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Eberhard Grube - One of the best experts on this subject based on the ideXlab platform.

  • long term impact of routinely detected early and late incomplete stent apposition an integrated intravascular ultrasound analysis of the Taxus iv v and vi and Taxus atlas workhorse long lesion and direct stent studies
    Jacc-cardiovascular Interventions, 2010
    Co-Authors: Daniel H Steinberg, Mark Turco, John A. Ormiston, Lazar Mandinov, Keith D. Dawkins, Gary S Mintz, Alan Yu, Steven G Ellis, Eberhard Grube, Gregg W Stone
    Abstract:

    Objectives We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events. Background The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and Taxus stents (Boston Scientific, Natick, Massachusetts) is debatable. Methods We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of Taxus IV, V, VI and Taxus-ATLAS WH, LL, and DS trials. Results There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) Taxus Express patients (p = 0.28 vs. BMS), and 35 (7.3%) Taxus Liberte patients (p = 0.21 vs. Taxus Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for Taxus (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with Taxus slow-release (Taxus Express or Taxus Liberte), and 12 (15.4%) patients receiving Taxus moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), Taxus (overall, 8.3% vs. 8.1% p = 0.87), or Taxus slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis. Conclusions Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or Taxus patients was associated with adverse clinical events over long-term follow-up.

  • impact of post intervention minimal stent area on 9 month follow up patency of paclitaxel eluting stents an integrated intravascular ultrasound analysis from the Taxus iv v and vi and Taxus atlas workhorse long lesion and direct stent trials
    Jacc-cardiovascular Interventions, 2009
    Co-Authors: Akiko Maehara, Jeffrey J Popma, Lazar Mandinov, Keith D. Dawkins, Gary S Mintz, Alan Yu, Eberhard Grube, Stephen G Ellis, Hong Wang, Neil J. Weissman
    Abstract:

    Objectives We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on 9-month follow-up paclitaxel-eluting stent (PES) patency compared with bare-metal stents (BMS). Background Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in PES is still unknown. Methods From the combined Taxus IV, V, and VI and Taxus ATLAS Workhorse, Long Lesion, and Direct Stent trials, 1,580 patients (PES 1,098, BMS 482) in IVUS substudies were analyzed. The MSA that best predicted angiographic in-stent restenosis (ISR) (% diameter stenosis ≥50%) was determined. Results The post-intervention IVUS MSA was similar in PES and BMS (6.6 ± 2.5 mm2 vs. 6.7 ± 2.3 mm2, p = 0.92). At 9-month follow-up, ISR was lower in the PES group versus the BMS group (10% vs. 31%, p < 0.0001). Using multivariable logistic regression analysis, post-intervention IVUS MSA was the independent predictor of subsequent ISR in both the PES and BMS groups (p = 0.0002 for PES and p = 0.0002 for BMS). The ability of the post-intervention IVUS MSA to predict ISR was further assessed using receiver operating characteristic analysis. The post-intervention IVUS MSA was found to be a faithful discriminator between patients with and without ISR in both PES (c = 0.6382) and BMS (c = 0.6373). Finally, the optimal thresholds of post-intervention IVUS MSA that best predicted stent patency at 9 months were 5.7 mm2 for PES and 6.4 mm2 for BMS. Conclusions Post-intervention MSA measured by IVUS can predict 9-month follow-up stent patency after both PES and BMS implantation. (Randomized Trial Evaluating Slow-Release Formulation Taxus Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions; NCT00301522) (Direct Stenting of Taxus Liberte-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions; NCT00371423) (A Study of the Taxus Liberte Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475) (A Study of the Taxus Liberte Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748)

  • final 5 year results of the Taxus ii trial a randomized study to assess the effectiveness of slow and moderate release polymer based paclitaxel eluting stents for de novo coronary artery lesions
    Circulation, 2009
    Co-Authors: Sigmund Silber, Eberhard Grube, Antonio Colombo, Adrian P Banning, Karl Eugen Hauptmann, J Drzewiecki, Dariusz Dudek, Donald S Baim
    Abstract:

    Background— The Taxus II trial was designed to evaluate the safety and efficacy of the commercialized slow-release (SR) and an investigation-only moderate-release (MR) polymer-based Taxus paclitaxel-eluting stent compared with a bare-metal stent for the treatment of de novo coronary lesions. Methods and Results— This prospective, randomized, double-blind, controlled trial enrolled 536 patients in 2 consecutive cohorts to compare Taxus SR (n=131) and Taxus MR (n=135) with an identical but uncoated bare-metal stent control (n=270). The present analysis reports final 5-year clinical outcomes of Taxus II. At 5 years, both Taxus SR and MR showed superior outcomes compared with control. The 5-year rates of major adverse cardiac events were 27.6%, 20.4%, and 15.1% (P=0.01); rates of target-vessel revascularization were 22.5%, 16.6%, and 9.0% (P=0.004); and rates of target-lesion revascularization were 18.4%, 10.3%, and 4.5% (P<0.001) for the control, Taxus SR, and Taxus MR groups, respectively. The rates of all-...

