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1. Impact of COVID-19 pandemic on acute heart failure admissions and mortality: a multicentre study (COV-HF-SIRIO 6 study)

Author: Tomasz Kulawik, Leszek Kamiński, Janusz Prokopczuk, Klaudyna Grzelakowska, Marcin Gruchała, Michał Kasprzak, Jacek Kubica, Przemysław Podhajski, Anna Tomaszuk-Kazberuk, Aldona Kubica, Oliwia Brycht, Marcin Mindykowski, Piotr Jankowski, Paweł Grzelakowski, Andrzej Kleinrok, Eliano Pio Navarese, Agnieszka Tycińska, Marek Koziński, Maciej Lesiak, Stanisław Bartuś, Andrzej Wester, Małgorzata Ostrowska, Sergiusz Sowiński, Jarosław Kaźmierczak, Piotr Adamski, Miłosz Jaguszewski, Mariusz Gąsior, Jacek Kryś, Agnieszka Pawlak, Sebastian Stankala, Gleb Minczew, Jadwiga Nessler, Grzegorz Skonieczny, Bożena Sobkowicz, Paweł Król, Marcin Kostkiewicz, Paweł Szymański, Edyta Anielska-Michalak, Jacek Legutko, Andrzej Curzytek, Przemysław Leszek, Andrzej Budaj, Wioleta Stolarek, Aneta Dudek, Przemysław Wilczewski, Jarosław Drożdż, Leszek Gromadziński, Tomasz Zdrojewski, and Przemysław Mitkowski
Subjects: medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Heart failure, Medical care, Levodopa, COVID‐19, Internal medicine, Pandemic, medicine, Humans, Diseases of the circulatory (Cardiovascular) system, In patient, Pandemics, Retrospective Studies, SARS-CoV-2, business.industry, Mortality rate, Carbidopa, COVID-19, Original Articles, medicine.disease, In‐hospital mortality, Hospitalization, Drug Combinations, In-hospital mortality, RC666-701, Concomitant, Acute Disease, Original Article, Cardiology and Cardiovascular Medicine, business, Hospital stay
Abstract: Aims The coronavirus disease‐2019 (COVID‐19) pandemic has changed the landscape of medical care delivery worldwide. We aimed to assess the influence of COVID‐19 pandemic on hospital admissions and in‐hospital mortality rate in patients with acute heart failure (AHF) in a retrospective, multicentre study. Methods and results From 1 January 2019 to 31 December 2020, a total of 101 433 patients were hospitalized in 24 Cardiology Departments in Poland. The number of patients admitted due to AHF decreased by 23.4% from 9853 in 2019 to 7546 in 2020 (P
Published: 2022
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2. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug‐Eluting Stent Implantation: Per‐Protocol Analysis of the GLOBAL LEADERS Trial

Author: Felice Gragnano, Marcel Zwahlen, Pascal Vranckx, Dik Heg, Kurt Schmidlin, Christian Hamm, Philippe Gabriel Steg, Giuseppe Gargiulo, Eugene P. McFadden, Yoshinobu Onuma, Ply Chichareon, Edouard Benit, Helge Möllmann, Luc Janssens, Sergio Leonardi, Aleksander Zurakowski, Alessio Arrivi, Robert Jan Van Geuns, Kurt Huber, Ton Slagboom, Paolo Calabrò, Patrick W. Serruys, Peter Jüni, Marco Valgimigli, Stephan Windecker, Mohamed Abdellaoui, David Adlam, Ibrahim Akin, Agustin Albarran Gonzalez‐Trevilla, Manuel Almeida, Pedro Alves Lemos Neto, Adel Aminian, Richard Anderson, Rick Andreae, Michael Angioi, Taku Asano, Emanuele Barbato, Peter Barlis, Pascal Barraud, Olivier Bertrand, Farzin Beygui, Leonardo Bolognese, Roberto Botelho, Coby Bouwman, Marco Bressers, Philippe Brunel, Pawel Buszman, Ian Buysschaert, Pedro Canas da Silva, Didier Carrie, Angel Cequier, Chun Chin Chang, Saqib Chowdhary, Carlos Collet, Antonio Colombo, James Cotton, Rui Cruz Ferreira, Salvatore Curello, Nick Curzen, Judith de Bot, Tone de Vreede, Georg Delle Karth, Lynn Dijksma, Marcello Dominici, István Édes, Eric Eeckhout, Ingo Eitel, József Faluközy, Farzin Fath‐Ordoubadi, Maurizio Ferrario, Geza Fontos, Jose Francisco Diaz, Edgard Freitas Quintella, Bernhard Frey, Guy Friedrich, Gavin Galasko, Grzegorz Galuszka, Vasco Gama Ribeiro, Scot Garg, Tobias Geisler, Valeri Gelev, Art Ghandilyan, Javier Goicolea, Tommaso Gori, Ana Guimarães, Michael Haude, Pieter Heijke, Rosa Ana Hernández Antolin, David Hildick‐Smith, Dorien Hillen, Ina Hoekman, Sjoerd Hofma, Lene Holmvang, Stephen Hoole, Iván Horváth, Annemarie Hugense, Karim Ibrahim, Andres Iñiguez, Karl Isaaz, Zoltán Jambrik, Pawel Jasionowicz, Judith Jonk, Werner Jung, Yuki Katagiri, Norihiro Kogame, Tian Hai Koh, René Koning, Mariana Konteva, Zsolt Kőszegi, Florian Krackhardt, Yvonne Kreuger, Neville Kukreja, Boudijn Ladan, Pierre Lantelme, Sergio Leandro, Gregor Leibundgut, Christoph Liebetrau, Wietze Lindeboom, Carlos Macaya Miguel, François Mach, Michael Magro, Luc Maillard, Negar Manavifar, Laura Mauri, Eugene McFadden, Bela Merkely, Yosuke Miyazaki, Adam Młodziankowski, Tiziano Moccetti, Rodrigo Modolo, Helge Möllman, Jean‐François Morelle, Aris Moschovitis, Michael Munndt Ottesen, Martin Muurling, Christoph Kurt Naber, Franz‐Josef Neumann, Keith Oldroyd, Paul Ong, Sanne Palsrok, Ivo Petrov, Sylvain Plante, Janusz Prokopczuk, Tessa Rademaker‐Havinga, Christopher Raffel, Benno Rensing, Marco Roffi, Kees‐Jan Royaards, Manel Sabate, Volker Schächinger, Tim Seidler, Antonio Serra Peñaranda, Patrick Serruys, Lali Sikarulidze, Osama I Soliman, Amanda Sousa, Ernest Spitzer, Rod Stables, Gabriel Steg, Clemens Steinwender, Eduardas Subkovas, Harry Suryapranata, Kuniaki Takahashi, Suneel Talwar, Emmanuel Teiger, Addy Ter Weele, Eva Teurlings, Attila Thury, Jan Tijssen, Gincho Tonev, Diana Trendafilova‐Lazarova, Carlo Tumscitz, Victor Umans, Imre Ungi, Veselin Valkov, Pim van der Harst, Robert Jan van Geuns, Cokky van Meijeren, Dobrin Vassilev, Vasil Velchev, Esther Velthuizen, Freek Verheugt, Natalia Vlcek, Jürgen Vom Dahl, Mathias Vrolix, Simon Walsh, Nikos Werner, Maarten Witsenburg, Azfar Zaman, Krzysztof Żmudka, Bernhard Zrenner, Robert Zweiker, Arrivi, Alessio/0000-0003-0001-2522, Asano, Taku/0000-0001-5733-3381, STEG, Philippe Gabriel/0000-0001-6896-2941, Gragnano, Felice/0000-0002-6943-278X, Gragnano, Felice, Zwahlen, Marcel, Vranckx, Pascal, Heg, Dik, Schmidlin, Kurt, Hamm, Christian, Steg, Philippe Gabriel, Gargiulo, Giuseppe, Mcfadden, Eugene P, Onuma, Yoshinobu, Chichareon, Ply, Benit, Edouard, Möllmann, Helge, Janssens, Luc, Leonardi, Sergio, Zurakowski, Aleksander, Arrivi, Alessio, Van Geuns, Robert Jan, Huber, Kurt, Slagboom, Ton, Calabrò, Paolo, Serruys, Patrick W, Jüni, Peter, Valgimigli, Marco, and Windecker, Stephan
Subjects: Aspirin, Platelet Aggregation Inhibitor, intention‐to‐treat, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Drug-Eluting Stents, 610 Medicine & health, DAPT, intention-to-treat, P2Y(12), inhibitor monotherapy, per-protocol, ticagrelor, Treatment Outcome, Percutaneous Coronary Intervention, P2Y12 inhibitor monotherapy, 360 Social problems & social services, Drug-Eluting Stent, Humans, Drug Therapy, Combination, Cardiology and Cardiovascular Medicine, Platelet Aggregation Inhibitors, per‐protocol, Human
Abstract: Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention‐to‐treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention‐to‐treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per‐protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time‐varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all‐cause mortality or nonfatal Q‐wave myocardial infarction at 2 years. At 2‐year follow‐up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per‐protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75–1.03; P =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79–1.26; P =0.99). The per‐protocol and intention‐to‐treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1‐year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435.
Published: 2022
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3. Comparison of Investigator-Reported and Clinical Event Committee-Adjudicated Outcome Events in GLASSY

