May 4, 2004Circulation
Impact of Sirolimus-Eluting Stents on Outcome in Diabetic Patients
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.
Why the study?
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?
Population
1058 patients with de novo native coronary artery lesions, including 279 with diabetes mellitus and 778…
Comparison
Sirolimus-eluting stent implantation vs Bare metal stent implantation
Design
RCT, randomized, double-blind
Follow-up
270 days
Authors
Discussion
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Implication
Supports sirolimus-eluting stent preference in diabetics; extends overall trial benefit to this high-risk subgroup.
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
Main Result
Absolute Event Rate: 6.9% vs 22.3%
p-value: p=<0.001
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.
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.