  • an integrated Taxus iv v and vi intravascular ultrasound analysis of the predictors of edge restenosis after bare metal or paclitaxel eluting stents
    American Journal of Cardiology, 2009
    Co-Authors: Akiko Maehara, Neil J. Weissman, Jeffrey J Popma, Lazar Mandinov, Gary S Mintz, Alan Yu, Eberhard Grube, Stephen G Ellis, Hong Wang, Keith D. Dawkins
    Abstract:

    We used intravascular ultrasound data after stent implantation from the Taxus IV, V, and VI trials to determine predictors of angiographic stent edge restenosis. In the combined Taxus IV, V, and VI trials, intravascular ultrasound was performed at implantation in 255 patients with bare metals stents (BMSs) and 276 patients with paclitaxel-eluting stents who underwent quantitative coronary angiography at 9 months. At follow-up, 6 BMSs (2.5%) had proximal edge and 6 BMSs (2.4%) had distal edge angiographic restenosis; 14 Taxus stents (5.2%) had proximal edge and 1 Taxus stent (0.4%) had distal edge angiographic restenosis. Although univariate analysis identified external elastic membrane, lumen areas, and plaque burden (external elastic membrane minus lumen/ external elastic membrane) as predictors of 9-month angiographic edge restenosis in the overall cohort and in BMS- and Taxus-treated patients separately, only edge plaque burden was an independent predictor of 9-month angiographic edge restenosis. Receiver operator characteristic analysis showed that residual plaque burden, but not edge lumen area, was predictive of 9-month angiographic edge restenosis in BMS-treated patients (cutoff 47.7%, c = 0.70, p = 0.0244) and in Taxus-treated patients (cutoff 47.1%, c = 0.69, p = 0.0137). In conclusion, residual edge plaque burden predicts stent edge restenosis after BMS or Taxus stent implantation and the optimal plaque burden for stent edge landing zones are the same for BMSs and Taxus stents, independent of vessel size and edge lumen dimensions.

  • Taxus vi 2 year follow up randomized comparison of polymer based paclitaxel eluting with bare metal stents for treatment of long complex lesions
    European Heart Journal, 2007
    Co-Authors: Eberhard Grube, Keith D. Dawkins, Antonio Colombo, Adrian P Banning, Giulio Guagliumi, Krzysztof Zmudka, Leif Thuesen, Karl Hauptman, Jean Marco, William Wijns
    Abstract:

    Aims Drug-eluting stents (DESs) have shown to be effective in reducing in-stent restenosis, although data relating to long-term experience in treating more complex lesion subsets are limited. In order to assess the long-term safety and clinical efficacy of the polymer-based moderate release (MR) paclitaxel-eluting Taxus™ MR stent in treatment of complex lesion subsets, we evaluated the 2-year follow-up of Taxus VI. Method and results Taxus VI was a randomized multi-centre study enrolling 446 patients with complex lesions, including small vessels in 28% of patients and a mean lesion length of 20.6 mm. At 9-month follow-up, the use of the Taxus MR stent was highly effective, resulting in a significant 53% reduction of the target vessel revascularization (TVR) rate (primary endpoint) from 19.4% in the control group to 9.1% in the Taxus group ( P = 0.0027). Clinical follow-up at 2 years post-stenting was available in 98.6% of the Taxus group and 95.6% of the control group. The incidence of major adverse cardiac event at 1- and 2-year follow-up was 16.4% and 21.3% in the Taxus group when compared with 22.5 and 25.1% in the control group, respectively. A significant difference in TVR was maintained at 2-year follow-up (Taxus 13.9%; control 21.9%; P = 0.0335). The cumulative 1- and 2-year survival rates free from TVR were, respectively, 91.7 and 90.3% in the Taxus group vs. 80.0 and 79.0% in the control group (log-rank P < 0.001). The number of patients required to be treated with a Taxus stent to prevent one re-percutaneous coronary intervention at 2 years was 12.5. Conclusion Treatment of complex coronary lesions with the polymer-based MR paclitaxel-eluting Taxus MR stent is associated with a sustained clinical benefit and low rates of TVR up to 2 years after device implantation.

Keith D. Dawkins - One of the best experts on this subject based on the ideXlab platform.

  • Final 5-year results of the Taxus ATLAS, Taxus ATLAS Small Vessel, and Taxus ATLAS Long Lesion clinical trials of the Taxus Liberté paclitaxel-eluting stent in de-novo coronary artery lesions.
    Coronary Artery Disease, 2013
    Co-Authors: John A. Ormiston, Tift Mann, Louis Cannon, Mark Webster, Jack J. Hall, Gregory Mishkel, O’shaughnessy Charles, Thomas J. Mcgarry, Paul Underwood, Keith D. Dawkins
    Abstract:

    OBJECTIVE: To report the final, cumulative, 5-year outcomes from the Taxus ATLAS program, which studied the use of the Taxus Liberte paclitaxel-eluting stent in de-novo coronary artery lesions. METHODS: Taxus ATLAS Workhorse, Small Vessel, and Long Lesion are nonrandomized studies comparing Taxus Liberte (N=871), Taxus Liberte 2.25 mm (N=261), and Taxus Liberte 38 mm (N=150) stents, respectively, with case-matched Taxus Express historical controls. RESULTS: In the unadjusted analysis, Taxus Liberte showed comparable 5-year rates of major adverse cardiac events (27.1% Taxus Express vs. 26.2% Taxus Liberte, P=0.70) in workhorse lesions and greater 5-year cumulative freedom from target lesion revascularization (78.4 vs. 87.3%, P=0.03) in small vessels. In addition, a lower periprocedural myocardial infarction rate (MI, 4.1 vs. 0.0%; P=0.01) was observed in long lesions versus Taxus Express. After propensity score adjustment, no statistically significant effect of Taxus Liberte on the 5-year rates of TLR in small vessels (17.9 vs. 13.3%, P=0.36) or MI in long lesions (9.1 vs. 7.0%, P=0.53) was found, although the rates remained numerically lower with Taxus Liberte. CONCLUSION: Cumulative 5-year results of the Taxus ATLAS studies suggest that the Taxus Liberte stent provides similar safety and effectiveness in workhorse lesions, and may provide lower revascularization rates in small vessels and lower periprocedural MI rates in long lesions compared with the Taxus Express stent, although no statistically significant differences were found following propensity adjustment.