Author: Mattia Branca, Scot Garg, Christoph Liebetrau, Paweł Buszman, Marcello Dominici, Ivo Petrov, Carlo Tumscitz, Adel Aminian, Pascal Vranckx, Eùgene P. McFadden, Raffaele Piccolo, Cristoph Naber, Mathias Vrolix, Luc Janssens, Roberto Diletti, Stephan Windecker, Krzysztof Bryniarski, Patrick W. Serruys, Janusz Prokopczuk, Maurizio Ferrario, Ton Slagboom, Anna Franzone, Aleksander Zurakowski, Marco Valgimigli, Edouard Benit, Christian W. Hamm, Leonardo Bolognese, Peter Jüni, Kurt Huber, Dik Heg, Sergio Leonardi, Philippe Gabriel Steg, and Cardiology
Subjects: medicine.medical_specialty, clinical trials, business.industry, Clinical events, Editorials, Hemorrhage, Original Articles, Outcome assessment, Outcome (probability), Stroke, Treatment Outcome, Editorial, myocardial infarction, Emergency medicine, cardiovascular system, Medicine, Humans, Cardiology and Cardiovascular Medicine, business, 610 Medicine & health, pragmatic clinical trial, Adjudication, Event (probability theory)
Abstract: Background: Event adjudication by a clinical event committee (CEC) provides a standardized, independent outcome assessment. However, the added value of CEC to investigators reporting remains debated. GLASSY (GLOBAL LEADERS Adjudication Sub-Study) implemented, in a subset of the open-label, investigator-reported (IR) GLOBAL LEADERS trial, an independent adjudication process of reported and unreported potential outcome events (triggers). We describe metrics of GLASSY feasibility and efficiency, diagnostic accuracy of IR events, and their concordance with corresponding CEC-adjudicated events. Methods: We report the proportion of myocardial infarction, bleeding, stroke, and stent thrombosis triggers with sufficient evidence for assessment (feasibility) that were adjudicated as outcome events (efficiency), stratified by source (IR or non-IR). Using CEC-adjudicated events as criterion standard, we describe sensitivity, specificity, positive and negative predictive value, and global diagnostic accuracy of IR events. Using Gwet AC coefficient, we examine the concordance between IR- and corresponding CEC-adjudicated triggers. There was sufficient evidence for assessment for 2592 (98.3%) of 2636 triggers. Results: Overall, the adjudicated end point-to-trigger ratio was high and similar between IR- (88%) and non-IR–reported (87%) triggers. The global diagnostic accuracy and concordance between IR-reported and CEC-adjudicated outcome events was 0.70 (95% CI, 0.65–0.74) and 0.54 (95% CI, 0.45–0.62), respectively, for myocardial infarction; 0.77 (95% CI, 0.75–0.79) and 0.71 (95% CI, 0.68–0.74) for bleeding; 0.70 (95% CI, 0.62–0.79) and 0.59 (95% CI, 0.43–0.74) for stroke; 0.59 (95% CI, 0.52–0.66) and 0.39 (95% CI, 0.25–0.53) for stent thrombosis. For IR bleedings, the concordance with the CEC on type of events was generally weak. Conclusions: Implementing CEC adjudication in a pragmatic open-label trial with IR events is feasible and efficient. Our findings of modest global diagnostic accuracy for IR events and generally weak concordance between investigators and CEC support the role for CEC adjudication in such settings. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03231059.
Published: 2021

4. Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial

Author: Kuniaki Takahashi, Clemens Steinwender, Mariusz Tomaniak, Usman Baber, Paweł Buszman, Marcello Dominici, Philippe Gabriel Steg, Janusz Prokopczuk, Stephan Windecker, Patrick W. Serruys, Yoshinobu Onuma, Peter Jüni, Richard Anderson, Marco Valgimigli, Rodrigo Modolo, Ply Chichareon, Chun Chin Chang, Tessa Rademaker-Havinga, Pascal Vranckx, Ernest Spitzer, Norihiro Kogame, Manel Sabaté, Krzysztof Zmudka, Christian W. Hamm, Tobias Geisler, Veselin Valkov, Robert-Jan van Geuns, Jan G.P. Tijssen, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ACS - Heart failure & arrhythmias, Cardiology, University of Zurich, and Serruys, Patrick W
Subjects: Stable angina, medicine.medical_specialty, Ticagrelor, 610 Medicine & health, Subgroup analysis, 030204 cardiovascular system & hematology, 11171 Cardiocentro Ticino, 2705 Cardiology and Cardiovascular Medicine, law.invention, Time, 03 medical and health sciences, 0302 clinical medicine, Percutaneous Coronary Intervention, Randomized controlled trial, law, Internal medicine, medicine, Clinical endpoint, Adjunctive pharmacotherapy, Humans, 030212 general & internal medicine, Myocardial infarction, Aged, Aged, 80 and over, Aspirin, ACS/NSTE-ACS, business.industry, 75%29%22">Elderly (>75), Bleeding, Hazard ratio, medicine.disease, Treatment Outcome, Conventional PCI, Purinergic P2Y Receptor Antagonists, Drug Therapy, Combination, Cardiology and Cardiovascular Medicine, business, Platelet Aggregation Inhibitors, medicine.drug
Abstract: AIMS: Antiplatelet treatment in the elderly post percutaneous coronary interventions (PCI) remains a complex issue. Here we report the results of the pre-specified subgroup analysis of the GLOBAL LEADERS trial evaluating the long-term safety and cardiovascular efficacy of ticagrelor monotherapy among patients categorised according to the pre-specified cut-off value of 75 years of age. METHODS AND RESULTS: This was a pre-specified analysis of the randomised GLOBAL LEADERS trial (n=15,991), comparing 23-month ticagrelor monotherapy (after one month of DAPT) with the reference treatment (12-month DAPT followed by 12 months of aspirin). Among elderly patients (>75 years; n=2,565), the primary endpoint (two-year all-cause mortality or new Q-wave core lab-adjudicated myocardial infarction [MI]) occurred in 7.2% and 9.4% of patients in the ticagrelor monotherapy and the reference group, respectively (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.58-0.99, p=0.041; pint=0.23); BARC-defined bleeding type 3/5 occurred in 5.2% and 4.1%, respectively (HR 1.29, 95% CI: 0.89-1.86; p=0.180; pint=0.06). The elderly with stable CAD had a higher rate of BARC 3/5 type bleeding (HR 2.05, 95% CI: 1.18-3.55) with ticagrelor monotherapy versus the reference treatment (pint=0.02). Elderly patients had a lower rate of definite or probable stent thrombosis (ST) with ticagrelor monotherapy (0.4% vs 1.4%, p=0.015, pint=0.01), compared with the reference group. CONCLUSIONS: In this pre-specified, exploratory analysis of the overall neutral trial, there was no differential treatment effect of ticagrelor monotherapy (after one-month dual therapy with aspirin) found in elderly patients undergoing PCI with respect to the rate of the primary endpoint of all-cause death or new Q-wave MI. The lower rate of ST in the elderly with ticagrelor monotherapy is hypothesis-generating. ClinicalTrials.gov identifier: NCT01813435.
Published: 2019

5. Predictive ability of ACEF and ACEF II score in patients undergoing percutaneous coronary intervention in the GLOBAL LEADERS study

Author: Ernest Spitzer, Kuniaki Takahashi, P G Steg, Ply Chichareon, Jan J. Piek, Paweł Buszman, Béla Merkely, Yuki Katagiri, Rodrigo Modolo, Mariusz Tomaniak, Patrick W. Serruys, Stephan Windecker, Norihiro Kogame, Joanna J. Wykrzykowska, Chun-Chin Chang, Ian Buysschaert, Keith G. Oldroyd, Pascal Vranckx, Marco Valgimigli, Yoshinobu Onuma, Janusz Prokopczuk, Scot Garg, Farzin Fath-Ordoubadi, Christian W. Hamm, Taku Asano, Peter Jüni, David van Klaveren, Richard D. Anderson, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Graduate School, ACS - Heart failure & arrhythmias, and Cardiology
Subjects: Male, medicine.medical_specialty, Acute coronary syndrome, medicine.medical_treatment, Heart Ventricles, Population, Coronary Artery Disease, 030204 cardiovascular system & hematology, Coronary Angiography, Risk Assessment, Percutaneous coronary intervention, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, Cause of Death, Risk of mortality, Medicine, Humans, In patient, 030212 general & internal medicine, Postoperative Period, Prospective Studies, Registries, Mortality, education, 610 Medicine & health, GLOBAL LEADERS, education.field_of_study, business.industry, Mortality rate, Incidence, Age Factors, Stroke Volume, Middle Aged, medicine.disease, Prognosis, Europe, Survival Rate, Conventional PCI, Female, Cardiology and Cardiovascular Medicine, business, ACEF, ACEF II
Abstract: Background ACEF score has been shown to have predictive ability in the patients undergoing percutaneous coronary intervention (PCI). The ACEF II score has recently been developed to predict short-term mortality after cardiac surgery. We compared the predictive ability of the ACEF and ACEF II scores to predict mortality after PCI in the all-comers population. Methods The ACEF and ACEF II scores were calculated in 15,968 patients enrolled in the GLOBAL LEADERS study. Discrimination and calibration were assessed for outcomes after PCI. Recalibration of the regression model by updating the intercept and slope were performed to adjust the original ACEF model to the PCI setting. In a stratified approach, patients were divided into quintiles according to the score. Outcomes were compared between quintiles. Results The ACEF and ACEF II score were available in 14,941 and 14,355 patients respectively. Discrimination for 30-day all-cause mortality was acceptable for both scores (C-statistic ACEF 0.75 and ACEF II 0.77). For 2-year all-cause mortality, the discrimination of ACEF score was acceptable (C-statistic 0.72) while the discrimination of ACEF II score was moderate (C-statistic 0.69). Both scores identified patients at high risk of mortality but overestimated all-cause mortality at 30 days in all quintiles. After recalibration, agreement between predicted and observed 30-day all-cause mortality in both scores are close to the identity line. Conclusions The ACEF II model did not improve the predictive ability of the ACEF score. Recalibrated ACEF model can be used to estimated all-cause mortality rate at 30 days after PCI.
Published: 2019
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6. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial

Author: Deepak L Bhatt, Philippe Gabriel Steg, Shamir R Mehta, Lawrence A Leiter, Tabassome Simon, Kim Fox, Claes Held, Marielle Andersson, Anders Himmelmann, Wilhelm Ridderstråle, Jersey Chen, Yang Song, Rafael Diaz, Shinya Goto, Stefan K James, Kausik K Ray, Alexander N Parkhomenko, Mikhail N Kosiborod, Darren K McGuire, Robert A Harrington, Vladimir Santos, Ashit Jain, Irina Lendel, Michael Russo, W H Haught, Manuel Bouza, Harinder Gogia, Supratim Banerjee, George Kichura, Louis Kantaros, Francisco Padron, Rakesh Passi, Jay Stone, Michael Pursley, Michael D'Urso, Timothy Gardner, James Bennett, Khaled Nour, Satinder Saini, Wenwu Zhang, Dharam Kumbhani, Dustin Thomas, Dominick Angiolillo, Barry Bertolet, Amaury Roman-Miranda, Robert Black, Ramin Manshadi, Carlos Vaca, Antonio Blanco, Mark Napoli, David Brabham, Ayim Akyea-Djamson, Pratik Desai, Sudhir Prasada, Ajit Khaira, Leslie Forgosh, Ira Lieber, Guillermo Umpierrez, Dinesh Singal, Juan Londono, Neil Fraser, Jose Ruiz, Damaris Vega, Lilia Rodriguez, Christopher Brown, Faizullah Syed, Guarav Aggarwala, William Eaves, Michael Foster, Dinesh Gupta, David Avino, Wail Asfour, Glen Tonnessen, Xue-Qiao Zhao, Narendra Singh, Andrew Brockmyre, Norman Lepor, Nicolas Shammas, David Blick, Steven Hearne, John Prodafikas, Edgar Carell, Mark Izzo, Amin Karim, Bosh Zakhary, Mahmoud Atieh, Steven Leichter, Charles Meadows, David Hotchkiss, Mazen Abu-Fadel, Alan Wiseman, Jeffrey Bander, Mahesh Shah, Subhash Banerjee, Ricky Ganim, Karen Sopko, Misal Khan, Ramon Lloret, Troy Weirick, Rajendra Mehta, Udho Thadani, Anuj Bhargava, Mikhail Kosiborod, Jaynier Moya, Cezar Staniloae, Yamirka D Guerra, Anil Chhabra, Douglas Kosmicki, Wassim Shaheen, Akber Mohammed, J'Cinda Bitters, Jan Pattanayak, Julian Javier, Sunny Srivastava, Roland Phillips, Jessie Al-Amin, Michael Lillestol, Patrick Simpson, Lydie Hazan, Amit Amin, Gopi Shah, Denes Korpas, Bruce Platt, Jim Dickert, Orlando Puente, Louis Hiotis, Timothy Doyle, Raj Rajan, Alan Meholick, Christian Gring, Elie Hage-Korban, Robert Feldman, Harry Colfer, Samuel Butman, Malcolm Foster, Terence Hart, Randall Huling, Shervin Eshaghian, Ofsman Quintana, Deanna Cheung, Franklin Handel, Mara Rodriguez, David Suh, Paul Gordon, Gregg Pressman, Michael Bauer, William French, Mark Barettella, Sridhar Chatrathi, Damodhar Suresh, Ronald Goldberg, Mark Huth, Liwa Younis, Aref Rahman, Richard Mascolo, Michelle Welch, Randeep Suneja, Stephen Smith, Scott Shurmur, John Agaiby, Ahmad Jingo, Janice Johnston, Mary Beth, Anthony Vlastaris, Susan Kemp, Hamid Taheri, Edward Pereira, Michael Deyoung, Zafir Hawa, Ray Smith, Thomas Galski, Samer Garas, M Reddy, Susheel Sharma, Joeseph Hargrove, Charles Treasure, Ronald Emerson, Tariq Haddad, Kathryn Rohr, Larry Levinson, Raul Gaona, Barry Uretsky, Hiralal Maheshwari, Denny Lee, Stephanie Kinnaman, Robert Singal, Jeffrey Geohas, Osvaldo Gigliotti, Ajit Raisinghani, Charanjit Khurana, Brent Hella, Michael Kelberman, Steven Voyce, Sanjay Singh, Eric Lo, Pradeep Singh, Ross Goodfellow, Stuart Fischer, Richard Lorraine, Traci Turner, Jeffrey Shanes, Robert Busch, Robert Broker, Michelle Zaniewski, Kevin Pounds, Giselle Debs-Perez, Stephen Ong, Brad Frandsen, Douglas Fullington, Naseem Jaffrani, Ahtaram Khan, Marcus Lee, Joe Pouzar, George Revtyak, Julian Gonzalez, Samer Nakhle, Abel Murillo, Douglas Young, Sashi Makam, Mushtaq Syed, Kevin Woolf, Paul Grena, Sarab Alfata, Sharan Mahal, David Hoffman, Tinoy Kizhakekuttu, Joseph Deering, Janak Bhavsar, Scott Mikesell, William Wilson, Vance Wilson, Salah El, Francis Spinale, Vinod Kannarkat, Sunder Rao, Lenita Hanson, John Bertsch, Elena Gonzalez-Ortiz, Norma Severino, John Willis, Joel Schock, Ladan Bakhtari, Raul Gazmuri, Saadat Ansari, Jason Hall, Arvind Mehta, Neal Shealy, Stuart Zarich, Deovrat Singh, Kishor Vora, Nabil Andrawis, Darron Molter, David Maron, Jose Cardona, Ronald D'Agostino, Tamjeed Arshad, Rodney Samaan, David Jones, Dale Presser, John Heath, Sandy Green, George Bittar, Sheldon Henry, David Korn, John Schmedtje, Venkatesh Nadar, Bruce Graham, Ajay Labroo, Leonardo Clavijo, Hal Roseman, Gilbert Ledesma, Robert Rosen, Isaac Dor, William Kirby, Jennefer Sutton, Frank Eder, Bruce Iteld, Jose Gomez-Cortes, Maurice Buchbinder, Joseph Kasper, Antonio Terrelonge, Gustavo Torres, Ted Jagielo, Jose Alvarez, Yehuda Handelsman, Mario Guillen, Randall Richwine, Lorena Lewy-Alterbaum, Clinton Corder, Moogali Arvind, David Bolshoun, Magdy Mikhail, Stephen Minton, Odilon Alvarado, J Abbott, Brett Cauthen, Ryan Welter, Randy Mintz, John Cox, Annette Quick, Melvin Weiss, Johnny Dy, James Zebrack, Glenn Gandelman, Vinayak Hegde, Marc Silver, Michele DeGregorio, William Lawson, Christopher Paa, Anna Bortnick, Merrill Krolick, Rodolfo Sotolongo, Jorge Cheirif, Priya Kumar, Preetham Jetty, Ambar Patel, Mariusz Kruk, Iwona Kobielusz-Gembala, Barbara Rewerska, Adam Madrzejewski, Krzysztof Milewski, Jerzy Cygler, Joanna Petryka-Mazurkiewicz, Waldemar Jastrzebski, Janusz Korecki, Wojciech Fil, Janusz Prokopczuk, Anna Bochenek, Marek Wujkowski, Robert Witek, Piotr Konczakowski, Pawel Miekus, Marcin Szczasny, Wlodzimierz Musial, Krzysztof Cymerman, Jacek Lampart, Jacek Mikosinski, Slawomir Szynal, Issa Fares, Grzegorz Opolski, Stanislaw Mazur, Beata Wozakowska-Kaplon, Renata Bijata-Bronisz, Lukasz Wierucki, Beata Losa, Grzegorz Drelich, Marek Konieczny, Pawel Starczewski, Lidia Pawlowicz, Pawel Jesionowski, Jaroslaw Jurowiecki, Jacek Gniot, Mariusz Czyzycki, Karol Stania, Izabela Kucharczyk-Bauman, Benita Busz-Papiez, Agnieszka Karczmarczyk, Wanda Sudnik, Alina Koszek, Piotr Kolodziej, Bartosz Skwarna, Nicolás Jaramillo, Maciej Jankowski, Wojciech Czochra, Leszek Kinasz, Beata Miklaszewicz, Teresa Stasinska, Wladyslaw Pluta, Marcin Basiak, Teresa Rusicka, Izabela Niedbal-Yahfouf, Grazyna Popenda, Romuald Korzeniak, Agnieszka Mirek, Rafal Mariankowski, Lukasz Wojnowski, Marek Korol, Jacek Baszak, Piotr Podolec, Wojciech Piesiewicz, Aleksander Zurakowski, Carlos Luengas, Marek Skura, Piotr Pilecki, Piotr Majchrzak, Ewa Krzyzagórska, Marcin Drozd, Barbara Kaczmarek, Teresa Sliwinska, Katarzyna Zelazowska, Rafal Sztembis, Katarzyna Landa, Lidia Matyszczak-Toniak, Krzysztof Strojek, Marek Piepiorka, Robert Malinowski, Maria Górska, Edyta Stolarczyk-Sowa, Leszek Romanowski, Elzbieta Zinka, Zygfryd Reszka, Joanna Skierkowska, Anna Uzunow, Ewa Laskowska-Derlaga, Ekaterina Puntus, Elena D Kosmacheva, Natalia Koziolova, Prokhor Pavlov, Tatiana Supryadkina, Yury Didenko, Philipp Kopylov, Andrei Kazakov, Sergei Aksentiev, Elena Vishneva, Alexey Repin, Olga Smolenskaya, Olga Mantserova, Oleg Khrustalev, Elena Privalova, Vladimir Konstantinov, Svetlana Boldueva, Andrey Ezhov, Alexander Chernyavsky, Gadel Kamalov, Albert Galyavich, Galina Zubeeva, Galina Nechaeva, Sergey Shustov, Nino Dzhaiani, Tatiana Treshkur, Nataliya Osokina, Alexey Panov, Elena Shutemova, Valeriy Makukhin, Tatiana Kropotina, Larisa Tsyba, Yuri Karpov, J M Sizova, Marina Ballyuzek, Nikolay Tarasov, Elena Demchenko, Olga Barbarash, Valentin Moiseev, Valentin Markov, Vadim Kuznetsov, Inna Viktorova, Igor Sergienko, Lyudmila Ermoshkina, Niyaz Khasanov, Tatiana Khlevchuk, Andrey Baglikov, Sergey Shalaev, Elena Zonova, Elena Reznik, Larisa Haisheva, Tatyana Morugova, Nikita Lomakin, Alexander Vishnevsky, Yuri Shvarts, Olga Magnitskaya, Marina Mikhailusova, Elena Pavlysh, Igor Libov, Anna Zateyschikova, Victor Kostenko, Anton Edin, Yaroslava Khovaeva, Konstantin Zakharov, Raisa Stryuk, Vladimir Khirmanov, Sergey Kanorskiy, Sergey Yakushin, Anna Barabashkina, Hongwei Li, Qiang Zhao, Jian Zhang, Jianhua Ma, Yong He, Ming Luo, Aidong Zhang, Ningru Zhang, Yingru Chai, Genshan Ma, Hao Wang, Zhigang Liu, Lanjie He, Zhifang Song, Xiaolin Dong, Liang Tao, Zhanquan Li, Xi Su, Xiangqing Kong, Heping Niu, Junbo Ge, Zhurong Luo, Wenjun Huang, Daoquan Peng, Zuyi Yuan, Maria Milanova, Doncho Tenev, Antoni Gogov, Dimitar Karageorgiev, Todor Kolchev, Nikolay Rusev, Nikolina Georgieva, Rumen Kondov, Veselin Rusinov, Ivo Petrov, Georgi Stanchev, Mariana Konteva, Adriana Dincheva, Zdravka Yaneva, Ralitsa Vatova, Katya Ilieva, Nikolai Runev, Borislav Kolomanov, Ivan Petrov, Nikolay Iliev, Snezhanka Tisheva, Boryana Chompalova, Maria Tokmakova, Dimitar Raev, Kolyo Byanov, Dimitar Markov, Lenko Mihov, Atanas Mihov, Nora Milcheva, Milen Minchev, Mihail Mollov, Borislav Borisov, Tihomir Tihchev, Venelin Karakolev, Bojidar Dimov, Svetoslav Georgiev, Lachezar Smilov, Bon K Koo, Taehoon Ahn, Soon J Hong, Junghan Yoon, Seok K Oh, Myung H Jeong, Doo-Il Kim, Kiyuk Chang, Weon Kim, Joo-Yong Hahn, Kwang S Cha, Jung-Hee Lee, Si-Wan Choi, Chang-Wook Nam, In-Ho Chae, Yong H Park, Seung-Jea Tahk, Won-Yong Shin, Jei-Keon Chae, Byung J Kim, Jang-Whan Bae, Woo J Park, Seung W Rha, Young J Choi, Jin-Yong Hwang, Hun S Park, Luciano Baracioli, Fabio Guimaraes, Eduardo Vasconcellos, José Saraiva, Adamastor Pereira, Queulla Santos, Paulo Rossi, Lilia Maia, Miguel Madeira, Marcio Pereira, Roberto Botelho, Gilmar Reis, Freddy Eliaschewitz, Joao Borges, Carlos Nascimento, Jose A Fortes, Weimar de Souza, Pedro Pimentel, Miguel Hissa, Marcos Franchetti, Dalton Precoma, Costantino Ortiz, Mauro Hernandes, Wladmir Saporito, Fabio R dos Santos, Adrian Kormann, Fernando Neuenschwander, Oscar Dutra, Nelson Rassi, Luiz Tanajura, Juliana Souza, Delcio S Junior, Paulo Leaes, Adriana Forte, Teresa C Bonansea, Jose Marin, Bruno Machado, Maria J Cerqueira, Frederico Silva, Yorghos Michalaros, Euler Manenti, Cintia Cercato, Estevao Figueiredo, Ming-En Liu, Yi-Chih Wang, Tsung-Ming Lee, Chih Fang, Yen-Wen Wu, Kwo-Chang Ueng, Huey-Herng Sheu, Wen T Lai, I-Chang Hsieh, Zhih-Cherng Chen, Mu-Jang Lee, Chern Chiang, Kou-Gi Shyu, Chien-Hsun Hsia, Guang-Yuan Mar, Shih-Hung Chan, Chih-Cheng Wu, Wei-Kung Tseng, Kuan-Cheng Chang, Hung-I Yeh, Ji-Hung Wang, Charles Hou, Inna Sorokina, Maryna Dolzhenko, Olha Horoshko, Oleksandr Karpenko, Leonid Rudenko, Igor Vakaliuk, Anna Kulyk, Olena Levchenko, Oleksandr Prokhorov, Dmytro Reshotko, Mykhaylo Sorokivskyy, Nataliia Velichko, Valentyn Maslovskyi, Zinaida Teliatnikova, Sergiy Dotsenko, Olena Krakhmalova, Igor Kraiz, Viktoria Zharinova, Larysa Bula, Igor Kaydashev, Valeriy Molodtsov, Lesya Rasputina, Viktoriya Pidlisna, Olena Lysunets, Anatoliy Kravchenko, Liubomyr Glushko, Tetyana Khomazyuk, Yevgeniya Svyshchenko, Oleksandr Parkhomenko, Boris Mankovsky, Orest Abrahamovych, Andriy Yagensky, Mykola Stanislavchuk, Larisa Vasilyeva, Liubov Sokolova, Oleg Sychov, Vira Tseluyko, Igor Kyrychenko, Mykola Rishko, Sergiy Furkalo, Richard Gallo, Olivier Bertrand, Shamir Mehta, Christian Constance, Bruce Sussex, Remo Zadra, Simon Kouz, Raja Chehayeb, Amritanshu Pandey, Danielle Dion, Gordon Bailey, Laurie Hill, Krishnan Ramanathan, Micha Dorsch, Alykhan Nanji, Mohan Babapulle, Martine Montigny, Gilbert Gosselin, Payam Dehghani, Dennis Rupka, Michel Le May, Francis Pichette, Francois St-Maurice, Patrick Teefy, Samer Mansour, Saleem Kassam, Stephen Cheung, Anthony D Siega, Dennis O'Keefe, Eric Sabbah, Alan Bell, Guy Chouinard, Brian Wong, Mark Miller, Daniel Gaudet, Pierre Lachance, Iqbal Bata, Robert Petrella, Denis Gossard, Richard Dumas, Douglas Ing, Hagop Boyrazian, Ricardo Bessoudo, Thao T Huynh, Randy Hart, Jasmin Belle-Isle, Dinkar Shukla, Allan Kelly, Giuseppe Mazza, James Cha, Sam Henein, Andre Frechette, Saul Vizel, Joanne F Liutkus, Michael O'Mahony, Frank Halperin, Jacobus Kooy, John Graham, Allan Bailey, Ronald Wojcik, Igor Wilderman, Tibor Turi, Ákos Motyovszki, Béla Merkely, Csaba Király, Péter Andrássy, Zsolt Sárszegi, Tibor Fülöp, Zsolt Zilahi, István Édes, Andras Papp, Gábor Müller, Anna Czigány, Szilárd Zólyomi, László Korányi, János Takács, Ferenc Juhász, Bela Benczur, Sándor Kancz, András Földi, András C Nagy, Judit Bakai, István Greschik, László Püski, László Nagy, Róbert Kirschner, Roman Kuchar, Petr Hajek, Ladislav Busak, Daniel Michalik, Ivo Matyasek, Ivana Marusincova, Dusan Kucera, Ondrej Jerabek, Michaela Honkova, Vratislav Dedek, Ivan Rihacek, Pavel Kos, Josef Slaby, Martina Machkova, Eva Zidkova, Lubomir Elbl, Hana Grunfeldova, Jiri Carda, Vladimir Mrozek, Jiri Maly, Richard Milkovic, Jan Malecha, Hana Skalicka, Ivo Oral, Eva Krcova, Libor Lisa, Jan Belohlavek, Roman Miklik, Ondrej Cermak, Jana Bednarova, Zdenek Peroutka, Jindrich Spinar, Andreas Wilke, Karl-Friedrich Appel, Jens Taggeselle, Andreas Förster, Nicole Toursarkissian, Ekkehard Schmidt, Jochen Bott, Ayham Al-Zoebi, Dirk Hennig, Sabine Fischer, Norbert Schön, Joachim Sauter, Gregor Simonis, Ruth Nischik, Werner Rieker, Isabelle Schenkenberger, Thomas Behnke, Gerhard Klausmann, Michael Jeserich, Dietmar Trenk, Ingo Weigmann, Hannes Reuter, Reinhard Rummel, Candy von Münchhausen, Charlotte von Engelhardt, Eishun Horibe, Taro Shibasaki, Tomohiko Sato, Tsunekazu Kakuta, Ichiro Michishita, Michinao Tan, Ryoji Ishiki, Takahiko Aoyama, Shinichi Higashiue, Yawara Niijima, Akira Idogaki, Toru Hasegawa, Arihiro Kiyosue, Yoshiaki Tomobuchi, Katsunori Kawamitsu, Satsuki Kawasaki, Yoshiki Hata, Kazuki Fukui, Kozaburo Seki, Takashi Takenaka, Mitsuru Abe, Noriaki Utsu, Atsuyuki Oono, Kazuhisa Mitsuo, Atsushi Sueyoshi, Atsushi Hirohata, Mitsuru Tsujimoto, Osamu Ueda, Shinichi Takase, Masahiro Suzuki, Satoru Sakuragi, Fumi Yamamoto, Noritaka Fujimoto, Shigeo Kakinoki, Tatsushi Sugiura, Hiroshi Sugino, Toshihiro Nakamura, Toshiaki Kadokami, Hiroki Uehara, Masahiro Ono, Koichi Yokoya, Akihiro Koike, Sei Komatsu, Masahiro Sonoda, Hideki Ueno, Tomofumi Doi, Yuichiro Takagi, Kazuteru Fujimoto, Yutaka Eki, Munenori Okubo, Kenichiro Sasaki, Martijn van Eck, Eelko Ronner, Salem The, Ruud van de Wal, Pieter Nierop, Cornelis de Nooijer, Henri Werner, Iris Westendorp, Coen van der Zwaan, Hendrikus Crijns, Jan H Cornel, Sipke Strikwerda, Robert