Comparison of Six-Month Angiographic and Three-Year Outcomes After Sirolimus-Eluting Stent Implantation Versus Brachytherapy for Bare Metal In-Stent Restenosis
University of Ulsan, Urusan, Ulsan, South KoreaThe American Journal of Cardiology (Impact Factor: 3.28). 08/2007; 100(3):425-30. DOI: 10.1016/j.amjcard.2007.03.040
To evaluate long-term effectiveness of sirolimus-eluting stent (SES) implantation for diffuse bare metal in-stent restenosis (ISR), we compared 6-month angiographic and long-term (3-year) clinical outcomes of SES implantation and intracoronary brachytherapy (ICBT). SES implantation for diffuse ISR was performed in 120 consecutive patients and their results were compared with those from 240 patients treated with beta-radiation with balloons filled with rhenium-188 and mercaptoacetyltriglycine. The radiation dose was 15 or 18 Gy at a depth of 1.0 mm into the vessel wall. The primary end point was 3-year major adverse cardiac events including myocardial infarction, cardiac death, and target lesion revascularization. The 2 groups were similar in baseline clinical and angiographic characteristics. Lesion lengths were 25.1 +/- 14.2 mm in the SES group and 24.5 +/- 10.4 mm in the ICBT group (p = 0.15). In-stent acute gain was greater in the SES group than in the ICBT group (2.23 +/- 0.62 vs 1.91 +/- 0.54 mm, p <0.001). We obtained 6-month angiographic follow-up in 287 patients (79.7%). In-segment angiographic restenoses were 7.4% (7 of 94) in the SES group and 26.4% (51 of 193) in the ICBT group (p <0.05). Two myocardial infarctions (1 in each group) and 5 deaths (4 in SES group, 1 in ICBT group) occurred during 3-year follow-up. At 3 years, survival rates without target lesion revascularization (94.1 +/- 2.2% vs 84.6 +/- 2.3%, p = 0.011) and major adverse cardiac events (92.5 +/- 2.4% vs 84.2 +/- 2.4%, respectively, p = 0.03) were higher in the SES than in the ICBT group. In conclusion, compared with ICBT, SES implantation for diffuse ISR is more effective in decreasing recurrent restenosis and improving long-term outcomes.
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ABSTRACT: Objective: To evaluate the histopathological characteristics of the china-made sirolimus-heparin eluting stent placed in the dog's peripheral arteries. Methods: A total of 28 stents (12 sirolimus-heparin eluting stents, 8 sirolimus stents and 8 bare stents) were implanted into peripheral arteries of 14 dogs. Seven dogs were killed after 30 days, the others were killed after 60 days. The stented-arteries of 14 dogs were dissected and observed focusing on the thrombosis, hemorrhage, necrosis and inflammation, and the neointimal thickness, neoinitial area, intimal endothelialization score, initial fibrin content, initial smooth muscle cell content were calculatedand statistically analyzed. Results: At 30 days, the sirolimus-heparin stent and sirolimus stent had no initial hyperplasia, but small quantity of smooth muscle cells, large quantity of fibrins and a little of endothelial cells. The bare stent had a large quantity of smooth muscle cells, a little fibrins and a little of endothelial cells without initial hyperplasia. At 60 days, the sirolimus-heparin stent had no initial hyperplasia, small quantity of smooth muscle cells, large quantity of fibrins, a little endothelial cells. The sirolimus stent had no initial hyperplasia, while small quantity of smooth muscle cells, large quantity of fibrins, a little of endothelial cells and thrombosis were observed in 2 stents. The bare stent had initial hyperplasia, large quantity of smooth muscle cells and endothelial cells, and a little of fibrins. At 30 days, there were statistic significant differences in initial 1 fibrin content and initial smooth muscle cell content among sirolimus-heparin stent, sirolimus stent and bare stent (P<0.01). At 60 days, significant differences were found among sirolimus-heparin stent, sirolimus stent and bare stent in the neointimal thickness, neointimal area, initial endothelialization score, initial fibrin content and initial smooth muscle cell content (P<0.01). Conclusion: The china-made peripheral arterial sirolimus-heparin eluting stent may inhibit initial hyperplasia and had the ability of anticoagulation.
