Key result
Sirolimus-eluting stents were associated with a significantly higher rate of late target lesion revascularization after 450 days compared to bare metal stents (2.2% vs 0.3%, HR 8.468).
Why the study?
Does sirolimus-eluting stent implantation prevent late target lesion revascularization and angiographic progression compared to bare metal stent implantation in patients with de novo coronary lesions?
Cohort (n=984)
No
Does sirolimus-eluting stent implantation prevent late target lesion revascularization and angiographic progression compared to bare metal stent implantation in patients with de novo coronary lesions?
Hazard Ratio: 8.468 (95% CI 1.68–42.681)
Absolute Event Rate: 2.2% vs 0.3%
p-value: p=0.010
Sirolimus-eluting stents are associated with late angiographic progression and a higher rate of late target lesion revascularization (>450 days) compared to bare metal stents, which tend to regress and stabilize after 1 year.
May warrant extended surveillance after sirolimus-eluting stents; leaves open whether the association holds in randomized trials of modern devices.
BACKGROUND: In previous studies, the minimal luminal diameter (MLD) of lesions treated with a bare metal stent (BMS) was shown to improve from 6 months to 3 years. However, the long-term response to a sirolimus-eluting stent (SES) implantation remains unclear. METHODS AND RESULTS: To evaluate 6-month, 12-month and 3-year outcomes, clinical and angiographic follow-up data were analyzed for 367 consecutive patients (506 de novo lesions) who underwent successful SES implantation compared to follow-up data for 617 consecutive patients (802 de novo lesions) who underwent BMS implantation. Clinical follow-up information was obtained for 363 SES-treated patients (98.9%) and 581 BMS-treated patients (94.2%) at 1 year, and 334 SES-treated patients (91.0%) and 566 BMS-treated patients (91.7%) at 3 years. At 3 years, there were no significant differences in the cumulative cardiac death and myocardial infarction. Target lesion revascularization (TLR) rates were significantly higher in BMS-treated patients than in SES-treated patients. In BMS-treated patients, most TLR was performed within 450 days, however, after 450 days, the TLR rate was significantly lower than that for the SES-treated patients. In quantitative coronary angiographic data, among lesions that required no revascularization at the initial 12-month follow up, MLD increased significantly from the 12-month to the 3-year follow-up angiography in BMS-treated lesions. However, MLD decreased significantly in SES-treated lesions. CONCLUSIONS: From a 12-month follow-up to a 3-year follow-up, stenosis in BMS-treated lesions regressed, but stenosis in SES-treated lesions progressed. And late TLR was more frequently required in the SES-treated patients.
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Shiode et al. (2010) conducted a cohort in De novo coronary lesions (n=984). Sirolimus-eluting stent (SES) vs. Bare metal stent (BMS) was evaluated on Target lesion revascularization (TLR) after 450 days (HR 8.468, 95% CI 1.680-42.681, p=0.010). Sirolimus-eluting stents were associated with a significantly higher rate of late target lesion revascularization after 450 days compared to bare metal stents (2.2% vs 0.3%, HR 8.468).
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