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Everolimus versus sirolimus-eluting stents for the treatment of sirolimus-eluting stent restenosis
IJCA-15217; No of Pages 2 International Journal of Cardiology xxx (2012) xxx–xxx
Contents lists available at SciVerse ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
Everolimus versus sirolimus-eluting stents for the treatment of sirolimus-eluting stent restenosis Rong-Qiang Yan, Li-Jian Gao, Ji-Lin Chen ⁎ State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China
a r t i c l e
i n f o
Article history: Received 12 June 2012 Accepted 15 September 2012 Available online xxxx Keywords: Sirolimus-eluting stents Everolimus-eluting stents Restenosis
With both efficacy and superiority over bare-metal stents (BMS) and paclitaxel-eluting stents (PES) demonstrated in clinical trials [1,2], sirolimus-eluting stents (SES) were widely used in clinical practice, leading to an increasing number of patients with SES restenosis. However, in patients with SES restenosis, the optimal treatment was less well defined. Experiences from the successful management of BMS restenosis inspired repeated drug-eluting stent (DES) implantation for SES restenosis. Unfortunately, several studies have found that repeated DES had a higher target lesion revascularization (TLR) rate after treating SES restenosis than BMS restenosis [3,4]. Newer generation everolimus-eluting stents (EES), with lower strut thickness and a biocompatible polymer less prone to hypersensitivity reactions, have been developed with the aim to improve the safety and efficacy of early generation devices. Thus, EES may be an attractive option for the treatment of SES restenosis. We therefore compared the outcomes of EES (XIENCE V, Abbott Vascular, Santa Clara, California; or PROMUS, Boston Scientific, Natick, Massachusetts) and SES (Cypher, Cordis/Johnson & Johnson, Warren, NJ, USA) for SES restenosis. From Fuwai Hospital catheterization laboratory database, 161 consecutive patients with at least 1 SES restenosis coronary lesion treated with EES or SES between May 2005 and January 2011 were screened. After the exclusion of 3 patients with left main stem restenosis and 2 patients with clinical contraindication against double antiplatelet therapy, 156 patients with 157 lesions were investigated. Patients with acute myocardial infarction were included in our study. ⁎ Corresponding author at: State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167, North Lishi Road, Beijing 100037, China. Tel.: + 86 10 88398044; fax: + 86 10 68331759. E-mail address: [email protected] (J.-L. Chen).
Among 156 patients, 39 patients (39 lesions, EES group) were treated with EES and 117 with SES (118 lesions, SES group). The study protocol was approved by the ethics committee in Fuwai Hospital and informed consent was obtained from all patients. The authors of this article have certified that they comply with the principles of Ethical Publishing in the International Journal of Cardiology [5]. In-stent restenosis was defined using quantitative coronary angiography (QCA) as luminal stenosis of > 50% within the stent or 5 mm of the stent edges. Minimal luminal diameter (MLD), reference luminal diameter, and diameter stenosis at baseline, post procedure and at follow up were measured. Angiographic re-restenosis was defined by QCA as stenosis of > 50% diameter within a previously stented segment (within the stent or 5 mm of the stent edges). QCA was performed by 2 observers blinded to the early and late results, using a validated, edge detection system (MED CON QCA software). The pattern of restenosis was adjudicated according