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ABSTRACT: Objective: To evaluate the physical properties, biocompatibility, and pharmacokinetics of the China-made sirolimus-heparin eluting stent (SHES) as well as its inhibition effect on the in-stent restenosis in vitro and in vivo. Methods: Polylactide coglycotide (PLGA)-heparin complex was sprayed to the surface of sirolimus-coated nitinol stent to make the sirolimus-heparin eluting stent (SHES). The physical and degrading efficiency, blood compatibility, and pharmacokinetics of this stent were studied in vitro. Fifteen dogs were implanted with SHES + bare-metal stent (BMS) into the bilateral iliac arteries (n = 4), sirolimus-eluting stent (SES) + BMS into the bilateral iliac arteries (n = 4), SHES + SES into the bilateral iliac arteries (n = 4), and with 2 SHESs into the bilateral iliac arteries (n = 2), and 2 SHESs into the abdominal aorta (n = 1). Based on the condition of strict anticoagulation, 30, 60, and 240 days after the implantation angiography of the peripheral arteries where the stents were placed was performed in 7, 7, and 1 dog respectively. Then all of the dogs were killed. The compliance, radial force, and visibility of stent, in-stent thrombosis, in-stent diameter, reference segment diameter, late loss of diameter, and restenosis rate were observed. Results: The SHES had even surface coating, and good compliance and radial extension. Blood compatibility test showed only few platelets adhered to the stent surface without deformity or obvious aggregation, and the clotting time was prolonged because of the blood coagulation factors to be activated in a low level. Degrading test and pharmacokinetics in vitro showed that sirolimus could be continuously released in a period of 3 months and heparin in a period of 50 day. The whole 30 stents were successfully implanted into the dog peripheral arteries without complication. The SHES showed satisfactory compliance and good visibility, and its blood concentration of sirolimus was 1.79 - 2.22 ng/ml immediately after stent implantation, 0.4 ng/ml 7 d later, and its release could be continuous about 3 months. Angiography 30 days after the implantation showed no thrombosis and intimal hyperplasia. Angiography 60 days after the implantation showed 2 cases of SES obstruction due to in-stent thrombosis, 1 case of SHES stricture and 3 cases of BMS stricture resulted from intimal hyperplasia, and 1 case of mild sinking of the arterial lumen proximate to the SHES. There were significant differences in the in-stent diameter and its late loss value between the SHES,SES, and bare stent(F:0.049, P < 0.05; F:0.047, P < 0.05). 240 days after the implantation two SHESs placed in bilateral iliac arteries of a dog were un-obstructed. Conclusion: The China-made peripheral arterial SHES not only has good physical properties and biocompatibility, but also reduces the restenosis rate resulted thanks to its effective anticoagulation and the inhibitory effect on the intimal hyperplasia simultaneously.
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ABSTRACT: The aim of this study was to evaluate long-term outcome of patients treated for in-stent restenosis of bare-metal stents (BMS). Treatment of restenosis of BMS is characterized by high recurrence rates. Vascular brachytherapy (VBT) improved outcome although late catch-up events were documented. Drug-eluting stents tested against VBT in this setting were found superior for at least the first year; superiority at longer follow-up is uncertain. We evaluated 3-year outcome of the multicenter SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial, which randomized patients with restenosis of BMS to either a sirolimus-eluting stents (SES) or VBT. Target vessel failure (cardiac death, infarction, or target vessel revascularization [TVR]) at 9 months as previously reported was significantly improved with SES. Kaplan-Meier analysis at 3 years documented that survival free from target lesion revascularization (TLR) and TVR continues to be significantly improved with SES: freedom from TLR 81.0% versus 71.6% (log-rank p = 0.018), and TVR 78.2% versus 68.8% (log-rank p = 0.022), SES versus VBT. At 3 years, target vessel failure and major adverse cardiac events (death, infarction, emergency coronary artery bypass grafting, or repeat TLR) remained improved with SES, but did not reach statistical significance. There was no statistically significant difference in definite or probable stent thrombosis (3.5% for SES, 2.4% for VBT; p = 0.758). At 3 years of follow-up, after treatment of in-stent restenosis of BMS, patients treated with SES have improved survival free of TLR and TVR compared with patients treated with VBT. Stent thrombosis rates are not different between the 2 groups but are higher than reported in trials of treatment of de novo lesions.
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