Integrated analysis of medically treated diabetic patients in the TAXUS(R) program: benefits across stent platforms, paclitaxel release formulations, and diabetic treatments.
OBJECTIVE
The TAXUS(R) database was used to perform an integrated analysis across several large phase II and III trials to assess outcomes of polymer-based paclitaxel-eluting TAXUS stents in diabetic patients.


BACKGROUND
While drug-eluting stents have reduced the risk for restenosis, diabetic patients remain at higher risk.


METHODS
This post hoc analysis of clinical and angiographic outcomes combined individual patient data from four randomized, multicentre, controlled clinical trials (TAXUS II, IV, V, and VI) representing outcomes across two paclitaxel release formulations and stent platforms.


RESULTS
Breslow-Day analysis indicated homogeneous odds ratios across dose formulations and stent platforms, thus clinical data (9 months) were pooled from 3445 patients, including 814 diabetic patients. The randomized quantitative coronary angiography subset (n=2863) included 469 diabetic patients requiring oral medications only and 216 insulin-treated. Among patients receiving bare metal stents (BMS), those with diabetes had worse clinical and angiographic outcomes than non-diabetic patients. Target lesion revascularization rates were decreased in TAXUS patients relative to BMS controls by 59% (p=0.0001) among diabetic patients requiring oral medications, by 66% (p=0.006) among insulin-treated. Insulin-treated patients showed a significant TAXUS benefit for in-stent and in-segment percent diameter stenosis (p=0.0001, p=0.001, respectively) and late loss (p=0.001); a similar TAXUS benefit was seen in diabetic patients treated with oral medications (p<0.0001). Binary restenosis in-segment was significantly decreased 65% in both diabetic subsets (p=0.0001).


CONCLUSIONS
This post hoc analysis of data from four combined randomized TAXUS trials suggests the TAXUS benefit observed in non-diabetic patients is carried over into the high-risk diabetic population.
Dawkins
Keith D
KD
Southampton University Hospital, Southampton, United Kingdom.
Stone
Gregg W
GW
Colombo
Antonio
A
Grube
Eberhard
E
Ellis
Stephen G
SG
Popma
Jeffrey J
JJ
Serruys
Patrick W
PW
Lam
Peter
P
Koglin
Joerg
J
Russell
Mary E
ME