to the classification of Mehran et al. [6]. The primary end point in our study was the occurrence of MACE, defined as a composite of all-cause death, nonfatal myocardial infarction (MI), and TLR. We defined MI as the presence of a new Q wave in ≥2 contiguous ECG leads and/or a creatine kinase-MB concentration elevated to >3-fold the upper normal limit. TLR was defined as either PCI or coronary artery bypass grafting surgery to treat a restenosis accompanied by symptoms or objective signs of ischemia (ischemia-driven TLR). TVR included any percutaneous or surgical revascularization of the stented epicardial vessel. Stent thrombosis (ST) was defined according to Academic Research Consortium criteria [7]. Baseline clinical data were collected for all patients. Follow-up included visits to the outpatient clinic at 30 days and 3 months after the procedure and every 6 months thereafter. Patients lost to regular clinical follow-up were contacted by telephone. Patients were encouraged to return for follow-up angiography 6 to 8 months after the procedure, unless clinical presentation suggested the presence of ischemia. Statistical analysis was performed using SPSS19.0 statistical software package (SPSS Inc., Chicago, IL, USA). Normally distributed continuous variables are shown as mean ± SD and were compared by independent-samples or paired-samples 2-tailed t-test. Categorical variables are presented as counts and percentages and were compared with chi-square test or Fisher exact test. All statistical tests were 2-tailed. p b 0.05 was considered statistically significant. A total of 156 consecutive patients with SES restenosis (157 lesions) were enrolled in our study and received either EES (EES group, 39 lesions in 39 patients) or SES (SES group, 118 lesions in
0167-5273/$ – see front matter © 2012 Published by Elsevier Ireland Ltd. http://dx.doi.org/10.1016/j.ijcard.2012.09.040
Please cite this article as: Yan RQ, et al, Everolimus versus sirolimus-eluting stents for the treatment of sirolimus-eluting stent restenosis, Int J Cardiol (2012), http://dx.doi.org/10.1016/j.ijcard.2012.09.040
2
R.Q. Yan et al. / International Journal of Cardiology xxx (2012) xxx–xxx
117 patients). Baseline characteristics are reported in Table 1. The 2 groups were similar for all examined characteristics. Patients treated with SES had a higher prevalence of hypercholesterolemia, but the difference was not statistically significant (Table 1). Angiographic and procedure characteristics are displayed in Table 2. The lesion characteristics and pattern of restenosis, in accordance with the classification of Mehran et al. [6] were comparable between groups. There were also no significant differences between the two groups with regard to restenosis lesion location, lesion length, reference luminal diameter, minimal luminal diameter and diameter stenosis. Similarly, the stent length and diameter of previous stents and treated stents were not significantly different between groups (Table 2). Angiographic follow-up data were available for 30 patients (76.9%) and 88 patients (75.2%) treated with EES and SES, respectively. There were no significant differences between groups in terms of binary re-restenosis (EES 20% vs. SES 21.6%, p = 0.854). Similarly, the late lumen loss (EES 0.28 ± 0.43 vs. SES 0.42 ±0.39 mm, p = 0.101) and minimal luminal diameter (EES 2.57 ±0.39 vs. SES 2.41 ±0.48 mm, p = 0.102) were not different between groups. Complete follow-up was obtained in all patients at 12 months. Three patients (7.7%) treated with EES and 11 patients (9.4%) treated with SES had ischemia-driven TLR (p = 1.000). One patient (2.6%) treated