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Gregg W Stone - One of the best experts on this subject based on the ideXlab platform.
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incidence timing and correlates of Stent thrombosis with the polymeric paclitaxel drug eluting Stent a Taxus ii iv v and vi meta analysis of 3 445 patients followed for up to 3 years
Journal of the American College of Cardiology, 2007Co-Authors: Antonio Colombo, Joerg Koglin, Keith D Dawkins, Eberhard Grube, Gregg W StoneAbstract:Objectives This study sought to study Stent thrombosis with the paclitaxel-eluting Taxus Stent. Background The incidence and timing of Stent thrombosis after drug-eluting Stent placement compared with bare-metal Stent implantation remain unsettled, with consequent uncertainty about risk stratification and long-term recommendations for antiplatelet medications. Methods This study used a patient-based meta-analysis using the 4 principal Taxus randomized trials (3,445 patients) with a follow-up duration of ≥1 year. Results Cumulative Stent thrombosis occurred in 1.28% ± 0.31% in the Taxus group and 0.76% ± 0.23% in the bare-metal Stent group at 3 years (hazard ratio 1.51 [95% confidence interval 0.73 to 3.14], p = 0.26). Hazard ratios (per 100 patients per 6 months) were similar between the Taxus Stent group (0.59 [95% confidence interval 0.22 to 0.95]) and the bare-metal Stent group (0.64 [95% confidence interval 0.26 to 1.02]) through 6 months during the prescribed clopidogrel period. However, from 6 months to 3 years there were more Stent thromboses in the Taxus group (hazard ratio 0.19 [95% confidence interval 0.06 to 0.32] vs. 0.02 [95% confidence interval 0.00 to 0.07], p = 0.049). Of 8 patients with Taxus-related thrombosis after 6 months, 0 were taking clopidogrel and 2 were not taking aspirin consiStently. No Taxus-related Stent thrombosis occurred after 2 years (922 patients thus far followed up for 3 years). Independent correlates of Stent thrombosis were nonuse of clopidogrel, male gender, smoking, and possibly use of multiple nonoverlapping Stents. Conclusions Approximately 0.8% of Taxus patients have Stent thrombosis in the first 6 months after Stent implantation, similar to bare-metal Stents. However, a modest increase in risk is present with Taxus Stents beyond 6 months, possibly because of inadequate antiplatelet drug therapy.
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late Stent thrombosis considerations and practical advice for the use of drug eluting Stents a report from the society for cardiovascular angiography and interventions drug eluting Stent task force
Catheterization and Cardiovascular Interventions, 2007Co-Authors: John Mcb Hodgson, Martin B Leon, Gregg W Stone, Michael A Lincoff, Lloyd W Klein, Howard Walpole, Randy K Bottner, Bonnie H Weiner, Ted Feldman, Joseph D BabbAbstract:Recent analyses have suggested that implantation of drug-eluting Stents (DES) is associated with a higher rate of very late Stent thrombosis when compared with bare metal Stents. This complication is evident with both sirolimus-eluting Stents as well as polymer-based paclitaxel-eluting Stents, but the precise magnitude of this risk and whether this applies to all patients or only a subset of those who have received DES is incompletely characterized. This alert is designed to provide the practicing interventional cardiologist with practical advice in light of this new information. It is not the purpose of this document to provide an exhaustive review of the literature on DES and the risk of Stent thrombosis; however a brief summary is appropriate. While exact definitions have been variable in different trials, late Stent thrombosis generally refers to Stent thrombosis occurring at least 1 month following Stent implantation, while very late Stent thrombosis refers to events occurring more than 12 months following Stent placement. Following bare metal Stent implantation, Stent thrombosis is rare after 2 weeks, and dual antiplatelet therapy (aspirin and a thienopyridine) was typically prescribed for 3–6 weeks. In contrast, sporadic reports of late Stent thrombosis in patients receiving DES have occurred over the past few years. These events often (but not always) occurred in the setting of premature discontinuation of dual antiplatelet therapy. In March 2006, the BASKET-LATE trial was reported, describing a significantly greater composite occurrence of cardiac death and non-fatal myocardial infarction in patients treated with DES when compared with bare-metal Stents after clopidogrel had been discontinued at 6 months [1]. Other meta-analyses of the existing DES trials also showed an increase in late events in the DES cohort although these analyses were limited by incomplete data in publications, abstracts, and Internet sources [2,3]. In October 2006, an independent patient-level meta analysis of the four pivotal randomized Cypher Stent trials and the five pivotal randomized Taxus Stent trials was publicly presented. These analyses demonstrated an increased rate of Stent thrombosis with both sirolimus-eluting and paclitaxelJ_ID: Z7V Customer A_ID: 06-0418 Cadmus Art: CCI 21093 Date: 5-JANUARY-07 Stage: I Page: 1
