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Preliminary Results Show TAXUS Stent Significantly Reduces Clinical and Angiographic Restenosis Rates: Presented at AHA

By Peggy Peck

ORLANDO, FL -- November 11, 2003 -- Twelve-month results from a randomized trial of an investigational slow-release paclitaxel eluting stent (TAXUS) indicate that the stent markedly reduces clinical restenosis -- with no evidence of increased stent thrombosis -- while demonstrating good efficacy in diabetics as well as patients with small vessel disease.

Principle investigators Gregg W. Stone, MD, vice chairman of The Cardiovascular Research Foundation, Lenox Hill Heart and Vascular Institute, New York, New York, United States, and Stephen G. Ellis, MD, director of the Sones Cardiac Catheterization Laboratories, Cleveland Clinic Foundation, Cleveland, Ohio, United States, presented the findings here November 11^th at the American Heart Association's Scientific Sessions 2003.

Clinical restenosis rate, as measured by the rate of target vessel revascularization (TVR), the primary endpoint of TAXUS IV, was 6.8% in patients who received the TAXUS stent, compared with 16.7% for patients who received the bare stent; target lesion revascularization (TLR) was 4.2% in the TAXUS arm versus 14.7% in the control arm.

The 12-month major acute coronary events (MACE) rate was 10.6% in the TAXUS arm and 19.8% in the control arm. Twelve-month MACE, TVR, and TLR rates all reached significance at P < .0001.

The double-blind study enrolled 1,326 patients who were undergoing stenting for de novo lesions. Twelve patients dropped out, leaving a study population of 1,314, with 662 randomized to the TAXUS stent and 652 to the Express™ bare metal stent. Both are made by Boston Scientific Corp., which sponsored the study. Dr. Stone noted that "the stents looked the same, so both patients and investigators were blinded and will remain blinded for 5 years." Twenty-five percent of the patients in the control arm were medically treated diabetics (8.3% requiring insulin), as were 23.4% of the patients in the TAXUS arm (7.7% requiring insulin).

Among patients with small vessels (diameter 2.5 mm or less), the TLR in the control arm (n = 214) was 15.4% compared with just 3.4% (n = 206) among patients who received the TAXUS stent (P = .0001). For diabetics, the results were just slightly less impressive: TLR of 17.4% for non-insulin-dependent diabetics (n = 109) treated with bare metal stents and 13.0% for insulin-dependent diabetics (n = 54) in the control group, while the TLR for diabetics in the TAXUS arm was 4.8% for non-insulin-dependent diabetics (n = 104) and 5.9% for diabetics receiving insulin (n = 51), for a P value of .004.

The TAXUS stent will be reviewed by the U.S. Food and Drug Administration later this month, and FDA approval of the new drug eluting stent is expected by early 2004.


[Study titles: The Taxus IV Study: Final Angiographic Results. Abstract 2429; The Pivotal U.S. Study of the Slow-Rate Release Polymer-Based Paclitaxel-Eluting TAXUS Stent in Patients with De Novo Coronary Lesions: 1 Year Clinical Results of the TAXUS IV Trial. Abstract 2435]

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