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Christoph Stettler - One of the best experts on this subject based on the ideXlab platform.
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stent thrombosis with drug eluting and Bare Metal stents evidence from a comprehensive network meta analysis
The Lancet, 2012Co-Authors: Tullio Palmerini, Diego Sangiorgi, Carlo Briguori, Christoph Stettler, Takeshi Kimura, Manel Sabate, Giuseppe Biondizoccai, Diego Della Riva, Fabrizio Dascenzo, Antoinette De WahaAbstract:Summary Background The relative safety of drug-eluting stents and Bare-Metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between Bare-Metal and drug-eluting stents. Methods For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with Bare-Metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. Findings 49 trials including 50 844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with Bare-Metal stents (odds ratio [OR] 0·23, 95% CI 0·13–0·41). The significant difference in stent thrombosis between CoCr-EES and Bare-Metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11–0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08–0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16–0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24–0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10–0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03–0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were Bare-Metal (OR 0·35, 95% CI 0·17–0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19–0·62). No other drug-eluting stent had lower definite thrombosis rates compared with Bare-Metal stents at 2-year follow-up. Interpretation In randomised studies completed to date, CoCr-EES has the lowest rate of stent thrombosis within 2 years of implantation. The finding that CoCr-EES also reduced stent thrombosis compared with Bare-Metal stents, if confirmed in future randomised trials, represents a paradigm shift. Funding The Cardiovascular Research Foundation.
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Stent thrombosis with drug-eluting and Bare-Metal stents: Evidence from a comprehensive network meta-analysis
The Lancet, 2012Co-Authors: Tullio Palmerini, Diego Della Riva, Diego Sangiorgi, Fabrizio D'ascenzo, Carlo Briguori, Manel Sabat, Christoph Stettler, Giuseppe Biondi-zoccai, Takeshi Kimura, Hyo Soo KimAbstract:Background: The relative safety of drug-eluting stents and Bare-Metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between Bare-Metal and drug-eluting stents. Methods: For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with Bare-Metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. Findings: 49 trials including 50 844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with Bare-Metal stents (odds ratio [OR] 0·23, 95 CI 0·13-0·41). The significant difference in stent thrombosis between CoCr-EES and Bare-Metal stents was evident as early as 30 days (OR 0·21, 95 CI 0·11-0·42) and was also significant between 31 days and 1 year (OR 0·27, 95 CI 0·08-0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95 CI 0·16-0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95 CI 0·24-0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95 CI 0·10-0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95 CI 0·03- 0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were Bare-Metal (OR 0·35, 95 CI 0·17-0·69) and paclitaxel-eluting stents (OR 0·34, 95 CI 0·19-0·62). No other drug-eluting stent had lower definite thrombosis rates compared with Bare-Metal stents at 2-year follow-up. Interpretation: In randomised studies completed to date, CoCr-EES has the lowest rate of stent thrombosis within 2 years of implantation. The finding that CoCr-EES also reduced stent thrombosis compared with Bare-Metal stents, if confirmed in future randomised trials, represents a paradigm shift. Funding: The Cardiovascular Research Foundation. © 2012 Elsevier Ltd.
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outcomes associated with drug eluting and Bare Metal stents a collaborative network meta analysis
The Lancet, 2007Co-Authors: Christoph Stettler, Simon Wandel, Sabin Allemann, Matthias E. Pfisterer, Gregg W. Stone, Albert Schömig, Adnan Kastrati, Marie-claude Morice, Martin B. LeonAbstract:Summary Background Whether the two drug-eluting stents approved by the US Food and Drug Administration—a sirolimus-eluting stent and a paclitaxel-eluting stent—are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with Bare-Metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. Methods We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with Bare-Metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18 023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Findings Mortality was similar in the three groups: hazard ratios (HR) were 1·00 (95% credibility interval 0·82–1·25) for sirolimus-eluting versus Bare-Metal stents, 1·03 (0·84–1·22) for paclitaxel-eluting versus Bare-Metal stents, and 0·96 (0·83–1·24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0·81, 95% credibility interval 0·66–0·97, p=0·030 vs Bare-Metal stents; 0·83, 0·71–1·00, p=0·045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2·11, 95% credibility interval 1·19–4·23, p=0·017 vs Bare-Metal stents; 1·85, 1·02–3·85, p=0·041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with Bare-Metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0·70, 0·56–0·84; p=0·0021). Interpretation The risks of mortality associated with drug-eluting and Bare-Metal stents are similar. Sirolimus-eluting stents seem to be clinically better than Bare-Metal and paclitaxel-eluting stents.