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late Stent thrombosis considerations and practical advice for the use of drug eluting Stents a report from the society for cardiovascular angiography and interventions drug eluting Stent task force
Catheterization and Cardiovascular Interventions, 2007Co-Authors: John Mcb Hodgson, Martin B Leon, Gregg W Stone, Michael A Lincoff, Lloyd W Klein, Howard Walpole, Randy K Bottner, Bonnie H Weiner, Ted Feldman, Joseph D BabbAbstract:Recent analyses have suggested that implantation of drug-eluting Stents (DES) is associated with a higher rate of very late Stent thrombosis when compared with bare metal Stents. This complication is evident with both sirolimus-eluting Stents as well as polymer-based paclitaxel-eluting Stents, but the precise magnitude of this risk and whether this applies to all patients or only a subset of those who have received DES is incompletely characterized. This alert is designed to provide the practicing interventional cardiologist with practical advice in light of this new information. It is not the purpose of this document to provide an exhaustive review of the literature on DES and the risk of Stent thrombosis; however a brief summary is appropriate. While exact definitions have been variable in different trials, late Stent thrombosis generally refers to Stent thrombosis occurring at least 1 month following Stent implantation, while very late Stent thrombosis refers to events occurring more than 12 months following Stent placement. Following bare metal Stent implantation, Stent thrombosis is rare after 2 weeks, and dual antiplatelet therapy (aspirin and a thienopyridine) was typically prescribed for 3–6 weeks. In contrast, sporadic reports of late Stent thrombosis in patients receiving DES have occurred over the past few years. These events often (but not always) occurred in the setting of premature discontinuation of dual antiplatelet therapy. In March 2006, the BASKET-LATE trial was reported, describing a significantly greater composite occurrence of cardiac death and non-fatal myocardial infarction in patients treated with DES when compared with bare-metal Stents after clopidogrel had been discontinued at 6 months [1]. Other meta-analyses of the existing DES trials also showed an increase in late events in the DES cohort although these analyses were limited by incomplete data in publications, abstracts, and Internet sources [2,3]. In October 2006, an independent patient-level meta analysis of the four pivotal randomized Cypher Stent trials and the five pivotal randomized Taxus Stent trials was publicly presented. These analyses demonstrated an increased rate of Stent thrombosis with both sirolimus-eluting and paclitaxelJ_ID: Z7V Customer A_ID: 06-0418 Cadmus Art: CCI 21093 Date: 5-JANUARY-07 Stage: I Page: 1
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impact of moderate renal insufficiency on restenosis and adverse clinical events after paclitaxel eluting and bare metal Stent implantation results from the Taxus iv trial
American Heart Journal, 2005Co-Authors: Amir Halkin, Christopher W Casey, Ray V Matthews, Hadley B Wilson, Mary E Russell, Paul Gordon, Martin B Leon, Roxana Mehran, Gregg W StoneAbstract:Background Mortality and restenosis may be increased in patients with mild to moderate renal insufficiency (RI) after coronary Stent implantation. Whether drug-eluting Stents safely reduce restenosis and enhance event-free survival in these patients is unknown. We sought to evaluate the impact of baseline RI on clinical and angiographic outcomes in patients undergoing elective percutaneous coronary intervention using either bare metal or paclitaxel-eluting Stents. Methods In the Taxus-IV trial, 1314 patients were randomized to either the polymer-based paclitaxel-eluting Taxus Stent or an identical-appearing bare metal Stent. Outcomes were stratified on the basis of the presence of RI, defined as a baseline creatinine clearance 3 /min calculated by the Cockcroft-Gault formula. Results Baseline RI was present in 223 (17.2%) patients, in whom the mean creatinine clearance was 49.6 ± 8.5 cm 3 /min. Compared with bare metal Stents, treatment with the Taxus Stent resulted in lower rates of 9-month angiographic restenosis rates in both patients with (2.1% vs 20.5%, P = .009) and without (9.2% vs 27.8%, P P = .01) and without (4.7% vs 15.8%, P Conclusions The polymer-based paclitaxel-eluting Taxus Stent safely reduces clinical and angiographic restenosis in patients with preserved as well as moderate impairment of baseline renal function.
