36 results on '"Joerg Koglin"'
Search Results
2. Renal function and the effects of vericiguat in patients with worsening heart failure with reduced ejection fraction
- Author
-
Christopher M. O'Connor, Lothar Roessig, Justin A. Ezekowitz, Adrian F. Hernandez, Carolyn S.P. Lam, Eugene B. Reyes, Joerg Koglin, Hillary Mulder, Johan Lassus, Martin R. Cowie, Javed Butler, Piotr Ponikowski, Paul W. Armstrong, Kevin J. Anstrom, Adriaan A. Voors, Burkert Pieske, Cardiovascular Centre (CVC), and HUS Heart and Lung Center
- Subjects
Male ,Cardiac & Cardiovascular Systems ,VICTORIA Study Group ,030204 cardiovascular system & hematology ,Kidney ,chemistry.chemical_compound ,0302 clinical medicine ,Medicine ,Estimated glomerular filtration rate ,1102 Cardiorespiratory Medicine and Haematology ,Research Articles ,Victoria Trial ,Ejection fraction ,Hazard ratio ,Heart failure with reduced ejection fraction ,3. Good health ,Treatment Outcome ,ENALAPRIL ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,Life Sciences & Biomedicine ,Research Article ,Glomerular Filtration Rate ,medicine.drug ,medicine.medical_specialty ,Renal function ,Heart failure ,Heterocyclic Compounds, 2-Ring ,03 medical and health sciences ,Internal medicine ,Humans ,Enalapril ,Aged ,Creatinine ,Science & Technology ,business.industry ,Proportional hazards model ,Stroke Volume ,medicine.disease ,Confidence interval ,Pyrimidines ,Cardiovascular System & Hematology ,chemistry ,3121 General medicine, internal medicine and other clinical medicine ,Cardiovascular System & Cardiology ,INHIBITORS ,business - Abstract
Aims Vericiguat reduced the primary composite outcome of cardiovascular death or heart failure (HF) hospitalization in patients with worsening HF with reduced ejection fraction (HFrEF) and a lower limit of baseline estimated glomerular filtration rate (eGFR) of 15 mL/min/1.73 m2. We evaluated the relationship between the efficacy of vericiguat and baseline and subsequent changes in renal function. Methods and results In VICTORIA, core laboratory serum creatinine was measured at baseline (n = 4956) and weeks 16, 32, and 48. Worsening renal function (WRF), defined as an increase ≥0.3 mg/dL in creatinine from baseline to week 16, was assessed via a Cox model with respect to subsequent primary events. Mean age was 69 years, 24% were female, and mean baseline eGFR was 61 mL/min/1.73 m2. During 48 weeks of treatment, the trajectories in eGFR and creatinine with vericiguat were similar to placebo (P = 0.50 and 0.18). The beneficial effects of vericiguat on the primary outcome were not influenced by baseline eGFR (interaction P = 0.48). WRF occurred in 15% of patients and was associated with worse outcomes (adjusted hazard ratio 1.28, 95% confidence interval 1.11–1.47; P, The left panel shows no differences in the change in creatinine (P = 0.18) between the vericiguat and placebo groups, as evaluated by the interaction between treatment and study visit in the model. The right panel shows a natural cubic spline plot showing that the treatment effect of vericiguat on the primary outcome was similar across the full range of estimated glomerular filtration rate (eGFR) (P = 0.23).
- Published
- 2021
3. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator
- Author
-
Mahesh J. Patel, Lothar Roessig, Adriaan A. Voors, Piotr Ponikowski, Javed Butler, Tracy Temple, Paul W. Armstrong, Burkert Pieske, Adrian F. Hernandez, Kevin J. Anstrom, Christopher M. O'Connor, Justin A. Ezekowitz, Joerg Koglin, and Carolyn S.P. Lam
- Subjects
Ejection fraction ,business.industry ,medicine.drug_class ,Placebo-controlled study ,030204 cardiovascular system & hematology ,medicine.disease ,Placebo ,Left ventricular hypertrophy ,Pulmonary hypertension ,Riociguat ,03 medical and health sciences ,0302 clinical medicine ,Heart failure ,Anesthesia ,Natriuretic peptide ,Medicine ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
This trial sought to evaluate whether vericiguat, a novel oral soluble guanylate cyclase (sGC) stimulator, was superior to placebo, on a background of standard of care, in increasing the time to the first occurrence of the composite endpoints of cardiovascular (CV) death and heart failure (HF) hospitalization in patients with HF with reduced ejection fraction (HFrEF). Deficiency in sGC-derived cyclic guanosine monophosphate (cGMP) causes both myocardial dysfunction and impaired endothelium-dependent vasomotor regulation that includes the myocardial microcirculation. Experimental studies have suggested multiple potential benefits of sGC stimulators including prevention, or even reversal, of left ventricular hypertrophy and fibrosis, as well as reduction of ventricular afterload through both systemic and pulmonary vasodilation. Hence, restoration of sufficient nitric oxide (NO)-sGC–cGMP signaling has been proposed as an important treatment target in HF. Vericiguat has been shown to directly stimulate sGC and enhance sGC sensitivity to endogenous NO. Available phase IIb data in HFrEF patients indicate vericiguat is safe and well-tolerated, and exploratory analyses indicate that it results in a dose-dependent, clinically significant reduction in N-terminal pro–B-type natriuretic peptide (NT-proBNP) at the highest tested dose. VICTORIA (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction) is a randomized, placebo-controlled, parallel group, multicenter, double-blind, event-driven phase 3 trial of vericiguat in subjects with HFrEF. Approximately 4,872 subjects will be randomized to evaluate the efficacy and safety of vericiguat compared with placebo on a background of standard of care. After a screening phase of up to 30 days, eligible subjects will be treated until the required number of cardiovascular deaths is observed. The estimated median follow-up duration is approximately 18 months. All subjects will be followed until study completion to assess for the occurrence of endpoint events. VICTORIA will establish the efficacy and safety of vericiguat on cardiovascular death and HF hospitalization in patients with HFrEF. (A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction [HFrEF]—VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction [VICTORIA]; NCT02861534)
- Published
- 2018
- Full Text
- View/download PDF
4. Baseline features of the VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial
- Author
-
Burkert, Pieske, Mahesh J, Patel, Cynthia M, Westerhout, Kevin J, Anstrom, Javed, Butler, Justin, Ezekowitz, Adrian F, Hernandez, Joerg, Koglin, Carolyn S P, Lam, Piotr, Ponikowski, Lothar, Roessig, Adriaan A, Voors, Christopher M, O'Connor, Paul W, Armstrong, Jian, Zhang, leboeuf, Christophe, Charité Campus Virchow-Klinikum (CVK), German Center for Cardiovascular Research (DZHK), Berlin Institute of Health (BIH), Merck & Co. Inc. [Kenilworth, NJ, USA], University of Alberta, Duke University Medical Center, University of Mississippi Medical Center (UMMC), King‘s College London, University of Wrocław [Poland] (UWr), Bayer Pharma AG [Berlin], University Medical Center Groningen [Groningen] (UMCG), Duke University [Durham], VICTORIA Study Group: Imran Zainal Abidin, Dan Atar, M Cecilia Bahit, Juan Luis Arango Benecke, Edimar A Bocchi, Diana Bonderman, Myeong-Chan Cho, Chern-En Chiang, Alain Cohen-Solal, Martin Cowie, Frank Edelmann, Michele Emdin, Jorge Escobedo, Justin A Ezekowitz, Michael M Givertz, David M Kaye, Fernando Lanas, Johan Lassus, Basil S Lewis, Yury Lopatin, José López-Sendón, Lars H Lund, Kenneth McDonald, Vojtěch Melenovský, Arend Mosterd, Ebrahim Noori, M Ali Oto, Armando Lionel Godoy Palomino, Ileana L Piña, Piotr Ponikowski, Anne-Catherine Pouleur, Jens Refsgaard, Eugene Reyes, Clara Saldarriaga, Michele Senni, David Sim, David Siu, Karen Sliwa-Hähnle, Nancy K Sweitzer, Richard W Troughton, Hiroyuki Tsutsui, Dimitrios N Tziakas, Jose B Vazquez-Tanus, Jian Zhang., and Cardiovascular Centre (CVC)
- Subjects
Male ,030204 cardiovascular system & hematology ,Coronary artery disease ,0302 clinical medicine ,Interquartile range ,Natriuretic Peptide, Brain ,Heart Failure/blood ,Myocardial infarction ,Prospective Studies ,education.field_of_study ,Framingham Risk Score ,Ejection fraction ,Atrial fibrillation ,Heart failure with reduced ejection fraction ,[SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system ,Clinical trial ,Treatment Outcome ,STIMULATOR ,ENALAPRIL ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,medicine.medical_specialty ,Population ,Heterocyclic Compounds, 2-Ring ,03 medical and health sciences ,[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system ,Internal medicine ,medicine ,SOLUBLE GUANYLATE-CYCLASE ,Humans ,Soluble guanylate cyclase ,Cyclic guanosine monophosphate ,Protein Precursors ,education ,Heterocyclic Compounds, 2-Ring/therapeutic use ,Aged ,Heart Failure ,business.industry ,Pyrimidines/therapeutic use ,Stroke Volume ,medicine.disease ,Peptide Fragments ,Pyrimidines ,Stroke Volume/physiology ,Heart failure ,Natriuretic Peptide, Brain/blood ,business ,Peptide Fragments/blood ,Biomarkers ,Biomarkers/blood ,Follow-Up Studies - Abstract
