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 Korea
The American Journal of Cardiology (Impact Factor: 3.28). 08/2007; 100(3):425-30. DOI: 10.1016/j.amjcard.2007.03.040
Source: PubMed


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: 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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    ABSTRACT: We sought to assess the long-term effectiveness and safety of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR). Treatment of patients with ISR remains a challenge. The long-term outcome of patients with ISR treated with SES remains unknown. The RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study was a randomized trial conducted in 150 patients with ISR (76 SES, 74 balloon angioplasty [BA]). The long-term (>1 year) clinical outcome and pre-specified subgroup analyses were pre-defined secondary study end points. At 1 year, the event-free survival (death, myocardial infarction, target vessel revascularization [TVR]) was better in the SES group (88% vs. 69%, p < 0.005). Additional long-term (>3 years) clinical follow-up was obtained in 97% of patients (median 3.3 years). After the first year, 3 patients died (1 SES, 2 BA), 5 suffered myocardial infarction (4 SES, 1 BA), and 7 required TVR (4 SES, 3 BA). At last follow-up, definitive/probable/possible stent thrombosis was similar in both groups (2/2/1 SES vs. 1/0/3 BA, p = NS). At 4 years, the event-free survival was 76% in the SES arm and 65% in the BA arm (p = 0.019). On multivariate analysis, SES implantation was an independent predictor of event-free survival. Subgroup analyses were consistent with the main outcome measure. In patients with ISR, SES implantation remains effective and safe at very long-term clinical follow-up.
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