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outcomes with the polymer based paclitaxel eluting Taxus Stent in patients with diabetes mellitus the Taxus iv trial
Journal of the American College of Cardiology, 2005Co-Authors: James B Hermiller, Michael A Kutcher, Mary E Russell, Roxana Mehran, Stephen G Ellis, Albert E Raizner, Louis Cannon, Paul A Gurbel, Chiu S Wong, Gregg W StoneAbstract:Objectives We sought to determine the safety and efficacy of polymer-regulated site-specific delivery of paclitaxel in patients with diabetes mellitus undergoing Stent implantation. Background Percutaneous coronary intervention in patients with diabetes is associated with high rates of restenosis and repeat revascularization due to excessive neointimal proliferation, a process that may be blunted with the site-specific delivery of paclitaxel. Methods In the Taxus-IV trial, 1,314 patients were prospectively randomized to the slow rate-release polymer-based paclitaxel-eluting Taxus Stent or the bare-metal EXPRESS Stent (Boston Scientific Corp., Natick, Massachusetts). Medically treated diabetes was present in 318 patients (24%), 105 of whom required insulin. Results Among patients with diabetes, the Taxus Stent, compared to the bare-metal Stent, reduced the rate of 9-month binary angiographic restenosis by 81% (6.4% vs. 34.5%, p Conclusions The site-specific delivery of paclitaxel after coronary Stent implantation is highly effective in reducing clinical and angiographic restenosis in patients with diabetes mellitus.
James B Hermiller - One of the best experts on this subject based on the ideXlab platform.
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polymer based paclitaxel eluting Stents reduce in Stent neointimal tissue proliferation a serial volumetric intravascular ultrasound analysis from the Taxus iv trial
Journal of the American College of Cardiology, 2005Co-Authors: Neil J. Weissman, Joerg Koglin, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Joel Greenberg, Mark Turco, Michael A KutcherAbstract:Objectives The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effects of polymer-based, paclitaxel-eluting Stents on in-Stent neointima formation and late incomplete Stent apposition. Background The Taxus-IV trial demonstrated that the slow-release, polymer-based, paclitaxel-eluting Stent reduces angiographic restenosis and the need for repeat revascularization procedures. Serial IVUS studies reveal details of the pattern of vascular responses provoked by Stent implantation that provide insight into device safety and efficacy. Methods In the Taxus-IV trial, patients were randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or a bare-metal EXPRESS Stent (Boston Scientific Corp., Natick, Massachusetts). As part of a formal substudy, complete volumetric IVUS data were available in 170 patients, including 88 Taxus patients and 82 controls, at implantation and at nine-month follow-up. Results No baseline differences were present in the clinical characteristics or IVUS parameters between the control and Taxus groups. At nine-month follow-up, IVUS lumen volumes were larger in the Taxus group (123 ± 43 mm 3 vs. 104 ± 44 mm 3 , p = 0.005), due to a reduction in neointimal volume (18 ± 18 mm 3 vs. 41 ± 23 mm 3 , p Conclusions Polymer-based, paclitaxel-eluting Taxus Stents are effective in inhibiting neointimal tissue proliferation, and do not result in late incomplete Stent apposition.
