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Masato Nakamura - One of the best experts on this subject based on the ideXlab platform.
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the long term efficacy of sirolimus eluting Stent for small vessel disease subanalysis of Cypher Stent japan post marketing surveillance registry
Journal of Cardiology, 2013Co-Authors: Hajime Fujimoto, Yuji Ikari, Masato NakamuraAbstract:Abstract Background Percutaneous coronary intervention for lesions with small vessel diameter may have high event rates. Although drug-eluting Stents reduce the risk of restenosis, the long-term efficacy of drug-eluting Stent implantation in small vessels is unclear. Methods and results We reviewed the data of Cypher Stent Japan Post-Marketing Surveillance Registry including 2356 lesions of 1959 patients, and retrospectively investigated the angiographic outcomes at 8 months, and the clinical outcomes at 1800 days after sirolimus-eluting Stent (SES) implantation in vessels with diameter less than 2.5 mm (small vessel group) compared to that with diameter of 2.5 mm or more (non-small vessel group). The rate of major adverse cardiac events (MACE) at 1800 days was slightly higher in the small vessel group than in the non-small vessel group, but not statistically significant (24.4% vs 21.0%, p = 0.086). The rate of target lesion revascularization was higher in the small vessel group than in the non-small vessel group (10.2% vs 6.4%, p = 0.004). The rate of Stent thrombosis was almost the same in the two groups. Multivariate Cox hazard model analysis revealed that a vessel diameter less than 2.5 mm was not an independent risk factor for MACE. Conclusion SES implantation for vessels with diameter less than 2.5 mm is safe and provides good long-term outcomes.
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The long-term efficacy of sirolimus-eluting Stent for small vessel disease—Subanalysis of Cypher Stent Japan Post-Marketing Surveillance Registry
Journal of cardiology, 2012Co-Authors: Hajime Fujimoto, Yuji Ikari, Masato NakamuraAbstract:Abstract Background Percutaneous coronary intervention for lesions with small vessel diameter may have high event rates. Although drug-eluting Stents reduce the risk of restenosis, the long-term efficacy of drug-eluting Stent implantation in small vessels is unclear. Methods and results We reviewed the data of Cypher Stent Japan Post-Marketing Surveillance Registry including 2356 lesions of 1959 patients, and retrospectively investigated the angiographic outcomes at 8 months, and the clinical outcomes at 1800 days after sirolimus-eluting Stent (SES) implantation in vessels with diameter less than 2.5 mm (small vessel group) compared to that with diameter of 2.5 mm or more (non-small vessel group). The rate of major adverse cardiac events (MACE) at 1800 days was slightly higher in the small vessel group than in the non-small vessel group, but not statistically significant (24.4% vs 21.0%, p = 0.086). The rate of target lesion revascularization was higher in the small vessel group than in the non-small vessel group (10.2% vs 6.4%, p = 0.004). The rate of Stent thrombosis was almost the same in the two groups. Multivariate Cox hazard model analysis revealed that a vessel diameter less than 2.5 mm was not an independent risk factor for MACE. Conclusion SES implantation for vessels with diameter less than 2.5 mm is safe and provides good long-term outcomes.
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Comparison of pharmacokinetics of the limus-eluting Stents in Japanese patients.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2011Co-Authors: Yoritaka Otsuka, Masato Nakamura, Shigeru Saito, Hideo Shuto, Kazuaki MitsudoAbstract:OBJECTIVES The aim of this study was to compare the pharmacokinetics of the four limus-eluting Stents used in Japanese patients. BACKGROUND There are presently no reports comparing human pharmacokinetics among drug-eluting Stents (DESs). METHODS We retrospectively analyzed data from pharmacokinetic studies of patients implanted with an 18-mm DES: Cypher Stent (sirolimus, n = 10), Endeavor Stent (zotarolimus, n = 7), Xience V Stent (everolimus, n = 6), and Nobori Stent (biolimus A9, n = 10), in multicenter trials of Japan. Total drug doses of the Cypher Stent, Endeavor Stent, Xience V Stent, and Nobori Stent were 150, 180, 88, and 293 μg, respectively. Drug concentrations were measured in serial whole blood samples after implantation and the pharmacokinetics were analyzed. RESULTS Mean peak drug levels were 0.86 ng mL(-1) for Cypher, 1.80 ng mL(-1) for Endeavor, 0.50 ng mL(-1) for Xience V, and 0.09 ng mL(-1) for Nobori. After adjustment for the loaded dose, mean peak drug levels of the Cypher and Xience V Stents were similar (0.0057 ng mL(-1) μg(-1) each) while the Endeavor (0.0100 ng mL(-1) μg(-1)) was higher, and the Nobori (0.0003 ng mL(-1) μg(-1)) was lower, compared with the Cypher and Xience V Stents. The other pharmacokinetic parameters of four DESs differed according to characteristics of the coated drug. The systemic exposure of biolimus A9 was much lower than that of the other DESs studied. CONCLUSIONS In Japanese patients, systemic exposure was low, regardless of the type of limus drug eluted from the Stents; but specific pharmacokinetic activities were varied according to the drug characteristics, concentration, and DES design.
