Impact of Sirolimus-Eluting Stents on Outcome in Diabetic Patients

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 (PϽ0.001) and in nondiabetic patients from 14.1% to 2.99% (PϽ0.001), respectively. Major adverse cardiac events were reduced in diabetic patients from 25% with bare metal stents to 9.2% with sirolimus-eluting stents (PϽ0.001) and from 16.5% to 6.5% (PϽ0.001) 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.

Late outcomes following percutaneous coronary interventions: Results from a large, observational registry

“…Additionally, more than one-half of the procedures (53%) were performed urgently, with 1.3% of patients presenting in cardiogenic shock. The present patient population is not generally well represented in RCTs, although evidence for the role of PCI, particularly with DES, in specific high-risk subsets can be inferred from various subgroup analyses (22) and smaller targeted trials (23,24).…”

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

“…[5][6][7][8][9] In contrast, several recent drug-eluting stent (DES) trials have demonstrated a breakthrough in the reduction of late restenosis compared with bare metal stents, with a consistent incidence of BAR and TLR below 10%. 10,11 Even with the achieved low rates, which may underestimate the rate in actual practice or in high-risk groups, [12][13][14][15][16][17] cost-effectiveness analysis provides economic and quality-of-life incentives to distinguish therapies with restenosis rates below 10%. 18 However, the statistical power available to determine superiority (or demonstrate noninferiority) in competing DES treatments is markedly reduced when sample sizes of 2000 subjects or less are used.…”

Angiographic and Clinical Outcome Following Sirolimus-Eluting Stent (Cypher) Implantation A Single Center Experience

“…In clinical trials 8,11,18,19) that evaluated single de novo lesions and ISR in patients with CAD, the SES was associated with minimal neointimal hyperplasia. In clinical trials with de novo lesions, sirolimus-eluting stents produced a significantly lower incidence of major adverse cardiac events (MACE) than that observed in patients with uncoated stents.…”

“…[4][5][6][7] In addition, although the restenosis rate following bare metal stent implantation has been reported to be higher in diabetics compared to nondiabetics, the reports related to DES implantation are not always in agreement. [6][7][8][9] Therefore, the aim of the present study was to investigate the late angiographic and clinical findings as well as major adverse cardiac events (MACE) in subjects who underwent Cypher stent implantation. We also compared these late angiographic and clinical findings and MACE following Cypher stent implantation in patients with and without diabetes mellitus (DM).…”