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1. Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study

Author

Ronny R Buechel, Gregg W Stone, Giulio Pompilio, Antonio L Bartorelli, Saima Mushtaq, Enrico Ferrari, Mark La Meir, Johan De Mey, Ulrich Schneider, Ulf Teichgräber, Robbert de Winter, Brian Thomsen, Charles Taylor, Campbell Rogers, and Yoshinobu Onuma

Subjects
Medicine
Abstract

Introduction The previously published SYNTAX III REVOLUTION trial demonstrated that clinical decision-making between coronary artery bypass graft (CABG) and percutaneous coronary intervention based on coronary CT angiography (CCTA) had a very high agreement with the treatment decision derived from invasive coronary angiography (ICA). The study objective of the FASTTRACK CABG is to assess the feasibility of CCTA and fractional flow reserve derived from CTA (FFRCT) to replace ICA as a surgical guidance method for planning and execution of CABG in patients with three-vessel disease with or without left main disease.Methods and analysis The FASTTRACK CABG is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept and first-in-man study with feasibility and safety analysis. Surgical revascularisation strategy and treatment planning will be solely based on CCTA and FFRCT without knowledge of the anatomy defined by ICA. Clinical follow-up visit including CCTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularisation with respect to the surgical planning based on non-invasive imaging (CCTA) with functional assessment (FFRCT) and compared with ICA. Primary feasibility endpoint is CABG planning and execution solely based on CCTA and FFRCT in 114 patients. Primary safety endpoint based on 30 day CCTA is graft assessment and topographical adequacy of the revascularisation procedure. Automatic non-invasive assessment of functional coronary anatomy complexity is also evaluated with FFRCT for functional Synergy Between percutaneous coronary intervention With Taxus and Cardiac Surgery Score assessment on CCTA. CCTA with FFRCT might provide better anatomical and functional analysis of the coronary circulation leading to appropriate anatomical and functional revascularisation, and thereby contributing to a better outcome.Ethics and dissemination Each patient has to provide written informed consent as approved by the ethical committee of the respective clinical site. Results will be submitted for publication in peer-reviewed journals and will be disseminated at scientific conferences.Trial registration number NCT04142021.

Published
2020
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2. Cangrelor With and Without Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing Percutaneous Coronary Intervention