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Impact of Insulin-Treated Diabetes and Hemodialysis on Long-Term Clinical Outcomes Following Sirolimus-Eluting Stent Deployment – Insights From a Sub-Study of The Cypher Stent Japan Post-Marketing Surveillance (Cypher J-PMS) Registry –
Circulation journal : official journal of the Japanese Circulation Society, 2010Co-Authors: Masato Nakamura, Hiroyoshi Yokoi, Yuji Hamazaki, Masato Watarai, Mikihiro Kijima, Kazuaki MitsudoAbstract:Background: Long-term clinical outcomes of diabetes mellitus (DM) patients who underwent drug-eluting Stent deployment has not well investigated. Methods and Results: A total of 2,050 cases were enrolled consecutively from 50 sites in Japan into the Cypher Stent Japan Post-Marketing Surveillance (Cypher J-PMS) registry, and the 3-year outcomes of DM patients were analyzed. Subjects were divided into 2 groups based on the treatment of DM (insulin-treated diabetes (IT) group, n=207; and non insulin-treated diabetes (NIT) group, n=682). Major adverse cardiac event (MACE) rates in the IT group and the NIT group were 26.0% and 14.5% at 3 years, respectively (P
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impact of insulin treated diabetes and hemodialysis on long term clinical outcomes following sirolimus eluting Stent deployment insights from a sub study of the Cypher Stent japan post marketing surveillance Cypher j pms registry
Circulation, 2010Co-Authors: Masato Nakamura, Hiroyoshi Yokoi, Yuji Hamazaki, Masato Watarai, Mikihiro Kijima, Kazuaki MitsudoAbstract:Background: Long-term clinical outcomes of diabetes mellitus (DM) patients who underwent drug-eluting Stent deployment has not well investigated. Methods and Results: A total of 2,050 cases were enrolled consecutively from 50 sites in Japan into the Cypher Stent Japan Post-Marketing Surveillance (Cypher J-PMS) registry, and the 3-year outcomes of DM patients were analyzed. Subjects were divided into 2 groups based on the treatment of DM (insulin-treated diabetes (IT) group, n=207; and non insulin-treated diabetes (NIT) group, n=682). Major adverse cardiac event (MACE) rates in the IT group and the NIT group were 26.0% and 14.5% at 3 years, respectively (P<0.001). There were no significant differences in Stent thrombosis rates (definite and probable by Academic Research Consortium (ARC) definition) (0% and 1.08%, respectively). Multivariate analysis suggested that hemodialysis and insulin-treated DM were independent predictors for MACE, and insulin-treated DM, hemodialysis and long lesions were strong independent predictors for target-lesion revascularization (TLR). Conclusions: Hemodialysis and insulin-treated DM were strong independent predictors of mortality and TLR in DM patients. These results might suggest that special attention to patients with hemodialysis and insulin-treated DM is warranted in the setting of sirolimus-eluting Stent deployment for DM patients. (Circ J 2010; 74: 2592-2597)
Hiroyoshi Yokoi - One of the best experts on this subject based on the ideXlab platform.