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Outcomes associated with drug-eluting and Bare-Metal stents: a collaborative network meta-analysis
Lancet, 2007Co-Authors: Christoph Stettler, Simon Wandel, Sabin Allemann, Matthias E. Pfisterer, Gregg W. Stone, Martin B. Leon, Albert Schömig, Adnan Kastrati, Marie-claude Morice, José Suarez De LezoAbstract:Background: Whether the two drug-eluting stents approved by the US Food and Drug Administration-a sirolimus-eluting stent and a paclitaxel-eluting stent-are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with Bare-Metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. Methods: We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with Bare-Metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18 023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Findings: Mortality was similar in the three groups: hazard ratios (HR) were 1·00 (95% credibility interval 0·82-1·25) for sirolimus-eluting versus Bare-Metal stents, 1·03 (0·84-1·22) for paclitaxel-eluting versus Bare-Metal stents, and 0·96 (0·83-1·24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0·81, 95% credibility interval 0·66-0·97, p=0·030 vs Bare-Metal stents; 0·83, 0·71-1·00, p=0·045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2·11, 95% credibility interval 1·19-4·23, p=0·017 vs Bare-Metal stents; 1·85, 1·02-3·85, p=0·041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with Bare-Metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0·70, 0·56-0·84; p=0·0021). Interpretation: The risks of mortality associated with drug-eluting and Bare-Metal stents are similar. Sirolimus-eluting stents seem to be clinically better than Bare-Metal and paclitaxel-eluting stents. © 2007 Elsevier Ltd. All rights reserved.
Gregg W. Stone - One of the best experts on this subject based on the ideXlab platform.
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Drug-Eluting Versus Bare-Metal Stents
2016Co-Authors: Ajay J. Kirtane, Gregg W. Stone, Dean J. Kereiakes, Antonio ColomboAbstract:Dr. Gregg Stone from Columbia University Medical Center, New York, NY moderated the topic "Drug-Eluting Versus Bare-Metal Stents" with Drs. Antonio Colombo from San Raffaele Scientific Institute and Columbus Hospital, Milan, Italy, Dean Kereiakes from The Christ Hospital Heart and Vascular Center, Cincinnati, OH, and Ajay Kirtane from Columbia University Medical Center/New York-Presbyterian Hospital, New York, NY. The discussion focused primarily on: Advantages, disadvantages, and nuances of drug-eluting and Bare-Metal stents; pathophysiology and clinical manifestations of coronary restenosis; evolution from first-generation, drug-eluting stents to current generation devices; current dual antiplatelet therapy (DAPT) recommendations (especially with regard to DAPT duration); the appropriateness of drug-eluting vs Bare-Metal stents for particular patients; and the future of stent technology. (Med Roundtable Cardiovasc Ed. 2014;3(4):208–217) ©2014 FoxP2 Media, LLC
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paclitaxel eluting stents versus Bare Metal stents in acute myocardial infarction
The New England Journal of Medicine, 2009Co-Authors: Gregg W. Stone, Alexandra J Lansky, Stuart J Pocock, Bernard J Gersh, George Dangas, Chiu S Wong, Bernhard Witzenbichler, Giulio Guagliumi, Jan Z Peruga, Bruce R BrodieAbstract:Background There is no consensus regarding the safety and efficacy of drug-eluting stents, as compared with Bare-Metal stents, in patients with ST-segment elevation myocardial infarction who are undergoing primary percutaneous coronary intervention (PCI). Methods We randomly assigned, in a 3:1 ratio, 3006 patients presenting with ST-segment elevation myocardial infarction to receive paclitaxel-eluting stents (2257 patients) or otherwise identical Bare-Metal stents (749 patients). The two primary end points of the study were the 12-month rates of target-lesion revascularization for ischemia (analysis powered for superiority) and a composite safety outcome measure of death, reinfarction, stroke, or stent thrombosis (powered for noninferiority with a 3.0% margin). The major secondary end point was angiographic evidence of restenosis at 13 months. Results Patients who received paclitaxel-eluting stents, as compared with those who received Bare-Metal stents, had significantly lower 12-month rates of ischemia-d...