Author

Muthiah Vaduganathan, Robert A. Harrington, Gregg W. Stone, Efthymios N. Deliargyris, Ph. Gabriel Steg, C. Michael Gibson, Christian W. Hamm, Matthew J. Price, Alberto Menozzi, Jayne Prats, Steven Elkin, Kenneth W. Mahaffey, Harvey D. White, Deepak L. Bhatt, Fernando Cura, Miguel Ballarino, Anibal Agustín Damonte, Diego Grinfeld, Carlos Alejandro Álvarez, Alberto Fernandez, Ahmad Farshid, Brendan Gunalingam, Craig Jeurgens, Harry Lowe, Hisham Hallani, Greg Nelson, Gishel New, Ronald Dick, Jeffrey Lefkovits, Stephen Duffy, Nick Bett, Raibhan Yadav, Paul Garrahy, Ron Lehman, Philip Aylward, John Horowitz, Matthew Worthley, David Cross, Jaime Rankin, Peter Thompson, Phil Roberts-Thomson, Rohan Jayasinghe, Con Aroney, Kurt Huber, Franz Leisch, Johann Altenberger, Georg Gaul, Thomas Neunteufl, Franz Weidinger, Herwig Schuchlenz, Heinrich Weber, Werner Benzer, Paulo Rossi, Breno Almeida, Antonio Godinho, Fabio Vilas-Boas, Luciano Vacanti, Renato Serpa, José Antonio Jatene, Gilmar Reis, Jamil Saad, Marcos Marino, Roberto Botelho, Constantino Costantini, Ricardo Wang, Dalton Precoma, Miguel Rati, Luis Bodanese, Euler Manenti, João Paulo Zouvi, Rogerio Tumelero, Arthur Herdy, Eulogio Martinez Filho, Antônio Carvalho, Roberto Franken, Lawrence Title, Charles Lazzam, Francois Reeves, Tamaz Shaburishvili, Gulnara Chapidze, Merab Mamatsashvili, Irakli Khintibidze, Hubertus Heuer, Hans-Georg Olbrich, Sabine Genth-Zotz, Sven Moebius-Winkler, Michael Buerke, Stefan Hoffmann, Peter Radke, Helge Moellmann, Hugo Katus, Hans-Friedrich Voehringer, Christian Hengstenberg, Volker Klauss, Johannes Brachmann, Aftab Khan, Sampath Kumar, Padinhare Mohanan, Praveen Chandra, Maddury Rao, S.S. Ramesh, Keyur Parikh, Arun Srinivas, Nakul Sinha, V.S. Prakash, Shirish Hiremath, Anil Mishra, Sanjeeb Roy, Kamal Sethi, Ashwani Mehta, Tejas Patel, Suman Bhandari, Milind Gadkari, Stefano De Servi, Giuseppe Musumeci, Bernardo Cortese, Giancarlo Marenzi, Raffaele De Caterina, Ralph Stewart, Gerard Devlin, Scott Harding, John Elliott, Gerard Wilkins, Douglas Scott, Slawomir Dobrzycki, Waldemar Dorniak, Dariusz Dudek, Zbigniew Gasior, Jaroslaw Hiczkiewicz, Zdzislawa Kornacewicz-Jach, Leszek Kubik, Krzysztof Kuc, Jerzy Kuzniar, Walentyna Mazurek, Jakub Ostrowski, Michal Tendera, Andrzej Wisniewski, Elzbieta Zinka, Krzysztof Zmudka, Jana Pawła, Maciej Kosmider, null Seweryna, Andres Iñiguez, Rafael Melgares, Francisco Goicolea, Jose Hernandez, Javier Zueco, Igor Kraiz, Mykola Vatutin, Anatoliy Polyakov, Yury Sokolov, Kenneth House, Charles Campbell, Timothy Trageser, Kenneth Baran, Neal Kleiman, Roberto Medina, Roger Hill, M. Zubair Jafar, David Drenning, Herbert Ladley, Ahed Nahhas, Alan Niederman, Amit Goyal, William Abernethy, Naseem Jaffrani, Richard Zelman, Brian Negus, Jose Marquez, Ehtisham Mahmud, William French, John Paulowski, Charles Pollack, Mark Mines, Robert Federici, Marc Schweiger, Kalim