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relationship between angiographic late loss and target lesion revascularization after coronary Stent implantation analysis from the Taxus iv trial
Journal of the American College of Cardiology, 2005Co-Authors: Stephen G Ellis, Joerg Koglin, James B Hermiller, Charles Oshaughnessy, James Tift Mann, Mark Turco, John M Lasala, David A Cox, Ronald P CaputoAbstract:Objectives We sought to evaluate the relationship between angiographic late loss and clinical outcomes in the drug-eluting Stent era. Background The interrelationship between angiographic late loss, binary restenosis, and clinical recurrence (target lesion revascularization [TLR]) after coronary Stent implantation has been incompletely evaluated. Methods Using the angiographic substudy of the Taxus-IV trial, in which 1,314 patients with de novo coronary lesions were randomized to either the paclitaxel-eluting Taxus Stent or to its bare-metal equivalent, we defined the relationship between in-Stent and analysis segment late loss, the shape of the late loss histogram (variance and skewedness), and nine-month TLR. Results Late loss by several measures was closely related to TLR (area under the receiver-operator curve >0.90). For individual vessels of the size in this study (2.8 ± 0.5 mm), the likelihood of TLR did not exceed 5% until analysis segment late loss was >0.5 mm, and did not exceed 10% until late loss was >0.65 mm. At greater late losses, the late loss TLR relationship was steep and nearly linear. For the overall patient cohort, the rate of TLR was related, however, not only to median late loss, but also to measures of its statistical distribution (TLR increased with lack of homogeneous biologic response [greater variance and greater right skewedness]). Similar relationships held for late loss measured within the confines of the Stent itself. Conclusions Coronary Stents result in large lumens with “room” to accommodate up to ∼0.5 to 0.65 mm of tissue (angiographic analysis segment late loss) before the likelihood of clinical restenosis (TLR) exceeds 5% to 10%. These data have important implications toward understanding the absolute and relative efficacy of drug-eluting Stents.
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outcomes with the polymer based paclitaxel eluting Taxus Stent in patients with diabetes mellitus the Taxus iv trial
Journal of the American College of Cardiology, 2005Co-Authors: James B Hermiller, Michael A Kutcher, Mary E Russell, Roxana Mehran, Stephen G Ellis, Albert E Raizner, Louis Cannon, Paul A Gurbel, Chiu S Wong, Gregg W StoneAbstract:Objectives We sought to determine the safety and efficacy of polymer-regulated site-specific delivery of paclitaxel in patients with diabetes mellitus undergoing Stent implantation. Background Percutaneous coronary intervention in patients with diabetes is associated with high rates of restenosis and repeat revascularization due to excessive neointimal proliferation, a process that may be blunted with the site-specific delivery of paclitaxel. Methods In the Taxus-IV trial, 1,314 patients were prospectively randomized to the slow rate-release polymer-based paclitaxel-eluting Taxus Stent or the bare-metal EXPRESS Stent (Boston Scientific Corp., Natick, Massachusetts). Medically treated diabetes was present in 318 patients (24%), 105 of whom required insulin. Results Among patients with diabetes, the Taxus Stent, compared to the bare-metal Stent, reduced the rate of 9-month binary angiographic restenosis by 81% (6.4% vs. 34.5%, p Conclusions The site-specific delivery of paclitaxel after coronary Stent implantation is highly effective in reducing clinical and angiographic restenosis in patients with diabetes mellitus.
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one year clinical results with the slow release polymer based paclitaxel eluting Taxus Stent the Taxus iv trial
Circulation, 2004Co-Authors: Gregg W Stone, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Joel Greenberg, Mark Turco, Stephen G Ellis, Jeffrey J PopmaAbstract:BACKGROUND: The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting Stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. METHODS AND RESULTS: In the Taxus-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study Stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or an identical-appearing bare-metal EXPRESS Stent. By actuarial analysis, the Taxus Stent compared with the bare-metal Stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7%), and subacute thrombosis (0.6% versus 0.8%) were similar between the paclitaxel-eluting and control Stents, respectively. Between 9 and 12 months, there were significantly fewer myocardial infarctions (0% versus 1.1%, P=0.007), target-vessel revascularizations (2.4% versus 5.8%, P=0.002), and major adverse cardiac events (2.4% versus 6.3%, P=0.0009) in the paclitaxel-eluting Stent than in the control Stent group, respectively. CONCLUSIONS: The relative efficacy reported at 9 months for the polymer-based, paclitaxel-eluting Taxus Stent compared with the EXPRESS Stent is preserved and continues to increase at 1 year, with no safety concerns apparent.
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one year clinical results with the slow release polymer based paclitaxel eluting Taxus Stent the Taxus iv trial
Circulation, 2004Co-Authors: Gregg W Stone, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Mark Turco, Stephen G Ellis, David A Cox, Joel GreenbergAbstract:Background— The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting Stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. Methods and Results— In the Taxus-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study Stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or an identical-appearing bare-metal EXPRESS Stent. By actuarial analysis, the Taxus Stent compared with the bare-metal Stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7...
