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DIABETES trial. 149 patients with type 2 diabetes (1/3 on insulin) and native coronary lesions appropriate for stent implantation . Cypher sirolimus-eluting stent. Bare-metal stent. Primary Endpoint: In-stent and late lumen loss at 9 months (determined by QCA) Secondary Endpoints:

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diabetes trial
DIABETES trial

149 patients with type 2 diabetes (1/3 on insulin) and native coronary lesions appropriate for stent implantation

Cypher sirolimus-eluting stent

Bare-metal stent

  • Primary Endpoint:
    • In-stent and late lumen loss at 9 months (determined by QCA)

Secondary Endpoints:

    • MACE (cardiac death, MI, TLR) at 30 days, 9, 12, and 24 months
    • Mean in-stent and edge neointimal hyperplasia
    • Percent volume obstruction (determined by IVUS)
    • Complications

Presented at TCT 2004

slide2

Primary End Point – Late Loss at 9 Months

p=<0.0001

p=<0.0001

  • In-stent and overall in-segment late lumen loss was significantly reduced in the drug eluting stent group.
  • No significant difference was seen in the degree of late loss reduction between insulin-dependent patients (99% reduction) and patients on oral agents (72 % reduction.)

mm

Presented at ACC Scientific Sessions 2004

secondary end points restenosis tlr mace
Secondary end points – Restenosis, TLR, MACE

Angiographic restenosis, TLR, and overall MACE were significantly reduced. (Reduction in overall MACE was primarily due to the reduction in TLR – rates of cardiac death and MI were not significantly different between the two groups.)

p =<0.001

p=<0.0001

p =<0.0001

%

TCT 2004

diabetes trial 9 month results
DIABETES trial – 9 month results
  • Among patients with native coronary lesions and type 2 diabetes (insulin requiring and noninsulin requiring), treatment with a sirolimus-eluting stent was associated with a reduction in late loss (in-stent and in-segment) at 9 months compared with treatment with a bare stent
  • Consistent with other drug-eluting stent trials, the sirolimus –eluting stent was not associated with a reduction in death or MI
  • A subanalysis of the SIRIUS trial showed that diabetics treated with a drug-eluting stent had significant reductions in TLR, MACE, late loss and restenosis compared with diabetics treated with bare stent, but the degree of improvement in diabetic patients was less than in nondiabetic patients, with no significant benefit in the insulin-dependent patients
  • The current trial showed no significant difference in late loss reduction between insulin-dependent and noninsulin-dependent diabetics, but the sample size of insulin-dependent patients (and the overall trial) was small