International audience; Aim: Describe the distinguishing features of heart failure (HF) patients with reduced ejection fraction (HFrEF) in the VICTORIA (Vericiguat Global Study in Patients with Heart Failure with Reduced Ejection Fraction) trial.Methods and results: Key background characteristics were evaluated in 5050 patients randomized in VICTORIA and categorized into three cohorts reflecting their index worsening HF event. Differences within the VICTORIA population were assessed and compared with PARADIGM-HF (Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) and COMMANDER HF (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure). VICTORIA patients had increased risk of mortality and rehospitalization: New York Heart Association class (40% class III), atrial fibrillation (45%), diabetes (47%), hypertension (79%) and mean estimated glomerular filtration rate of 61.5 mL/min/1.73 m2 . Baseline standard of HF care was very good: 60% received triple therapy. Their N-terminal pro-B-type natriuretic peptide was 3377 pg/mL [interquartile range (IQR) 1992-6380]. Natriuretic peptides were 30% higher level in the 67% patients with HF hospitalization
- Published
- 2019
- Full Text
- View/download PDF
5. CORONARY ARTERY DISEASE AND CARDIOVASCULAR OUTCOMES IN HEART FAILURE: INSIGHTS FROM THE VERICIGUAT GLOBAL STUDY IN SUBJECTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION (VICTORIA) TRIAL
- Author
-
Carolyn S.P. Lam, Amanda Stebbins, Adrian F. Hernandez, Paul W. Armstrong, Dan Atar, Adriaan A. Voors, Lothar Roessig, Imran Zainal Abidin, Javed Butler, Kevin J. Anstrom, Burkert Pieske, Christopher M. O'Connor, Basil S. Lewis, Clara Ines Saldarriaga Giraldo, Justin A. Ezekowitz, Joerg Koglin, and Piotr Ponikowski
- Subjects
Coronary artery disease ,medicine.medical_specialty ,Ejection fraction ,business.industry ,Internal medicine ,Heart failure ,medicine ,Cardiology ,Vericiguat ,Cardiology and Cardiovascular Medicine ,medicine.disease ,business ,Cardiovascular outcomes - Published
- 2021
- Full Text
- View/download PDF
6. BASELINE CARDIAC TROPONIN T, CLINICAL OUTCOMES AND VERICIGUAT TREATMENT EFFECT IN HEART FAILURE WITH REDUCED EJECTION FRACTION STUDY: INSIGHTS FROM THE VICTORIA TRIAL
- Author
-
Adrian F. Hernandez, Paul W. Armstrong, Javed Butler, Cynthia M. Westerhout, Kevin J. Anstrom, Wendimagegn Alemayehu, Adriaan A. Voors, Carolyn S.P. Lam, David M. Kaye, Burkert Pieske, Stephen L. Seliger, Lothar Roessig, Christopher M. O'Connor, Christopher DeFilippi, Joerg Koglin, Justin A. Ezekowitz, and Piotr Ponikowski
- Subjects
medicine.medical_specialty ,Cardiac troponin ,Ejection fraction ,business.industry ,medicine.disease ,Heart failure ,Internal medicine ,medicine ,Cardiology ,Treatment effect ,Vericiguat ,Cardiology and Cardiovascular Medicine ,business ,Baseline (configuration management) - Published
- 2021
- Full Text
- View/download PDF
7. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator: The VICTORIA Trial
- Author
-
Paul W, Armstrong, Lothar, Roessig, Mahesh J, Patel, Kevin J, Anstrom, Javed, Butler, Adriaan A, Voors, Carolyn S P, Lam, Piotr, Ponikowski, Tracy, Temple, Burkert, Pieske, Justin, Ezekowitz, Adrian F, Hernandez, Joerg, Koglin, and Christopher M, O'Connor
- Subjects
Heart Failure ,Pyrimidines ,Soluble Guanylyl Cyclase ,Treatment Outcome ,Administration, Oral ,Humans ,Multicenter Studies as Topic ,Stroke Volume ,Heterocyclic Compounds, 2-Ring ,Randomized Controlled Trials as Topic - Abstract
This trial sought to evaluate whether vericiguat, a novel oral soluble guanylate cyclase (sGC) stimulator, was superior to placebo, on a background of standard of care, in increasing the time to the first occurrence of the composite endpoints of cardiovascular (CV) death and heart failure (HF) hospitalization in patients with HF with reduced ejection fraction (HFrEF). Deficiency in sGC-derived cyclic guanosine monophosphate (cGMP) causes both myocardial dysfunction and impaired endothelium-dependent vasomotor regulation that includes the myocardial microcirculation. Experimental studies have suggested multiple potential benefits of sGC stimulators including prevention, or even reversal, of left ventricular hypertrophy and fibrosis, as well as reduction of ventricular afterload through both systemic and pulmonary vasodilation. Hence, restoration of sufficient nitric oxide (NO)-sGC-cGMP signaling has been proposed as an important treatment target in HF. Vericiguat has been shown to directly stimulate sGC and enhance sGC sensitivity to endogenous NO. Available phase IIb data in HFrEF patients indicate vericiguat is safe and well-tolerated, and exploratory analyses indicate that it results in a dose-dependent, clinically significant reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at the highest tested dose. VICTORIA (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction) is a randomized, placebo-controlled, parallel group, multicenter, double-blind, event-driven phase 3 trial of vericiguat in subjects with HFrEF. Approximately 4,872 subjects will be randomized to evaluate the efficacy and safety of vericiguat compared with placebo on a background of standard of care. After a screening phase of up to 30 days, eligible subjects will be treated until the required number of cardiovascular deaths is observed. The estimated median follow-up duration is approximately 18 months. All subjects will be followed until study completion to assess for the occurrence of endpoint events. VICTORIA will establish the efficacy and safety of vericiguat on cardiovascular death and HF hospitalization in patients with HFrEF. (A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction [HFrEF]-VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction [VICTORIA]; NCT02861534).
- Published
- 2017
8. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document
- Author
-
Gonzalo Calvo, Adriaan A. Voors, Stefan D. Anker, Gerasimos Filippatos, Norman Stockbridge, Aldo P. Maggioni, Scott D. Solomon, Burkert Pieske, John J.V. McMurray, Paul W. Armstrong, Marco Metra, Luigi Tavazzi, Andrew Zalewski, John G.F. Cleland, Karl Swedberg, Mihai Gheorghiade, Kenneth M. Stein, Scott M. Wasserman, Thomas Severin, Giuseppe M.C. Rosano, Joerg Koglin, Marvin A. Konstam, Angeles Alonso Garcia, Stuart J. Pocock, Inger Ekman, Alexandre Mebazaa, Tiny Jaarsma, Kenneth Dickstein, Faiez Zannad, Ileana L. Piña, Stuart Kupfer, Piotr Ponikowski, Wendy Gattis Stough, Christina Nowack, Adrian F. Hernandez, Jay N. Cohn, Michael J. Domanski, Luis M. Ruilope, Holger Woehrle, and Frank Ruschitzka
- Subjects
medicine.medical_specialty ,Clinical trials ,Heart failure ,Morbidity ,Mortality ,Clinical Trials as Topic ,Heart Failure ,Hospitalization ,Humans ,Outcome Assessment (Health Care) ,Recurrence ,Nice ,INITIATE LIFESAVING TREATMENT ,Outcome (game theory) ,IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS ,Internal medicine ,Outcome Assessment, Health Care ,Medicine ,Myocardial infarction ,Intensive care medicine ,Practical implications ,Pharmaceutical industry ,computer.programming_language ,business.industry ,Clinical study design ,WORSENING RENAL-FUNCTION ,medicine.disease ,VASOPRESSIN ANTAGONISM ,VENTRICULAR SYSTOLIC DYSFUNCTION ,Clinical trial ,PRESERVED EJECTION FRACTION ,MYOCARDIAL-INFARCTION ,VISUAL ANALOG SCALES ,Cardiology ,EVENTS COMMITTEE ,QUALITY-OF-CARE ,Cardiology and Cardiovascular Medicine ,business ,computer - Abstract
Endpoint selection is a critically important step in clinical trial design. It poses major challenges for investigators, regulators, and study sponsors, and it also has important clinical and practical implications for physicians and patients. Clinical outcomes of interest in heart failure trials include all-cause mortality, cause-specific mortality, relevant non-fatal morbidity (e.g., all-cause and cause-specific hospitalization), composites capturing both morbidity and mortality, safety, symptoms, functional capacity, and patient-reported outcomes. Each of these endpoints has strengths and weaknesses that create controversies regarding which is most appropriate in terms of clinical importance, sensitivity, reliability, and consistency. Not surprisingly, a lack of consensus exists within the scientific community regarding the optimal endpoint(s) for both acute and chronic heart failure trials. In an effort to address these issues, the Heart Failure Association of the European Society of Cardiology (HFA-ESC) convened a group of expert heart failure clinical investigators, biostatisticians, regulators, and pharmaceutical industry scientists (Nice, France, 12-13 February 2012) to evaluate the challenges of defining heart failure endpoints in clinical trials and to develop a consensus framework. This report summarizes the group's recommendations for achieving common views on heart failure endpoints in clinical trials.