with EES was in need of bypass surgery as compared with 2 patients (1.7%) treated with SES. With respect to safety end point, 2 patients treated with SES died (1 patient died from cardiac death and the other died from ischemia stroke) compared to no patients treated with EES. There were no patients who experienced MI in the groups. The rate of definite thrombosis was also not significantly different (EES 0 vs. SES 0.9%, p = 1.000). In terms of overall MACE, there was no difference in the composite of death, myocardial infarction and TLR (EES 7.7% vs. SES 10.3%, p = 0.763). In relation to antiplatelet therapy, all the patients at 8 months were taking dual antiplatelet regimens, except 1 patient treated with SES who stopped dual antiplatelet therapy at 120 days after the procedure because of non-fatal cerebral hemorrhage. Everolimus-eluting stent (EES) was a newer generation DES using the Multi-Link Vision stent platform (Abbott Vascular, Santa Clara, California), with low strut thickness, high flexibility and deliverability. EES showed superiority to the first-generation drug-eluting stent PES but not to SES in clinical trials [8,9]. However, the newer generation EES for the treatment of restenosis was not well established. Almalla et al. [10] studied 174 patients with BMS restenosis who underwent percutaneous coronary intervention using PES or EES. The rate of TLR was higher in patients treated with PES at 1 year of follow-up compared to those treated with EES (1% vs 11.5%, p = 0.0193). The rates of myocardial infarction, death, and definite stent thrombosis in patients treated with EES Table 1 Baseline clinical characteristics. Variable (n, %)
EES (n = 39)
SES (n = 117)
p
Men Age (years) Hypertension Hypercholesterolemia Smoking Diabetes mellitus Stroke Family history Prior myocardial infarction Prior CABG Stable angina Unstable angina Acute myocardial infarction LVEF b 40% Multivessel coronary disease
33 (84.6) 57.64 ± 10.29 22 (56.4) 14 (35.9) 11 (28.2) 11 (28.2) 2 (5.1) 3 (7.7) 10 (25.6) 2 (5.1) 15 (38.5) 21 (53.8) 3 (7.7) 3 (7.7) 26 (66.7)
96 (82.1) 57.39 ± 9.71 79 (67.5) 62 (53.0) 49 (41.9) 36 (30.8) 3 (2.6) 10 (8.5) 47 (40.2) 6 (5.1) 35 (29.9) 80 (68.4) 2 (1.7) 8 (6.8) 82 (70.1)
0.714 0.892 0.208 0.064 0.128 0.762 0.599 1.000 0.103 1.000 0.322 0.100 0.100 1.000 0.689
EES: everolimus-eluting stents, SES: sirolimus-eluting stents, CABG: coronary artery bypass grafting, LVEF: left ventricular ejection fraction.
Table 2 Angiographic and quantitative coronary angiography analysis. Variable (n, %) Coronary lesion location LAD LCX RCA Bypass vessel Patterns of restenosis Focal Diffuse Proliferative Total occlusion ISR lesion length (mm) Previous stent length (mm) Previous stent diameter (mm) Reference luminal diameter (mm) Minimal luminal diameter (mm) Diameter stenosis, % Implanted stent length (mm) Implanted stent diameter (mm) Minimal luminal diameter (after intervention, mm) Number of implanted stents Cutting balloon
EES (n = 39)
SES (n = 118)
p
23 (59.0) 7 (17.9) 8 (20.5) 1 (2.6)
63 (53.4) 23 (19.5) 29 (24.6) 3 (2.5)
4 (10.3) 21 (53.8) 6 (15.4) 8 (20.5) 15.97 ± 4.55 23.87 ± 5.51 3.06 ± 0.36 3.02 ± 0.44 0.31 ± 0.25 89.7 ± 8.0 21.62 ± 5.44 2.99 ± 0.44 2.98 ± 0.44
25 (21.2) 67 (56.8) 11 (9.3) 15 (12.7) 14.44 ± 4.51 24.37 ± 6.51 2.97 ± 0.33 2.99 ± 0.36 0.38 ± 0.29 87.6 ± 8.8 21.58 ± 6.95 3.0 ± 0.36 2.97 ± 0.35
0.068 0.640 0.141 0.709 0.191 0.195 0.974 0.914 0.968
1.08 ± 0.27 3 (7.7)
1.09 ± 0.29 12 (10.2)
0.748 0.764
0.938
0.245
EES: everolimus-eluting stents, SES: sirolimus-eluting stents, LAD: left anterior descending coronary, LCX: left circumflex coronary, RCA: right coronary artery.
