What is the clinical evidence from this study?

Study design: RCT. Population: de novo native coronary artery lesions (n=1058). Intervention: sirolimus-eluting stent vs. bare metal stent. Primary outcome: target lesion revascularization in diabetic patients (p=<0.001).

May 4, 2004

Impact of Sirolimus-Eluting Stents on Outcome in Diabetic Patients

Q: What are the key findings of this study?

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 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.

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?

Population

1058 patients with de novo native coronary artery lesions, including 279 (26%) with diabetes mellitus and 778 without diabetes mellitus

Intervention

Sirolimus-eluting stent implantation

Comparator

Bare metal stent implantation

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.