Clinical and angiographic outcomes in diabetic patients following single or multivessel stenting in the COSTAR II randomized trial.
BACKGROUND
Percutaneous coronary intervention (PCI) is associated with increased clinical and angiographic restenosis in diabetic patients. Stent-based elution of paclitaxel from a biostable polymer reduces restenosis and major adverse cardiovascular events (MACE) when compared with bare-metal stent deployment. The safety and efficacy of paclitaxel elution from a bioresorbable polymer has not been studied in diabetic patients.


METHODS
Patients (n = 1700) with single- or multivessel coronary disease were randomized (3:2) to receive the CoStar or Taxus stent. All patients had glycolated hemoglobin (HbA1c) obtained at enrollment.


RESULTS
Medically-treated diabetes was present in 469 patients (117 insulin-treated) and 77 patients had elevated HbA1c > 6.5% in the absence of previously diagnosed diabetes. MACE were increased in diabetics and were greatest in those requiring insulin. Elevated HbA1c, in the absence of diagnosed diabetes, was not associated with adverse outcomes. MACE (8 months) in the diabetic cohort trended lower with Taxus versus CoStar (10.9 vs. 14.4%, respectively; p = 0.271) due to a reduction in target vessel revascularization. Late lumen loss in-segment (9 months) was reduced by Taxus compared to CoStar (0.20 vs. 0.52 mm, respectively; p < 0.05).


CONCLUSIONS
Diabetes is associated with adverse outcomes following stent deployment. Taxus stents improved angiographic outcomes with a trend toward improved clinical outcomes when compared with CoStar stents following PCI in diabetic patients. As a measure of preprocedural glycemic control, the HbA1c level was weakly correlated with outcomes.
Kereiakes
Dean J
DJ
The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH 45219, USA. lindner@fuse.net
Petersen
John L
JL
Batchelor
Wayne B
WB
Fitzgerald
Peter J
PJ
Mehran
Roxana
R
Lansky
Alexandra
A
Tsujino
Ichizo
I
Schofer
Joachim
J
Dubois
Christophe
C
Verheye
Stefan
S
Cristea
Ecaterina
E
Garg
Jyotsna
J
Wijns
William
W
Krucoff
Mitchell W
MW
D000792:Angiography; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D001786:Blood Glucose / Q000378:metabolism; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000378:metabolism / Q000628:therapy*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000378:metabolism*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012189:Retrospective Studies; D016037:Single-Blind Method; D015607:Stents; D016896:Treatment Outcome
D001786:Blood Glucose; D006442:Glycated Hemoglobin