and PES at 1 year were 0% vs. 4.2% (p = 0.0984), 3% vs.2.1% (p = 0.6855), and 0% vs. 2.1% (p = 0.2382), respectively. The present study focused on the treatments of SES restenosis, and observed that both EES and SES implantations showed favorable performance in patients with SES restenosis. At 12 months, the EES was associated with major adverse cardiac events, death, myocardial infarction, stent thrombosis and TLR rates comparable to those with the SES for treatment of SES restenosis. Our study had several limitations. It was a nonrandomized, retrospective study from a single center. In addition, the number of patients who received EES was relatively small, reflecting the later introduction of the EES into China. Finally, there may be differences in patterns of restenosis and mechanical factors because we did not use intravascular ultrasound during the procedure. Additional studies will hopefully elucidate these issues and determine the precise role of the EES in SES restenosis. References [1] Windecker S, Remondino A, Eberli FR, et al. Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med 2005;353:653-62. [2] Schömig A, Dibra A, Windecker S, et al. A meta-analysis of 16 randomized trials of sirolimus-eluting stents in patients with coronary artery disease. J Am Coll Cardiol 2007;50:1373-80. [3] Nishihira K, Shibata K, Ishikawa T, et al. Repeated sirolimus-eluting stent implantation to treat sirolimus-eluting stent and bare-metal stent restenosis. Circ J 2010;74:2329-33. [4] Abizaid A, Costa Jr JR, Banning A, et al. The sirolimus-eluting cypher select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis. Insights from the e-SELECT (Multicenter Post-Market Surveillance) Registry. J Am Coll Cardiol Interv 2012;5:64-71. [5] Coats AJS, Shewan LG. Statement on authorship and publishing ethics in the International Journal of Cardiology. Int J Cardiol 2011;153:239-40. [6] Mehran R, Dangas G, Abizaid AS, et al. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation 1999;100:1872-8. [7] Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-51. [8] Stone GW, Rizvi A, Newman W, et al. Everolimus-eluting versus paclitaxel‐eluting stents in coronary artery disease. N Engl J Med 2010;362:1663-74. [9] Byrne RA, Kastrati A, Massberg S, et al. Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus- versus sirolimus-eluting stents in patients with coronary artery disease: 3-year outcomes from a randomized clinical trial. J Am Coll Cardiol 2011;58:1325-31. [10] Almalla M, Schröder JW, Pross V, Stegemann E, Marx N, Hoffmann R. Everolimuseluting versus paclitaxel-eluting stents for treatment of bare metal stent restenosis. Am J Cardiol 2011;108:518-22.
Please cite this article as: Yan RQ, et al, Everolimus versus sirolimus-eluting stents for the treatment of sirolimus-eluting stent restenosis, Int J Cardiol (2012), http://dx.doi.org/10.1016/j.ijcard.2012.09.040
Contents lists available at SciVerse ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
Everolimus versus sirolimus-eluting stents for the treatment of sirolimus-eluting stent restenosis Rong-Qiang Yan, Li-Jian Gao, Ji-Lin Chen ⁎ State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China
a r t i c l e
i n f o
Article history: Received 12 June 2012 Accepted 15 September 2012 Available online xxxx Keywords: Sirolimus-eluting stents Everolimus-eluting stents Restenosis
With both efficacy and superiority over bare-metal stents (BMS) and paclitaxel-eluting stents (PES) demonstrated in clinical trials [1,2], sirolimus-eluting stents (SES) were widely used in clinical practice, leading to an increasing number of patients with SES restenosis. However, in patients with SES restenosis, the optimal treatment was less well defined. Experiences from the successful management of BMS restenosis inspired repeated drug-eluting stent (DES) implantation for SES restenosis. Unfortunately, several studies have found that repeated DES had a higher target lesion revascularization (TLR) rate after treating SES restenosis than BMS restenosis [3,4]. Newer generation everolimus-eluting stents (EES), with lower strut thickness and a biocompatible polymer less prone to hypersensitivity reactions, have been developed with the aim to improve the safety and efficacy of early generation devices. Thus, EES may be an attractive option for the treatment of SES restenosis. We therefore compared the outcomes of EES (XIENCE V, Abbott Vascular, Santa Clara, California; or PROMUS, Boston Scientific, Natick, Massachusetts) and SES (Cypher, Cordis/Johnson & Johnson, Warren, NJ, USA) for SES restenosis. From Fuwai Hospital catheterization laboratory database, 161 consecutive patients with at least 1 SES restenosis coronary lesion treated with EES or SES between May 2005 and January 2011 were screened. After the exclusion of 3 patients with left main stem restenosis and 2 patients with clinical contraindication against double antiplatelet therapy, 156 patients with 157 lesions were investigated. Patients with acute myocardial infarction were included in our study. ⁎ Corresponding author at: State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167, North Lishi Road, Beijing 100037, China. Tel.: + 86 10 88398044; fax: + 86 10 68331759. E-mail address: [email protected] (J.-L. Chen).