  • Economic modeling of new stent platforms to evaluate cost effectiveness: analysis of the Taxus Liberté versus Taxus express stents.
    Journal of Interventional Cardiology, 2012
    Co-Authors: Mark A. Turco, Anuraag R. Kansal, B A Sean Stern, Stacey L. Amorosi, Paul L. Underwood, M.p.h. Greg De Lissovoy, Keith D. Dawkins
    Abstract:

    Background: With the changing health care environment, cost effectiveness is an important adjunct to clinical investigation when assessing new medical devices. This study presents an economic model to evaluate cost effectiveness of coronary stents. Methods: Markov modeling was developed comparing total costs (Medicare payer perspective) between Taxus Liberte and Taxus Express based on 3-year clinical outcomes from the Taxus ATLAS Small Vessel and Long Lesion trials. Results: The Taxus Liberte 2.25-mm stent provided cost savings relative to Taxus Express from a payer perspective ($17,605 vs. $20,281), driven by reduced target vessel revascularization (0.16 events/patient vs. 0.33 events/patient). In probabilistic sensitivity analyses, Taxus Liberte was less costly with fewer major adverse cardiac events in over 99% of parameter sets. The Taxus Liberte Long (38 mm) stent was cost neutral relative to Taxus Express from a payer perspective ($18,545 vs. $18,551) with fewer myocardial infarctions and cardiac deaths. Accounting for angiography-driven revascularizations, Taxus Liberte 2.25 mm still provided cost savings relative to Taxus Express ($16,822 vs. $19,139), although Taxus Liberte Long was more expensive than Taxus Express ($17,886 vs. $17,652). From a hospital perspective, Taxus Liberte Long provided cost savings up to a price premium of $671/stent, driven by fewer stents employed per patient. Conclusions: This analysis confirms the utility of economic modeling in assessing new stent platforms. Taxus Liberte 2.25 mm is economically dominant relative to Taxus Express when treating small vessels. Taxus Liberte Long is cost neutral to modestly more costly than Taxus Express 2.25 mm from a payer perspective. (J Interven Cardiol 2012;25:353–363)

  • Propensity-Matched Patient-Level Comparison of the Taxus Liberté and Taxus Element (ION) Paclitaxel-Eluting Stents
    American Journal of Cardiology, 2011
    Co-Authors: Dean J Kereiakes, Mark Turco, John A. Ormiston, Tift Mann, Louis Cannon, Gregory Mishkel, Thomas J. Mcgarry, Paul Underwood, Hong Wang, Keith D. Dawkins
    Abstract:

    Stent design, metal alloy composition, and strut thickness may influence late lumen loss and clinical outcomes after bare metal stent deployment; however, their impact on outcomes after drug-eluting stent deployment is unknown. Although the Taxus Liberte and ION paclitaxel-eluting stents use similar polymer and drug, the ION stent incorporates a novel thin-strut platinum chromium metal alloy and cell design. We therefore compared patient-level data from 2,298 subjects enrolled into the Taxus ATLAS (Taxus Liberte) and PERSEUS (ION) clinical trials. Propensity-score (1:1) matching was performed to adjust for covariate imbalance between stent types. Twelve-month major adverse cardiac events were less frequent after use of the ION compared to the Taxus Liberte (12.7% vs 8.3%, p

  • long term impact of routinely detected early and late incomplete stent apposition an integrated intravascular ultrasound analysis of the Taxus iv v and vi and Taxus atlas workhorse long lesion and direct stent studies
    Jacc-cardiovascular Interventions, 2010
    Co-Authors: Daniel H Steinberg, Mark Turco, John A. Ormiston, Lazar Mandinov, Keith D. Dawkins, Gary S Mintz, Alan Yu, Steven G Ellis, Eberhard Grube, Gregg W Stone
    Abstract:

    Objectives We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events. Background The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and Taxus stents (Boston Scientific, Natick, Massachusetts) is debatable. Methods We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of Taxus IV, V, VI and Taxus-ATLAS WH, LL, and DS trials. Results There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) Taxus Express patients (p = 0.28 vs. BMS), and 35 (7.3%) Taxus Liberte patients (p = 0.21 vs. Taxus Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for Taxus (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with Taxus slow-release (Taxus Express or Taxus Liberte), and 12 (15.4%) patients receiving Taxus moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), Taxus (overall, 8.3% vs. 8.1% p = 0.87), or Taxus slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis. Conclusions Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or Taxus patients was associated with adverse clinical events over long-term follow-up.

  • A prospective evaluation of the safety and efficacy of the Taxus Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program
    Trials, 2010
    Co-Authors: Dominic J Allocco, Keith D. Dawkins, Louis A Cannon, Amy Britt, John E Heil, Andrey Nersesov, Scott Wehrenberg, Dean J Kereiakes
    Abstract:

    Background Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. Taxus Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the Taxus Element stent are being evaluated in the pivotal PERSEUS clinical trials. Methods/Design The PERSEUS trials include two parallel studies of the Taxus Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1), single-blind, non-inferiority trial in subjects with lesion length ≤28 mm and vessel diameter ≥2.75 mm to ≤4.0 mm which compares Taxus Element to the Taxus Express^2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the Taxus Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length ≤20 mm and vessel diameter ≥2.25 mm to

Neil J. Weissman - One of the best experts on this subject based on the ideXlab platform.

