Mar 2008 - 1:00 PDT

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Boston Scientific Corporation (NYSE: BSX) welcomed an article in the February 19 issue of the Journal of American College of Cardiology (JACC),1 which reported the TAXUS™ paclitaxel-eluting coronary stent system, when used in diabetic patients, lowered the need for repeat procedures by 50 percent versus bare-metal stents while maintaining numerically lower but not significantly different rates of heart attack and death. The relative safety and efficacy advantage of TAXUS Stents over bare-metal stents (BMS) in diabetic patients extended to both those requiring and not requiring insulin and was sustained and durable over a period of four years.

The TAXUS™ Liberté™ Stent received European CE Mark approval for use in patients with diabetes2 in December 2007 and is to date the only drug-eluting stent specifically indicated for use in diabetics in the European Economic Area.

The pooled analysis included five prospective, double-blind, randomised trials comprising a total of 3,513 patients treated with the TAXUS Stent and BMS of which 827 were diabetics. At four-year follow-up, there were no significant differences between the TAXUS Stent and BMS among diabetic patients in the rates of death (8.4% vs. 10.3%, respectively, p=0.61), myocardial infarction (6.9% vs. 8.9%, p=0.17), or stent thrombosis (1.4% vs. 1.2%, p=0.92, per protocol). The use of the TAXUS Stent compared with BMS was associated with a significant and durable reduction in target lesion revascularisation over the four-year follow-up period (12.4% vs. 24.7%, p <0.0001).

"Coronary artery disease is the most common cause of death among European adults with diabetes," said David McFaul, Boston Scientific Senior Vice President, International. "This study offers evidence-based results confirming the safety and efficacy of the TAXUS Stent in diabetics, and should be worthy of consideration when determining the best treatment options for this high-risk patient population."

The TAXUS Liberté Stent System is available outside the United States in a wide range of sizes to treat a diversity of vessel sizes and lesion lengths seen in patients with coronary artery disease.

The TAXUS Liberté Stent system is currently pending approval by the U.S. Food and Drug Administration and is limited by federal law to investigational use and not available for sale in the United States.

Diabetes affects more than 200 million people worldwide and is expected to affect 360 million people by 2030.3 Approximately half of all patients presenting with coronary artery disease (CAD) in Europe have diabetes.4 Diabetic patients with CAD often have poorer outcomes after revascularisation procedures because their blood vessels tend to build up more plaque than the vessels of non-diabetic patients, and their CAD advances more quickly. CAD is the most common cause of death among European adults with diabetes.5

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-international.com.

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References

1. Kirtane AJ, Ellis SG, Dawkins KD, et al. Paclitaxel-eluting coronary stents in patients with diabetes mellitus: pooled analysis from 5 randomized trials. J Am Coll Cardiol 2008;51(7):708-15.

2. Indicated for patients with concomitant diabetes mellitus.

3. Wild S, Roglic G, Green A, et al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27(5):1047-53.

4. Bartnik M, Ryden L, Ferrari R, et al. The prevalence of abnormal glucose regulation in patients with coronary artery disease across Europe. The Euro Heart Survey on diabetes and the heart. Eur Heart J 2004;25(21):1880-90.

5. Ryden L, Standl E, Bartnik M, et al. Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J 2007;28(1):88-136.

Boston Scientific