May 4, 2004Circulation398 citations
Impact of Sirolimus-Eluting Stents on Outcome in Diabetic Patients
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Key Result
Sirolimus-eluting stents reduced target lesion revascularization (6.9% vs 22.3%, P<0.001) and major adverse cardiac events (9.2% vs 25%, P<0.001) compared to bare metal stents in diabetic patients.
Key Points
- To analyze the impact of sirolimus-eluting stents on outcomes in diabetic versus nondiabetic patients.
- Randomized, double-blind trial comparing sirolimus-eluting and bare metal stents in 1058 patients.
- Included 279 diabetic patients with a focus on coronary artery lesions.
- Follow-up assessments were conducted at 270 days.
- Target lesion revascularization decreased in diabetic patients from 22.3% to 6.9% with sirolimus-eluting stents (P<0.001).
- Major adverse cardiac events were reduced in diabetic patients from 25% to 9.2% (P<0.001).
- Diabetic patients showed a higher frequency of repeat intervention compared to nondiabetic patients despite improved outcomes.
Study Design
Type
RCT (n=1,058)
Blinding
double-blind
Randomization
randomized
Structured PICO
Does sirolimus-eluting stent implantation reduce target lesion revascularization and major adverse cardiac events in patients with de novo native coronary artery lesions with and without diabetes?
P
Population
1058 patients with de novo native coronary artery lesions, including 279 (26%) with diabetes mellitus and 778 without diabetes mellitus
I
Intervention
Sirolimus-eluting stent implantation
C
Comparator
Bare metal stent implantation
O
Outcome
Target lesion revascularization and major adverse cardiac events at 270 dayscomposite
Sirolimus-eluting stents significantly reduce target lesion revascularization and major adverse cardiac events compared to bare metal stents in patients with de novo coronary lesions, regardless of diabetes status.
Main Result
Absolute Event Rate: 6.9% vs 22.3%
p-value: p=<0.001
Abstract
BACKGROUND: Randomized clinical trials have shown that a sirolimus-eluting stent significantly reduces restenosis after percutaneous coronary revascularization. Diabetic patients are known to have a higher risk of restenosis compared with nondiabetic patients. The purpose of this analysis was to determine the impact of sirolimus-eluting stents on outcomes of diabetic compared with nondiabetic patients. METHODS AND RESULTS: The SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) trial is a randomized, double-blind study that compared sirolimus-eluting and bare metal stent implantation in 1058 patients with de novo native coronary artery lesions. Diabetes mellitus was present in 279 (26%) patients (diabetes mellitus group, 131 patients received sirolimus-eluting stents and 148 patients received bare metal stents) and was absent in 778 patients (no-diabetes mellitus group, 402 patients received sirolimus-eluting stents and 376 patients received bare metal stents). At 270 days, target lesion revascularization was reduced in diabetic patients from 22.3% with bare metal stents to 6.9% with sirolimus-eluting stents (P<0.001) and in nondiabetic patients from 14.1% to 2.99% (P<0.001), respectively. Major adverse cardiac events were reduced in diabetic patients from 25% with bare metal stents to 9.2% with sirolimus-eluting stents (P<0.001) and from 16.5% to 6.5% (P<0.001) in nondiabetic patients, respectively. CONCLUSIONS: Implantation of sirolimus-eluting stents compared with bare metal stents in de novo coronary lesions reduces major adverse cardiac events in patients with and without diabetes mellitus. However, among patients receiving sirolimus-eluting stents, there remains a trend toward a higher frequency of repeat intervention in diabetic patients compared with nondiabetic patients, particularly in the insulin-requiring patients.
Cite This Study
Moussa et al. (2004) conducted an RCT in de novo native coronary artery lesions (n=1,058). sirolimus-eluting stent vs. bare metal stent was evaluated on target lesion revascularization in diabetic patients (p=<0.001). Sirolimus-eluting stents reduced target lesion revascularization (6.9% vs 22.3%, P<0.001) and major adverse cardiac events (9.2% vs 25%, P<0.001) compared to bare metal stents in diabetic patients.