  • Improved strut coverage and less late incomplete apposition with thin-strut Taxus Liberté vs. Taxus Express: the importance of stent platform design for drug-eluting stents
    Cardiovascular Revascularization Medicine, 2010
    Co-Authors: Neil J. Weissman, Mark Turco, John A. Ormiston, Tift Mann, Louis Cannon, Thomas F. Mcgarry, Mark Webster, Jack J. Hall, Michael J. Lucca, Gregory Mishkel
    Abstract:

    Abstract Background The objective of this intravascular ultrasound (IVUS) analysis was to evaluate the vascular response of the thin-strut Taxus Liberte stent compared with the otherwise identical Taxus Express stent. Methods and Materials The Taxus ATLAS and Taxus ATLAS Long Lesion studies are nonrandomized trials comparing the thin-strut Taxus Liberte stent to historical Taxus Express controls from the Taxus IV and Taxus V trials. A total of 377 patients enrolled in the two Taxus ATLAS studies were randomly selected for the IVUS subset and compared to 314 Taxus Express IVUS controls. Results Despite increased lesion complexity in the Taxus Liberte group, neointimal formation at 9 months was similar in both stents (Taxus Liberte 13.8±11.0%; Taxus Express 13.1±13.8%, P =.56). However, this neointima covered more of the overall stent in the Taxus Liberte (67.9±32.5%) compared with the Taxus Express (54.4±37.2%, P P =.04) late incomplete stent apposition (ISA). Conclusions Despite identical polymer and drug release characteristic, the thin-strut Taxus Liberte stent demonstrates improved neointimal coverage, better edge remodeling, and less late ISA vs. Taxus Express, hereby highlighting the importance of the platform design for drug-eluting stents.

  • impact of post intervention minimal stent area on 9 month follow up patency of paclitaxel eluting stents an integrated intravascular ultrasound analysis from the Taxus iv v and vi and Taxus atlas workhorse long lesion and direct stent trials
    Jacc-cardiovascular Interventions, 2009
    Co-Authors: Akiko Maehara, Jeffrey J Popma, Lazar Mandinov, Keith D. Dawkins, Gary S Mintz, Alan Yu, Eberhard Grube, Stephen G Ellis, Hong Wang, Neil J. Weissman
    Abstract:

    Objectives We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on 9-month follow-up paclitaxel-eluting stent (PES) patency compared with bare-metal stents (BMS). Background Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in PES is still unknown. Methods From the combined Taxus IV, V, and VI and Taxus ATLAS Workhorse, Long Lesion, and Direct Stent trials, 1,580 patients (PES 1,098, BMS 482) in IVUS substudies were analyzed. The MSA that best predicted angiographic in-stent restenosis (ISR) (% diameter stenosis ≥50%) was determined. Results The post-intervention IVUS MSA was similar in PES and BMS (6.6 ± 2.5 mm2 vs. 6.7 ± 2.3 mm2, p = 0.92). At 9-month follow-up, ISR was lower in the PES group versus the BMS group (10% vs. 31%, p < 0.0001). Using multivariable logistic regression analysis, post-intervention IVUS MSA was the independent predictor of subsequent ISR in both the PES and BMS groups (p = 0.0002 for PES and p = 0.0002 for BMS). The ability of the post-intervention IVUS MSA to predict ISR was further assessed using receiver operating characteristic analysis. The post-intervention IVUS MSA was found to be a faithful discriminator between patients with and without ISR in both PES (c = 0.6382) and BMS (c = 0.6373). Finally, the optimal thresholds of post-intervention IVUS MSA that best predicted stent patency at 9 months were 5.7 mm2 for PES and 6.4 mm2 for BMS. Conclusions Post-intervention MSA measured by IVUS can predict 9-month follow-up stent patency after both PES and BMS implantation. (Randomized Trial Evaluating Slow-Release Formulation Taxus Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions; NCT00301522) (Direct Stenting of Taxus Liberte-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions; NCT00371423) (A Study of the Taxus Liberte Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475) (A Study of the Taxus Liberte Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748)

  • an integrated Taxus iv v and vi intravascular ultrasound analysis of the predictors of edge restenosis after bare metal or paclitaxel eluting stents
    American Journal of Cardiology, 2009
    Co-Authors: Akiko Maehara, Neil J. Weissman, Jeffrey J Popma, Lazar Mandinov, Gary S Mintz, Alan Yu, Eberhard Grube, Stephen G Ellis, Hong Wang, Keith D. Dawkins
    Abstract:

    We used intravascular ultrasound data after stent implantation from the Taxus IV, V, and VI trials to determine predictors of angiographic stent edge restenosis. In the combined Taxus IV, V, and VI trials, intravascular ultrasound was performed at implantation in 255 patients with bare metals stents (BMSs) and 276 patients with paclitaxel-eluting stents who underwent quantitative coronary angiography at 9 months. At follow-up, 6 BMSs (2.5%) had proximal edge and 6 BMSs (2.4%) had distal edge angiographic restenosis; 14 Taxus stents (5.2%) had proximal edge and 1 Taxus stent (0.4%) had distal edge angiographic restenosis. Although univariate analysis identified external elastic membrane, lumen areas, and plaque burden (external elastic membrane minus lumen/ external elastic membrane) as predictors of 9-month angiographic edge restenosis in the overall cohort and in BMS- and Taxus-treated patients separately, only edge plaque burden was an independent predictor of 9-month angiographic edge restenosis. Receiver operator characteristic analysis showed that residual plaque burden, but not edge lumen area, was predictive of 9-month angiographic edge restenosis in BMS-treated patients (cutoff 47.7%, c = 0.70, p = 0.0244) and in Taxus-treated patients (cutoff 47.1%, c = 0.69, p = 0.0137). In conclusion, residual edge plaque burden predicts stent edge restenosis after BMS or Taxus stent implantation and the optimal plaque burden for stent edge landing zones are the same for BMSs and Taxus stents, independent of vessel size and edge lumen dimensions.