- Published
- 2013
- Full Text
- View/download PDF
9. Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations
- Author
-
Patricia Kay-Mugford, Judith Hsia, Christopher O'Connor, Martha Mayo, Afshin Salsali, Li-Ming Gan, Udo Michael Gohring, Barry Ticho, Christopher J. Larson, Marco Metra, Regina Frische-Danielson, Michael van der Laan, Pierrre Mugnier, James E. Udelson, Mihai Gheorghiade, Sekayi Mushonga, John R. Teerlink, Robert J.A. Frost, Joerg Koglin, Carol Satler, Sanjiv J. Shah, Gabriel Brooks, Javed Butler, Lothar Roessig, Mary M. DeSouza, Dalane W. Kitzman, Clyde W. Yancy, Carine E. Hamo, Mark Donovan, Shiro Ishihara, Dahlia Garza, Cesare Russo, Victor Shi, Norman Stockbridge, Christophe Depre, Jennifer Hellawell, Harold S. Bernstein, Wilfried Dinh, Hani N. Sabbah, and Marc Kozinn
- Subjects
safety ,medicine.medical_specialty ,Consensus ,Clinical Trials and Supportive Activities ,Medical Physiology ,030204 cardiovascular system & hematology ,Cardiorespiratory Medicine and Haematology ,Cardiovascular ,Phase (combat) ,Article ,Food and drug administration ,03 medical and health sciences ,0302 clinical medicine ,Clinical Trials, Phase II as Topic ,Clinical Research ,medicine ,Humans ,In patient ,Clinical Trials ,030212 general & internal medicine ,Intensive care medicine ,Heart Failure ,business.industry ,United States Food and Drug Administration ,Clinical study design ,Phase II as Topic ,Clinical course ,clinical trial ,Cardiovascular Agents ,medicine.disease ,mortality ,United States ,Clinical trial ,Heart Disease ,Treatment Outcome ,Cardiovascular System & Hematology ,Research Design ,Heart failure ,Biochemistry and Cell Biology ,business ,heart failure ,Cardiology and Cardiovascular Medicine ,Expansive - Abstract
The increasing burden and the continued suboptimal outcomes for patients with heart failure underlines the importance of continued research to develop novel therapeutics for this disorder. This can only be accomplished with successful translation of basic science discoveries into direct human application through effective clinical trial design and execution that results in a substantially improved clinical course and outcomes. In this respect, phase II clinical trials play a pivotal role in determining which of the multitude of potential basic science discoveries should move to the large and expansive registration trials in humans. A critical examination of the phase II trials in heart failure reveals multiple shortcomings in their concept, design, execution, and interpretation. To further a dialogue on the challenges and potential for improvement and the role of phase II trials in patients with heart failure, the Food and Drug Administration facilitated a meeting on October 17, 2016, represented by clinicians, researchers, industry members, and regulators. This document summarizes the discussion from this meeting and provides key recommendations for future directions.
- Published
- 2016
10. Association between sitagliptin use and heart failure hospitalization and related outcomes in type 2 diabetes mellitus: secondary analysis of a randomized clinical trial
- Author
-
Darren K. McGuire, Jyotsna Garg, Rury R. Holman, Frans Van de Werf, Michael J. Pencina, Joerg Koglin, Giuseppe Ambrosio, Robert G. Josse, John B. Buse, Paul W. Armstrong, Eric D. Peterson, Renato D. Lopes, Yuliya Lokhnygina, Jan H. Cornel, Sigrun Halvorsen, M. Angelyn Bethel, John M. Lachin, Eberhard Standl, and Jennifer B. Green
- Subjects
Male ,medicine.medical_specialty ,Dipeptidyl peptidase-4 inhibitor ,030204 cardiovascular system & hematology ,Placebo ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Risk Factors ,law ,Cause of Death ,Internal medicine ,Diabetes mellitus ,Outcome Assessment, Health Care ,Prevalence ,Humans ,Medicine ,Hospital Mortality ,030212 general & internal medicine ,Aged ,Heart Failure ,Dipeptidyl-Peptidase IV Inhibitors ,business.industry ,Sitagliptin Phosphate ,Hazard ratio ,Secondary data ,Middle Aged ,Atherosclerosis ,medicine.disease ,Surgery ,Hospitalization ,Diabetes Mellitus, Type 2 ,Cardiovascular Diseases ,Sitagliptin ,Heart failure ,Female ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Importance Previous trial results have suggested that dipeptidyl peptidase 4 inhibitor (DPP4i) use might increase heart failure (HF) risk in type 2 diabetes mellitus (T2DM). The DPP4i sitagliptin has been shown to be noninferior to placebo with regard to primary and secondary composite atherosclerotic cardiovascular (CV) outcomes in the Trial Evaluating Cardiovascular Outcomes With Sitagliptin (TECOS). Objective To assess the association of sitagliptin use with hospitalization for HF (hHF) and related outcomes. Design, Setting, and Participants TECOS was a randomized, double-blind, placebo-controlled study evaluating the CV safety of sitagliptin vs placebo, each added to usual antihyperglycemic therapy and CV care among patients with T2DM and prevalent atherosclerotic vascular disease. The median follow-up was 2.9 years. The setting was 673 sites in 38 countries. Participants included 14 671 patients with T2DM and atherosclerotic vascular disease. The study dates were December 2008 through March 2015. Interventions Patients were randomized to sitagliptin vs placebo added to standard care. Main Outcomes and Measures Prespecified secondary analyses compared the effect on hHF, hHF or CV death, and hHF or all-cause death composite outcomes overall and in prespecified subgroups. Supportive analyses included total hHF events (first plus recurrent) and post-hHF death. Meta-analyses evaluated DPP4i effects on hHF and on hHF or CV death. Results Of 14 671 patients, 7332 were randomized to sitagliptin and 7339 to placebo. Hospitalization for HF occurred in 3.1% (n = 228) and 3.1% (n = 229) of the sitagliptin and placebo groups, respectively (unadjusted hazard ratio, 1.00; 95% CI, 0.83-1.19). There was also no difference in total hHF events between the sitagliptin (n = 345) and placebo (n = 347) groups (unadjusted hazard ratio, 1.00; 95% CI, 0.80-1.25). Post-hHF all-cause death was similar in the sitagliptin and placebo groups (29.8% vs 28.8%, respectively), as was CV death (22.4% vs 23.1%, respectively). No heterogeneity for the effect of sitagliptin on hHF was observed in subgroup analyses across 21 factors ( P > .10 for all interactions). Meta-analysis of the hHF results from the 3 reported DPP4i CV outcomes trials revealed moderate heterogeneity ( I2 = 44.9, P = .16). Conclusions and Relevance Sitagliptin use does not affect the risk for hHF in T2DM, both overall and among high-risk patient subgroups. Trial Registration clinicaltrials.gov Identifier:NCT00790205
- Published
- 2016
11. Chronic Arterial Responses to Overlapping Paclitaxel-Eluting Stents
- Author
-
Jiro Aoki, Gary S. Mintz, Joerg Koglin, Lazar Mandinov, Eberhard Grube, Neil J. Weissman, Joel Greenberg, Gregg W. Stone, Louis Cannon, A. R. Zaki Masud, and J. Tift Mann
- Subjects
medicine.medical_specialty ,Intimal hyperplasia ,medicine.diagnostic_test ,biology ,business.industry ,medicine.medical_treatment ,Stent ,Hyperplasia ,equipment and supplies ,Balloon ,biology.organism_classification ,medicine.disease ,Surgery ,chemistry.chemical_compound ,Taxus ,Paclitaxel ,chemistry ,Angioplasty ,Intravascular ultrasound ,medicine ,cardiovascular diseases ,Nuclear medicine ,business ,Cardiology and Cardiovascular Medicine - Abstract
Objectives The purpose of this study was to use intravascular ultrasound (IVUS) to investigate chronic arterial responses at the site of and adjacent to overlapping paclitaxel-eluting TAXUS stents (PES) compared with overlapping bare-metal stents (BMS). Background Increased paclitaxel dose in the PES-overlap region might be associated with arterial toxicity expressed as excessive expansive remodeling, incomplete stent apposition, or aneurysm formation. Methods In the TAXUS-V and -VI trials, 51 patients with overlapping stents (27 PES and 24 BMS) were imaged with serial IVUS immediately after procedure and at 9 months. The IVUS measurements included intimal hyperplasia (IH), peri-stent plaque plus media (PaM), and external elastic membrane (EEM) areas. Vascular responses were assessed at the proximal and distal single stent strut regions and the central overlap region. Results Compared with BMS, all 3 PES stent regions showed: 1) significantly decreased IH (proximal: 0.97 ± 1.06 mm2 vs. 3.12 ± 2.40 mm2, overlap: 0.74 ± 0.91 mm2 vs. 3.23 ± 1.75 mm2, distal: 0.88 ± 0.85 mm2 vs. 2.69 ± 1.49 mm2, all p l 0.05); and 2) increased PaM and EEM areas (Delta PaM; proximal: 0.96 ± 1.36 mm2 vs. −0.02 ± 1.48 mm2, overlap: 1.56 ± 1.88 mm2 vs. 0.29 ± 1.82 mm2, distal: 1.03 ± 1.81 mm2 vs. 0.11 ± 0.89 mm2, all p l 0.05). The IH and changes in EEM and PaM areas were not significantly different in both the BMS and PES groups comparing the single stent strut and overlap regions. Incomplete stent apposition did not occur at the site of overlapping PES in any patient. Conclusions Nine months after stent implantation, neointimal tissue growth was reduced and expansive remodeling was greater with PES compared with BMS—effects that were not exaggerated at the overlap region of PES.