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outcomes associated with drug eluting and Bare Metal stents a collaborative network meta analysis
The Lancet, 2007Co-Authors: Christoph Stettler, Simon Wandel, Sabin Allemann, Matthias E. Pfisterer, Gregg W. Stone, Albert Schömig, Adnan Kastrati, Marie-claude Morice, Martin B. LeonAbstract:Summary Background Whether the two drug-eluting stents approved by the US Food and Drug Administration—a sirolimus-eluting stent and a paclitaxel-eluting stent—are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with Bare-Metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. Methods We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with Bare-Metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18 023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Findings Mortality was similar in the three groups: hazard ratios (HR) were 1·00 (95% credibility interval 0·82–1·25) for sirolimus-eluting versus Bare-Metal stents, 1·03 (0·84–1·22) for paclitaxel-eluting versus Bare-Metal stents, and 0·96 (0·83–1·24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0·81, 95% credibility interval 0·66–0·97, p=0·030 vs Bare-Metal stents; 0·83, 0·71–1·00, p=0·045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2·11, 95% credibility interval 1·19–4·23, p=0·017 vs Bare-Metal stents; 1·85, 1·02–3·85, p=0·041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with Bare-Metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0·70, 0·56–0·84; p=0·0021). Interpretation The risks of mortality associated with drug-eluting and Bare-Metal stents are similar. Sirolimus-eluting stents seem to be clinically better than Bare-Metal and paclitaxel-eluting stents.
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Outcomes associated with drug-eluting and Bare-Metal stents: a collaborative network meta-analysis
Lancet, 2007Co-Authors: Christoph Stettler, Simon Wandel, Sabin Allemann, Matthias E. Pfisterer, Gregg W. Stone, Martin B. Leon, Albert Schömig, Adnan Kastrati, Marie-claude Morice, José Suarez De LezoAbstract:Background: Whether the two drug-eluting stents approved by the US Food and Drug Administration-a sirolimus-eluting stent and a paclitaxel-eluting stent-are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with Bare-Metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. Methods: We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with Bare-Metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18 023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Findings: Mortality was similar in the three groups: hazard ratios (HR) were 1·00 (95% credibility interval 0·82-1·25) for sirolimus-eluting versus Bare-Metal stents, 1·03 (0·84-1·22) for paclitaxel-eluting versus Bare-Metal stents, and 0·96 (0·83-1·24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0·81, 95% credibility interval 0·66-0·97, p=0·030 vs Bare-Metal stents; 0·83, 0·71-1·00, p=0·045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2·11, 95% credibility interval 1·19-4·23, p=0·017 vs Bare-Metal stents; 1·85, 1·02-3·85, p=0·041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with Bare-Metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0·70, 0·56-0·84; p=0·0021). Interpretation: The risks of mortality associated with drug-eluting and Bare-Metal stents are similar. Sirolimus-eluting stents seem to be clinically better than Bare-Metal and paclitaxel-eluting stents. © 2007 Elsevier Ltd. All rights reserved.
Adnan Kastrati - One of the best experts on this subject based on the ideXlab platform.
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Drug-Eluting Balloons or Stents for Bare-Metal Stent Restenosis.