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Impact of Insulin-Treated Diabetes and Hemodialysis on Long-Term Clinical Outcomes Following Sirolimus-Eluting Stent Deployment – Insights From a Sub-Study of The Cypher Stent Japan Post-Marketing Surveillance (Cypher J-PMS) Registry –
Circulation journal : official journal of the Japanese Circulation Society, 2010Co-Authors: Masato Nakamura, Hiroyoshi Yokoi, Yuji Hamazaki, Masato Watarai, Mikihiro Kijima, Kazuaki MitsudoAbstract:Background: Long-term clinical outcomes of diabetes mellitus (DM) patients who underwent drug-eluting Stent deployment has not well investigated. Methods and Results: A total of 2,050 cases were enrolled consecutively from 50 sites in Japan into the Cypher Stent Japan Post-Marketing Surveillance (Cypher J-PMS) registry, and the 3-year outcomes of DM patients were analyzed. Subjects were divided into 2 groups based on the treatment of DM (insulin-treated diabetes (IT) group, n=207; and non insulin-treated diabetes (NIT) group, n=682). Major adverse cardiac event (MACE) rates in the IT group and the NIT group were 26.0% and 14.5% at 3 years, respectively (P
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impact of insulin treated diabetes and hemodialysis on long term clinical outcomes following sirolimus eluting Stent deployment insights from a sub study of the Cypher Stent japan post marketing surveillance Cypher j pms registry
Circulation, 2010Co-Authors: Masato Nakamura, Hiroyoshi Yokoi, Yuji Hamazaki, Masato Watarai, Mikihiro Kijima, Kazuaki MitsudoAbstract:Background: Long-term clinical outcomes of diabetes mellitus (DM) patients who underwent drug-eluting Stent deployment has not well investigated. Methods and Results: A total of 2,050 cases were enrolled consecutively from 50 sites in Japan into the Cypher Stent Japan Post-Marketing Surveillance (Cypher J-PMS) registry, and the 3-year outcomes of DM patients were analyzed. Subjects were divided into 2 groups based on the treatment of DM (insulin-treated diabetes (IT) group, n=207; and non insulin-treated diabetes (NIT) group, n=682). Major adverse cardiac event (MACE) rates in the IT group and the NIT group were 26.0% and 14.5% at 3 years, respectively (P<0.001). There were no significant differences in Stent thrombosis rates (definite and probable by Academic Research Consortium (ARC) definition) (0% and 1.08%, respectively). Multivariate analysis suggested that hemodialysis and insulin-treated DM were independent predictors for MACE, and insulin-treated DM, hemodialysis and long lesions were strong independent predictors for target-lesion revascularization (TLR). Conclusions: Hemodialysis and insulin-treated DM were strong independent predictors of mortality and TLR in DM patients. These results might suggest that special attention to patients with hemodialysis and insulin-treated DM is warranted in the setting of sirolimus-eluting Stent deployment for DM patients. (Circ J 2010; 74: 2592-2597)
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assessment of sirolimus eluting coronary Stent implantation with aspirin plus low dose ticlopidine administration
Circulation, 2009Co-Authors: Yuji Ikari, Masato Nakamura, Junichi Kotani, Ken Kozuma, Hiroyoshi YokoiAbstract:BACKGROUND: Clinical data of sirolimus-eluting Stent (SES) implantation are under investigation in Japan. METHODS AND RESULTS: The Cypher Stent Japan Post-Marketing Surveillance Registry (J-PMS) was conducted at 50 medical centers to assess the results of SES in daily clinical practice exclusively under aspirin plus low dose ticlopidine (200 mg/day). A total of 2,459 lesions in 2,054 patients were treated with 3,285 SES. The mean age was 67.1 +/-10.1 years, 75.6% were men and 43.3% were diabetics. Intravascular ultrasound was used in 77.2%. The 8-month angiographic and 1-year clinical follow-up data were available in 85.4% and 96.8%, respectively. Quantitative coronary angiography showed the reference vessel diameter and percentage diameter stenosis at baseline were 2.47 +/-0.58 mm and 72.0 +/-16.1%. The 8-month late loss was 0.20 +/-0.50 mm. The major adverse cardiovascular events at 1 year was 7.3%; cardiac death: 1.1%, myocardial infarction (MI): 1.2%, and target lesion revascularization (TLR): 4.2%. The rates of definite and probable Stent thrombosis at 1 year were 0.30% and 0.10%, respectively. Hemodialysis was the strongest predictor of death/MI or TLR. CONCLUSIONS: J-PMS showed the effectiveness of SES implantation under aspirin plus low dose ticlopidine administration at 1 year, although further studies are necessary to demonstrate the safety.