Among 156 patients, 39 patients (39 lesions, EES group) were treated with EES and 117 with SES (118 lesions, SES group). The study protocol was approved by the ethics committee in Fuwai Hospital and informed consent was obtained from all patients. The authors of this article have certified that they comply with the principles of Ethical Publishing in the International Journal of Cardiology [5]. In-stent restenosis was defined using quantitative coronary angiography (QCA) as luminal stenosis of > 50% within the stent or 5 mm of the stent edges. Minimal luminal diameter (MLD), reference luminal diameter, and diameter stenosis at baseline, post procedure and at follow up were measured. Angiographic re-restenosis was defined by QCA as stenosis of > 50% diameter within a previously stented segment (within the stent or 5 mm of the stent edges). QCA was performed by 2 observers blinded to the early and late results, using a validated, edge detection system (MED CON QCA software). The pattern of restenosis was adjudicated according to the classification of Mehran et al. [6]. The primary end point in our study was the occurrence of MACE, defined as a composite of all-cause death, nonfatal myocardial infarction (MI), and TLR. We defined MI as the presence of a new Q wave in ≥2 contiguous ECG leads and/or a creatine kinase-MB concentration elevated to >3-fold the upper normal limit. TLR was defined as either PCI or coronary artery bypass grafting surgery to treat a restenosis accompanied by symptoms or objective signs of ischemia (ischemia-driven TLR). TVR included any percutaneous or surgical revascularization of the stented epicardial vessel. Stent thrombosis (ST) was defined according to Academic Research Consortium criteria [7]. Baseline clinical data were collected for all patients. Follow-up included visits to the outpatient clinic at 30 days and 3 months after the procedure and every 6 months thereafter. Patients lost to regular clinical follow-up were contacted by telephone. Patients were encouraged to return for follow-up angiography 6 to 8 months after the procedure, unless clinical presentation suggested the presence of ischemia. Statistical analysis was performed using SPSS19.0 statistical software package (SPSS Inc., Chicago, IL, USA). Normally distributed continuous variables are shown as mean ± SD and were compared by independent-samples or paired-samples 2-tailed t-test. Categorical variables are presented as counts and percentages and were compared with chi-square test or Fisher exact test. All statistical tests were 2-tailed. p b 0.05 was considered statistically significant. A total of 156 consecutive patients with SES restenosis (157 lesions) were enrolled in our study and received either EES (EES group, 39 lesions in 39 patients) or SES (SES group, 118 lesions in
0167-5273/$ – see front matter © 2012 Published by Elsevier Ireland Ltd. http://dx.doi.org/10.1016/j.ijcard.2012.09.040
Please cite this article as: Yan RQ, et al, Everolimus versus sirolimus-eluting stents for the treatment of sirolimus-eluting stent restenosis, Int J Cardiol (2012), http://dx.doi.org/10.1016/j.ijcard.2012.09.040
2
R.Q. Yan et al. / International Journal of Cardiology xxx (2012) xxx–xxx