Habet, Ofsman Quintana, Thomas Nygaard, Steve Orlow, Douglas Spriggs, Ivan Chavez, Mark Warner, Richard Paulus, David Cochran, Cary Hirsch, Ajay Virmani, Peter Soukas, Nalin Srivastava, L. Norman Ferrier, Annapoorna Kini, Mark Greenberg, Howard Herrmann, Valerian Fernandes, Barry Bertolet, Ron Waksman, Joseph Henderson, Harinder Gogia, Maged Amine, Kourosh Mastali, Thomas Stuckey, Peter Hui, Luigi Pacifico, Todd Caulfield, Wilson Ginete, William Ballard, Robert Iwaoka, Joseph Stella, Vijay Misra, Costa Andreou, Michele Voeltz, Wayne Batchelor, Cezar Staniloae, Sanford Gips, Jeffrey Kramer, Paul Mahoney, John Wang, Prospero Gogo, David Rizik, Rex Winters, Garry MacKenzie, Stephen Jenkins, Paul Teirstein, Pierre Leimgruber, J. Christopher Scott, Seth Krauss, Steven Rohrbeck, Robert Martin, Gustavo Grieco, Louis Cannon, Don Westerhausen, F. David Fortuin, Steven Schulman, Joel Cohn, Brent McLaurin, Jorge Saucedo, Robert Wozniak, Jack Hall, Kevin Marzo, Merrill Krolick, Lawrence Gimple, Eric Hockstad, Arsenio Rodriguez, John Kao, Adhir Shroff, Michael Attubato, Ramon Quesada, Ernesto Rivera, Dean Kereiakes, Russell Raymond, Thomas Amidon, David Lee, Spencer King, John Douglas, Abnash Jain, J. Patrick Kleaveland, Mitchell Driesman, Krishna Kumar, Glen Kowalchuk, Behzad Taghizadeh, Lawrence Barr, Keith Benzuly, Tarek Helmy, Duane Pinto, Joseph Aragon, Reginald Low, Phillip Horwitz, Thomas LeGalley, Dominick Angiolillo, Rajesh Sachdeva, Kenneth Kent, Luis Gruberg, Richard Bach, Thomas Pow, Charles O'Shaughnessy, Shing Wong, Saeed R. Shaikh, Arthur Reitman, Mark Lawrence, Alejandro Garcia Escudero, Carlos Poy, Miguel Miceli, Antonio Pocovi, Hugo Londero, Jorge Baccaro, Leonid Polonetsky, Aliaksey Karotkin, Leanid Shubau, Eduardo Maffini, Bruno Machado, José Airton, Valter Lima, Jose Jatene, Marco Perin, Paulo Caramori, Iran Castro, Ivan Manukov, Mladen Grigorov, Plamen Milkov, Julia Jorgova, Svetoslav Georgiev, Nizar Rifai, Alexander Doganov, Ivo Petrov, William Hui, Jean-Francois Tanguay, Marek Richter, Frantisek Tousek, Zdenek Klimsa, Michal Padour, Jan Mrozek, Marian Branny, Zdenek Coufal, Stanislav Simek, Vladimir Rozsival, Leos Pleva, Josef Stasek, Petr Kala, Ladislav Groch, Viktor Kocka, Rajesh Jain, Darshan Banker, Lanka Krishna, Hasit Joshi, Jaspal Arneja, Virgilijus Grinius, Sigute Norkiene, Birute Petrauskiene, Rolf Michels, Melvin Tjon, Hans de Swart, Robbert de Winter, Harvey White, Malcolm Abernethey, Alexander Osiev, Kirill Linev, Svetlana Kalinina, Svetlana Baum, Elena Kosmachova, Zaur Shogenov, Valentin Markov, Svetlana Boldueva, Olga Barbarash, Victor Kostenko, Elena Vasilieva, Aleksey Gruzdev, Victor Lusov, Pavel Dovgalevsky, Oleg Azarin, Sergey Chernov, Olga Smolenskaya, Alexey Duda, Viliam Fridrich, Marian Hranai, Martin Studenčan, Peter Kurray, John Bennett, Pieter Blomerus, Laurence Disler, Johannes Engelbrecht, Eric Klug, Robert Routier, Tjaart