Charles Oshaughnessy - One of the best experts on this subject based on the ideXlab platform.
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a randomized controlled multi center trial comparing the safety and efficacy of zotarolimus eluting and paclitaxel eluting Stents in de novo lesions in coronary arteries final results of the zomaxx ii trial
International Journal of Cardiology, 2012Co-Authors: William A Gray, Charles Oshaughnessy, Jeffrey J Popma, Alan C Yeung, Donald E Cutlip, Peter J Fitzgerald, David O Williams, Hubertus Heuer, Paul Overlie, Tift J MannAbstract:Abstract Background/Objectives The purpose of this prospective, randomized, single-blind controlled clinical trial was to compare the effectiveness of a zotarolimus-eluting Stent (ZoMaxx™) with a paclitaxel-eluting coronary Stent (Taxus™ Express 2 ™) in patients with angina pectoris and a single native coronary artery lesion between 10–28mm in length and 2.5–3.75mm in diameter. Methods Patients were enrolled at 75 international institutions between June 2005 and November 2006. Results 1099 (1672 originally planned) patients received 557 ZoMaxx and 542 Taxus Stents: cohorts were well-matched for diabetes (27% vs . 27%), reference vessel diameter (2.73±0.46mm vs . 2.74±0.45mm) and lesion length (14.8±6.7mm vs . 14.3±6.4mm). Nine month clinical and angiographic follow-up was available in 1052/1099 (96%) and 649/836 (78%) patients, respectively. The safety profiles for the two Stents (myocardial infarction (MI), cardiac death and/or target vessel revascularization (TVR)) were similar (ZoMaxx 8.7% vs . Taxus 6.9%, p=NS). The primary endpoint of 9-month TVR occurred more frequently after treatment with ZoMaxx (6.8%) as compared with Taxus (4.2%), therefore the primary clinical endpoint was not met. However, the 9-month in-segment late lumen loss for ZoMaxx (0.29±0.47mm) and Taxus (0.22±0.41mm, p=NS) were similar, thus satisfying the primary angiographic endpoint. Secondary endpoints of the rates of in-segment and in-Stent binary restenosis were also similar (5.9% vs . 5.8%, 7.8% vs . 7.9%, respectively). Conclusions At 9months, the ZoMaxx Stent failed to achieve the primary endpoint of non-inferiority in TVR to the Taxus Stent, but safety endpoints were equal between the two Stent systems.
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polymer based paclitaxel eluting Stents reduce in Stent neointimal tissue proliferation a serial volumetric intravascular ultrasound analysis from the Taxus iv trial
Journal of the American College of Cardiology, 2005Co-Authors: Neil J. Weissman, Joerg Koglin, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Joel Greenberg, Mark Turco, Michael A KutcherAbstract:Objectives The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effects of polymer-based, paclitaxel-eluting Stents on in-Stent neointima formation and late incomplete Stent apposition. Background The Taxus-IV trial demonstrated that the slow-release, polymer-based, paclitaxel-eluting Stent reduces angiographic restenosis and the need for repeat revascularization procedures. Serial IVUS studies reveal details of the pattern of vascular responses provoked by Stent implantation that provide insight into device safety and efficacy. Methods In the Taxus-IV trial, patients were randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or a bare-metal EXPRESS Stent (Boston Scientific Corp., Natick, Massachusetts). As part of a formal substudy, complete volumetric IVUS data were available in 170 patients, including 88 Taxus patients and 82 controls, at implantation and at nine-month follow-up. Results No baseline differences were present in the clinical characteristics or IVUS parameters between the control and Taxus groups. At nine-month follow-up, IVUS lumen volumes were larger in the Taxus group (123 ± 43 mm 3 vs. 104 ± 44 mm 3 , p = 0.005), due to a reduction in neointimal volume (18 ± 18 mm 3 vs. 41 ± 23 mm 3 , p Conclusions Polymer-based, paclitaxel-eluting Taxus Stents are effective in inhibiting neointimal tissue proliferation, and do not result in late incomplete Stent apposition.
