Persistent Inhibition of Neointimal Hyperplasia After Sirolimus-Eluting Stent Implantation

Değertekin, Muzaffer; Serruys, Patrick W.; Foley, David P.; Tanabe, Kengo; Regar, Evelyn; Vos, Jeroen; Smits, Peter; Giessen, Wim J. van der; Brand, Marcel van den; Feyter, Pim de; Popma, Jeffrey J.

doi:10.1161/01.cir.0000034447.02535.d5

Cited by 162 publications

(52 citation statements)

References 20 publications

(17 reference statements)

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“…This is the first randomized, controlled trial of a drug-eluting stent to demonstrate sustained safety and efficacy up to 3 years. These findings, taken in conjunction with the previously reported angiographic and intravascular ultrasound studies of the sirolimus-eluting stents at earlier time points in RAVEL and SIRIUS, 10,11 and the uncontrolled angiographic and intravascular ultrasound observations made up to 2 years after implantation of sirolimus-eluting stents for de novo coronary stenoses, 20,21 and up to 1 year after treatment of in-stent restenosis, 22 confirm that neointimal hyperplasia is effectively suppressed over the long term by sirolimus without interfering with normal reendothelialization. Taken together, these results should dispel the theoretical concerns regarding the long-term biocompatibility of the drug-carrying polymer or other unexpected processes promoting delayed inflammatory, hyperplastic, or thrombotic complications with this particular device.…”

Section: Discussionsupporting

confidence: 68%

Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Coronary Stents

et al. 2005

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Background-The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term. Methods and Results-This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (PϽ0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (Pϭ0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months. Conclusions-Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation. (Circulation.

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Section: Discussionsupporting

confidence: 68%

Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Coronary Stents

et al. 2005

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“…Two-year data have also been reported for the 15 patients from The Netherlands. 177 Within the following 2 years there were no additional events in these patients except that two had undergone significant lesion progression in a site remote from the sirolimuseluting stent and which required further intervention. Angiography showed no significant change in the stent minimal luminal diameter or percentage diameter stenosis compared with earlier angiography.…”

Section: Figure 17 Des: Meta-analysis Of Any Myocardial Infarctionmentioning

confidence: 85%

Coronary artery stents: a rapid systematic review and economic evaluation

Hill¹,

Bagust²,

Bakhai³

et al. 2004

Health Technol Assess

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“…11 These results were confirmed with serial intravascular ultrasound, which showed a marked reduction in neointimal volume in patients treated with the SES. 24 …”

Section: Previous Restenosis Studies Using Sesmentioning

confidence: 99%

Quantitative Assessment of Angiographic Restenosis After Sirolimus-Eluting Stent Implantation in Native Coronary Arteries

et al. 2004

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Background-Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis. Methods and Results-Angiographic follow-up at 240 days was obtained in 701 patients with long (15-to 25-mm) lesions in small-diameter (2.5-to 3.5-mm) native vessels who were randomly assigned to treatment with SESs or bare-metal stents (BMSs) in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary (Ͼ50% diameter stenosis) angiographic restenosis within the segment (8.9% versus 36.3% with the BMS; PϽ0.001) and within the stent (3.2% versus 35.4% with the BMS; PϽ0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges (all PϽ0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups. Conclusions-Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions.

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Persistent Inhibition of Neointimal Hyperplasia After Sirolimus-Eluting Stent Implantation

Cited by 162 publications

References 20 publications

Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Coronary Stents

Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Coronary Stents

Coronary artery stents: a rapid systematic review and economic evaluation

Quantitative Assessment of Angiographic Restenosis After Sirolimus-Eluting Stent Implantation in Native Coronary Arteries

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