117 patients). Baseline characteristics are reported in Table 1. The 2 groups were similar for all examined characteristics. Patients treated with SES had a higher prevalence of hypercholesterolemia, but the difference was not statistically significant (Table 1). Angiographic and procedure characteristics are displayed in Table 2. The lesion characteristics and pattern of restenosis, in accordance with the classification of Mehran et al. [6] were comparable between groups. There were also no significant differences between the two groups with regard to restenosis lesion location, lesion length, reference luminal diameter, minimal luminal diameter and diameter stenosis. Similarly, the stent length and diameter of previous stents and treated stents were not significantly different between groups (Table 2). Angiographic follow-up data were available for 30 patients (76.9%) and 88 patients (75.2%) treated with EES and SES, respectively. There were no significant differences between groups in terms of binary re-restenosis (EES 20% vs. SES 21.6%, p = 0.854). Similarly, the late lumen loss (EES 0.28 ± 0.43 vs. SES 0.42 ±0.39 mm, p = 0.101) and minimal luminal diameter (EES 2.57 ±0.39 vs. SES 2.41 ±0.48 mm, p = 0.102) were not different between groups. Complete follow-up was obtained in all patients at 12 months. Three patients (7.7%) treated with EES and 11 patients (9.4%) treated with SES had ischemia-driven TLR (p = 1.000). One patient (2.6%) treated with EES was in need of bypass surgery as compared with 2 patients (1.7%) treated with SES. With respect to safety end point, 2 patients treated with SES died (1 patient died from cardiac death and the other died from ischemia stroke) compared to no patients treated with EES. There were no patients who experienced MI in the groups. The rate of definite thrombosis was also not significantly different (EES 0 vs. SES 0.9%, p = 1.000). In terms of overall MACE, there was no difference in the composite of death, myocardial infarction and TLR (EES 7.7% vs. SES 10.3%, p = 0.763). In relation to antiplatelet therapy, all the patients at 8 months were taking dual antiplatelet regimens, except 1 patient treated with SES who stopped dual antiplatelet therapy at 120 days after the procedure because of non-fatal cerebral hemorrhage. Everolimus-eluting stent (EES) was a newer generation DES using the Multi-Link Vision stent platform (Abbott Vascular, Santa Clara, California), with low strut thickness, high flexibility and deliverability. EES showed superiority to the first-generation drug-eluting stent PES but not to SES in clinical trials [8,9]. However, the newer generation EES for the treatment of restenosis was not well established. Almalla et al. [10] studied 174 patients with BMS restenosis who underwent percutaneous coronary intervention using PES or EES. The rate of TLR was higher in patients treated with PES at 1 year of follow-up compared to those treated with EES (1% vs 11.5%, p = 0.0193). The rates of myocardial infarction, death, and definite stent thrombosis in patients treated with EES Table 1 Baseline clinical characteristics. Variable (n, %)
EES (n = 39)
SES (n = 117)
p
Men Age (years) Hypertension Hypercholesterolemia Smoking Diabetes mellitus Stroke Family history Prior myocardial infarction Prior CABG Stable angina Unstable angina Acute myocardial infarction LVEF b 40% Multivessel coronary disease
33 (84.6) 57.64 ± 10.29 22 (56.4) 14 (35.9) 11 (28.2) 11 (28.2) 2 (5.1) 3 (7.7) 10 (25.6) 2 (5.1) 15 (38.5) 21 (53.8) 3 (7.7) 3 (7.7) 26 (66.7)
96 (82.1) 57.39 ± 9.71 79 (67.5) 62 (53.0) 49 (41.9) 36 (30.8) 3 (2.6) 10 (8.5) 47 (40.2) 6 (5.1) 35 (29.9) 80 (68.4) 2 (1.7) 8 (6.8) 82 (70.1)
0.714 0.892 0.208 0.064 0.128 0.762 0.599 1.000 0.103 1.000 0.322 0.100 0.100 1.000 0.689
EES: everolimus-eluting stents, SES: sirolimus-eluting stents, CABG: coronary artery bypass grafting, LVEF: left ventricular ejection fraction.