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relationship between angiographic late loss and target lesion revascularization after coronary Stent implantation analysis from the Taxus iv trial
Journal of the American College of Cardiology, 2005Co-Authors: Stephen G Ellis, Joerg Koglin, James B Hermiller, Charles Oshaughnessy, James Tift Mann, Mark Turco, John M Lasala, David A Cox, Ronald P CaputoAbstract:Objectives We sought to evaluate the relationship between angiographic late loss and clinical outcomes in the drug-eluting Stent era. Background The interrelationship between angiographic late loss, binary restenosis, and clinical recurrence (target lesion revascularization [TLR]) after coronary Stent implantation has been incompletely evaluated. Methods Using the angiographic substudy of the Taxus-IV trial, in which 1,314 patients with de novo coronary lesions were randomized to either the paclitaxel-eluting Taxus Stent or to its bare-metal equivalent, we defined the relationship between in-Stent and analysis segment late loss, the shape of the late loss histogram (variance and skewedness), and nine-month TLR. Results Late loss by several measures was closely related to TLR (area under the receiver-operator curve >0.90). For individual vessels of the size in this study (2.8 ± 0.5 mm), the likelihood of TLR did not exceed 5% until analysis segment late loss was >0.5 mm, and did not exceed 10% until late loss was >0.65 mm. At greater late losses, the late loss TLR relationship was steep and nearly linear. For the overall patient cohort, the rate of TLR was related, however, not only to median late loss, but also to measures of its statistical distribution (TLR increased with lack of homogeneous biologic response [greater variance and greater right skewedness]). Similar relationships held for late loss measured within the confines of the Stent itself. Conclusions Coronary Stents result in large lumens with “room” to accommodate up to ∼0.5 to 0.65 mm of tissue (angiographic analysis segment late loss) before the likelihood of clinical restenosis (TLR) exceeds 5% to 10%. These data have important implications toward understanding the absolute and relative efficacy of drug-eluting Stents.
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one year clinical results with the slow release polymer based paclitaxel eluting Taxus Stent the Taxus iv trial
Circulation, 2004Co-Authors: Gregg W Stone, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Joel Greenberg, Mark Turco, Stephen G Ellis, Jeffrey J PopmaAbstract:BACKGROUND: The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting Stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. METHODS AND RESULTS: In the Taxus-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study Stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or an identical-appearing bare-metal EXPRESS Stent. By actuarial analysis, the Taxus Stent compared with the bare-metal Stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7%), and subacute thrombosis (0.6% versus 0.8%) were similar between the paclitaxel-eluting and control Stents, respectively. Between 9 and 12 months, there were significantly fewer myocardial infarctions (0% versus 1.1%, P=0.007), target-vessel revascularizations (2.4% versus 5.8%, P=0.002), and major adverse cardiac events (2.4% versus 6.3%, P=0.0009) in the paclitaxel-eluting Stent than in the control Stent group, respectively. CONCLUSIONS: The relative efficacy reported at 9 months for the polymer-based, paclitaxel-eluting Taxus Stent compared with the EXPRESS Stent is preserved and continues to increase at 1 year, with no safety concerns apparent.
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one year clinical results with the slow release polymer based paclitaxel eluting Taxus Stent the Taxus iv trial
Circulation, 2004Co-Authors: Gregg W Stone, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Mark Turco, Stephen G Ellis, David A Cox, Joel GreenbergAbstract:Background— The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting Stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. Methods and Results— In the Taxus-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study Stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or an identical-appearing bare-metal EXPRESS Stent. By actuarial analysis, the Taxus Stent compared with the bare-metal Stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7...
Ronald P Caputo - One of the best experts on this subject based on the ideXlab platform.
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polymer based paclitaxel eluting Stents reduce in Stent neointimal tissue proliferation a serial volumetric intravascular ultrasound analysis from the Taxus iv trial
Journal of the American College of Cardiology, 2005Co-Authors: Neil J. Weissman, Joerg Koglin, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Joel Greenberg, Mark Turco, Michael A KutcherAbstract:Objectives The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effects of polymer-based, paclitaxel-eluting Stents on in-Stent neointima formation and late incomplete Stent apposition. Background The Taxus-IV trial demonstrated that the slow-release, polymer-based, paclitaxel-eluting Stent reduces angiographic restenosis and the need for repeat revascularization procedures. Serial IVUS studies reveal details of the pattern of vascular responses provoked by Stent implantation that provide insight into device safety and efficacy. Methods In the Taxus-IV trial, patients were randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or a bare-metal EXPRESS Stent (Boston Scientific Corp., Natick, Massachusetts). As part of a formal substudy, complete volumetric IVUS data were available in 170 patients, including 88 Taxus patients and 82 controls, at implantation and at nine-month follow-up. Results No baseline differences were present in the clinical characteristics or IVUS parameters between the control and Taxus groups. At nine-month follow-up, IVUS lumen volumes were larger in the Taxus group (123 ± 43 mm 3 vs. 104 ± 44 mm 3 , p = 0.005), due to a reduction in neointimal volume (18 ± 18 mm 3 vs. 41 ± 23 mm 3 , p Conclusions Polymer-based, paclitaxel-eluting Taxus Stents are effective in inhibiting neointimal tissue proliferation, and do not result in late incomplete Stent apposition.