  • Direct Stenting With the Taxus Liberté Drug-Eluting Stent: Results From the Taxus ATLAS DIRECT STENT Study
    Jacc-cardiovascular Interventions, 2008
    Co-Authors: John A. Ormiston, Neil J. Weissman, Mark Turco, Tift Mann, Louis Cannon, Michael J. Lucca, Jeffrey J Popma, Ehtisham Mahmud, Jack J. Hall
    Abstract:

    Objectives This study was conducted to determine whether direct stenting with Taxus Liberte is noninferior to stenting after pre-dilation. Background Direct stenting is performed in approximately 30% of patients, but data on clinical and angiographic outcomes with drug-eluting stents are limited. Methods The Taxus ATLAS DIRECT STENT is a single-arm, multicenter study that enrolled patients with de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is the quantitative coronary angiography (QCA) subset of the Taxus ATLAS trial, which used identical inclusion and exclusion criteria but mandated pre-dilation. The primary end point is 9-month analysis-segment percent diameter stenosis (%DS). Results Baseline patient characteristics were similar between the groups. On QCA analysis, significantly shorter lesions with larger lumen diameter and less calcification were observed in the direct stent group. Direct stenting was successful in 97.6% of patients and was associated with a shorter procedure time and fewer complications. Follow-up %DS was noninferior for direct stent (26.41%) versus pre-dilation (29.14%) with a 1-sided 95% confidence interval of the difference between the groups (−0.34%) well below the pre-specified noninferiority margin (6.75%). Additionally, significantly lower restenosis (5.9% vs. 11.4%, p = 0.0229) and target lesion revascularization (TLR) 2.9% vs. 7.8%, p = 0.0087) rates were seen for direct stent versus pre-dilation. Conclusions Direct stenting of Taxus Liberte is feasible and highly successful in carefully selected lesions. Direct stenting is noninferior to stenting after pre-dilation on the basis of %DS and can significantly reduce procedural time, procedural complications, and possibly angiographic restenosis and TLR. (Taxus Liberte-SR Paclitaxel-Eluting Coronary Stent System; NCT00371423).

  • effect of the polymer based paclitaxel eluting Taxus express stent on vascular tissue responses a volumetric intravascular ultrasound integrated analysis from the Taxus iv v and vi trials
    European Heart Journal, 2007
    Co-Authors: Neil J. Weissman, Tift Mann, Louis Cannon, Keith D. Dawkins, Eberhard Grube, Stephen G Ellis, Joel Greenberg, Patrick Cambier, Stephen Fernandez, Gary S Mintz
    Abstract:

    Aims The Taxus® Express® stent has been shown to reduce angiographic restenosis, repeat revascularizations, and neointimal hyperplasia when compared with bare metal stent (BMS) control (Taxus IV, V, and VI) in individual Taxus trials. Since intravascular ultrasound (IVUS) methodology and core laboratory were consistent among all three Taxus trials, an integrated analysis of 956 patients across all IVUS cohorts can be performed providing superior power. Methods and results In the Taxus randomized trials, patients received an Express BMS or paclitaxel-eluting Taxus Express stent. Volumetric analysis was performed on a selected subgroup at implantation and 9 months. Compared with BMS control, Taxus increased 9-month lumen volumes (144 ± 79 vs. 179 ± 95 mm3; P < 0.0001) due to reduced neointimal volume (66 ± 49 vs. 27 ± 30 mm3; P < 0.0001). This corresponded to a 61% decrease in net lumen volume obstruction (31 ± 15 vs. 12 ± 12 mm3; P < 0.0001). Lumen loss was similar between groups for the proximal 5 mm outside the stent but was reduced in Taxus at the distal edge ( P = 0.0056). Neointimal hyperplasia was significantly reduced in the double-strut region of overlapping Taxus vs. BMS control and in high-risk patients with diabetes, long lesions, multiple stents, and multiple overlapping stents. Late-acquired incomplete stent apposition (ISA) was more common with moderate-release Taxus stents. Importantly, there were no major adverse cardiac events or stent thromboses in any late-acquired ISA patient through 2 years. Univariate and multivariable analyses revealed that longer lesion length and previous myocardial infarction are risk factors for late-acquired ISA. Conclusion Integrated analysis of the Taxus trials shows that the paclitaxel-eluting Taxus Express stent effectively inhibits in-stent neointimal proliferation, even in high-risk and overlapping stent patients.

Sigmund Silber - One of the best experts on this subject based on the ideXlab platform.

