Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial.
OBJECTIVE
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.
Hermiller
James B
JB
St. Vincent's Hospital, Indianapolis, Indiana, USA.
Raizner
Albert
A
Cannon
Louis
L
Gurbel
Paul A
PA
Kutcher
Michael A
MA
Wong
S Chiu
SC
Russell
Mary E
ME
Ellis
Stephen G
SG
Mehran
Roxana
R
Stone
Gregg W
GW
D000970:Antineoplastic Agents / Q000008:administration & dosage*; D023903:Coronary Restenosis / Q000517:prevention & control*; D048909:Diabetes Complications / Q000628:therapy*; D003920:Diabetes Mellitus / Q000188:drug therapy; D003925:Diabetic Angiopathies / Q000628:therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization; D017239:Paclitaxel / Q000008:administration & dosage*; D011108:Polymers; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D011108:Polymers; D017239:Paclitaxel