Venter, Nico Van Der Merwe, Anthony Becker, Kwang-Soo Cha, Seung-Hwan Lee, Sang-Jin Han, Tae Jin Youn, Seung-Ho Hur, Hong Seog Seo, Hun-Sik Park, Chong-Yun Rhim, Wook-Bum Pyun, Hyunmin Choe, Myung-Ho Jeong, Jong-Seon Park, Eak-Kyun Shin, Felipe Hernández, Jaume Figueras, Rosana Hernández, José Ramón López-Minguez, José Ramón González Juanatey, Ramón López Palop, Guillermo Galeote, Noppadol Chamnarnphol, Wacin Buddhari, Nakarin Sansanayudh, Srun Kuanprasert, William Penny, Charles Lui, Garfield Grimmett, Venkatraman Srinivasan, Kevin Ariani, Waqor Khan, James Blankenship, Steven Eisenberg, Jerry Greenberg, Jeffrey Breall, Harish Chandna, Paul Tolerico, Georges Nseir, Adam Greenbaum, Pierre Istfan, Joel Sklar, Robert Smith, Nicholaos Xenopoulos, Mahesh Mulumudi, James Hoback, Gregory Eaton, John Griffin, Ramin Ebrahimi, Robert Lundstrom, Dogan Temizer, Kenneth Tam, Jose Suarez, Amish Raval, Jay Kaufman, Emmanouil Brilakis, Michael Stillabower, Kathleen Quealy, Boris Nunez, Bruce Samuels, Agustin Argenal, Vankeepuram Srinivas, Andrew Rosenthal, Pradyumna Tummala, Paul Myers, Nelson LaMarche, Michael Chan, Daniel Simon, Richard Kettelkamp, Gary Schaer, Edward Kosinski, Maurice Buchbinder, Mukesh Sharma, Mark Goodwin, J. Tift Mann, David Holmes, Sunil Rao, Michael Azrin, Roger Gammon, Kreton Mavromatis, Abdel Ahmed, Marcel Zughaib, R. Jeffrey Westcott, Ash Jain, Georg Delle-Karth, Jamil Abdalla Saad, Alexandre Abizaid, Carlos Augusto Formiga Areas, Expedito E. Ribeiro, Fabio Rossi Dos Santos, Rogerio Tadeu Tumelero, Roberto Vieira Botelho, Borislav Atzev, Boicho Boichev, Georgi Grigorov, Nikolay Penkov, Boris Zehirov, Pavel Cervinka, Petr Hajek, David Horak, Petr Kmonicek, Jan Sitar, Nodar Emukhvari, George Khabeishvili, Steffen Behrens, Harald Darius, Martin Dissmann, Stephan Fichtlscherer, Wolfgang Franz, Tobias Geisler, Britta Goldmann, Andreas Mugge, Tudor Poerner, Gert Richardt, Christoph Stellbrink, Nikos Werner, Ezio Bramucci, Gennaro Galasso, Andrea Picchi, Patrizia Presbitero, Alexander Sasse, Szyszka Andrzej, Witold Dubaniewicz, Jaroslaw Kasprzak, Andrzej Kleinrok, Andrzej Rynkiewicz, Cezary Sosnowski, Radoslaw Targonski, Jaroslaw Trebacz, Adam Witkowski, Yakov Dovgalevsky, Ivan Gordeev, Prokhor Pavlov, Sergey Shalaev, Irina Sukmanova, Alexey Yakovlev, Sarana Boonbaichaiyapruck, Pinij Kaewsuwanna, Dilok Piyayotai, Imran Arif, Joseph Cinderella, Brent Davis, Chandanreddy Devireddy, Mark Dorogy, Norman Ferrier, Daniel Fisher, Robert Foster, John Galla, Raghava Gollapudi, James Hermiller, Richard Heuser, Zubair Jafar, Carey Kimmelstiel, Scott Kinlay, James Leggett, Dustin Letts, Michael Lipsitt, Joaquin Martinez-Arraras, Marc Mayhew, Paul McWhirter, Ayoub Mirza, William O'Riordan, John Petersen, Hector Picon, Mark Picone, Matthew Price, Virender Sethi, Craig Siegel, Daniel Steinberg, Jeffrey Tauth, Mladen Vidovich, Jonathan Waltman, and Michael Wilensky