- Published
- 2008
- Full Text
- View/download PDF
12. 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
- Author
-
Stephen Fernandez, Joel Greenberg, Stephen G. Ellis, Keith D. Dawkins, Lazar Mandinov, Patrick Cambier, Louis Cannon, Gregg W. Stone, Tift Mann, Joerg Koglin, Eberhard Grube, Gary S. Mintz, and Neil J. Weissman
- Subjects
Male ,Bare-metal stent ,medicine.medical_specialty ,Paclitaxel ,Polymers ,medicine.medical_treatment ,Urology ,Lumen (anatomy) ,Coronary Restenosis ,Double-Blind Method ,Restenosis ,Risk Factors ,Intravascular ultrasound ,Myocardial Revascularization ,medicine ,Humans ,Multicenter Studies as Topic ,cardiovascular diseases ,Randomized Controlled Trials as Topic ,Ultrasonography ,Drug Implants ,Neointimal hyperplasia ,biology ,medicine.diagnostic_test ,business.industry ,Stent ,Middle Aged ,equipment and supplies ,medicine.disease ,biology.organism_classification ,Tubulin Modulators ,Treatment Outcome ,Taxus ,Drug-eluting stent ,Female ,Stents ,Radiology ,Tunica Intima ,Cardiology and Cardiovascular Medicine ,business - 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.
- Published
- 2007
- Full Text
- View/download PDF
13. Polymer-Based, Paclitaxel-Eluting TAXUS Liberté Stent in De Novo Lesions
- Author
-
Chiung-Jen Wu, Charles Chan, John A. Ormiston, Lazar Mandinov, Charles O'Shaughnessy, Mark Webster, Gregory J. Mishkel, Louis Cannon, Donald S. Baim, Mark Turco, Thomas F. McGarry, Jack J. Hall, Tift Mann, Joerg Koglin, and Jeffrey J. Popma
- Subjects
medicine.medical_specialty ,biology ,business.industry ,medicine.medical_treatment ,Stent ,biology.organism_classification ,Surgery ,chemistry.chemical_compound ,Paclitaxel ,chemistry ,Taxus ,Drug-eluting stent ,medicine ,business ,Cardiology and Cardiovascular Medicine ,Mace - Abstract
Polymer-Based, Paclitaxel-Eluting TAXUS Liberte Stent in De Novo Lesions: The Pivotal TAXUS ATLAS TrialMark A. Turco, John A. Ormiston, Jeffrey J. Popma, Lazar Mandinov, Charles D. O’Shaughnessy, T...
- Published
- 2007
- Full Text
- View/download PDF
14. Incidence, Timing, and Correlates of Stent Thrombosis With the Polymeric Paclitaxel Drug-Eluting Stent
- Author
-
Jeffrey J. Popma, Stephen G. Ellis, Antonio Colombo, Keith D. Dawkins, Gregg W. Stone, Eberhard Grube, and Joerg Koglin
- Subjects
medicine.medical_specialty ,Antiplatelet drug ,business.industry ,medicine.medical_treatment ,Hazard ratio ,Stent ,equipment and supplies ,Clopidogrel ,medicine.disease ,Thrombosis ,Confidence interval ,Surgery ,surgical procedures, operative ,Drug-eluting stent ,Angioplasty ,Medicine ,cardiovascular diseases ,business ,Cardiology and Cardiovascular Medicine ,medicine.drug - Abstract
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.
- Published
- 2007
- Full Text
- View/download PDF
15. Two-Year Serial Coronary Angiographic and Intravascular Ultrasound Analysis of In-Stent Angiographic Late Lumen Loss and Ultrasonic Neointimal Volume from the TAXUS II Trial
- Author
-
Adrian P. Banning, Dariusz Dudek, Patrick W. Serruys, Gerrit Anne van Es, Nico Bruining, Zheng Zhou, Keiichi Tsuchida, Mary E. Russell, Tessa Rademaker, Joerg Koglin, Janusz Drzewiecki, Antonio Colombo, Krzysztof Zmudka, Francois Schiele, Erasmus MC other, Cardiology, and Epidemiology
- Subjects
Bare-metal stent ,medicine.medical_specialty ,Time Factors ,Paclitaxel ,medicine.medical_treatment ,Coronary Disease ,Coronary Angiography ,Internal medicine ,Intravascular ultrasound ,medicine ,Humans ,cardiovascular diseases ,Ultrasonography, Interventional ,medicine.diagnostic_test ,biology ,Surrogate endpoint ,business.industry ,Ultrasound ,Graft Occlusion, Vascular ,Stent ,Equipment Design ,equipment and supplies ,biology.organism_classification ,Tubulin Modulators ,Treatment Outcome ,surgical procedures, operative ,Taxus ,Angiography ,Circulatory system ,Cardiology ,Stents ,Radiology ,Tunica Intima ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
Late loss has been used as a reliable surrogate end point for evaluation and differentiation of short-term performance of drug-eluting stents. This study investigated the consistency between angiographic and intravascular ultrasound (IVUS) outcomes of late lumen loss (late loss) and neointimal growth to measure restenotic plaque load in TAXUS and bare metal stents. The randomized TAXUS II trial evaluates the polymer-based paclitaxel-eluting TAXUS stent in slow- and moderate-release formulations. Serial angiographic and IVUS analyses were available in 155 event-free patients (bare metal stent, 74; TAXUS stent, 81) after the procedure, at 6 months, and at 2 years. For this subanalysis, quantitative coronary angiographic (QCA) and IVUS measurements were used to derive late loss and neointimal volume. From after the procedure to 6 months, quantitative coronary angiography and IVUS showed matching results for the 2 groups with significant decreases in late loss and neointimal volume in the TAXUS versus the control group. From 6 months to 2 years, QCA and IVUS measurements also showed results similar to those in the control group, demonstrating neointimal compaction over time. However, in the TAXUS group, QCA late loss showed a nonsignificant decrease from 6 months to 2 years, whereas IVUS neointimal volume increased. In conclusion, although QCA and IVUS results were similar over the first 6 months, long-term assessment of changes in restenotic plaque load showed discrepant findings for the TAXUS. These findings suggest the need for critical reevaluation of current end points and the use of more precise techniques to detect lumen and stent boundaries.
- Published
- 2007
- Full Text
- View/download PDF
16. Clinical Efficacy of Polymer-Based Paclitaxel-Eluting Stents in the Treatment of Complex, Long Coronary Artery Lesions From a Multicenter, Randomized Trial
- Author
-
Krzysztof Zmudka, Eberhard Grube, Karl Hauptman, Giulio Guagliumi, William Wijns, Antonio Colombo, Keith D. Dawkins, Leif Thuesen, Joerg Koglin, Jeffrey J. Popma, Jean Marco, Mary E. Russell, and Adrian P. Banning
- Subjects
Adult ,Male ,medicine.medical_specialty ,Paclitaxel ,Polymers ,medicine.medical_treatment ,Coronary Artery Disease ,Coronary Angiography ,Revascularization ,law.invention ,Coronary Restenosis ,Coronary artery disease ,chemistry.chemical_compound ,Randomized controlled trial ,Restenosis ,law ,Physiology (medical) ,Angioplasty ,medicine ,Clinical endpoint ,Humans ,Angioplasty, Balloon, Coronary ,Aged ,business.industry ,Stent ,Middle Aged ,medicine.disease ,Antineoplastic Agents, Phytogenic ,Surgery ,Treatment Outcome ,chemistry ,Female ,Stents ,Radiology ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
Background— Intracoronary polymer-based stent delivery of paclitaxel has been shown to be effective in reducing restenosis in simple coronary lesions, but the evidence base for contemporary use in longer, more complex coronary stenoses is lacking. Methods and Results— TAXUS VI is a prospective, multicenter, double-blind, randomized trial assessing clinical and angiographic outcomes of the TAXUS Moderate Release paclitaxel-eluting stent in the treatment of long, complex coronary artery lesions. Four hundred forty-eight patients at 44 sites were randomized (1:1) between a drug-eluting TAXUS Express 2 and an uncoated Express 2 control stent. Per protocol, the 9-month follow-up included an angiographic reevaluation in all patients. The primary end point was the rate of target-vessel revascularization 9 months after the study procedure; secondary end points included the rate of target-lesion revascularization and binary restenosis at follow-up. Mean lesion length in the study was 20.6 mm, with a mean stent-covered length of 33.4 mm. Of all lesions, 55.6% were classified as complex lesions (type C of the AHA/ACC classification). At 9 months, target-vessel revascularization was 9.1% in the TAXUS group and 19.4% in the control group ( P =0.0027; relative reduction, 53%). Target-lesion revascularization was reduced from 18.9% to 6.8%, respectively ( P =0.0001). The incidence of major adverse cardiac events was similar in the 2 groups, 16.4% and 22.5% in TAXUS and control, respectively ( P =0.12), including comparable rates for acute myocardial infarction. Binary restenosis in the stented area was reduced from 32.9% in the control group to 9.1% in the TAXUS patients ( P Conclusions— The finding that the TAXUS Moderate Release stent system is safe and effective in the treatment of long, complex coronary artery lesions provides the evidence base for the more widespread use of drug-eluting stents in contemporary clinical practice.