Yuji Ikari - One of the best experts on this subject based on the ideXlab platform.
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the long term efficacy of sirolimus eluting Stent for small vessel disease subanalysis of Cypher Stent japan post marketing surveillance registry
Journal of Cardiology, 2013Co-Authors: Hajime Fujimoto, Yuji Ikari, Masato NakamuraAbstract:Abstract Background Percutaneous coronary intervention for lesions with small vessel diameter may have high event rates. Although drug-eluting Stents reduce the risk of restenosis, the long-term efficacy of drug-eluting Stent implantation in small vessels is unclear. Methods and results We reviewed the data of Cypher Stent Japan Post-Marketing Surveillance Registry including 2356 lesions of 1959 patients, and retrospectively investigated the angiographic outcomes at 8 months, and the clinical outcomes at 1800 days after sirolimus-eluting Stent (SES) implantation in vessels with diameter less than 2.5 mm (small vessel group) compared to that with diameter of 2.5 mm or more (non-small vessel group). The rate of major adverse cardiac events (MACE) at 1800 days was slightly higher in the small vessel group than in the non-small vessel group, but not statistically significant (24.4% vs 21.0%, p = 0.086). The rate of target lesion revascularization was higher in the small vessel group than in the non-small vessel group (10.2% vs 6.4%, p = 0.004). The rate of Stent thrombosis was almost the same in the two groups. Multivariate Cox hazard model analysis revealed that a vessel diameter less than 2.5 mm was not an independent risk factor for MACE. Conclusion SES implantation for vessels with diameter less than 2.5 mm is safe and provides good long-term outcomes.
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The long-term efficacy of sirolimus-eluting Stent for small vessel disease—Subanalysis of Cypher Stent Japan Post-Marketing Surveillance Registry
Journal of cardiology, 2012Co-Authors: Hajime Fujimoto, Yuji Ikari, Masato NakamuraAbstract:Abstract Background Percutaneous coronary intervention for lesions with small vessel diameter may have high event rates. Although drug-eluting Stents reduce the risk of restenosis, the long-term efficacy of drug-eluting Stent implantation in small vessels is unclear. Methods and results We reviewed the data of Cypher Stent Japan Post-Marketing Surveillance Registry including 2356 lesions of 1959 patients, and retrospectively investigated the angiographic outcomes at 8 months, and the clinical outcomes at 1800 days after sirolimus-eluting Stent (SES) implantation in vessels with diameter less than 2.5 mm (small vessel group) compared to that with diameter of 2.5 mm or more (non-small vessel group). The rate of major adverse cardiac events (MACE) at 1800 days was slightly higher in the small vessel group than in the non-small vessel group, but not statistically significant (24.4% vs 21.0%, p = 0.086). The rate of target lesion revascularization was higher in the small vessel group than in the non-small vessel group (10.2% vs 6.4%, p = 0.004). The rate of Stent thrombosis was almost the same in the two groups. Multivariate Cox hazard model analysis revealed that a vessel diameter less than 2.5 mm was not an independent risk factor for MACE. Conclusion SES implantation for vessels with diameter less than 2.5 mm is safe and provides good long-term outcomes.