Bos, Edwin de Melker, Adrianus Kuijper, Hans Louwerenburg, Jacobus Plomp, Jan-Melle Dantzig, Francisco Prins, Henricus van Kesteren, Frank Willems, Giovanni Amoroso, Gabriela Carnero, Ernesto Duronto, Diego Besada, Carolina Chacon, Pedro Zangroniz, Silvana Solis, Alberto Liberman, Virginia Sernia, Andres Alvarisqueta, Laura Maffei, Oscar G Vilamajo, Celso García, Maximiliano Sicer, Juan Muntaner, Anselmo Bordonava, Juan Albisu, Alejandra Zanini, Lucas Rista, Miguel Hominal, José N Estrada, Aldo Prado, Diego M Gosparini, Beatriz Schiavi, Armando G Castillo, José G Ruíz, Guillermo R Martinez, Víctor G López, Enrique L Rosas, Gabriel R Lopez, Elias G Cantu, Manuel de los Ríos Ibarra, Francisco P Padilla, Jose P Carrasco, Luis V Carrillo, Joel D García, Alfredo N Askar, Carlos A Salinas, Marco A Gamba, Carlos G Sanchez, Arnulfo G Cantú, Raul V Sánchez, Jaime C Madrigal, Rafael H Urbano, Andrés Í Romo, José R González Juanatey, Paolo Racugno, Angel C Fillat, José M de la Torre Hernández, Juan A Peláez, Jorge B Cortada, Pablo G Pavia, Manuel J Navarro, Roberto M Asenjo, Francisco F Díaz, Eduard B Peligero, Fernando A Manterola, Antonio F Ortiz, Juan D Mediavilla García, Francisco M Ortuño, Tomás R Vera, Alfonso S González, Jaime A Viñas, Francisco J Fernández Portales, Petra S Mayordomo, Francisco B Ojeda, Antonio R Domínguez, Rosa S González, Diego B Guerrero, Juan M Ruiz Nodar, Xavier G Marimon, José G Margáez, Roberto M Aguilera, José F Díaz Fernández, José L Zamorano Gómez, Vicente B González, Bruno G del Blanco, Ignacio P Pérez, Mercé R Moreno, Ainhoa R Ereño, José A García Lledó, Juan Prieto, Alex Villablanca, Carlos Raffo, Christian Pincetti, Carlos Conejeros, Oscar Roman, Manuel Rodriguez, Paola Varleta, Cindy Goldberg, Jorge Sandoval, German Arriagada, Lucio Leon, Sergio Potthoff, Jorge Cobos, Christian Figueroa, Ellen Makotoko, Nyda Fourie, Lesley Burgess, Hendrik Nortje, Rust Theron, Perumal Pillai, Naresh Ranjith, Julien Trokis, Soobramoney Pillay, Jeevren Reddy, Theema Nunkoo, Cornelia Kapp, Dorothea Urbach, Lawrence Distiller, Adrian Horak, Louis van Zyl, Kathleen Coetzee, Zelda Punt, Junaid Bayat, Saleem Dawood, Ismail Mitha, Trevenesan Padayachee, Farzana Hoosen, Anthony Dalby, null Prabhavathi, Prakash Gowdaiah, Vimal Mehta, Milan Chag, Milind Gadkari, Kannaiyan Ramamurthee, Asit Das, Jitendra S Sawhney, Suvro Banerjee, Prachee Sathe, Srilakshmi Adhyapak, Tuan Nguyen, Vinh Pham, Huan Do, Anh Nguyen, Hien Nguyen, Binh Truong, Shahnaz Jamil-Copley, Chim Lang, Alastair Pell, Azfar Zaman, Robert Storey, Neil Swanson, Simon Smith, David Sharman, Denise Braganza, Peter Hammond, Andrew Moriarty, Stephen Bain, Maurice Pye, Andrew Sharp, Mark Blagden, Harpal Randeva, Timothy Myhill, Girish Viswanathan, Philip Keeling, Piers Clifford, Manish Saxena, Kristopher Lyons, John McMurray, Feeroz Jaafar, Clare Murphy, Simon Cartwright, Kamal Abouglila, Lubomir Antalik, Peter Krajci, Miroslav Urban, Frantisek Fazekas, Daniel Pella, Daniel Koleny, Tatiana Vykoukalova, Vladimir Macek, Daniela Vinanska, Livia Jamriskova, Slavomir Such, Peter Fulop, Stefan Farsky, Viliam Bugan, Jaroslava Strbova, Karol Micko, Juraj Palka Jr, Vladimir Sivak, Dalby Kristensen, Jens Refsgaard, Lene Holmvang, Ulrik Dixen, Henrik Nielsen, Kenneth Egstrup, Lisette O Jensen, Roman Sykulski, Ole Rasmussen, Alin Andries, Anders Luckow, Gitte Nielsen, Torben Sørensen, Chaiyasith Wongvipaporn, Noppadol Chamnarnphol, Suphot Srimahachota, Nakarin Sansanayudh, Srun Kuanprasert, Damras Tresukosol, Bancha Sookananchai, Mehmet Kanadasi, Turkay Ozcan, Murathan Kucuk, Zeki Ongen, Ertugrul Okuyan, Alev Arat, Sadik Acikel, Ahmet Yalcin, Umit Guray, Ceyhun Ceyhan, Necla Ozer, Sakir Arslan, Oskar Angerås, Nina Johnston, Ann-Charlotte Weiderman, Stellan Bandh, Ole Hansen, Hans Larnefeldt, Dawid Kusiak, Carl-Johan Lindholm, Anders Hedman, David Erlinge, Dan Curiac, Pia Lundman, Roberto Zucconi-Mazzini, Layth Aladellie, Jens Jensen, Jan Verwerft, Mathias Vrolix, Dirk Faes, Harry Striekwold, Peter Sinnaeve, Patrick Timmermans, Antoine Guedes, Marc Delforge, Jan Nimmegeers, Francis Stammen, Ian Buysschaert, Etienne Hoffer, Geert Hollanders, Geert Vervoort, Patrick Coussement, Stefan de Maeseneire, Luc Janssens, Stein A Gravdal, Knut Risberg, Lars Gullestad, Ola D Hofseth, Dennis Nilsen, Knut T Lappegård, Christian van den Heuvel, Charlotte Gibbs, Alamdar Khusrawi, Satish Arora, Tadeusz Tomala, Thorbjørn Kjærnli, Jan Berg-Johansen, Robert Hagemeier, Gunnar Skjelvan, David Colquhoun, John Amerena, Claire Morbey, Christopher Hammett, Anthony Dart, Ronald Lehman, Andrew Hamilton, Matthew Worthley, Peter Purnell, Alan Whelan, Richard MacIsaac, Ktut Arya, Sultan Linjawi, Joseph Proietto, Lakshman Prasad, Aldo Rodriguez, Armando Godoy, Victor Rodriguez, Percy Berrospi, Carlos Chavez, Sandra Negron, Javier Heredia, Felix Medina, Helard Manrique, Walter Cabrera, Fernando Cordova, Trinidad Quinteros, Jaime M Haro, Susana Regalado, Javier Guitton, Hugo Arbanil, Michel Pansieri, Eric Decoulx, Pascal Goube, Axel de Labriolle, Jean N Labeque, Gregoire Range, Yves Cottin, Gilles Montalescot, Guillaume Cayla, Nicolas Danchin, Denis Angoulvant, Emile Ferrario, Meyer Elbaz, Olivier Dubreuil, Philippe G Steg, Caroline Fontaine, Emmanuel Sorbets, Hafiz Omer, Shukri Al-Saif, Hussam Al-Faleh, Abdullah Al-Shehri, Halia Alshehri, Rasha Bazari, Pak Hei, Man Ying, Michael Chan, Michelle Wong, Ronald Ma, Shing C Siu, Chiu C Tsang, Maurizio Ferrario, Emilio Assanelli, Michele Senni, Piermarco Piatti, Paolo Calabrò, Stefano Urbinati, Massimo Michisanti, Ferdinando Varbella, Salvatore de Cosmo, Roberto Trevisan, Sandro Bellotti, Giuseppe Di Pasquale, Angelo S Bongo, Massimo Uguccioni, Edoardo Mannucci, Ciro Mauro, Mauro Ragonese, Claudio Fresco, Maurizio Turturo, Rossella Marcucci, Manuel J Lievano Triana, Camilo Arana, Jose Accini, Rodrigo Botero, Marlena Muzyk-Osikowicz, Fredy T Dada, Gregorio S Vallejo, Fernando Manzur, Daniel Isaza, Dora Molina, Juan G Mesa, Alvaro Quintero, Kai Nyman, Jyrki Mäkelä, Jorma Strand, Sakari Nieminen, Jyrki Taurio, Matti Kuusela, Timo Valle, Mikko Pietilä, Sakari Kekki, Timo Strandberg, Marc Klutstein, Gabriel Greenberg, Yoseph Rozenman, Ehud Chorin, Ariel Roguin, Basil Lewis, Amir Bashkin, Edgar Tan, Jose P Prado, Arthur Ferrolino, Noe Babilonia, Benny Barbas, Generoso Matiga, Raul M Coching, Heinz Drexel, Helmut Brath, Christoph Schnack, Ursula Hanusch, Evelyn Fließer-Görzer, Bernhard Paulweber, Christoph Ebenbichler, Rudolf Prager, Kurt Huber, Michael Wolzt, Johann Auer, Rudolf Berger, Gerit-Holger Schernthaner, Gabriela Stanciulescu, Mihai Creteanu, Marilena Spiridon, Viorica Dobreanu, Dragos Vinereanu, Laura C Iosipescu, Octavian Istratoaie, Ioan Coman, Constantin Militaru, Mircea Cinteza, Peter R Sinnaeve, José C Nicolau, José F Kerr Saraiva, Ramón Corbalán, Petr Widimský, Steen D Kristensen, Juha Hartikainen, Harald Darius, Hung F Tse, Robert G Kiss, Prem Pais, Eli Lev, Leonardo de Luca, Gabriel A Ramos López, Frederic Kontny, Noe A Babilonia, Dmitry A Zateyshchikov, Mikhail Ruda, Omer Elamin, František Kovář, Anthony J Dalby, Héctor Bueno, Chern-En Chiang, Alexander Parkhomenko, Tuan Q Nguyen, Maria Leonsson-Zachrisson, Herrada, Anthony, Brigham & Women’s Hospital [Boston] (BWH), Harvard Medical School [Boston] (HMS), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Laboratoire de Recherche Vasculaire Translationnelle (LVTS (UMR_S_1148 / U1148)), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Royal Brompton Hospital, McMaster University [Hamilton, Ontario], Keenan Research Centre of the Li Ka Shing Knowledge Institute [Toronto], St. Michael's Hospital, University of Toronto, Service de Pharmacologie médicale = service de pharmacologie - Dosage de médicaments [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), National Heart and Lung Institute [London] (NHLI), Imperial College London-Royal Brompton and Harefield NHS Foundation Trust, Uppsala University Hospital, Uppsala Universitet [Uppsala], AstraZeneca, Tokai University, Uppsala University, Imperial College London, Saint Luke's Mid America Heart Institute, University of Missouri [Kansas City] (UMKC), University of Missouri System, University of New South Wales [Sydney] (UNSW), University of Texas Southwestern Medical Center [Dallas], Stanford University, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Université de Montpellier (UM), Bhatt, D, Steg, P, Mehta, S, Leiter, L, Simon, T, Fox, K, Held, C, Andersson, M, Himmelmann, A, Ridderstrale, W, Chen, J, Song, Y, Diaz, R, Goto, S, James, S, Ray, K, Parkhomenko, A, Kosiborod, M, Mcguire, D, Harrington, R, Santos, V, Jain, A, Lendel, I, Russo, M, Haught, W, Bouza, M, Gogia, H, Banerjee, S, Kichura, G, Kantaros, L, Padron, F, Passi, R, Stone, J, Pursley, M, D'Urso, M, Gardner, T, Bennett, J, Nour, K, Saini, S, Zhang, W, Kumbhani, D, Thomas, D, Angiolillo, D, Bertolet, B, Roman-Miranda, A, Black, R, Manshadi, R, Vaca, C, Blanco, A, Napoli, M, Brabham, D, Akyea-Djamson, A, Desai, P, Prasada, S, Khaira, A, Forgosh, L, Lieber, I, Umpierrez, G, Singal, D, Londono, J, Fraser, N, Ruiz, J, Vega, D, Rodriguez, L, Brown, C, Syed, F, Aggarwala, G, Eaves, W, Foster, M, Gupta, D, Avino, D, Asfour, W, Tonnessen, G, Zhao, X, Singh, N, Brockmyre, A, Lepor, N, Shammas, N, Blick, D, Hearne, S, Prodafikas, J, Carell, E, Izzo, M, Karim, A, Zakhary, B, Atieh, M, Leichter, S, Meadows, C, Hotchkiss, D, Abu-Fadel, M, Wiseman, A, Bander, J, Shah, M, Ganim, R, Sopko, K, Khan, M, Lloret, R, Weirick, T, Mehta, R, Thadani, U, Bhargava, A, Moya, J, Staniloae, C, Guerra, Y, Chhabra, A, Kosmicki, D, Shaheen, W, Mohammed, A, Bitters, J, Pattanayak, J, Javier, J, Srivastava, S, Phillips, R, Al-Amin, J, Lillestol, M, Simpson, P, Hazan, L, Amin, A, Shah, G, Korpas, D, Platt, B, 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Mannucci, E, Mauro, C, Ragonese, M, Fresco, C, Turturo, M, Marcucci, R, Lievano Triana, M, Arana, C, Accini, J, Botero, R, Muzyk-Osikowicz, M, Dada, F, Vallejo, G, Manzur, F, Isaza, D, Molina, D, Mesa, J, Quintero, A, Nyman, K, Makela, J, Strand, J, Nieminen, S, Taurio, J, Kuusela, M, Valle, T, Pietila, M, Kekki, S, Strandberg, T, Klutstein, M, Greenberg, G, Rozenman, Y, Chorin, E, Roguin, A, Lewis, B, Bashkin, A, Tan, E, Prado, J, Ferrolino, A, Babilonia, N, Barbas, B, Matiga, G, Coching, R, Drexel, H, Brath, H, Schnack, C, Hanusch, U, Fliesser-Gorzer, E, Paulweber, B, Ebenbichler, C, Prager, R, Huber, K, Wolzt, M, Auer, J, Berger, R, Schernthaner, G, Stanciulescu, G, Creteanu, M, Spiridon, M, Dobreanu, V, Vinereanu, D, Iosipescu, L, Istratoaie, O, Coman, I, Militaru, C, Cinteza, M, Nicolau, J, Kerr Saraiva, J, Widimsky, P, Kristensen, S, Hartikainen, J, Darius, H, Tse, H, Pais, P, Lev, E, de Luca, L, Ramos Lopez, G, Kontny, F, Zateyshchikov, D, Ruda, M, Elamin, O, Kovar, F, Bueno, H, Leonsson-Zachrisson, M, Université Paris Diderot - Paris 7 (UPD7)-Université Paris 13 (UP13)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de pharmacologie - Dosage de médicaments [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), and Royal Brompton and Harefield NHS Foundation Trust-Imperial College London
Subjects: Male, Platelet Aggregation Inhibitors/therapeutic use, THEMIS Steering Committee and Investigators, medicine.medical_treatment, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], 030204 cardiovascular system & hematology, Coronary Angiography, Stroke/epidemiology, Coronary artery disease, DOUBLE-BLIND, 0302 clinical medicine, Hemorrhage/chemically induced, acetylsalicylic acid, antidiabetic agent, placebo, ticagrelor, Secondary Prevention, Medicine, 030212 general & internal medicine, Myocardial infarction, Coronary Artery Bypass, Cardiovascular Diseases/mortality, 11 Medical and Health Sciences, OUTCOMES, Aspirin, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, General Medicine, Middle Aged, Clopidogrel, 3. Good health, Ticagrelor/therapeutic use, DRUG-ELUTING STENTS, CLOPIDOGREL, Cardiology, PLATELET INHIBITION, Drug Therapy, Combination, Female, Life Sciences & Biomedicine, Ticagrelor, TIMI, medicine.drug, Coronary Artery Disease/complications, medicine.medical_specialty, Hypoglycemic Agents/therapeutic use, POOLED ANALYSIS, 03 medical and health sciences, Medicine, General & Internal, Percutaneous Coronary Intervention, Double-Blind Method, General & Internal Medicine, Internal medicine, Myocardial Infarction/epidemiology, Humans, Aged, Science & Technology, ANTIPLATELET THERAPY, business.industry, Diabetes Mellitus, Type 2/complications, ELEVATION MYOCARDIAL-INFARCTION, RIVAROXABAN, Percutaneous coronary intervention, medicine.disease, ASPIRIN, Coronary Stenosis/diagnostic imaging, Aspirin/therapeutic use, Conventional PCI, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Contains fulltext : 215333.pdf (Publisher’s version ) (Closed access) BACKGROUND: Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor. METHODS: The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population). FINDINGS: Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3.3 years (IQR 2.8-3.8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7.3%] of 5558 vs 480 [8.6%] of 5596; HR 0.85 [95% CI 0.74-0.97], p=0.013). The same effect was not observed in patients without PCI (p=0.76, pinteraction=0.16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3.1%] with ticagrelor vs 183 (3.3%) with placebo; HR 0.96 [95% CI 0.78-1.18], p=0.68), as well as all-cause death (282 [5.1%] vs 323 [5.8%]; 0.88 [0.75-1.03], p=0.11). TIMI major bleeding occurred in 111 (2.0%) of 5536 patients receiving ticagrelor and 62 (1.1%) of 5564 patients receiving placebo (HR 2.03 [95% CI 1.48-2.76], p
Published: 2019
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7. Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting

Author: Christian W. Hamm, Peter Jüni, Leonardo Bolognese, Luc Janssens, Scot Garg, Ton Slagboom, Ivo Petrov, Edouard Benit, Janusz Prokopczuk, Patrick W. Serruys, Maurizio Ferrario, Glassy Investigators, Marco Valgimigli, Pascal Vranckx, Dik Heg, Adel Aminian, Christoph Naber, Roberto Diletti, Christoph Liebetrau, Carlo Tumscitz, Eugene P. McFadden, Stephan Windecker, Krzysztof Bryniarski, Anna Franzone, Aleksander Zurakowski, Kurt Huber, Sergio Leonardi, Raffaele Piccolo, Paweł Buszman, Marcello Dominici, Philippe Gabriel Steg, Mathias Vrolix, Cardiology, Franzone, A., Mcfadden, E., Leonardi, S., Piccolo, R., Vranckx, P., Serruys, P. W., Benit, E., Liebetrau, C., Janssens, L., Ferrario, M., Zurakowski, A., Diletti, R., Dominici, M., Huber, K., Slagboom, T., Buszman, P., Bolognese, L., Tumscitz, C., Bryniarski, K., Aminian, A., Vrolix, M., Petrov, I., Garg, S., Naber, C., Prokopczuk, J., Hamm, C., Steg, P. G., Heg, D., Juni, P., Windecker, S., and Valgimigli, M.
Subjects: Male, Ticagrelor, medicine.medical_specialty, medicine.medical_treatment, Coronary Artery Disease, 030204 cardiovascular system & hematology, Rate ratio, Drug Administration Schedule, 03 medical and health sciences, Percutaneous Coronary Intervention, 0302 clinical medicine, Internal medicine, Statistical significance, medicine, Clinical endpoint, Humans, Prospective Studies, 030212 general & internal medicine, Myocardial infarction, 610 Medicine & health, Aged, Aspirin, business.industry, Dual Anti-Platelet Therapy, adjudication, Percutaneous coronary intervention, Drug-Eluting Stents, Middle Aged, medicine.disease, dual antiplatelet therapy, Confidence interval, Survival Rate, Treatment Outcome, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, Platelet Aggregation Inhibitors, Follow-Up Studies, medicine.drug
Abstract: Background: The GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported. Objectives: This was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error. Methods: An independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites. Results: The 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority
Published: 2019

8. Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). [Protocol]

Author: Adel Aminian, Christoph Naber, Edouard Benit, Luc Janssens, Eugene P. McFadden, Marco Valgimigli, Sergio Leonardi, Ivo Petrov, Ton Slagboom, Patrick W. Serruys, Christian W. Hamm, Gabriel Steg, Paweł Buszman, Marcello Dominici, Leonardo Bolognese, Janusz Prokopczuk, Pascal Vranckx, Dik Heg, Stephan Windecker, Mathias Vrolix, Maurizio Ferrario, Krzysztof Bryniarski, Raffaele Piccolo, Anna Franzone, Aleksander Zurakowski, Christoph Liebetrau, Kurt Huber, Scot Garg, Peter Jüni, Robert-Jan van Geuns, Carlo Tumscitz, Cardiology, Leonardi, S., Franzone, A., Piccolo, R., Mcfadden, E., Vranckx, P., Serruys, P., Benit, E., Liebetrau, C., Janssens, L., Ferrario, M., Zurakowski, A., Van Geuns, R. -J., Dominici, M., Huber, K., Slagboom, T., Buszman, P., Bolognese, L., Tumscitz, C., Bryniarski, K., Aminian, A., Vrolix, M., Petrov, I., Garg, S., Naber, C., Prokopczuk, J., Hamm, C., Steg, G., Heg, D., Juni, P., Windecker, S., and Valgimigli, M.
Subjects: Ticagrelor, Drug Administration Route, medicine.medical_treatment, Myocardial Infarction, Coronary Artery Disease, Cardiovascular Medicine, 030204 cardiovascular system & hematology, law.invention, Coronary artery disease, 0302 clinical medicine, Randomized controlled trial, Informed consent, law, Protocol, Myocardial Revascularization, Clinical endpoint, Prospective Studies, 030212 general & internal medicine, 610 Medicine & health, Adjudication, Drug Administration Routes, General Medicine, Stroke, Research Design, coronary intervention, Drug Therapy, Combination, 360 Social problems & social services, Human, medicine.drug, medicine.medical_specialty, Endpoint Determination, ischaemic heart disease, 03 medical and health sciences, Percutaneous Coronary Intervention, medicine, Humans, coronary heart disease, Aspirin, business.industry, Platelet Aggregation Inhibitor, Percutaneous coronary intervention, medicine.disease, Prospective Studie, Regimen, Emergency medicine, business, Platelet Aggregation Inhibitors
Abstract: IntroductionThe GLOBAL LEADERS is an open-label, pragmatic and superiority randomised controlled trial designed to challenge the current treatment paradigm of dual antiplatelet therapy (DAPT) for 12 months followed by aspirin monotherapy among patients undergoing percutaneous coronary intervention. By design, all study endpoints are investigator reported (IR) and not subject to formal adjudication by an independent Clinical Event Committee (CEC), which may introduce detection, reporting or ascertainment bias.Methods and analysisWe designed the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY) to prospectively implement, in a large sample of patients enrolled within the GLOBAL LEADERS trial (7585 of 15 991, 47.5%), an independent adjudication process of reported and unreported potential endpoints, using standardised CEC procedures, in order to assess whether 23-month ticagrelor monotherapy (90 mg twice daily) after 1-month DAPT is non-inferior to a standard regimen of DAPT for 12 months followed by aspirin monotherapy for the primary efficacy endpoint of death, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularisation and superior for the primary safety endpoint of type 3 or 5 bleeding according to the Bleeding Academic Research Consortium criteria.This study will comprehensively assess the comparative safety and efficacy of the two tested antithrombotic strategies on CEC-adjudicated ischaemic and bleeding endpoints and will provide insights into the role of a standardised CEC adjudication process on the interpretation of study findings by quantifying the level of concordance between IR-reported and CEC-adjudicated events.Ethics and disseminationGLASSY has been approved by local ethics committee of all study sites and/or by the central ethics committee for the country depending on country-specific regulations. In all cases, they deemed that it was not necessary to obtain further informed consent from individual subjects.Trial registration numberNCT01813435.
Published: 2019
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9. Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial

Author: Neville Kukreja, Osama Ibrahim Ibrahim Soliman, Upendra Kaul, Raúl Moreno, Béla Merkely, Gincho Tonev, Antonio Colombo, Sjoerd H. Hofma, Imre Ungi, Janusz Prokopczuk, Azfar Zaman, Pieter C. Smits, Antonio Serra, Rodrigo Modolo, Anirban Choudhury, Robert J. Gil, Pim A.L. Tonino, Ivo Petrov, Anthony Mathur, Norihiro Kogame, Andrés Iñiguez, Yoshinobu Onuma, Chun Chin Chang, Robbert J. de Winter, Patrick W. Serruys, Angel Cequier, Simon J Walsh, Aleksander Zurakowski, Ernest Spitzer, Sander IJsselmuiden, Angela Hoye, Cardiology, ACS - Heart failure & arrhythmias, Graduate School, ACS - Atherosclerosis & ischemic syndromes, and ACS - Microcirculation
Subjects: Male, medicine.medical_specialty, Endpoint Determination, medicine.medical_treatment, Population, Myocardial Infarction, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Percutaneous Coronary Intervention, Randomized controlled trial, law, Coronary stent, medicine, Clinical endpoint, Humans, Single-Blind Method, 030212 general & internal medicine, Myocardial infarction, Everolimus, Prospective Studies, education, Prospective cohort study, Aged, Sirolimus, education.field_of_study, business.industry, Percutaneous coronary intervention, Stent, Drug-Eluting Stents, Thrombosis, General Medicine, Middle Aged, medicine.disease, Atherosclerosis, Surgery, Female, business, Immunosuppressive Agents
Abstract: Background: Supraflex is a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts. We aimed to compare Supraflex with the standard of care, Xience, an everolimus-eluting stent with a durable polymer coating, regarding clinical outcomes with a randomised trial in an all-comer population. Methods: We did a prospective, randomised, single-blind, multicentre study (TALENT) across 23 centres in Europe (the Netherlands, Poland, the UK, Spain, Bulgaria, Hungary, and Italy). Eligible participants were aged 18 years or older, had one or more coronary artery stenosis of 50% or greater in a native coronary artery, saphenous venous graft, or arterial bypass conduit, and had a reference vessel diameter of 2·25–4·50 mm. Patients underwent percutaneous coronary intervention in an all-comer manner. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts (Supraflex) or an everolimus-eluting stent with a durable polymer coating (Xience). Randomisation was done by local investigators by use of a web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint—cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation—between groups at 12 months after the procedure, assessed in an intention-to-treat population. On assumption of 1-year composite endpoint prevalence of 8·3%, a margin of 4·0% was defined for non-inferiority of the Supraflex group compared with the Xience group. This trial is registered with ClinicalTrials.gov, number NCT02870140. Findings: Between Oct 21, 2016, and July 3, 2017, 1435 patients with 1046 lesions were randomly assigned to Supraflex, of whom 720 received the index procedure, and 715 patients with 1030 lesions were assigned to Xience, all receiving the index procedure. At 12 months, the primary endpoint had occurred in 35 patients (4·9 %) in the Supraflex group and in 37 patients (5·3%) in the Xience group (absolute difference −0·3% [one-sided 95% upper confidence bound 1·6%], p non-inferiority
Published: 2018

10. Effect of percutaneous interventions within the coronary sinus on the success rate of the implantations of resynchronization pacemakers

Author: Sławomir Pluta, Beata Średniawa, Agata Musialik-Łydka, Radosław Lenarczyk, Patrycja Pruszkowska-Skrzep, Tomasz Kukulski, Zbigniew Kalarus, Mariola Szulik, Oskar Kowalski, Janusz Prokopczuk, Lech Poloński M.D., and Teresa Zielińska
Subjects: Adult, Male, medicine.medical_specialty, Pacemaker, Artificial, Percutaneous, medicine.medical_treatment, Cardiac resynchronization therapy, Internal medicine, medicine, Fluoroscopy, Humans, Angioplasty, Balloon, Coronary, Lead (electronics), Vein, Coronary sinus, Aged, Heart Failure, medicine.diagnostic_test, business.industry, Gold standard, General Medicine, Middle Aged, medicine.disease, Coronary Vessels, Surgery, medicine.anatomical_structure, Heart failure, Cardiology, Feasibility Studies, Female, Stents, Cardiology and Cardiovascular Medicine, business
Abstract: Background: Cardiac resynchronization therapy (CRT) becomes a “gold standard” in therapy of selected patients with advanced heart failure. We set out to evaluate the feasibility and safety of percutaneous interventions within coronary sinus (CS) and their effect on the success rate of left ventricular (LV) lead implantation during CRT. Methods: The study analyzed eight consecutive patients with the indications for CRT, who needed additional procedures within CS to overcome technical problems during left ventricular (LV) electrode implantation. The analyzed group consisted of three subgroups: patients in whom percutaneous balloon angioplasty within CS was needed (n = 4); patients with acute instability of the lead, requiring stenting of the vein to fix the electrode (n = 2); and patients with the stenting of CS due to late dislocation of the lead (n = 2). Success rate, procedure duration, fluoroscopy, complications, and electrical parameters of leads were analyzed. Results: Success rate of the procedures was 87.5%; additional interventions increased overall efficacy of CRT implantation at our center from 88% to 98% (P < 0.05). Procedure duration (155.0 minute) and fluoroscopy time (42.5 minute) remained acceptable for the patient and operator; however, both were higher than in the procedures performed routinely in our hospital. Electrical properties of the LV leads were stable and within normal ranges during the observation period. We noted two local dissections of CS during the procedure, which remained clinically silent. Conclusion: Percutaneous interventions within CS seem to be feasible and safe treatment options, which can improve the short- and long-term success rates of CRT.
Published: 2006

11. Use of the LocaLisa mapping system during ablation procedures in patients with atrioventricular nodal reentrant tachycardia

Author: Oskar, Kowalski, Patrycja, Pruszkowska-Skrzep, Radosław, Lenarczyk, Janusz, Prokopczuk, Sławomir, Pluta, and Zbigniew, Kalarus
Subjects: Electrocardiography, Treatment Outcome, Surgery, Computer-Assisted, Fluoroscopy, Monitoring, Intraoperative, Body Surface Potential Mapping, Catheter Ablation, Humans, Tachycardia, Atrioventricular Nodal Reentry, Prospective Studies, Radiation Dosage, Follow-Up Studies
Abstract: LocaLisa is a novel system for anatomical mapping. It enables an assessment of the three-dimensional position of electrodes within cardiac chambers without fluoroscopy. With this technique it may be possible to reduce radiation exposure during catheter-based ablation procedures.To evaluate the efficacy and safety of ablation procedures performed using the LocaLisa mapping system in patients with atrioventricular nodal reentrant tachycardia (AVNRT).This study evaluated the course of the first 26 ablations performed using the LocaLisa system (studied group). The control group involved 30 consecutive patients with AVNRT treated with the conventional ablation technique that was routinely used prior to the introduction of the novel system into clinical practice.In the studied group procedural duration was 72.4+/-24.9 minutes, in the control group 80.1+/-18.2 minutes (NS). However, radiation exposure was significantly lower in the examined group -- 74.4+/-109.2 mGy compared to 184.8+/-59.9 mGy in the control group (p0.05). All procedures were successful. No complications related to the ablation were observed.Employment of the LocaLisa mapping system enables the reduction of fluoroscopic exposure without any decrease of efficacy or elevation of risk of any complications during AVNRT ablations.
Published: 2006