Jacc-cardiovascular Interventions, 2016Co-Authors: Jens Wiebe, Roisin Colleran, Adnan KastratiAbstract:Drug-eluting stents (DES) represent the gold standard device for percutaneous coronary intervention [(1)][1]. Nevertheless, Bare-Metal stents (BMS) are still used in patients at high bleeding risk or if immediate surgery is pending, to allow shorter dual-antiplatelet therapy duration in comparison
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outcomes associated with drug eluting and Bare Metal stents a collaborative network meta analysis
The Lancet, 2007Co-Authors: Christoph Stettler, Simon Wandel, Sabin Allemann, Matthias E. Pfisterer, Gregg W. Stone, Albert Schömig, Adnan Kastrati, Marie-claude Morice, Martin B. LeonAbstract:Summary Background Whether the two drug-eluting stents approved by the US Food and Drug Administration—a sirolimus-eluting stent and a paclitaxel-eluting stent—are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with Bare-Metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. Methods We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with Bare-Metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18 023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Findings Mortality was similar in the three groups: hazard ratios (HR) were 1·00 (95% credibility interval 0·82–1·25) for sirolimus-eluting versus Bare-Metal stents, 1·03 (0·84–1·22) for paclitaxel-eluting versus Bare-Metal stents, and 0·96 (0·83–1·24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0·81, 95% credibility interval 0·66–0·97, p=0·030 vs Bare-Metal stents; 0·83, 0·71–1·00, p=0·045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2·11, 95% credibility interval 1·19–4·23, p=0·017 vs Bare-Metal stents; 1·85, 1·02–3·85, p=0·041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with Bare-Metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0·70, 0·56–0·84; p=0·0021). Interpretation The risks of mortality associated with drug-eluting and Bare-Metal stents are similar. Sirolimus-eluting stents seem to be clinically better than Bare-Metal and paclitaxel-eluting stents.
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analysis of 14 trials comparing sirolimus eluting stents with Bare Metal stents
The New England Journal of Medicine, 2007Co-Authors: Adnan Kastrati, Julinda Mehilli, Jurgen Pache, Christoph Kaiser, Marco Valgimigli, Henning Kelbaek, Maurizio Menichelli, Manel Sabate, Maarten J Suttorp, Dietrich BaumgartAbstract:The overall risk of death (hazard ratio, 1.03; 95% confidence interval [CI], 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus Bare-Metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimuseluting stents versus Bare-Metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year. Conclusions The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with Bare-Metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with Bare-Metal stents.
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Outcomes associated with drug-eluting and Bare-Metal stents: a collaborative network meta-analysis
Lancet, 2007Co-Authors: Christoph Stettler, Simon Wandel, Sabin Allemann, Matthias E. Pfisterer, Gregg W. Stone, Martin B. Leon, Albert Schömig, Adnan Kastrati, Marie-claude Morice, José Suarez De LezoAbstract:Background: Whether the two drug-eluting stents approved by the US Food and Drug Administration-a sirolimus-eluting stent and a paclitaxel-eluting stent-are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with Bare-Metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. Methods: We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with Bare-Metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18 023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Findings: Mortality was similar in the three groups: hazard ratios (HR) were 1·00 (95% credibility interval 0·82-1·25) for sirolimus-eluting versus Bare-Metal stents, 1·03 (0·84-1·22) for paclitaxel-eluting versus Bare-Metal stents, and 0·96 (0·83-1·24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0·81, 95% credibility interval 0·66-0·97, p=0·030 vs Bare-Metal stents; 0·83, 0·71-1·00, p=0·045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2·11, 95% credibility interval 1·19-4·23, p=0·017 vs Bare-Metal stents; 1·85, 1·02-3·85, p=0·041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with Bare-Metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0·70, 0·56-0·84; p=0·0021). Interpretation: The risks of mortality associated with drug-eluting and Bare-Metal stents are similar. Sirolimus-eluting stents seem to be clinically better than Bare-Metal and paclitaxel-eluting stents. © 2007 Elsevier Ltd. All rights reserved.
Christopher Kruegel - One of the best experts on this subject based on the ideXlab platform.