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TCT-625 Three Year Follow up of a Randomized Comparison of Nobori, Biolimus A9 Eluting Stent(BES) with Cypher, Sirolimus Eluting Stent(SES) for Coronary Revascularization in Japanese Population
Journal of the American College of Cardiology, 2012Co-Authors: Takeshi Kimura, Yuji Ikari, Toshiya Muramatsu, Masashi Iwabuchi, Shigeru Saito, Yasuhiko Hayashi, Kenshi Fujii, Shinsuke Nanto, Naoto Inoue, Atsuo NamikiAbstract:Nobori Stent (Terumo Co., Tokyo Japan), is the new concept Drug Eluting Stent which has unique bioabsorbable polymer (Poly-Lactic Acid) and the anti-proliferative agent Biolimus A9. We investigated the safety and the efficacy of Nobori Stent comparing to Cypher Stent in Japanese population by a
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assessment of sirolimus eluting coronary Stent implantation with aspirin plus low dose ticlopidine administration
Circulation, 2009Co-Authors: Yuji Ikari, Masato Nakamura, Junichi Kotani, Ken Kozuma, Hiroyoshi YokoiAbstract:BACKGROUND: Clinical data of sirolimus-eluting Stent (SES) implantation are under investigation in Japan. METHODS AND RESULTS: The Cypher Stent Japan Post-Marketing Surveillance Registry (J-PMS) was conducted at 50 medical centers to assess the results of SES in daily clinical practice exclusively under aspirin plus low dose ticlopidine (200 mg/day). A total of 2,459 lesions in 2,054 patients were treated with 3,285 SES. The mean age was 67.1 +/-10.1 years, 75.6% were men and 43.3% were diabetics. Intravascular ultrasound was used in 77.2%. The 8-month angiographic and 1-year clinical follow-up data were available in 85.4% and 96.8%, respectively. Quantitative coronary angiography showed the reference vessel diameter and percentage diameter stenosis at baseline were 2.47 +/-0.58 mm and 72.0 +/-16.1%. The 8-month late loss was 0.20 +/-0.50 mm. The major adverse cardiovascular events at 1 year was 7.3%; cardiac death: 1.1%, myocardial infarction (MI): 1.2%, and target lesion revascularization (TLR): 4.2%. The rates of definite and probable Stent thrombosis at 1 year were 0.30% and 0.10%, respectively. Hemodialysis was the strongest predictor of death/MI or TLR. CONCLUSIONS: J-PMS showed the effectiveness of SES implantation under aspirin plus low dose ticlopidine administration at 1 year, although further studies are necessary to demonstrate the safety.
Steffen Schneider - One of the best experts on this subject based on the ideXlab platform.
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coronary Stenting with the sirolimus eluting Stent in clinical practice final results from the prospective multicenter german Cypher Stent registry
Journal of Interventional Cardiology, 2010Co-Authors: Ralf Zahn, Christian W. Hamm, Steffen Schneider, Gert Richardt, Malte Kelm, Benny Levenson, Tassilo Bonzel, Ulrich Tebbe, Georg V. Sabin, Christoph A. NienaberAbstract:atsklinikum, Kardiologie, Rostock Aims: Drug-eluting coronary Stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent “off-label” use data from “real life,” registries are necessary to monitor indications and outcome of DES in daily clinical practice. Methods and Results: We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting Stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 ± 0.41 SES were implanted with a mean length of 21.1 ± 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: twoor three-vessel disease, target vessel = coronary bypass, advanced age, Stent diameter, ostial lesions, indication in-Stent restenosis, renal failure, and target vessel = left anterior descended artery. Conclusions: These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters. (J Interven Cardiol 2009; ∗∗ :1–8)
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Coronary Stenting with the Sirolimus‐Eluting Stent in Clinical Practice: Final Results from the Prospective Multicenter German Cypher Stent Registry