  • final 5 year results of the Taxus ii trial a randomized study to assess the effectiveness of slow and moderate release polymer based paclitaxel eluting stents for de novo coronary artery lesions
    Circulation, 2009
    Co-Authors: Sigmund Silber, Eberhard Grube, Antonio Colombo, Adrian P Banning, Karl Eugen Hauptmann, J Drzewiecki, Dariusz Dudek, Donald S Baim
    Abstract:

    Background— The Taxus II trial was designed to evaluate the safety and efficacy of the commercialized slow-release (SR) and an investigation-only moderate-release (MR) polymer-based Taxus paclitaxel-eluting stent compared with a bare-metal stent for the treatment of de novo coronary lesions. Methods and Results— This prospective, randomized, double-blind, controlled trial enrolled 536 patients in 2 consecutive cohorts to compare Taxus SR (n=131) and Taxus MR (n=135) with an identical but uncoated bare-metal stent control (n=270). The present analysis reports final 5-year clinical outcomes of Taxus II. At 5 years, both Taxus SR and MR showed superior outcomes compared with control. The 5-year rates of major adverse cardiac events were 27.6%, 20.4%, and 15.1% (P=0.01); rates of target-vessel revascularization were 22.5%, 16.6%, and 9.0% (P=0.004); and rates of target-lesion revascularization were 18.4%, 10.3%, and 4.5% (P<0.001) for the control, Taxus SR, and Taxus MR groups, respectively. The rates of all-...

  • randomized comparison of the nobori biolimus a9 eluting coronary stent with the Taxus liberte paclitaxel eluting coronary stent in patients with stenosis in native coronary arteries the nobori 1 trial phase 2
    Circulation-cardiovascular Interventions, 2009
    Co-Authors: Bernard Chevalier, Sigmund Silber, Karl Eugen Hauptmann, William Wijns, Seungjung Park, Eulogio Garcia, Gerhard Schuler, Harry Suryapranata, Jacques J Koolen, Marieclaude Morice
    Abstract:

    Background —The newly developed Nobori coronary stent coated with a bioresorbable polymer, poly-lactic acid, and the anti-proliferative agent Biolimus A9 has the potential to reduce restenosis by suppressing neointima formation. Methods and Results —We conducted a randomized (2:1), controlled trial comparing the Biolimus A9-eluting stent Nobori and the paclitaxel-eluting stent Taxus Liberte, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia and Australia. Patients with previously untreated lesions in up to two native coronary arteries were considered for enrolment. The primary endpoint was in-stent late loss at 9 months, while secondary endpoints included other QCA parameters, such as in-segment late loss and the rate of restenosis as well as key IVUS parameters. Clinical secondary endpoints were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction and target vessel revascularization. At nine months the in-stent late loss was significantly lower in the Nobori group as compared to the Taxus group (0.11±0.30 mm versus 0.32±0.50 mm) reaching both the primary hypothesis of non-inferiority of Nobori stent versus Taxus Liberte stent (p<0.001), and the secondary hypothesis of superiority (p=0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (p=0.02) and neointimal volume obstruction, detected by IVUS, from 5.5±7.2% in Taxus to 1.8±5.2% in Nobori (p=0.01). Major adverse cardiac events rate was 4.6% in Nobori and 5.6% in Taxus cohort of patients. The stent thrombosis rate was 0% in the Nobori arm and 4.4% in the Taxus arm. Conclusions —The NOBORI 1 clinical trial confirmed its primary hypothesis - non-inferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberte stent in reducing neointimal proliferation. Both stents showed low major adverse cardiac events rate in the studied population.

  • randomised comparison of nobori biolimus a9 eluting coronary stent with a Taxus r paclitaxel eluting coronary stent in patients with stenosis in native coronary arteries the nobori 1 trial
    Eurointervention, 2007
    Co-Authors: Bernard Chevalier, Sigmund Silber, Karl Eugen Hauptmann, William Wijns, Eulogio Garcia, Gerhard Schuler, Harry Suryapranata, Patrick W Serruys, Farzin Fathordoubadi, Stephen G Worthley
    Abstract:

    Background: We studied the Nobori™ coronary stent coated with a bioabsorbable polymer and the antiproliferative agent Biolimus A9 which may reduce neointimal formation. Methods and results: Patients undergoing percutaneous coronary intervention for de novo lesions in up to two native coronary arteries, in 29 centres across Europe, Asia and Australia were randomly (2:1) assigned to receive the Biolimus A9 eluting stent Nobori™ (85 patients) or paclitaxel eluting stent Taxus ® (35 patients). The two groups were well matched in baseline characteristics. The primary end point of noninferiority for in-stent late loss of Nobori™ stent versus Taxus ® stent, at 9 months, was reached with the values of 0.15±0.27 mm with Nobori™ stent and 0.32±0.33 mm with Taxus ® stent (p=0.006). Neointimal volume obstruction was 2.2±6.0% and 8.9±9.2% for Nobori™ and Taxus ® stent respectively (p=0.017). The rates of death, myocardial infarction and any target vessel revascularisation at 9 months were 0%, 4.7%, and 7.1% respectively for Nobori™ stent, and 0%, 8.6% and 14.3% respectively for Taxus ® stent. Clinically-driven target lesion revascularisation rate was 0% for Nobori™ stent and 2.9% for Taxus ® stent. Stent thrombosis rates at 9 months were 0% in both groups. Conclusions: In this trial the Nobori™ Biolimus A9 eluting stent proved to be safe and effective in reducing neointimal proliferation. The long term safety remains to be confirmed during the extended follow-up period of 5 years.