- Published
- 2005
- Full Text
- View/download PDF
17. Expansion of Circulating Toll-Like Receptor 4–Positive Monocytes in Patients With Acute Coronary Syndrome
- Author
-
Heiko Methe, Sieglinde Kofler, Michael Nabauer, Joerg Koglin, Jong-Oh Kim, and Michael Weis
- Subjects
Lipopolysaccharides ,Male ,Acute coronary syndrome ,Heart Diseases ,Myocardial Infarction ,Disease ,Ligands ,Monocytes ,Angina Pectoris ,Immune system ,Physiology (medical) ,Humans ,Medicine ,RNA, Messenger ,Myocardial infarction ,Receptors, Immunologic ,Adaptor Proteins, Signal Transducing ,Aged ,Cell Proliferation ,Toll-like receptor ,business.industry ,Monocyte ,Case-control study ,Middle Aged ,Atherosclerosis ,medicine.disease ,Antigens, Differentiation ,Toll-Like Receptor 4 ,medicine.anatomical_structure ,Case-Control Studies ,Acute Disease ,Myeloid Differentiation Factor 88 ,Immunology ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background— Atherosclerosis is an inflammatory disease in which monocytes and macrophages have been suggested to play an essential role. The underlying signaling mechanisms are unknown thus far. We hypothesized that the human isoform of Toll-like receptor (hTLR)-4 is involved in monocyte activation of patients with accelerated forms of atherosclerosis. Methods and Results— Expression of hTLR4 on circulating monocytes from 30 controls, 20 patients with stable angina (SA), 40 patients with unstable angina (UA), and 28 patients with acute myocardial infarction (AMI) was compared with the use of flow-cytometry and reverse transcription–polymerase chain reaction. Regulation of interleukin (IL)-12 and B7-1 as downstream events of TLR4 activation was analyzed after lipopolysaccharide stimulation of monocytes. TLR4-transfected Chinese hamster ovary (CHO) cells were used to identify potential hTLR4 ligands in the serum of patients with UA or AMI. Circulating hTLR4 + /CD14 + monocytes were ≈2.5-fold increased above controls and patients with SA in the UA and AMI groups ( P P P P P Conclusions— UA and AMI are associated with enhanced expression and signaling events downstream of hTLR4 in circulating monocytes. These observations suggest hTLR4 activation as a signaling mechanism in immune-mediated progression of atherosclerosis.
- Published
- 2005
- Full Text
- View/download PDF
18. Relationship between angiographic late loss and target lesion revascularization after coronary stent implantation
- Author
-
James B. Hermiller, Stephen G. Ellis, Joel Greenberg, Jeffrey J. Popma, Mark Turco, James Tift Mann, Gregg W. Stone, Joerg Koglin, David A. Cox, Patrick Bergin, John M. Lasala, Ronald P. Caputo, and Charles O'Shaughnessy
- Subjects
medicine.medical_specialty ,biology ,business.industry ,medicine.medical_treatment ,Stent ,biology.organism_classification ,medicine.disease ,law.invention ,Lesion ,Clinical trial ,Taxus ,Restenosis ,Randomized controlled trial ,law ,Coronary stent ,Cohort ,medicine ,Radiology ,medicine.symptom ,business ,Cardiology and Cardiovascular Medicine - Abstract
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.
- Published
- 2005
- Full Text
- View/download PDF
19. Polymer-based paclitaxel-eluting stents reduce in-stent neointimal tissue proliferation
- Author
-
Joerg Koglin, Joel Greenberg, David A. Cox, Mark Turco, Stephen G. Ellis, Warren Strickland, Michael A. Kutcher, James B. Hermiller, S. Chiu Wong, Patrick Bergin, Ronald P. Caputo, Neil J. Weissman, Charles O'Shaughnessy, James Tift Mann, Michael Mooney, Mary E. Russell, and Gregg W. Stone
- Subjects
Neointima ,medicine.medical_specialty ,biology ,medicine.diagnostic_test ,business.industry ,medicine.medical_treatment ,Ultrasound ,Stent ,Lumen (anatomy) ,biology.organism_classification ,equipment and supplies ,chemistry.chemical_compound ,surgical procedures, operative ,Taxus ,Paclitaxel ,chemistry ,Drug-eluting stent ,Intravascular ultrasound ,Medicine ,Radiology ,cardiovascular diseases ,business ,Cardiology and Cardiovascular Medicine - Abstract
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 mm3vs. 104 ± 44 mm3, p = 0.005), due to a reduction in neointimal volume (18 ± 18 mm3vs. 41 ± 23 mm3, p Conclusions Polymer-based, paclitaxel-eluting TAXUS stents are effective in inhibiting neointimal tissue proliferation, and do not result in late incomplete stent apposition.
- Published
- 2005
- Full Text
- View/download PDF
20. Peristent remodeling and neointimal suppression 2 years after polymer-based, paclitaxel-eluting stent implantation - Insights from serial intravascular ultrasound analysis in the TAXUS II study
- Author
-
Jiro Aoki, Antonio Colombo, Janusz Drzewiecki, Patrick W. Serruys, Krzysztof Zmudka, Dariusz Dudek, Joerg Koglin, Francois Schiele, Adrian P. Banning, Mary E. Russell, and Cardiology
- Subjects
Male ,Neointima ,medicine.medical_specialty ,Paclitaxel ,Polymers ,medicine.medical_treatment ,restenosis ,chemistry.chemical_compound ,Double-Blind Method ,Restenosis ,Physiology (medical) ,Intravascular ultrasound ,medicine ,Humans ,Stent implantation ,Ultrasonography, Interventional ,remodeling ,Aged ,Cell Proliferation ,Dose-Response Relationship, Drug ,biology ,medicine.diagnostic_test ,business.industry ,Ultrasound ,Graft Occlusion, Vascular ,Stent ,Middle Aged ,biology.organism_classification ,medicine.disease ,Antineoplastic Agents, Phytogenic ,Taxus ,chemistry ,stents ,Female ,Stents ,Radiology ,Tunica Intima ,Cardiology and Cardiovascular Medicine ,business ,Nuclear medicine ,Follow-Up Studies - Abstract
Background— The purpose of this study was to evaluate long-term vascular responses as long as 2 years after implantation of polymer-based, paclitaxel-eluting stents in contrast to uncoated stents. Methods and Results— TAXUS II is a randomized, double-blind trial comparing slow-release (SR) and moderate-release (MR) TAXUS stents with bare-metal control stents (BMSs). One hundred sixty-one event-free patients (SR, 43; MR, 41; and BMS, 77) underwent serial intravascular ultrasound (IVUS) analysis after the procedure and at 6 months and 2 years. At 2 years, neointimal responses continued to be significantly suppressed in the SR and MR groups when compared with the BMS group (BMS, 1.49±1.12 mm 2 ; SR, 0.94±0.76 mm 2 [ P =0.004]; and MR, 1.06±0.90 mm 2 [ P =0.02]). Between 6 months and 2 years, the BMS group showed compaction of the neointima (Δ, −0.22±1.05 mm 2 [ P =0.08]). In contrast, both the SR and MR groups exhibited an increase (Δ SR, 0.30±0.76 mm 2 ( P =0.01); MR, 0.41±0.94 mm 2 [ P =0.009]). Between 6 months and 2 years, the initial increase in plaque outside the stent regressed in the BMS and SR groups to levels comparable to those after the procedure, whereas expansive remodeling partially regressed in the MR group (Δ between after the procedure and 2 years BMS, −0.34±1.28 mm 2 [ P =0.05]; SR, −0.02±1.40 mm 2 [ P =0.93]; MR, 0.32±1.56 mm 2 [ P =0.27]). Conclusions— The 2-year follow-up demonstrates that neointimal suppression was dose independent and that this effect was still sustained at 2 years. However, the increase in area outside the stent seen at 6 months regressed to different extents in a dose-dependent manner at 2 years.
- Published
- 2005
21. Is thrombosis a contributor to heart failure pathophysiology? Possible mechanisms, therapeutic opportunities, and clinical investigation challenges
- Author
-
Faiez Zannad, Scott D. Berkowitz, Gonzalo Calvo, Wendy Gattis Stough, Joerg Koglin, Véronique Regnault, Freek W.A. Verheugt, Sidney Goldstein, Stefan Agewall, C. Michael Gibson, Mihai Gheorghiade, Christopher M. O'Connor, Efthymios N. Deliargyris, and Paul Burton
- Subjects
medicine.medical_specialty ,Systemic inflammation ,law.invention ,Coronary thrombosis ,Randomized controlled trial ,law ,Antithrombotic ,medicine ,Animals ,Humans ,Intensive care medicine ,Heart Failure ,Clinical Trials as Topic ,Neurotransmitter Agents ,Cardiovascular diseases [NCEBP 14] ,business.industry ,Coronary Thrombosis ,Warfarin ,Venous Thromboembolism ,medicine.disease ,Thrombosis ,Surgery ,Clinical trial ,Treatment Outcome ,Heart failure ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Contains fulltext : 119127.pdf (Publisher’s version ) (Closed access) Thrombotic events (coronary thrombosis, venous thromboembolism, intraventricular thrombosis, intracranial and systemic thromboembolism) occur frequently in patients with heart failure. These events may be precipitated by several mechanisms including hypercoagulability through enhancement of procoagulant reactions, impairment of the protein C pathway, protease activated receptor (PAR) activation, adenosine-mediated thrombosis, or neurohormonal activation; stasis secondary to low cardiac output; and endothelial dysfunction from neurohormonal activation or systemic inflammation. Pathophysiologic evidence and analyses of retrospective data support the hypothesis that antithrombotic agents may improve outcomes in patients with heart failure. Warfarin has not been shown to reduce clinical events in patients with heart failure, although several of the completed randomized trials were underpowered, and the most recent was not placebo-controlled. Many unanswered questions remain that justify continued research in this area. This paper examines the conceptual framework, opportunities, and challenges of clinical investigative approaches with the newer anti-thrombotic agents in patients with heart failure. Critical questions are raised with regard to clinical trial designs that warrant consideration as the field progresses.