Journal of interventional cardiology, 2009Co-Authors: Ralf Zahn, Christian W. Hamm, Steffen Schneider, Gert Richardt, Malte Kelm, Benny Levenson, Tassilo Bonzel, Ulrich Tebbe, Georg V. Sabin, Christoph A. NienaberAbstract:atsklinikum, Kardiologie, Rostock Aims: Drug-eluting coronary Stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent “off-label” use data from “real life,” registries are necessary to monitor indications and outcome of DES in daily clinical practice. Methods and Results: We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting Stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 ± 0.41 SES were implanted with a mean length of 21.1 ± 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: twoor three-vessel disease, target vessel = coronary bypass, advanced age, Stent diameter, ostial lesions, indication in-Stent restenosis, renal failure, and target vessel = left anterior descended artery. Conclusions: These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters. (J Interven Cardiol 2009; ∗∗ :1–8)
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Treatment of in-Stent restenosis with sirolimus-eluting-Stents: results from the prospective German Cypher Stent registry
Clinical Research in Cardiology, 2008Co-Authors: Helge Möllmann, Steffen Schneider, Gert Richardt, Malte Kelm, Benny Levenson, Christoph A. Nienaber, Albrecht Elsässer, Holger Nef, Michael Weber, Tassilo BonzelAbstract:Aims Drug-eluting Stents have been reported to effectively reduce in-Stent restenosis (ISR). However, the effectiveness and safety have yet been investigated only in small trials or case series. The aim of this prospective large scale registry was to show that treatment of ISR with sirolimus eluting Stents (SES) is safe, effective and feasible in daily routine. Methods and results The German Cypher registry prospectively enrolled 6,555 patients undergoing implantation with SES for various indications, including 1,533 patients treated for ISR. Follow-up data (median 6.6 months) of this cohort was available for 1,531 patients (99.8%). Of these patients 75.8% were male. Of these patients 36.5% ( n = 552) presented with acute coronary syndromes. In total, 1,932 SES were used with successful implantation in 98.9%. MI during hospitalization was observed in 0.7% ( n = 11) while in-hospital mortality was only 0.1% ( n = 2). MACE-rate at follow-up was 13.8% ( n = 211) including a mortality of 1.3% ( n = 20) and MI in 1.9% ( n = 29). Total revascularization procedures including CABG (1.7%) were necessary in 12.3% ( n = 186). Target vessel revascularization (TVR) rate was 9.3% ( n = 139) and thus similar to patients with de novo lesions (8.1%, P = 0.69). Ten patients (0.65%) suffered from subacute Stent thrombosis Vs. 0.24% observed in patients with de novo lesions ( P = 0.03). Conclusion This large registry confirms that treatment of ISR with sirolimus-eluting-Stents is effective and save with good clinical results at index procedure and follow-up. TVR was not different from de novo lesions.
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sirolimus eluting Stents in the treatment of chronic total coronary occlusions results from the prospective multi center german Cypher Stent registry
Clinical Research in Cardiology, 2008Co-Authors: Christian Zellerhoff, Christian W. Hamm, Steffen Schneider, Jochen Senges, Thomas Pfannebecker, U. TebbeAbstract:Objectives We assessed the effectiveness and safety of the sirolimus-eluting Stent (SES) in the treatment of chronic total coronary occlusions.
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treatment of in Stent restenosis with sirolimus eluting Stents results from the prospective german Cypher Stent registry
Clinical Research in Cardiology, 2008Co-Authors: Helge Möllmann, Steffen Schneider, Gert Richardt, Malte Kelm, Benny Levenson, Christoph A. Nienaber, Albrecht Elsässer, Holger Nef, Michael Weber, Tassilo BonzelAbstract:Aims Drug-eluting Stents have been reported to effectively reduce in-Stent restenosis (ISR). However, the effectiveness and safety have yet been investigated only in small trials or case series. The aim of this prospective large scale registry was to show that treatment of ISR with sirolimus eluting Stents (SES) is safe, effective and feasible in daily routine.
Christian W. Hamm - One of the best experts on this subject based on the ideXlab platform.