  • Cypher Versus Taxus: Are There Differences?
    Journal of Interventional Cardiology, 2005
    Co-Authors: Sigmund Silber
    Abstract:

    Today, drug-eluting stents (DES) are the standard stenting procedure in the USA and in Switzerland. The objective of this analysis is to answer the two questions: what clinically relevant data regarding DES have been published, and is there a clinically relevant difference between the Cypher and the Taxus stents? Twenty-two randomized, controlled studies with a total of 11,118 patients were identified: 18 randomized studies compared a DES to a bare metal stent of identical design in 8,301 patients, and 4 randomized studies compared the Cypher and the Taxus stents in 2,817 patients. Three studies regarding Paclitaxel-releasing stents without polymer (1,235 pats) and five studies regarding Paclitaxel released from a polymer (3,513 pats) were analyzed. Sirolimus released from a polymer was investigated in five studies (2,070 pats). Everolimus released from a polymer was investigated in three studies (166 pats), Biolimus A9 released from a polymer in one (120 pats), and Zotarolimus (ABT-578) released from a polymer in also one (1,197 pats) trial. Thirteen studies chose either a surrogate primary endpoint (angiographic or IVUS) or a clinical endpoint insufficient for a power calculation. A primary clinical endpoint with an adequate sample size for a power calculation was chosen in three trials for the Taxus stent (Taxus-IV, Taxus-V, Taxus-VI; 2,916 patients), in one trial for the Cypher stent (SIRIUS; 1,058 patients), and in one trial for the Endeavor stent (ENDEAVOR-II; 1,197 patients). In all these trials, the primary clinical endpoint was reached. Of the four studies comparing Cypher stents to Taxus stents, one did not define the primary endpoint (TAXi), two assumed superiority of the Cypher stent (REALITY with a surrogate endpoint and SIRTAX, a single-center study), and one was designed as a non-inferiority trial (ISAR-Diabetes, single-center study with a surrogate endpoint). Based on the European Society of Cardiology established strict criteria with a clinical primary endpoint as a prerequisite to recommend a DES, only three DES have thus far had proven positive effects on clinical outcome: the Cypher-stents, Taxus-stents, and Endeavor-stents. A trial proving the superiority of one DES over another would require a multicenter study with a clinical primary endpoint at an adequate power. As long as such a trial does not exist, Cypher and Taxus are regarded as being equivalent. (J Interven Cardiol 2005;18:441‐446)

  • randomized study to assess the effectiveness of slow and moderate release polymer based paclitaxel eluting stents for coronary artery lesions
    Circulation, 2003
    Co-Authors: Antonio Colombo, Eberhard Grube, Sigmund Silber, Adrian P Banning, Karl Eugen Hauptmann, J Drzewiecki, Dariusz Dudek, Francois Schiele, Stephen Fort, Krysztof Zmudka
    Abstract:

    Background— Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations. Methods and Results— We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (Taxus) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared Taxus-SR with control stents, and Cohort II compared Taxus-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for Taxus stents ...

Karl Eugen Hauptmann - One of the best experts on this subject based on the ideXlab platform.

  • final 5 year results of the Taxus ii trial a randomized study to assess the effectiveness of slow and moderate release polymer based paclitaxel eluting stents for de novo coronary artery lesions
    Circulation, 2009
    Co-Authors: Sigmund Silber, Eberhard Grube, Antonio Colombo, Adrian P Banning, Karl Eugen Hauptmann, J Drzewiecki, Dariusz Dudek, Donald S Baim
    Abstract:

    Background— The Taxus II trial was designed to evaluate the safety and efficacy of the commercialized slow-release (SR) and an investigation-only moderate-release (MR) polymer-based Taxus paclitaxel-eluting stent compared with a bare-metal stent for the treatment of de novo coronary lesions. Methods and Results— This prospective, randomized, double-blind, controlled trial enrolled 536 patients in 2 consecutive cohorts to compare Taxus SR (n=131) and Taxus MR (n=135) with an identical but uncoated bare-metal stent control (n=270). The present analysis reports final 5-year clinical outcomes of Taxus II. At 5 years, both Taxus SR and MR showed superior outcomes compared with control. The 5-year rates of major adverse cardiac events were 27.6%, 20.4%, and 15.1% (P=0.01); rates of target-vessel revascularization were 22.5%, 16.6%, and 9.0% (P=0.004); and rates of target-lesion revascularization were 18.4%, 10.3%, and 4.5% (P<0.001) for the control, Taxus SR, and Taxus MR groups, respectively. The rates of all-...

  • randomized comparison of the nobori biolimus a9 eluting coronary stent with the Taxus liberte paclitaxel eluting coronary stent in patients with stenosis in native coronary arteries the nobori 1 trial phase 2
    Circulation-cardiovascular Interventions, 2009
    Co-Authors: Bernard Chevalier, Sigmund Silber, Karl Eugen Hauptmann, William Wijns, Seungjung Park, Eulogio Garcia, Gerhard Schuler, Harry Suryapranata, Jacques J Koolen, Marieclaude Morice
    Abstract:

    Background —The newly developed Nobori coronary stent coated with a bioresorbable polymer, poly-lactic acid, and the anti-proliferative agent Biolimus A9 has the potential to reduce restenosis by suppressing neointima formation. Methods and Results —We conducted a randomized (2:1), controlled trial comparing the Biolimus A9-eluting stent Nobori and the paclitaxel-eluting stent Taxus Liberte, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia and Australia. Patients with previously untreated lesions in up to two native coronary arteries were considered for enrolment. The primary endpoint was in-stent late loss at 9 months, while secondary endpoints included other QCA parameters, such as in-segment late loss and the rate of restenosis as well as key IVUS parameters. Clinical secondary endpoints were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction and target vessel revascularization. At nine months the in-stent late loss was significantly lower in the Nobori group as compared to the Taxus group (0.11±0.30 mm versus 0.32±0.50 mm) reaching both the primary hypothesis of non-inferiority of Nobori stent versus Taxus Liberte stent (p<0.001), and the secondary hypothesis of superiority (p=0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (p=0.02) and neointimal volume obstruction, detected by IVUS, from 5.5±7.2% in Taxus to 1.8±5.2% in Nobori (p=0.01). Major adverse cardiac events rate was 4.6% in Nobori and 5.6% in Taxus cohort of patients. The stent thrombosis rate was 0% in the Nobori arm and 4.4% in the Taxus arm. Conclusions —The NOBORI 1 clinical trial confirmed its primary hypothesis - non-inferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberte stent in reducing neointimal proliferation. Both stents showed low major adverse cardiac events rate in the studied population.