- Published
- 2013
- Full Text
- View/download PDF
22. Carotid Atherosclerosis Progression in Familial Hypercholesterolemia Patients A Pooled Analysis of the ASAP, ENHANCE, RADIANCE 1, and CAPTIVATE Studies
- Author
-
Yale B. Mitchel, Anton F. H. Stalenhoef, John J.P. Kastelein, Menno Vergeer, Jonathan L. Isaacsohn, Christie M. Ballantyne, Claude Gagné, Rong Zhou, Fatima Akdim, Roeland Huijgen, Richard C. Pasternak, Raphaël Duivenvoorden, Joerg Koglin, Eric de Groot, Eric J.G. Sijbrands, A. David Marais, Michiel L. Bots, Aditi Sapre, Vascular Medicine, Other departments, Amsterdam Cardiovascular Sciences, Epidemiology, Orthopedics and Sports Medicine, and Internal Medicine
- Subjects
Carotid Artery Diseases ,Male ,Carotid atherosclerosis ,medicine.medical_specialty ,Endpoint Determination ,Atorvastatin ,Quality of nursing and allied health care [NCEBP 6] ,Familial hypercholesterolemia ,law.invention ,Hyperlipoproteinemia Type II ,chemistry.chemical_compound ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,cardiovascular diseases ,Randomized Controlled Trials as Topic ,Retrospective Studies ,Vascular disease ,business.industry ,Torcetrapib ,Middle Aged ,medicine.disease ,Markov Chains ,Surgery ,Treatment Outcome ,Pooled analysis ,Intima-media thickness ,chemistry ,Disease Progression ,Cardiology ,cardiovascular system ,lipids (amino acids, peptides, and proteins) ,Female ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,Tunica Intima ,Tunica Media ,Cardiology and Cardiovascular Medicine ,business ,Monte Carlo Method ,medicine.drug - Abstract
Background— Until recently, patients with heterozygous familial hypercholesterolemia (HeFH) were considered the best subjects for the assessment of changes in carotid intima-media thickness (cIMT) in randomized intervention trials. Our aims were to investigate whether contemporary statin-treated HeFH patients still show accelerated cIMT increase and to assess the impact of statin treatment, before and after random assignment, on atherosclerosis progression. Methods and Results— We retrospectively evaluated cIMT change, and prior statin treatment and postbaseline LDL-C change as predictors of cIMT change, in 1513 HeFH patients who were randomly assigned to the statin arms of the early ASAP and more recent RADIANCE 1, CAPTIVATE, and ENHANCE studies. In the 3 recent studies combined, mean cIMT increased at only 33%of the rate of the simvastatin-treated patients in the ASAP study (0.014 mm/2 years [95% confidence interval, −0.0003–0.028] versus 0.041 mm/2 years [95% confidence interval, 0.020–0.061]; P Conclusions— Over the years, intensification of statin therapy in HeFH patients has resulted in an impressive decrease in carotid atherosclerosis progression. In studies that assess other antiatherosclerotic modalities, statin therapy may still induce rapid changes in cIMT. For future cIMT studies, our analyses suggest that patient populations other than intensively pretreated HeFH patients should be selected and that the statin regimen should not be changed on study initiation.
- Published
- 2010
23. Two-year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restenosis: the TAXUS V ISR trial
- Author
-
Stephen G. Ellis, Dean J. Kereiakes, Steven L. Martin, Kenneth M. Kent, Mark Turco, Joerg Koglin, Thomas F. McGarry, Charles O'Shaughnessy, Mark I Friedman, Jeffrey J. Popma, and Gregg W. Stone
- Subjects
Bare-metal stent ,Male ,medicine.medical_specialty ,Paclitaxel ,medicine.medical_treatment ,Brachytherapy ,Myocardial Infarction ,Revascularization ,Coronary Restenosis ,Restenosis ,Risk Factors ,Medicine ,Humans ,Aged ,business.industry ,Percutaneous coronary intervention ,Stent ,Drug-Eluting Stents ,Middle Aged ,medicine.disease ,Thrombosis ,Tubulin Modulators ,Surgery ,Treatment Outcome ,Drug-eluting stent ,Female ,Radiology ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
Aims This study sought to investigate the 2-year outcomes of patients treated with the paclitaxel-eluting TAXUS® stent (PES) or vascular brachytherapy (VBT), the previous ‘gold standard therapy’, for bare metal stent in-stent restenosis (ISR). Methods and results In the TAXUS V-ISR trial, 396 patients with bare metal stent ISR referred for percutaneous coronary intervention were prospectively randomized to either PES or beta source VBT. The present analysis reports 24-month clinical outcomes from that study. Between 9 and 24 months, ischaemia-driven target lesion revascularization tended to be required less frequently with assignment to PES compared to VBT (5.3 vs. 10.3%, P = .07). As a result, ischaemia-driven target lesion revascularization at 24 months was significantly reduced with PES compared with VBT (10.1 vs. 21.6%, P = 0.003), as was ischaemia-driven target vessel revascularization (18.1 vs. 27.5%, P = .03). There were no significant differences between the two groups with regard to death, myocardial infarction, or target vessel thrombosis either between 12 and 24 months, or cumulative to 24 months. Conclusion Freedom from clinical restenosis at 2 years is significantly enhanced after PES placement compared with VBT for bare metal stent ISR, with similar rates of death, myocardial infarction, and target vessel thrombosis.
- Published
- 2008
24. Abstract 2357: Effect of Prolonged Thienopyridine Use on Long-term Clinical Outcomes After Drug-eluting Stents: Landmark Analysis from the TAXUS Trials
- Author
-
Stephen G. Ellis, Mark I Friedman, Joerg Koglin, Donald S. Baim, David K Kong, and Gregg W. Stone
- Subjects
Drug ,medicine.medical_specialty ,Thienopyridine ,biology ,business.industry ,media_common.quotation_subject ,biology.organism_classification ,Surgery ,Term (time) ,Taxus ,Physiology (medical) ,Landmark analysis ,Medicine ,Registry data ,Observational study ,Cardiology and Cardiovascular Medicine ,business ,Intensive care medicine ,media_common - Abstract
Background A recent non-blinded, observational landmark study from uncontrolled registry data by Eisenstein et al. suggested that thienopyridine (T) use beyond 1 year may reduce death and MI in patients who have received drug-eluting stents (DES). We performed a similar examination of slow-release paclitaxel-eluting stents (PES) in the prospective, randomized, double-blind TAXUS DES trials. Methods Using data from the TAXUS II-SR, IV and V trials, a landmark analysis was performed on the 2,523 patients who were free of death, MI and stent thrombosis (ST) through 1 year. Patients were divided according to stent type (PES vs bare metal stent [BMS]) and thienopyridine usage at a 1-year landmark point: PES T+ (N=578), PES T− (N=683), BMS T+ (N=574), and BMS T− (N=688). Subsequent events (ST, death, MI) were tabulated for the next 3 years in TAXUS II-SR and IV, and for 1 year in TAXUS V. Results Thienopyridine and aspirin usage were well matched between BMS and PES patients at all time-points. T+ patients at 12 months had no ST events through 4 years, while T− patients had 6 ST events (0.57%; p=0.045, log-rank). This difference was not significant for BMS T+/T− (0.0% versus 0.22%, p=0.49), and borderline significant for PES T+/T− (0.0% versus 0.92%, p=0.056). There was no corresponding difference in death at either 2 or 4 years, but there was a borderline reduction in MI at 2 years for PES T+/T− (0.35% versus 1.49%, p=0.08; interaction term p=0.09 between stent type and thienopyridine use), which disappeared at 4 years (2.79% versus 3.42%, p=0.565; interaction term p=0.35). Conclusions Thienopyridine use at 1 year was associated with fewer subsequent late ST events overall, which was more pronounced for PES than BMS. While there was a borderline reduction in MI at 2 years, no sustained impact on death or MI at 4 years was demonstrated. These data will be updated with one additional year of follow-up in all 2,523 patients at the time of presentation.
- Published
- 2007
- Full Text
- View/download PDF
25. Abstract 2153: Taxus Atlas Long Lesion: First Report of 9-Month Clinical and Angiographic Outcomes for the TAXUS Liberté 38 mm Stent for Long Lesions
- Author
-
Mark Webster, Tift Mann, Joerg Koglin, Mark Turco, Jack J. Hall, Lazar Mandinov, John A. Ormiston, Neil J. Weissman, Donald S. Baim, Jeffrey J. Popma, Louis Cannon, and Charles O'Shaughnessy
- Subjects
medicine.medical_specialty ,Flexibility (anatomy) ,biology ,business.industry ,medicine.medical_treatment ,Stent ,biology.organism_classification ,Lesion ,medicine.anatomical_structure ,Taxus ,Atlas (anatomy) ,Physiology (medical) ,medicine ,Radiology ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Long lesions - Abstract
Background : The TAXUS Liberté (TL) 38 mm stent, the longest drug-eluting stent, was designed with more uniform drug distribution, thinner struts and increased flexibility and conformability for use specifically in very long lesions. Long lesions have been identified as a risk factor for instent restenosis, stent thrombosis and incomplete apposition. Thus, TAXUS ATLAS Long Lesion (LL) assesses the performance of the TL 38 mm stent vs the TAXUS Express (TE) stent. Methods : TAXUS ATLAS LL is a prospective, non-randomized trial enrolling 150 pts from 24 global sites. Pts undergoing single TL stent implantation of a de novo lesion visually estimated to be 26 – 34 mm in length, with a reference vessel diameter of 2.7 – 4.0 mm, were enrolled. A subset of patients underwent IVUS at 9m. The TE Control consists of a lesion-matched cohort derived from TAXUS IV and TAXUS V. The primary endpoint is non-inferiority of 9m % diameter stenosis (%DS) of the analysis segment as determined by quanitative coronary angiography (QCA). Results : Baseline pt characteristics were well-matched between the TL and TE arms. However, the TL pts presented with longer and more complex lesions (by QCA). Procedure time was significantly shorter for TL, and the use of multiple stents was significantly less in TL vs TE. Compared to TE, TL demonstrated non-inferiority for 9m %DS, analysis segment (pre-specified non-inferiority margin = 6.89%, difference = −0.93%, upper 1-sided 95% Confidence Interval = 3.19%, p=0.0010); thus, the primary endpoint objective was met. The cardiac death or MI rate was significantly lower for TL, while other clinical and angiographic parameters were similar between the groups. There were no stent thromboses for TL. The incidence of early or late incomplete apposition was low and comparable between TL and TE. Conclusions : The TL 38 mm stent, the longest drug-eluting stent, demonstrated similar efficacy in reducing stenosis but an enhanced safety profile in very long lesions vs TE.