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coronary Stenting with the sirolimus eluting Stent in clinical practice final results from the prospective multicenter german Cypher Stent registry
Journal of Interventional Cardiology, 2010Co-Authors: Ralf Zahn, Christian W. Hamm, Steffen Schneider, Gert Richardt, Malte Kelm, Benny Levenson, Tassilo Bonzel, Ulrich Tebbe, Georg V. Sabin, Christoph A. NienaberAbstract:atsklinikum, Kardiologie, Rostock Aims: Drug-eluting coronary Stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent “off-label” use data from “real life,” registries are necessary to monitor indications and outcome of DES in daily clinical practice. Methods and Results: We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting Stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 ± 0.41 SES were implanted with a mean length of 21.1 ± 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: twoor three-vessel disease, target vessel = coronary bypass, advanced age, Stent diameter, ostial lesions, indication in-Stent restenosis, renal failure, and target vessel = left anterior descended artery. Conclusions: These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters. (J Interven Cardiol 2009; ∗∗ :1–8)
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Coronary Stenting with the sirolimus-eluting Stent in patients with restenosis after intracoronary brachytherapy: results from the prospective multicentre German Cypher Stent Registry
Clinical Research in Cardiology, 2010Co-Authors: Ralf Zahn, Christian W. Hamm, Gert Richardt, Malte Kelm, Benny Levenson, Tassilo Bonzel, Ulrich Tebbe, Uwe Zeymer, Georg Sabin, Christoph A. NienaberAbstract:Background Treatment of restenosis following intracoronary brachytherapy (ICB) is still a challenging problem. Implantation of sirolimus-eluting Stents (SES) in this setting may be an option to be evaluated. Methods and results We analysed the prospective multicentre SES registry, the German Cypher Stent Registry . 7,445 patients treated with an SES during percutaneous coronary intervention (PCI) were registered. Out of these patients, 61 (0.8%) were treated for restenosis after ICB: 56 patients with completed follow-up could be evaluated. Median age was 65 years, with 80% male patients. 48% of patients had a prior myocardial infarction and 25% had already coronary bypass surgery (CABG). Type B2 lesion was present in 40% and type C lesion in 22.4%. Event rates from SES implantation until 6.6 months follow-up were death 0%, myocardial infarction 3.6%, stroke 2.1%. Target vessel revascularization rate (TVR) was 16.4%, and major adverse cardiovascular or cerebral events (MACCE) or TVR occurred in 17.9% of patients. This TVR rate was higher compared with that of other patients treated with an SES: 8.4% ( P = 0.04). During 65 months follow-up MACCE or TVR occurred in 44.6% of patients. Conclusions The treatment of lesions after ICB occurred in 0.8% out of all patients treated with an SES. Clinical event rates during early follow-up were low. However, the TVR rate was 16.4%, which was significantly higher when compared with other SES-treated patients (8.4%, P = 0.04). The treatment of restenosis after ICB with SES seems to be safe and reasonably effective; however, there might be a late catch-up phenomenon.
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Coronary Stenting with the Sirolimus‐Eluting Stent in Clinical Practice: Final Results from the Prospective Multicenter German Cypher Stent Registry
Journal of interventional cardiology, 2009Co-Authors: Ralf Zahn, Christian W. Hamm, Steffen Schneider, Gert Richardt, Malte Kelm, Benny Levenson, Tassilo Bonzel, Ulrich Tebbe, Georg V. Sabin, Christoph A. NienaberAbstract:atsklinikum, Kardiologie, Rostock Aims: Drug-eluting coronary Stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent “off-label” use data from “real life,” registries are necessary to monitor indications and outcome of DES in daily clinical practice. Methods and Results: We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting Stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 ± 0.41 SES were implanted with a mean length of 21.1 ± 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: twoor three-vessel disease, target vessel = coronary bypass, advanced age, Stent diameter, ostial lesions, indication in-Stent restenosis, renal failure, and target vessel = left anterior descended artery. Conclusions: These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters. (J Interven Cardiol 2009; ∗∗ :1–8)
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sirolimus eluting Stents in the treatment of chronic total coronary occlusions results from the prospective multi center german Cypher Stent registry
Clinical Research in Cardiology, 2008Co-Authors: Christian Zellerhoff, Christian W. Hamm, Steffen Schneider, Jochen Senges, Thomas Pfannebecker, U. TebbeAbstract:Objectives We assessed the effectiveness and safety of the sirolimus-eluting Stent (SES) in the treatment of chronic total coronary occlusions.
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sirolimus eluting Stent Cypher in patients with diabetes mellitus results from the german Cypher Stent registry
Clinical Research in Cardiology, 2008Co-Authors: Frank Weber, Christian W. Hamm, Steffen Schneider, Jochen Senges, U. Tebbe, Henrik Schneider, Marcus Wiemer, Thomas Pfannebecker, Christoph A. NienaberAbstract:Background Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) are at increased risk for adverse outcomes. The use of sirolimus eluting Stents (SES) has been shown to improve outcomes in diabetic patients. Since results from randomized trials were derived from selected patients scientific scrutiny under real world conditions is necessary.