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USENIX Security Symposium - Barecloud: Bare-Metal analysis-based evasive malware detection
2014Co-Authors: Dhilung Kirat, Giovanni Vigna, Christopher KruegelAbstract:The volume and the sophistication of malware are continuously increasing and evolving. Automated dynamic malware analysis is a widely-adopted approach for detecting malicious software. However, many recent malware samples try to evade detection by identifying the presence of the analysis environment itself, and refraining from performing malicious actions. Because of the sophistication of the techniques used by the malware authors, so far the analysis and detection of evasive malware has been largely a manual process. One approach to automatic detection of these evasive malware samples is to execute the same sample in multiple analysis environments, and then compare its behaviors, in the assumption that a deviation in the behavior is evidence of an attempt to evade one or more analysis systems. For this reason, it is important to provide a reference system (often called Bare-Metal) in which the malware is analyzed without the use of any detectable component. In this paper, we present BareCloud, an automated evasive malware detection system based on Bare-Metal dynamic malware analysis. Our Bare-Metal analysis system does not introduce any in-guest monitoring component into the malware execution platform. This makes our approach more transparent and robust against sophisticated evasion techniques. We compare the malware behavior observed in the Bare-Metal system with other popular malware analysis systems. We introduce a novel approach of hierarchical similarity-based malware behavior comparison to analyze the behavior of a sample in the various analysis systems. Our experiments show that our approach produces better evasion detection results compared to previous methods. BareCloud was able to automatically detect 5,835 evasive malware out of 110,005 recent samples.
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BareCloud: Bare-Metal Analysis-based Evasive Malware Detection
23rd USENIX Security Symposium (USENIX Security 14), 2014Co-Authors: Dhilung Kirat, Giovanni Vigna, Christopher KruegelAbstract:The volume and the sophistication of malware are continuously increasing and evolving. Automated dynamic malware analysis is a widely-adopted approach for detecting malicious software. However, many recent malware samples try to evade detection by identifying the presence of the analysis environment itself, and refraining from performing malicious actions. Because of the sophistication of the techniques used by the malware authors, so far the analysis and detection of evasive malware has been largely a manual process. One approach to automatic detection of these evasive malware samples is to execute the same sample in multiple analysis environments, and then compare its behaviors, in the assumption that a deviation in the behavior is evidence of an attempt to evade one or more analysis systems. For this reason, it is important to provide a reference system (often called Bare-Metal) in which the malware is analyzed without the use of any detectable component. In this paper, we present BareCloud, an automated evasive malware detection system based on Bare-Metal dynamic malware analysis. Our Bare-Metal analysis system does not introduce any in-guest monitoring component into the malware execution platform. This makes our approach more transparent and robust against sophisticated evasion techniques. We compare the malware behavior observed in the Bare-Metal system with other popular malware analysis systems. We introduce a novel approach of hierarchical similarity-based malware behavior comparison to analyze the behavior of a sample in the various analysis systems. Our experiments show that our approach produces better evasion detection results compared to previous methods. BareCloud was able to automatically detect 5,835 evasive malware out of 110,005 recent samples.
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Barebox efficient malware analysis on Bare Metal
Annual Computer Security Applications Conference, 2011Co-Authors: Dhilung Kirat, Giovanni Vigna, Christopher KruegelAbstract:Present-day malware analysis techniques use both virtualized and emulated environments to analyze malware. The reason is that such environments provide isolation and system restoring capabilities, which facilitate automated analysis of malware samples. However, there exists a class of malware, called VM-aware malware, which is capable of detecting such environments and then hide its malicious behavior to foil the analysis. Because of the artifacts introduced by virtualization or emulation layers, it has always been and will always be possible for malware to detect virtual environments. The definitive way to observe the actual behavior of VM-aware malware is to execute them in a system running on real hardware, which is called a "Bare-Metal" system. However, after each analysis, the system must be restored back to the previous clean state. This is because running a malware program can leave the system in an instable/insecure state and/or interfere with the results of a subsequent analysis run. Most of the available state-of-the-art system restore solutions are based on disk restoring and require a system reboot. This results in a significant downtime between each analysis. Because of this limitation, efficient automation of malware analysis in Bare-Metal systems has been a challenge. This paper presents the design, implementation, and evaluation of a malware analysis framework for Bare-Metal systems that is based on a fast and rebootless system restore technique. Live system restore is accomplished by restoring the entire physical memory of the analysis operating system from another, small operating system that runs outside of the target OS. By using this technique, we were able to perform a rebootless restore of a live Windows system, running on commodity hardware, within four seconds. We also analyzed 42 malware samples from seven different malware families, that are known to be "silent" in a virtualized or emulated environments, and all of them showed their true malicious behavior within our Bare-Metal analysis environment.
