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J Am Coll Cardiol, 2005; 45:1172-1179, doi:10.1016/j.jacc.2004.10.075 © 2005 by the American College of Cardiology Foundation |
,1,*
* St. Vincent’s Hospital, Indianapolis, Indiana
Cardiac Cath Lab Research Center, Houston, Texas
St. Mary’s Medical Center, Saginaw, Michigan
Sinai Hospital of Baltimore, Baltimore, Maryland
|| Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina
¶ New York Presbyterian Hospital, New York, New York
# Boston Scientific Corp., Natick, Massachusetts
** Cleveland Clinic Foundation, Cleveland, Ohio
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
Manuscript received June 28, 2004; revised manuscript received October 18, 2004, accepted October 19, 2004.
* Reprint requests and correspondence: Dr. Gregg W. Stone, Cardiovascular Research Foundation, 55 East 59th Street, 6th Floor, New York, New York 10022. (Email: gstone{at}crf.org).
OBJECTIVES: We sought to determine the safety and efficacy of polymer-regulated site-specific delivery of paclitaxel in patients with diabetes mellitus undergoing stent implantation.
BACKGROUND: Percutaneous coronary intervention in patients with diabetes is associated with high rates of restenosis and repeat revascularization due to excessive neointimal proliferation, a process that may be blunted with the site-specific delivery of paclitaxel.
METHODS: In the TAXUS-IV trial, 1,314 patients were prospectively randomized to the slow rate-release polymer-based paclitaxel-eluting TAXUS stent or the bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). Medically treated diabetes was present in 318 patients (24%), 105 of whom required insulin.
RESULTS: Among patients with diabetes, the TAXUS stent, compared to the bare-metal stent, reduced the rate of 9-month binary angiographic restenosis by 81% (6.4% vs. 34.5%, p < 0.0001), and reduced the 12-month rates of target lesion revascularization by 65% (7.4% vs. 20.9%, p = 0.0008), target vessel revascularization by 53% (11.3% vs. 24%, p < 0.004), and composite major adverse cardiac events by 44% (15.6% vs. 27.7%, p = 0.01). The one-year rates of cardiac death (1.9% vs. 2.5%), myocardial infarction (3.2% vs. 6.4%), and subacute thrombosis (0.6% vs. 1.2%) were comparable between the paclitaxel-eluting and control stents, respectively. In the insulin-requiring subgroup, the TAXUS stent reduced angiographic restenosis by 82% (7.7% vs. 42.9%, p = 0.0065), and reduced the one-year rate of target lesion revascularization by 68% (6.2% vs. 19.4%, p = 0.07), a relative reduction similar to patients without diabetes.
CONCLUSIONS: The site-specific delivery of paclitaxel after coronary stent implantation is highly effective in reducing clinical and angiographic restenosis in patients with diabetes mellitus.
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