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relationship between angiographic late loss and target lesion revascularization after coronary Stent implantation analysis from the Taxus iv trial
Journal of the American College of Cardiology, 2005Co-Authors: Stephen G Ellis, Joerg Koglin, James B Hermiller, Charles Oshaughnessy, James Tift Mann, Mark Turco, John M Lasala, David A Cox, Ronald P CaputoAbstract:Objectives We sought to evaluate the relationship between angiographic late loss and clinical outcomes in the drug-eluting Stent era. Background The interrelationship between angiographic late loss, binary restenosis, and clinical recurrence (target lesion revascularization [TLR]) after coronary Stent implantation has been incompletely evaluated. Methods Using the angiographic substudy of the Taxus-IV trial, in which 1,314 patients with de novo coronary lesions were randomized to either the paclitaxel-eluting Taxus Stent or to its bare-metal equivalent, we defined the relationship between in-Stent and analysis segment late loss, the shape of the late loss histogram (variance and skewedness), and nine-month TLR. Results Late loss by several measures was closely related to TLR (area under the receiver-operator curve >0.90). For individual vessels of the size in this study (2.8 ± 0.5 mm), the likelihood of TLR did not exceed 5% until analysis segment late loss was >0.5 mm, and did not exceed 10% until late loss was >0.65 mm. At greater late losses, the late loss TLR relationship was steep and nearly linear. For the overall patient cohort, the rate of TLR was related, however, not only to median late loss, but also to measures of its statistical distribution (TLR increased with lack of homogeneous biologic response [greater variance and greater right skewedness]). Similar relationships held for late loss measured within the confines of the Stent itself. Conclusions Coronary Stents result in large lumens with “room” to accommodate up to ∼0.5 to 0.65 mm of tissue (angiographic analysis segment late loss) before the likelihood of clinical restenosis (TLR) exceeds 5% to 10%. These data have important implications toward understanding the absolute and relative efficacy of drug-eluting Stents.
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one year clinical results with the slow release polymer based paclitaxel eluting Taxus Stent the Taxus iv trial
Circulation, 2004Co-Authors: Gregg W Stone, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Joel Greenberg, Mark Turco, Stephen G Ellis, Jeffrey J PopmaAbstract:BACKGROUND: The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting Stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. METHODS AND RESULTS: In the Taxus-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study Stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or an identical-appearing bare-metal EXPRESS Stent. By actuarial analysis, the Taxus Stent compared with the bare-metal Stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7%), and subacute thrombosis (0.6% versus 0.8%) were similar between the paclitaxel-eluting and control Stents, respectively. Between 9 and 12 months, there were significantly fewer myocardial infarctions (0% versus 1.1%, P=0.007), target-vessel revascularizations (2.4% versus 5.8%, P=0.002), and major adverse cardiac events (2.4% versus 6.3%, P=0.0009) in the paclitaxel-eluting Stent than in the control Stent group, respectively. CONCLUSIONS: The relative efficacy reported at 9 months for the polymer-based, paclitaxel-eluting Taxus Stent compared with the EXPRESS Stent is preserved and continues to increase at 1 year, with no safety concerns apparent.
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one year clinical results with the slow release polymer based paclitaxel eluting Taxus Stent the Taxus iv trial
Circulation, 2004Co-Authors: Gregg W Stone, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Mark Turco, Stephen G Ellis, David A Cox, Joel GreenbergAbstract:Background— The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting Stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. Methods and Results— In the Taxus-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study Stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or an identical-appearing bare-metal EXPRESS Stent. By actuarial analysis, the Taxus Stent compared with the bare-metal Stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7...