- Published
- 2007
- Full Text
- View/download PDF
26. Safety and efficacy of multiple, overlapping polymer-based paclitaxel-eluting stents
- Author
-
Karl Hauptman, Jeffrey J. Popma, Neil J. Weissman, William Wijns, Mary E. Russell, Adrian P. Banning, Krzysztof Zmudka, Joerg Koglin, Jean Marco, Leif Thuesen, Antonio Colombo, Keith D. Dawkins, Eberhard Grube, and Giulio Guagliumi
- Subjects
medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,medicine.medical_treatment ,Stent ,medicine.disease ,Surgery ,Coronary artery disease ,Overlap zone ,Restenosis ,Intravascular ultrasound ,medicine ,Radiology ,Myocardial infarction ,cardiovascular diseases ,Cardiology and Cardiovascular Medicine ,business ,Complication ,Mace - Abstract
Aims: To provide insight on the patients with long lesions that received multiple, overlapping stents by reporting clinical outcomes, together with a detailed angiographic and intravascular ultrasound analysis of the overlap zone. Methods and results: TAXUS VI is a prospective, multicentre, double-blind, trial, specifically designed to assess outcomes of paclitaxel-eluting stents in longer lesions by randomising 446 patients (1:1) between a drug-eluting TAXUS™ Express 2 Moderate Release (MR) and an uncoated Express 2 control stent. Multiple overlapping stents were implanted in 124 patients (27.8%) and are the subject of this report. Clinical, angiographic and IVUS outcomes at nine months were compared in the overlap group for patients receiving the TAXUS™ Express 2 MR stent and the uncoated Express 2 stent. In the overlap group, mean lesion length was 25.1 mm with a mean stent length of 43.6 mm. At nine months, TVR was reduced by 94% from 25.0% to 1.6% in the TAXUS patients compared with control (p=
- Published
- 2007
27. Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after paclitaxel-eluting and bare metal stent implantation
- Author
-
Mark I Friedman, Stephen G. Ellis, Eberhard Grube, Antonio Colombo, Gregg W. Stone, Joerg Koglin, Donald E. Cutlip, Donald S. Baim, and Keith D. Dawkins
- Subjects
Bare-metal stent ,Male ,medicine.medical_specialty ,Time Factors ,Heart disease ,medicine.medical_treatment ,Cardiovascular Abnormalities ,Myocardial Infarction ,Coronary Disease ,Coronary Restenosis ,Restenosis ,Physiology (medical) ,Angioplasty ,Internal medicine ,Medicine ,Humans ,Myocardial infarction ,Angioplasty, Balloon, Coronary ,Aged ,business.industry ,Vascular disease ,Stent ,Thrombosis ,Middle Aged ,medicine.disease ,Surgery ,Cardiology ,Female ,Stents ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
Background— Drug-eluting stents compared with bare metal stents (BMS) may increase late stent thrombosis (ST), although an accompanying increase in the rates of death and myocardial infarction (MI) has not been observed. We hypothesized that the prevention of restenosis-related adverse events by drug-eluting stents might offset some or all of the excess risk from ST. Methods and Results— We analyzed a pooled patient-level database from 4 prospective, double-blind trials in which 3445 patients were randomized to paclitaxel-eluting stents or BMS. The occurrence of death or MI within 7 days of ST or target lesion revascularization was assessed. With a median follow-up of 3.2 years, ST occurred in 34 patients (1.0%), 31 (91.1%) of whom sustained death or MI within 7 days. Target lesion revascularization was performed in 425 patients (12.3%), 15 (3.5%) of whom died or had MI within 7 days. ST occurred in 14 BMS and 20 paclitaxel-eluting stent patients, resulting in 12 and 19 deaths or MIs within 7 days, respectively. Target lesion revascularization was performed in 290 BMS and 135 paclitaxel-eluting stent patients, resulting in 11 and 4 deaths or MI events within 7 days, respectively. In total, 23 patients in both the BMS and paclitaxel-eluting stents groups died or had an MI event within 7 days of either ST or target lesion revascularization. Conclusions— ST, although infrequent, results in a high incident rate of death and MI, whereas the more frequent occurrence of target lesion revascularization is associated with a finite but lower rate of death and MI. The marked reduction in restenosis with drug-eluting stents compared with BMS may counterbalance the potential excess risk from late ST with drug-eluting stents.
- Published
- 2007
28. Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial
- Author
-
Mark A, Turco, John A, Ormiston, Jeffrey J, Popma, Lazar, Mandinov, Charles D, O'Shaughnessy, Tift, Mann, Thomas F, McGarry, Chiung-Jen, Wu, Charles, Chan, Mark W I, Webster, Jack J, Hall, Gregory J, Mishkel, Louis A, Cannon, Donald S, Baim, and Joerg, Koglin
- Subjects
Male ,Paclitaxel ,Endpoint Determination ,Polymers ,Coronary Stenosis ,Neovascularization, Physiologic ,Equipment Design ,Middle Aged ,Tubulin Modulators ,Humans ,Female ,Stents ,Prospective Studies ,Aged - Abstract
The goal of this research was to assess non-inferiority of the next-generation TAXUS Liberté stent (Boston Scientific Corp., Natick, Massachusetts) versus the TAXUS Express stent (Boston Scientific Corp.).The introduction of drug-eluting stents (DES) has shifted clinical practice towards more complex lesion subsets, prompting the need for more deliverable DES. TAXUS Liberté was designed to combine the established polymer-based, paclitaxel-elution TAXUS technology with the more advanced Liberté stent platform.The TAXUS ATLAS study is a global, prospective, single-arm trial evaluating outcomes in 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 an entry-criteria-matched population of TAXUS Express patients from the TAXUS IV and V trials. The primary end point is non-inferiority of TAXUS Liberté versus TAXUS Express for 9-month target vessel revascularization.Despite similar inclusion criteria, quantitative coronary angiography-determined baseline lesion characteristics were significantly more complex for TAXUS Liberté than TAXUS Express. The primary non-inferiority end point was met with the 1-sided 95% confidence bound of 2.98% less than the pre-specified non-inferiority margin of 3% (p = 0.0487).Despite the treatment of more complex lesions with TAXUS Liberté, the primary end point was met, demonstrating that TAXUS Liberté is non-inferior to TAXUS Express. The successful transfer of the proven TAXUS technology to the more advanced TAXUS Liberté platform was demonstrated. (TAXUS ATLAS: TAXUS Liberté-SR Stent for the Treatment of De Novo Coronary Artery Lesions; http://www.clinicaltrials.gov/ct/show/NCT00371709?order=1; NCT00371709).
- Published
- 2006
29. An overview of the TAXUS Express, paclitaxel-eluting stent clinical trial program
- Author
-
Gregg W. Stone, John M. Lasala, Keith D. Dawkins, Patrick W. Serruys, Joerg Koglin, Antonio Colombo, Eberhard Grube, Stephen Ellis, and Cardiology
- Subjects
medicine.medical_specialty ,Paclitaxel ,medicine.medical_treatment ,Coronary Artery Disease ,law.invention ,Coronary artery disease ,Coronary Restenosis ,Blood Vessel Prosthesis Implantation ,Restenosis ,Randomized controlled trial ,Coated Materials, Biocompatible ,law ,Internal medicine ,Angioplasty ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Angioplasty, Balloon, Coronary ,Ultrasonography, Interventional ,Randomized Controlled Trials as Topic ,business.industry ,Stent ,Percutaneous coronary intervention ,Cardiovascular Agents ,medicine.disease ,Surgery ,Clinical trial ,Research Design ,Meta-analysis ,Stents ,Cardiology and Cardiovascular Medicine ,business - Abstract
Restenosis remains a problem following percutaneous coronary intervention in patients with coronary artery disease. Drug-eluting stents (DES), which combine mechanical and pharmacologic properties, have been shown to prevent or reduce neointimal growth after deployment. This review describes the TAXUS paclitaxel-eluting stent clinical trial expansion program (TAXUS® Express®, Boston Scientific, Natick, MA). This program comprises the largest data set of randomized controlled trials (RCTs) of DES to date, with over 6,200 patients enrolled since 2000. The program includes treatment of de novo lesions, as well as higher-risk lesion and patient populations. In this review, we discuss the results from the TAXUS family of randomized clinical trials, and compare the findings with data from TAXUS registries. The data from the randomized clinical trials suggest that the paclitaxel-eluting stent provides consistent and durable benefits across multiple lesion and patient types. Evidence from peri-and postapproval registries, where patient populations are more heterogeneous than those eligible and included in the RCTs, corroborate these findings, with overall low rates of cardiac events, including reinterventions.