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ACSAC - BareBox: efficient malware analysis on Bare-Metal
Proceedings of the 27th Annual Computer Security Applications Conference on - ACSAC '11, 2011Co-Authors: Dhilung Kirat, Giovanni Vigna, Christopher KruegelAbstract:Present-day malware analysis techniques use both virtualized and emulated environments to analyze malware. The reason is that such environments provide isolation and system restoring capabilities, which facilitate automated analysis of malware samples. However, there exists a class of malware, called VM-aware malware, which is capable of detecting such environments and then hide its malicious behavior to foil the analysis. Because of the artifacts introduced by virtualization or emulation layers, it has always been and will always be possible for malware to detect virtual environments. The definitive way to observe the actual behavior of VM-aware malware is to execute them in a system running on real hardware, which is called a "Bare-Metal" system. However, after each analysis, the system must be restored back to the previous clean state. This is because running a malware program can leave the system in an instable/insecure state and/or interfere with the results of a subsequent analysis run. Most of the available state-of-the-art system restore solutions are based on disk restoring and require a system reboot. This results in a significant downtime between each analysis. Because of this limitation, efficient automation of malware analysis in Bare-Metal systems has been a challenge. This paper presents the design, implementation, and evaluation of a malware analysis framework for Bare-Metal systems that is based on a fast and rebootless system restore technique. Live system restore is accomplished by restoring the entire physical memory of the analysis operating system from another, small operating system that runs outside of the target OS. By using this technique, we were able to perform a rebootless restore of a live Windows system, running on commodity hardware, within four seconds. We also analyzed 42 malware samples from seven different malware families, that are known to be "silent" in a virtualized or emulated environments, and all of them showed their true malicious behavior within our Bare-Metal analysis environment.
Martin B. Leon - One of the best experts on this subject based on the ideXlab platform.
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outcomes associated with drug eluting and Bare Metal stents a collaborative network meta analysis
The Lancet, 2007Co-Authors: Christoph Stettler, Simon Wandel, Sabin Allemann, Matthias E. Pfisterer, Gregg W. Stone, Albert Schömig, Adnan Kastrati, Marie-claude Morice, Martin B. LeonAbstract:Summary Background Whether the two drug-eluting stents approved by the US Food and Drug Administration—a sirolimus-eluting stent and a paclitaxel-eluting stent—are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with Bare-Metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. Methods We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with Bare-Metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18 023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Findings Mortality was similar in the three groups: hazard ratios (HR) were 1·00 (95% credibility interval 0·82–1·25) for sirolimus-eluting versus Bare-Metal stents, 1·03 (0·84–1·22) for paclitaxel-eluting versus Bare-Metal stents, and 0·96 (0·83–1·24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0·81, 95% credibility interval 0·66–0·97, p=0·030 vs Bare-Metal stents; 0·83, 0·71–1·00, p=0·045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2·11, 95% credibility interval 1·19–4·23, p=0·017 vs Bare-Metal stents; 1·85, 1·02–3·85, p=0·041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with Bare-Metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0·70, 0·56–0·84; p=0·0021). Interpretation The risks of mortality associated with drug-eluting and Bare-Metal stents are similar. Sirolimus-eluting stents seem to be clinically better than Bare-Metal and paclitaxel-eluting stents.