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one year clinical results with the slow release polymer based paclitaxel eluting Taxus Stent the Taxus iv trial
Circulation, 2004Co-Authors: Gregg W Stone, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Joel Greenberg, Mark Turco, Stephen G Ellis, Jeffrey J PopmaAbstract:Background— The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting Stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. Methods and Results— In the Taxus-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study Stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or an identical-appearing bare-metal EXPRESS Stent. By actuarial analysis, the Taxus Stent compared with the bare-metal Stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7...
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polymer based paclitaxel eluting Stents reduce in Stent neointimal tissue proliferation a serial volumetric intravascular ultrasound analysis from the Taxus iv trial
Journal of the American College of Cardiology, 2005Co-Authors: Neil J. Weissman, Joerg Koglin, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Joel Greenberg, Mark Turco, Michael A KutcherAbstract:Objectives The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effects of polymer-based, paclitaxel-eluting Stents on in-Stent neointima formation and late incomplete Stent apposition. Background The Taxus-IV trial demonstrated that the slow-release, polymer-based, paclitaxel-eluting Stent reduces angiographic restenosis and the need for repeat revascularization procedures. Serial IVUS studies reveal details of the pattern of vascular responses provoked by Stent implantation that provide insight into device safety and efficacy. Methods In the Taxus-IV trial, patients were randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or a bare-metal EXPRESS Stent (Boston Scientific Corp., Natick, Massachusetts). As part of a formal substudy, complete volumetric IVUS data were available in 170 patients, including 88 Taxus patients and 82 controls, at implantation and at nine-month follow-up. Results No baseline differences were present in the clinical characteristics or IVUS parameters between the control and Taxus groups. At nine-month follow-up, IVUS lumen volumes were larger in the Taxus group (123 ± 43 mm 3 vs. 104 ± 44 mm 3 , p = 0.005), due to a reduction in neointimal volume (18 ± 18 mm 3 vs. 41 ± 23 mm 3 , p Conclusions Polymer-based, paclitaxel-eluting Taxus Stents are effective in inhibiting neointimal tissue proliferation, and do not result in late incomplete Stent apposition.
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one year clinical results with the slow release polymer based paclitaxel eluting Taxus Stent the Taxus iv trial
Circulation, 2004Co-Authors: Gregg W Stone, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Joel Greenberg, Mark Turco, Stephen G Ellis, Jeffrey J PopmaAbstract:BACKGROUND: The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting Stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. METHODS AND RESULTS: In the Taxus-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study Stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or an identical-appearing bare-metal EXPRESS Stent. By actuarial analysis, the Taxus Stent compared with the bare-metal Stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7%), and subacute thrombosis (0.6% versus 0.8%) were similar between the paclitaxel-eluting and control Stents, respectively. Between 9 and 12 months, there were significantly fewer myocardial infarctions (0% versus 1.1%, P=0.007), target-vessel revascularizations (2.4% versus 5.8%, P=0.002), and major adverse cardiac events (2.4% versus 6.3%, P=0.0009) in the paclitaxel-eluting Stent than in the control Stent group, respectively. CONCLUSIONS: The relative efficacy reported at 9 months for the polymer-based, paclitaxel-eluting Taxus Stent compared with the EXPRESS Stent is preserved and continues to increase at 1 year, with no safety concerns apparent.
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one year clinical results with the slow release polymer based paclitaxel eluting Taxus Stent the Taxus iv trial
Circulation, 2004Co-Authors: Gregg W Stone, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Mark Turco, Stephen G Ellis, David A Cox, Joel GreenbergAbstract:Background— The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting Stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. Methods and Results— In the Taxus-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study Stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or an identical-appearing bare-metal EXPRESS Stent. By actuarial analysis, the Taxus Stent compared with the bare-metal Stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7...
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one year clinical results with the slow release polymer based paclitaxel eluting Taxus Stent the Taxus iv trial
Circulation, 2004Co-Authors: Gregg W Stone, James B Hermiller, Charles Oshaughnessy, Ronald P Caputo, Patrick Bergin, James Tift Mann, Joel Greenberg, Mark Turco, Stephen G Ellis, Jeffrey J PopmaAbstract:Background— The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting Stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. Methods and Results— In the Taxus-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study Stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting Taxus Stent or an identical-appearing bare-metal EXPRESS Stent. By actuarial analysis, the Taxus Stent compared with the bare-metal Stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7...