  • randomised comparison of nobori biolimus a9 eluting coronary stent with a Taxus r paclitaxel eluting coronary stent in patients with stenosis in native coronary arteries the nobori 1 trial
    Eurointervention, 2007
    Co-Authors: Bernard Chevalier, Sigmund Silber, Karl Eugen Hauptmann, William Wijns, Eulogio Garcia, Gerhard Schuler, Harry Suryapranata, Patrick W Serruys, Farzin Fathordoubadi, Stephen G Worthley
    Abstract:

    Background: We studied the Nobori™ coronary stent coated with a bioabsorbable polymer and the antiproliferative agent Biolimus A9 which may reduce neointimal formation. Methods and results: Patients undergoing percutaneous coronary intervention for de novo lesions in up to two native coronary arteries, in 29 centres across Europe, Asia and Australia were randomly (2:1) assigned to receive the Biolimus A9 eluting stent Nobori™ (85 patients) or paclitaxel eluting stent Taxus ® (35 patients). The two groups were well matched in baseline characteristics. The primary end point of noninferiority for in-stent late loss of Nobori™ stent versus Taxus ® stent, at 9 months, was reached with the values of 0.15±0.27 mm with Nobori™ stent and 0.32±0.33 mm with Taxus ® stent (p=0.006). Neointimal volume obstruction was 2.2±6.0% and 8.9±9.2% for Nobori™ and Taxus ® stent respectively (p=0.017). The rates of death, myocardial infarction and any target vessel revascularisation at 9 months were 0%, 4.7%, and 7.1% respectively for Nobori™ stent, and 0%, 8.6% and 14.3% respectively for Taxus ® stent. Clinically-driven target lesion revascularisation rate was 0% for Nobori™ stent and 2.9% for Taxus ® stent. Stent thrombosis rates at 9 months were 0% in both groups. Conclusions: In this trial the Nobori™ Biolimus A9 eluting stent proved to be safe and effective in reducing neointimal proliferation. The long term safety remains to be confirmed during the extended follow-up period of 5 years.

  • randomized study to assess the effectiveness of slow and moderate release polymer based paclitaxel eluting stents for coronary artery lesions
    Circulation, 2003
    Co-Authors: Antonio Colombo, Eberhard Grube, Sigmund Silber, Adrian P Banning, Karl Eugen Hauptmann, J Drzewiecki, Dariusz Dudek, Francois Schiele, Stephen Fort, Krysztof Zmudka
    Abstract:

    Background— Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations. Methods and Results— We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (Taxus) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared Taxus-SR with control stents, and Cohort II compared Taxus-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for Taxus stents ...

  • Taxus i six and twelve month results from a randomized double blind trial on a slow release paclitaxel eluting stent for de novo coronary lesions
    Circulation, 2003
    Co-Authors: Eberhard Grube, Sigmund Silber, Karl Eugen Hauptmann, Ralf Mueller, Lutz Buellesfeld, Ulrich Gerckens, Mary E Russell
    Abstract:

    Background-The Taxus NIRx stent (Boston Scientific Corp) provides local delivery of paclitaxel via a slow-release polymer coating. The Taxus I trial was the first in-human experience evaluating safety and feasibility of the Taxus NIRx stent system compared with bare NIR stents (control) (Boston Scientific Corp) for treatment of coronary lesions. Methods and Results-The Taxus I trial was a prospective, double-blind, three-center study randomizing 61 patients with de novo or restenotic lesions (≤12 mm) to receive a Taxus (n=31) versus control (n=30) stent (diameter 3.0 or 3.5 mm). Demographics, lesion characteristics, clinical outcomes were comparable between the groups. The 30-day major adverse cardiac event (MACE) rate was 0% in both groups (P=NS). No stent thromboses were reported at 1, 6, 9, or 12 months. At 12 months, the MACE rate was 3% (1 event) in the Taxus group and 10% (4 events in 3 patients) in the control group (P=NS). Six-month angiographic restenosis rates were 0% for Taxus versus 10% for control (P=NS) patients. There were significant improvements in minimal lumen diameter (2.60±0.49 versus 2.19±0.65 mm), diameter stenosis (13.56±11.77 versus 27.23±16.69), and late lumen loss (0.36±0.48 versus 0.71±0.48 mm) in the Taxus group (all P<0.01). No evidence of edge restenosis was seen in either group. Intravascular ultrasound analysis showed significant improvements in normalized neointimal hyperplasia in the Taxus (14.8 mm 3 ) group compared with the control group (21.6 mm 3 ) (P<0.05). Conclusions-In this feasibility trial, the Taxus slow-release stent was well tolerated and showed promise for treatment of coronary lesions, with significant reductions in angiographic and intravascular ultrasound measures of restenosis.