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Outcomes associated with drug-eluting and Bare-Metal stents: a collaborative network meta-analysis
Lancet, 2007Co-Authors: Christoph Stettler, Simon Wandel, Sabin Allemann, Matthias E. Pfisterer, Gregg W. Stone, Martin B. Leon, Albert Schömig, Adnan Kastrati, Marie-claude Morice, José Suarez De LezoAbstract:Background: Whether the two drug-eluting stents approved by the US Food and Drug Administration-a sirolimus-eluting stent and a paclitaxel-eluting stent-are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with Bare-Metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. Methods: We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with Bare-Metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18 023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Findings: Mortality was similar in the three groups: hazard ratios (HR) were 1·00 (95% credibility interval 0·82-1·25) for sirolimus-eluting versus Bare-Metal stents, 1·03 (0·84-1·22) for paclitaxel-eluting versus Bare-Metal stents, and 0·96 (0·83-1·24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0·81, 95% credibility interval 0·66-0·97, p=0·030 vs Bare-Metal stents; 0·83, 0·71-1·00, p=0·045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2·11, 95% credibility interval 1·19-4·23, p=0·017 vs Bare-Metal stents; 1·85, 1·02-3·85, p=0·041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with Bare-Metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0·70, 0·56-0·84; p=0·0021). Interpretation: The risks of mortality associated with drug-eluting and Bare-Metal stents are similar. Sirolimus-eluting stents seem to be clinically better than Bare-Metal and paclitaxel-eluting stents. © 2007 Elsevier Ltd. All rights reserved.
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Cause of death with Bare Metal and sirolimus-eluting stents
European Heart Journal, 2006Co-Authors: David R. Holmes, Marie-claude Morice, Jeffrey W. Moses, Joachim Schofer, Erick Schampaert, Martin B. LeonAbstract:Aims Although drug-eluting stents have assumed a dominant role in interventional cardiology, concern has been raised about the potential for long-term adverse outcomes, including death. The aim of the present study was to compare the incidence and cause of death between patients who received sirolimus-eluting or Bare Metal stents. Methods and results An integrated analysis was performed on 1748 patients enrolled in four prospective double-blind trials that randomly assigned patients to receive either a sirolimus-eluting or a Bare Metal stent for treatment of a single de novo coronary stenosis. During a mean follow-up of 2.6±0.6 years, 64 patients (3.7%) died. Total mortality was 3.2% among 870 Bare Metal stent patients and 4.1% among 878 sirolimus-eluting stent patients ( P =0.37); there was no difference in cardiac mortality (1.4 vs. 1.3%; P =0.55) or causes of death between these two groups. The predominant cause of death was non-cardiac. Cardiac death was most frequently assigned owing to unwitnessed death. Death due to acute myocardial infarction, congestive heart failure, and stent thrombosis occurred infrequently. Conclusion At a mean follow-up of 2.6 years in percutaneous coronary intervention patients, the predominant cause of death was non-cardiac. There was no significant difference in either the frequency or the cause of death with implantation of either sirolimus-eluting or Bare Metal stents.
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Cause of death with Bare Metal and sirolimus-eluting stents. Commentary
European Heart Journal, 2006Co-Authors: William Wijns, Marie-claude Morice, David R. Holmes, Jeffrey W. Moses, Joachim Schofer, Erick Schampaert, Mitchell W. Krucoff, Martin B. LeonAbstract:Aims Although drug-eluting stents have assumed a dominant role in interventional cardiology, concern has been raised about the potential for long-term adverse outcomes, including death. The aim of the present study was to compare the incidence and cause of death between patients who received sirolimus-eluting or Bare Metal stents. Methods and results An integrated analysis was performed on 1748 patients enrolled in four prospective double-blind trials that randomly assigned patients to receive either a sirolimus-eluting or a Bare Metal stent for treatment of a single de novo coronary stenosis. During a mean follow-up of 2.6 ± 0.6 years, 64 patients (3.7%) died. Total mortality was 3.2% among 870 Bare Metal stent patients and 4.1% among 878 sirolimus-eluting stent patients (P= 0.37); there was no difference in cardiac mortality (1.4 vs. 1.3%; P=0.55) or causes of death between these two groups. The predominant cause of death was non-cardiac. Cardiac death was most frequently assigned owing to unwitnessed death. Death due to acute myocardial infarction, congestive heart failure, and stent thrombosis occurred infrequently. Conclusion At a mean follow-up of 2.6 years in percutaneous coronary intervention patients, the predominant cause of death was non-cardiac. There was no significant difference in either the frequency or the cause of death with implantation of either sirolimus-eluting or Bare Metal stents.