12. Coronary sinus stenting for the stabilization of left ventricular lead during resynchronization therapy

Author: Oskar Kowalski, Patrycja Pruszkowska-Skrzep, Janusz Prokopczuk, Zbigniew Kalarus, Lech Poloński, and Radosław Lenarczyk
Subjects: Cardiomyopathy, Dilated, Male, medicine.medical_specialty, medicine.medical_treatment, Heart Ventricles, Cardiomyopathy, Cardiac resynchronization therapy, Coronary Angiography, Physiology (medical), Internal medicine, Medicine, Fluoroscopy, Combined Modality Therapy, Humans, Vein, Lead (electronics), Coronary sinus, Heart Failure, medicine.diagnostic_test, business.industry, Cardiac Pacing, Artificial, Stent, Middle Aged, medicine.disease, Surgery, medicine.anatomical_structure, Cardiology, Female, Stents, Cardiology and Cardiovascular Medicine, business
Abstract: We report on two patients treated with cardiac resynchronization therapy, in whom early (intra-operatively, 64-year-old man) and late (4 months post-operatively, 57-year-old woman) instability of the left ventricular (LV) lead occurred. In order to stabilize the electrodes, stents were deployed in both patients within the coronary sinus, into the space between the lead and the wall of the vein effectively pinning the lead to the wall. During 3 and 5 months of follow-up, the electrodes remained stable and allowed for successful resynchronization in both cases. Stenting within the coronary sinus seems to be a safe method for LV lead stabilization, which can substantially increase the success rate of resynchronization therapy. This new approach, although promising, has to prove its safety and should not be practised routinely until long-term follow-up data are available.
Published: 2006

13. Radiofrequency ablation of typical atrial flutter with the use of electro-anatomical mapping system CARTO

Author: Oskar, Kowalski, Zbigniew, Kalarus, Radosław, Lenarczyk, Patrycja, Pruszkowska-Skrzep, Janusz, Prokopczuk, Teresa, Zielińska, and Lech, Poloński
Subjects: Male, Treatment Outcome, Atrial Flutter, Body Surface Potential Mapping, Catheter Ablation, Humans, Female, Middle Aged, Aged
Abstract: Radiofrequency (RF) ablation of typical atrial flutter (AFL) is a well-established method of treatment. Although its efficacy is high, a search for new, more effective techniques is continuing. These new methods include modern systems for electro-anatomical mapping and new types of ablating electrodes such as cooled-tip or dual-sensor catheters.To assess the efficacy of RF ablation of typical AFL with the use of electro-anatomical mapping system CARTO and to compare the effectiveness of various ablating catheters.The study group consisted of 60 consecutive patients who underwent RF ablation of typical AFL with the use of the CARTO system. In 35 patients standard ablating electrodes were used, in 15 -- cooled-tip catheters (Thermo-Cool), and in 10 -- Dual-Sensor catheters.Overall efficacy of RF ablation was 96.6%. In two procedures which occurred ineffective, standard ablating electrodes were used. In 4 (6.6%) patients a recurrence of AFL was noted -- also these patients had RF ablation performed with the use of standard ablating electrodes. None of the patients had procedure-related complications.RF ablation of typical AFL with the use of electro-anatomical system CARTO is effective, safe and associated with reduced fluoroscopy time. The use of cooled-tip or dual sensor ablating electrodes further enhances efficacy of the procedure.
Published: 2005

14. Effectiveness of radiofrequency catheter ablation of right ventricular outflow tract tachycardia using the CARTO system

Author: Patrycja, Pruszkowska-Skrzep, Zbigniew, Kalarus, Beata, Sredniawa, Radosław, Lenarczyk, Oskar, Kowalski, Agata, Musialik-Łydka, Joanna, Stabryła-Deska, Janusz, Prokopczuk, and Anna, Sliwińska
Subjects: Adult, Male, Treatment Outcome, Heart Ventricles, Body Surface Potential Mapping, Catheter Ablation, Tachycardia, Ventricular, Humans, Female, Middle Aged
Abstract: Ventricular ectopy or ventricular tachycardia (VT) originating from the right ventricular outflow tract (RVOT) are the most common forms of arrhythmias in patients with structurally normal heart. Pharmacological treatment is effective in no more than 50% of patients, whereas radio-frequency catheter ablation (RFCA) offers a much higher success rate.To assess early and late outcome in patients with RVOT arrhythmias treated with RFCA combined with electro-anatomical mapping system (CARTO).The study group consisted of 34 consecutive patients (mean age 38.8+/-12.0 years, range 21-52 years, 11 males, 23 females) with symptomatic arrhythmias originating from RVOT, who underwent RFCA in our department between December 2001 to July 2003. RFCA was performed with the use of the CARTO system. The power of RF current was set at 40 Watts, duration -- 90 seconds, and maximal temperature -- 55 degrees C. In order to assess short- and long-term RFCA efficacy, a 24-hour Holter ECG monitoring was performed before RFCA and shortly after the procedure as well as one and three months afterwards. Effective RFCA was defined as the reduction of ventricular ectopy1000 / 24 hours in Holter monitoring performed just after the procedure.Holter ECG monitoring performed after RFCA showed that the procedure was effective in 30 (88.2%) patients. In the remaining four patients no significant reduction in the frequency of ventricular ectopy was noted, however, no complex ventricular arrhythmias were present. In none of the patients neither early nor late complications were observed. The mean follow-up duration was 15.6 months (range 5-26 months). During Holter ECG monitoring performed one and three months after RFCA, a recurrence of frequent ventricular ectopy (7139 beats / 24 hours) was found in one patient, however, without complex arrhythmias. The remaining patients, in whom RFCA was found to be effective at Holter ECG monitoring performed just after the procedure, continue to be free from arrhythmia and do not require antiarrhythmic agents.RFCA with the use of the CARTO system is effective and safe in the treatment of arrhythmias originating from RVOT.
Published: 2005

15. [Diagnostic difficulties in acute pulmonary embolism diagnosis: ECG changes evolution: a case report]

Author: Ewa, Markowicz-Pawlus, Teresa, Zielińska, Janusz, Prokopczuk, and Jacek, Kaczmarski
Subjects: Diagnosis, Differential, Male, Electrocardiography, Fibrinolytic Agents, Acute Disease, Angiography, Humans, Streptokinase, Middle Aged, Pulmonary Embolism, Lung
Abstract: Pulmonary embolism is a common disease which may cause diagnostic difficulties. To establish a diagnosis additional examinations are needed. Except typical for pulmonary embolism EKG changes the value of untypical ST-T changes connected with cardiac ischaemia is appreciated. The case below presents the usefulness of EKG monitoring in acute pulmonary embolism.
Published: 2004

16. [Atrio-ventricular nodal reentrant tachycardia--concepts evolution on the propagation of the reentrant wave front]

Author: Radosław, Lenarczyk, Zbigniew, Kalarus, Oskar, Kowalski, Janusz, Prokopczuk, and Stanisław, Pasyk
Subjects: Catheter Ablation, Humans, Tachycardia, Atrioventricular Nodal Reentry
Abstract: Atrio-ventricular nodal reentrant tachycardia (AVNRT) is the most common narrow QRS tachycardia. The arrhythmia affects usually patients without any other structural heart disease. AVNRT may be the cause of the broad spectrum of symptoms, ranging from palpitations to clinical signs of impaired coronary and cerebral perfusion. Mechanism responsible for AVNRT is reentry, which involves right and some part of the left atrium. Employed in the early 80's the technique of radiofrequency current (RF) ablation (which allows removal of arrhythmic substrate by modification or destruction of the slow pathway), is safe and a high effective method of treatment in patients with AVNRT.
Published: 2003

17. [Permanent junction reciprocating tachycardia--treatment with radiofrequency current ablation]

Author: Zbigniew, Kalarus, Janusz, Prokopczuk, Oskar, Kowalski, Radosław, Lenarczyk, Patrycja, Pruszkowska-Skrzep, and Beata, Sredniawa
Subjects: Adult, Male, Electrocardiography, Treatment Outcome, Adolescent, Tachycardia, Ectopic Junctional, Catheter Ablation, Humans, Female, Wolff-Parkinson-White Syndrome, Tachycardia, Paroxysmal
Abstract: The patients with WPW syndrome demonstrate wide scale of clinical manifestation, from asymptomatic course to sudden cardiac death. Among this patients it is possible to identify the small group of patients with rare kind of atrioventricular reentrant tachycardia named permanent junctional reciprocating tachycardia (PJRT) associated with increased risk of development tachycardia-induced cardiomyopathy. This patients should be successful treated by radiofrequency catheter ablation (RFCA). Aim of the study was assessment of efficacy and safety of RFCA procedure in patients with preexcitation syndrome and PJRT. Analyzed group consisted of 7 patients with PJRT selected from 163 consecutive patients with symptomatic WPW--syndrome undergo electrophysiological study (EPS) and RFCA. Analyzed group consist of 4 women and 3 men. Mean age of patients was 22.71 SD +/- 7.99 (from 14 to 38 years). Every patients underwent EPS and RFCA simultaneously. Success-rate in first session was 71.42% (5 patients were successful ablated). Two women underwent second ablation one who has recurrent symptomatic arrhythmia and another who initially was unsuccessfully treated in first session. This two additional procedures were successful. RFCA-duration time was average 107.85 minutes SD +/- 21.95 (min-80, max-145 min) and fluoroscopy--time amount from 28 min to 55 min average 38.58 min (SD +/- 11.14). Among analyzed patients we did not noticed any complications during ablation procedure. Patients with PJRT could be safe and successfully treated using RFCA.
Published: 2002

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17 results on '"Janusz Prokopczuk"'

1. Impact of COVID-19 pandemic on acute heart failure admissions and mortality: a multicentre study (COV-HF-SIRIO 6 study)

2. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug‐Eluting Stent Implantation: Per‐Protocol Analysis of the GLOBAL LEADERS Trial

3. Comparison of Investigator-Reported and Clinical Event Committee-Adjudicated Outcome Events in GLASSY

4. Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial

5. Predictive ability of ACEF and ACEF II score in patients undergoing percutaneous coronary intervention in the GLOBAL LEADERS study

6. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial

7. Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting

8. Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). [Protocol]

9. Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial

10. Effect of percutaneous interventions within the coronary sinus on the success rate of the implantations of resynchronization pacemakers

11. Use of the LocaLisa mapping system during ablation procedures in patients with atrioventricular nodal reentrant tachycardia

12. Coronary sinus stenting for the stabilization of left ventricular lead during resynchronization therapy

13. Radiofrequency ablation of typical atrial flutter with the use of electro-anatomical mapping system CARTO

14. Effectiveness of radiofrequency catheter ablation of right ventricular outflow tract tachycardia using the CARTO system

15. [Diagnostic difficulties in acute pulmonary embolism diagnosis: ECG changes evolution: a case report]

16. [Atrio-ventricular nodal reentrant tachycardia--concepts evolution on the propagation of the reentrant wave front]

17. [Permanent junction reciprocating tachycardia--treatment with radiofrequency current ablation]

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