- Published
- 2006
30. 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
- Author
-
Stephen G, Ellis, Antonio, Colombo, Eberhard, Grube, Jeffrey, Popma, Joerg, Koglin, Keith D, Dawkins, and Gregg W, Stone
- Subjects
Aged, 80 and over ,Male ,Cardiac Catheterization ,Time Factors ,Adolescent ,Paclitaxel ,Drug Administration Routes ,Coronary Stenosis ,Thrombosis ,Middle Aged ,Coronary Angiography ,Prosthesis Design ,Risk Assessment ,Survival Analysis ,Blood Vessel Prosthesis ,Prosthesis Failure ,Confidence Intervals ,Humans ,Stents ,Angioplasty, Balloon, Coronary ,Taxus ,Aged ,Follow-Up Studies ,Probability ,Randomized Controlled Trials as Topic - Abstract
This study sought to study stent thrombosis with the paclitaxel-eluting Taxus stent.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.This study used a patient-based meta-analysis using the 4 principal TAXUS randomized trials (3,445 patients) with a follow-up duration ofor =1 year.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.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.
- Published
- 2006
31. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial
- Author
-
Gregg W. Stone, Stephen G. Ellis, Louis Cannon, J. Tift Mann, Joel D. Greenberg, Douglas Spriggs, Charles D. O'Shaughnessy, Samuel DeMaio, Patrick Hall, Jeffrey J. Popma, Joerg Koglin, Mary E. Russell, and for the TAXUS V Investigators
- Subjects
Bare-metal stent ,Male ,medicine.medical_specialty ,Paclitaxel ,Polymers ,medicine.medical_treatment ,Coronary Artery Disease ,Revascularization ,Lesion ,Coronary artery disease ,Coronary Restenosis ,Drug Delivery Systems ,Restenosis ,Double-Blind Method ,Medicine ,Humans ,cardiovascular diseases ,Angioplasty, Balloon, Coronary ,Aged ,business.industry ,Stent ,General Medicine ,Middle Aged ,equipment and supplies ,medicine.disease ,Surgery ,Radiography ,Stenosis ,Drug-eluting stent ,Female ,Stents ,medicine.symptom ,business ,Immunosuppressive Agents - Abstract
ContextCompared with bare metal stents, drug-eluting stents reduce restenosis in noncomplex lesions. The utility of drug-eluting stents has not been evaluated in more difficult stenoses.ObjectiveTo investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in a patient population with more complex lesions than previously studied.Design, Setting, and PatientsProspective, placebo-controlled, double-blind, multicenter randomized trial conducted from February 2003 to March 2004 at 66 academic and community-based institutions with 1156 patients who underwent stent implantation in a single coronary artery stenosis (vessel diameter, 2.25-4.0 mm; lesion length, 10-46 mm), including 664 patients (57.4%) with complex or previously unstudied lesions (requiring 2.25-mm, 4.0-mm, and/or multiple stents) and 9-month clinical and angiographic follow-up.InterventionsPatients were randomly assigned to receive 1 or more bare metal stents (n = 579) or identical-appearing paclitaxel-eluting stents (n = 577).Main Outcome MeasureIschemia-driven target vessel revascularization at 9 months.ResultsBaseline characteristics were well matched. Diabetes was present in 31% of patients. The mean (SD) reference vessel diameter was 2.69 (0.57) mm, the reference lesion length was 17.2 (9.2) mm, and 78% of lesions were type B2/C. A mean (SD) of 1.38 (0.58) stents (total mean [SD] length, 28.4 [13.1] mm) were implanted per lesion; 33% of lesions required multiple stents. Stents that were 2.25 mm and 4.0 mm in diameter were used in 18% and 17% of lesions, respectively. Compared with bare metal stents, paclitaxel-eluting stents reduced the 9-month rate of target lesion revascularization from 15.7% to 8.6% (P
- Published
- 2005
32. Enhanced T-helper-1 lymphocyte activation patterns in acute coronary syndromes
- Author
-
Joerg Koglin, Elazer R. Edelman, Heiko Methe, Daniela Wiegand, Michael Nabauer, and Stefan Brunner
- Subjects
Male ,medicine.medical_specialty ,Myocardial Infarction ,030204 cardiovascular system & hematology ,stat ,Angina Pectoris ,Coronary artery disease ,03 medical and health sciences ,Interferon-gamma ,0302 clinical medicine ,Text mining ,Internal medicine ,Medicine ,Humans ,RNA, Messenger ,030304 developmental biology ,Aged ,Aged, 80 and over ,0303 health sciences ,business.industry ,Interleukins ,Glyceraldehyde-3-Phosphate Dehydrogenases ,Syndrome ,T-Lymphocytes, Helper-Inducer ,Middle Aged ,STAT4 Transcription Factor ,medicine.disease ,Coronary heart disease ,DNA-Binding Proteins ,T helper 1 ,Case-Control Studies ,Circulatory system ,Lymphocyte activation ,Cardiology ,Trans-Activators ,Female ,business ,Cardiology and Cardiovascular Medicine ,STAT6 Transcription Factor - Abstract
We sought to determine whether different stages of coronary artery disease (CAD) are associated with distinct differentiation patterns of activated T cells.Atherosclerosis is an inflammatory disease. However, little is known about specific inflammatory cell activation in atherosclerosis, for example, the T-helper (Th)1/Th2-balance.We studied 18 patients with stable angina (SA), 28 patients with acute coronary syndrome (ACS) (16 with unstable angina pectoris and 12 with ST-segment elevation myocardial infarction), 19 patients with unheralded myocardial infarction (UH), and 16 control patients. Cytokine patterns and transcription factor signaling pathways of circulating T cells were characterized using reverse transcription polymerase chain reaction and flow cytometry.Although interferon (IFN)-gamma(+)/CD3(+) T cells were approximately 2-fold greater in patients with SA or UH than in control subjects, there was a massive expansion of Th1 cells in patients with ACS (p0.001). This increase was paralleled by significantly increased mRNA transcript levels for signal-transducer-and-activator-4 (ACS 1.17 +/- 0.14 relative units [RU]; control patients 0.44 +/- 0.09 RU; SA 0.67 +/- 0.12 RU; UH 0.61 +/- 0.17 RU), interleukin-2 (ACS 1.55 +/- 0.51 RU; control patients 0.21 +/- 0.09 RU; SA 0.54 +/- 0.18 RU; UH 0.45 +/- 0.16 RU), and IFN-gamma in ACS (1.27 +/- 0.39 RU; control patients 0.35 +/- 0.09 RU; SA 0.58 +/- 0.11 RU; UH 0.53 +/- 0.24 RU; p0.002). Th2 and Th0 cells were not different across patient subsets. The burden of CAD was identical between SA (1.4 +/- 0.2 diseased vessels, 68 +/- 13% diameter stenosis) and ACS (1.4 +/- 0.2 diseased vessels, 64 +/- 17% diameter stenosis) but significantly greater in patients with UH (2.5 +/- 0.5 diseased vessels, 95 +/- 7% diameter stenosis; p0.05).Patients with UH have a greater burden of obstructive CAD than SA but no greater T-cell activation. Patients with ACS have the same extent of CAD than SA but significantly greater activation of Th1 cells that may contribute to the increasing instability. Differences in circulating Th1 cells might indicate different pathogenic components, leading to ACS and UH.
- Published
- 2004
33. 1059-5 TAXUS IV diabetic subset analysis: Improvements in nine-month outcomes in diabetics on oral medication as well as insulin
- Author
-
James B. Hermiller, Jeffrey J. Popma, Stephen G. Ellis, Henry Lui, Michael Mooney, Mark Midei, Louis Cannon, Mary E. Russell, Gregg W. Stone, and Joerg Koglin
- Subjects
Subset Analysis ,medicine.medical_specialty ,biology ,business.industry ,Insulin ,medicine.medical_treatment ,biology.organism_classification ,Surgery ,Taxus ,Oral administration ,Internal medicine ,medicine ,Cardiology and Cardiovascular Medicine ,business - Published
- 2004
- Full Text
- View/download PDF
34. 1059-7 Impact of late loss on clinical, angiographic and intravascular ultrasound outcomes in the TAXUS IV trial
- Author
-
Stephen G. Ellis, Joel Greenberg, Mark Turco, Neil J. Weissman, Ronald P. Caputo, Joerg Koglin, Jeffrey J. Popma, Albert E. Raizner, Mary E. Russell, Patrick Bergin, and Gregg W. Stone
- Subjects
medicine.medical_specialty ,medicine.diagnostic_test ,Taxus ,biology ,business.industry ,Intravascular ultrasound ,medicine ,Late loss ,Radiology ,equipment and supplies ,Cardiology and Cardiovascular Medicine ,biology.organism_classification ,business - Published
- 2004
- Full Text
- View/download PDF
35. IL-10 and IFN-γ Mediate Cardiac Allograft Vascular Changes: Insights from IL-10 Knockout Mice
- Author
-
Troels Glysing-Jensen, Anne Räisänen-Sokolowski, Joerg Koglin, and Mary E. Russell
- Subjects
Transplantation ,Interleukin 10 ,Cardiac allograft ,Knockout mouse ,Immunology - Published
- 1998
- Full Text
- View/download PDF
36. Dichotomous roles for inducible nitric oxide synthase during cardiac allograft rejection
- Author
-
J. S. Mudgett, Mary E. Russell, T. Glysing-Jensen, and Joerg Koglin
- Subjects
Nitric oxide synthase ,biology ,Cardiac allograft ,business.industry ,biology.protein ,Medicine ,Pharmacology ,Cardiology and Cardiovascular Medicine ,business - Published
- 1998
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.