Subjects
Male, medicine.medical_specialty, Ticlopidine, medicine.medical_treatment, Myocardial Ischemia, Hemorrhage, Platelet Glycoprotein GPIIb-IIIa Complex, 030204 cardiovascular system & hematology, Cohort Studies, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Cangrelor, P2Y12, Double-Blind Method, Internal medicine, medicine, Humans, Prospective Studies, 030212 general & internal medicine, Angioplasty, Balloon, Coronary, Infusions, Intravenous, Aged, Aspirin, business.industry, Percutaneous coronary intervention, Middle Aged, Clopidogrel, Adenosine Monophosphate, Surgery, Treatment Outcome, chemistry, Glycoprotein IIb/IIIa inhibitors, Conventional PCI, Eptifibatide, Cardiology, Platelet aggregation inhibitor, Drug Therapy, Combination, Female, Cardiology and Cardiovascular Medicine, business, Platelet Aggregation Inhibitors, medicine.drug
Abstract

Background Cangrelor, an intravenous, reversible P2Y12 antagonist, is approved for use in patients undergoing percutaneous coronary intervention (PCI). Objectives This study sought to evaluate the efficacy and safety of cangrelor compared with clopidogrel in subgroups that did and did not receive glycoprotein IIb/IIIa inhibitors (GPIs). Methods This pooled, patient-level analysis of the 3 CHAMPION (Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition) trials analyzed all randomized patients who underwent PCI and received the study drug (n = 24,902). Only bailout/rescue GPI use was permitted, except in CHAMPION PCI, in which routine or bailout/rescue GPI use was at the site investigator’s discretion. The primary efficacy endpoint was the composite of all-cause mortality, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 h after randomization. Results Overall, 3,173 patients (12.7%) received a GPI, most commonly eptifibatide (69.4%). Despite variation in indications for GPIs, baseline characteristics were well balanced between the cangrelor and clopidogrel arms in subsets receiving and not receiving GPIs. Rates of the primary composite endpoint were lower with cangrelor compared with clopidogrel in patients who did (4.9% vs. 6.5%; odds ratio [OR]: 0.74; 95% confidence interval [CI]: 0.55 to 1.01) or did not receive a GPI (3.6% vs. 4.4%; OR: 0.82; 95% CI: 0.72 to 0.94; Pint = 0.55). Cangrelor did not increase the primary safety endpoint, GUSTO-defined severe/life-threatening bleeding, in patients who did (0.4% vs. 0.5%; OR: 0.71; 95% CI: 0.25 to 1.99) or did not receive GPIs (0.2% vs. 0.1%; OR: 1.56; 95% CI: 0.80 to 3.04; Pint = 0.21). GPI use was associated with increased risk of bleeding in both treatment arms. Conclusions Cangrelor’s efficacy in reducing ischemic complications in patients undergoing PCI was maintained irrespective of GPI administration. GPI use was associated with substantially higher bleeding rates, regardless of the randomization to cangrelor or clopidogrel. (A Clinical Trial to Demonstrate the Efficacy of Cangrelor [PCI]: NCT00305162 ; Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition [PLATFORM]: NCT00385138 ; A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX] [CHAMPION]: NCT01156571 )

Published
2017

3. Long-term safety and sustained left ventricular recovery: Long-term results of percutaneous left ventricular support with Impella LP2.5 in ST-elevation myocardial infarction

Author

Annemarie E, Engström, Annemarie, Engström, Krischan D, Sjauw, Krischan, Sjauw, Jan, Baan, Maurice, Remmelink, Bimmer E P M, Claessen, Bimmer, Claessen, Wouter J, Kikkert, Wouter, Kikkert, Loes P C, Hoebers, Loes, Hoebers, Marije M, Vis, Marije, Vis, Karel T, Koch, Karel, Koch, Martijn M, Meuwissen, Martijn, Meuwissen, Jan G P, Tijssen, Jan, Tijssen, Robbert J, De Winter, Robbert, De Winter, Jan J, Piek, Jan, Piek, José P S, Henriques, José, Henriques, Cardiology, and Amsterdam Cardiovascular Sciences

Subjects
Aortic valve, Male, medicine.medical_specialty, medicine.medical_treatment, Myocardial Infarction, 030204 cardiovascular system & hematology, Ventricular Function, Left, 03 medical and health sciences, Electrocardiography, 0302 clinical medicine, Internal medicine, medicine, Humans, 030212 general & internal medicine, Myocardial infarction, cardiovascular diseases, Angioplasty, Balloon, Coronary, Impella, Ejection fraction, medicine.diagnostic_test, business.industry, Hemodynamics, Percutaneous coronary intervention, Middle Aged, medicine.disease, 3. Good health, medicine.anatomical_structure, Echocardiography, Ventricular assist device, Aortic Valve, Conventional PCI, Cardiology, cardiovascular system, Female, Heart-Assist Devices, Cardiology and Cardiovascular Medicine, business
Abstract

Aims: Mechanical left ventricular (LV) unloading may reduce infarct size when combined with primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEM I). The Impella LP2.5 is a novel percutaneous left ventricular assist device. Although the short-term safety and feasibility of this device have been demonstrated, the long-term effects are unknown. The purpose of the current study was to evaluate the long-term effects of the Impella LP2.5 support on the aortic valve and left ventricular ejection fraction (LVEF). Methods and results: In 2006, 10 patients with anterior STEMI received 3-day support with the Impella LP2.5 after PCI. The control group consisted of 10 comparable patients, treated according to routine care. For the current study, echocardiography was performed and adverse events were recorded. Mean duration of follow-up was 2.9+/-0.6 years in the Impella group and 3.0+/-0.3 years in the control group. No differences in aortic valve abnormalities and LVEF were demonstrated between the groups; nevertheless, LVEF increase from baseline was significantly greater in Impella-treated patients (23.6+/-8.9% versus 6.7+/-7.0%, P=0.008). Conclusions: Three-day support with the Impella LP2.5 is not associated with adverse effects on the aortic valve at long-term follow-up. LVEF was similar in both groups; however, recovery was significantly greater in the Impella group

Published
2011
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