Table 2 Angiographic and quantitative coronary angiography analysis. Variable (n, %) Coronary lesion location LAD LCX RCA Bypass vessel Patterns of restenosis Focal Diffuse Proliferative Total occlusion ISR lesion length (mm) Previous stent length (mm) Previous stent diameter (mm) Reference luminal diameter (mm) Minimal luminal diameter (mm) Diameter stenosis, % Implanted stent length (mm) Implanted stent diameter (mm) Minimal luminal diameter (after intervention, mm) Number of implanted stents Cutting balloon
EES (n = 39)
SES (n = 118)
p
23 (59.0) 7 (17.9) 8 (20.5) 1 (2.6)
63 (53.4) 23 (19.5) 29 (24.6) 3 (2.5)
4 (10.3) 21 (53.8) 6 (15.4) 8 (20.5) 15.97 ± 4.55 23.87 ± 5.51 3.06 ± 0.36 3.02 ± 0.44 0.31 ± 0.25 89.7 ± 8.0 21.62 ± 5.44 2.99 ± 0.44 2.98 ± 0.44
25 (21.2) 67 (56.8) 11 (9.3) 15 (12.7) 14.44 ± 4.51 24.37 ± 6.51 2.97 ± 0.33 2.99 ± 0.36 0.38 ± 0.29 87.6 ± 8.8 21.58 ± 6.95 3.0 ± 0.36 2.97 ± 0.35
0.068 0.640 0.141 0.709 0.191 0.195 0.974 0.914 0.968
1.08 ± 0.27 3 (7.7)
1.09 ± 0.29 12 (10.2)
0.748 0.764
0.938
0.245
EES: everolimus-eluting stents, SES: sirolimus-eluting stents, LAD: left anterior descending coronary, LCX: left circumflex coronary, RCA: right coronary artery.
and PES at 1 year were 0% vs. 4.2% (p = 0.0984), 3% vs.2.1% (p = 0.6855), and 0% vs. 2.1% (p = 0.2382), respectively. The present study focused on the treatments of SES restenosis, and observed that both EES and SES implantations showed favorable performance in patients with SES restenosis. At 12 months, the EES was associated with major adverse cardiac events, death, myocardial infarction, stent thrombosis and TLR rates comparable to those with the SES for treatment of SES restenosis. Our study had several limitations. It was a nonrandomized, retrospective study from a single center. In addition, the number of patients who received EES was relatively small, reflecting the later introduction of the EES into China. Finally, there may be differences in patterns of restenosis and mechanical factors because we did not use intravascular ultrasound during the procedure. Additional studies will hopefully elucidate these issues and determine the precise role of the EES in SES restenosis. References [1] Windecker S, Remondino A, Eberli FR, et al. Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med 2005;353:653-62. [2] Schömig A, Dibra A, Windecker S, et al. A meta-analysis of 16 randomized trials of sirolimus-eluting stents in patients with coronary artery disease. J Am Coll Cardiol 2007;50:1373-80. [3] Nishihira K, Shibata K, Ishikawa T, et al. Repeated sirolimus-eluting stent implantation to treat sirolimus-eluting stent and bare-metal stent restenosis. Circ J 2010;74:2329-33. [4] Abizaid A, Costa Jr JR, Banning A, et al. The sirolimus-eluting cypher select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis. Insights from the e-SELECT (Multicenter Post-Market Surveillance) Registry. J Am Coll Cardiol Interv 2012;5:64-71. [5] Coats AJS, Shewan LG. Statement on authorship and publishing ethics in the International Journal of Cardiology. Int J Cardiol 2011;153:239-40. [6] Mehran R, Dangas G, Abizaid AS, et al. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation 1999;100:1872-8. [7] Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-51. [8] Stone GW, Rizvi A, Newman W, et al. Everolimus-eluting versus paclitaxel‐eluting stents in coronary artery disease. N Engl J Med 2010;362:1663-74. [9] Byrne RA, Kastrati A, Massberg S, et al. Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus- versus sirolimus-eluting stents in patients with coronary artery disease: 3-year outcomes from a randomized clinical trial. J Am Coll Cardiol 2011;58:1325-31. [10] Almalla M, Schröder JW, Pross V, Stegemann E, Marx N, Hoffmann R. Everolimuseluting versus paclitaxel-eluting stents for treatment of bare metal stent restenosis. Am J Cardiol 2011;108:518-22.
Please cite this article as: Yan RQ, et al, Everolimus versus sirolimus-eluting stents for the treatment of sirolimus-eluting stent restenosis, Int J Cardiol (2012), http://dx.doi.org/10.1016/j.ijcard.2012.09.040