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1. 1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry

Author

Jaya Chandrasekhar, Usman Baber, Samantha Sartori, Melissa B. Aquino, Petr Hájek, Borislav Atzev, Martin Hudec, Tiong Kiam Ong, Martin Mates, Borislav Borisov, Hazem M. Warda, Peter den Heijer, Jaroslaw Wojcik, Andres Iniguez, Zdeněk Coufal, Ahmed Khashaba, Muhammad Munawar, Robert T. Gerber, Bryan P. Yan, Paula Tejedor, Petr Kala, Houng Bang Liew, Michael Lee, Deborah N. Kalkman, George D. Dangas, Robbert J. de Winter, Antonio Colombo, and Roxana Mehran

Subjects
PARIS bleeding risk score, COMBO stent, Endothelial progenitor cell capture, Dual therapy stent, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: The COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. Objective: We analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. Methods: MASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score ≤ 3 and intermediate-to-high (IHBR) for score > 3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. Results: The study included 56% (n = 1270) LBR and 44% (n = 1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p = 0.047) driven by cardiac death (1.7% vs. 0.7%, p = 0.029) with similar rates of MI (1.8% vs. 1.1%, p = 0.17), TLR (1.5% vs. 1.6%, p = 0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p = 0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p = 0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p

Published
2020
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2. Sex differences in 1-year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the COMBO collaboration

Author

Borislav Atzev, Robert Gerber, Antonio Colombo, Martin Hudec, Peter den Heijer, Melissa Aquino, Muhammad Munawar, Usman Baber, Michael S. Lee, Bryan P. Yan, Roxana Mehran, Jan G.P. Tijssen, Karel T. Koch, Deborah N. Kalkman, Robbert J. de Winter, Andrés Iñiguez, Hazem M. Warda, George Dangas, Ahmed Khashaba, Pier Woudstra, Laura S.M. Kerkmeijer, Samantha Sartori, Petr Hájek, Tiong Kiam Ong, Jaya Chandrasekhar, Borislav Borisov, Jarosław Wójcik, Marcel A.M. Beijk, Martin Mates, Zdeněk Coufal, Cardiology, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, and ACS - Pulmonary hypertension & thrombosis

Subjects
Target lesion, Male, endothelial progenitor cell capture, sex differences, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Infarction, Coronary Artery Disease, 030204 cardiovascular system & hematology, Dual therapy stent, Prosthesis Design, Article, 03 medical and health sciences, 0302 clinical medicine, dual therapy stent, Risk Factors, Internal medicine, medicine, Clinical endpoint, Humans, Radiology, Nuclear Medicine and imaging, 030212 general & internal medicine, Sex Characteristics, business.industry, Proportional hazards model, Incidence (epidemiology), percutaneous coronary intervention, Percutaneous coronary intervention, Drug-Eluting Stents, General Medicine, medicine.disease, Treatment Outcome, Drug-eluting stent, Female, Stents, Cardiology and Cardiovascular Medicine, business, anti-CD34 antibodies
Abstract

BACKGROUND The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization. METHODS AND RESULTS We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV-MI (1.5% vs. 1.1%, p = .32), or CD-TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069). CONCLUSIONS Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.

Published
2021

3. 1-Year Clinical Outcomes of All-Comer Patients Treated With the Dual-Therapy COMBO Stent

Author

Robbert J. de Winter, Jaya Chandrasekhar, Deborah N. Kalkman, Melissa B. Aquino, Pier Woudstra, Marcel A. Beijk, Samantha Sartori, Usman Baber, Jan G. Tijssen, Karel T. Koch, George D. Dangas, Antonio Colombo, Roxana Mehran, Tiong Kiam Ong, Michael Lee, Andres Iniguez, Stephen Rowland, Newsha Ghodsi, Steven Marx, Douglas DiStefano, Jesse Weinberger, Shing Chiu Wong, Bruce Darrow, David Kaufman, Mark Milstein, Melissa Aquino, Clayton Snyder, Theresa Franklin-Bond, Jin Young Cha, Lynn Vandertie, Emma Whittaker, Kate Allen, Birgit Vogel, Serdar Farhan, Sabato Sorrentino, Zhen Ge, Marc Carlier, Suzanne Pourbaix, Borislav Borisov, Borislav Atzev, Dobrin Vasilev, Christos Christou, Ladislav Pešl, Zdeněk Coufal, Petr Kala, Petr Jeřábek, Petr Hájek, Alexander Schee, Roman Ondrejcak, Vladimír Rozsíval, Jan Matějka, Martin Mates, Ahmed Khashaba, Hazem Warda, Sulev Margus, Bryan Yan, Cheuk Sum Lam, Tak Sun Chung, Li Wah Tam, Alan Ka Chun Chan, Ping Tim Tsui, Kin Lam Tsui, Teguh Santoso, Muhammad Munawar, Muhammad Syukri, Dasdo Antonius Sinaga, Alessandro Lupi, Carlo Briguori, Oteh Maskon, Sazzli Kazim, Chuey Yan Lee, Houng Bang Liew, Rosli Mohammad Ali, Ramesh Singh, Peter Den Heijer, Jaroslaw Wojcik, Vladan Vukčević, Martin Hudec, Anton Farkaš, Stanislav Juhás, Monika Jankajová, Milan Dragula, Carlos Cuellas Ramon, Paula Tejedor, Fernando Lozano Ruiz-Poveda, Alfonso Torres Bosco, Essia Boughzela, Medhi Slim, Habib Haouala, Dhaker Lahidheb, Mohamed Rachid Boujnah, Grahame K. Goode, Sukhbir Dhamrait, Robert Gerber, Piers Clifford, Timothy Kinnaird, Gabriel Varnagy, Pedro J. Aguiar R., Thuong Van Huynh, Ian B Menown, Peter den Heijer, Arnoud WJ van't Hof, Andrejs Erglis, Harry Suryapranata, Karin E Arkenbout, Andrés Iñiguez, Philippe Muller, Jan Tijssen, Robbert J de Winter, Marcel A Beijk, Karel Koch, and Deborah N Kalkman

Subjects
Target lesion, medicine.medical_specialty, Acute coronary syndrome, Everolimus, business.industry, medicine.medical_treatment, Stent, Percutaneous coronary intervention, 030204 cardiovascular system & hematology, equipment and supplies, medicine.disease, Surgery, 03 medical and health sciences, 0302 clinical medicine, Sirolimus, medicine, Clinical endpoint, 030212 general & internal medicine, Myocardial infarction, Cardiology and Cardiovascular Medicine, business, medicine.drug
Abstract

Objectives The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort. Background The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization. Methods The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF. Results A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF. Conclusions In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002)

Published
2018

4. Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX

Author

Matthew A. Cavender, Robert A. Harrington, Gregg W. Stone, Ph. Gabriel Steg, C. Michael Gibson, Christian W. Hamm, Matthew J. Price, Renato D. Lopes, Sergio Leonardi, Efthymios N. Deliargyris, Jayne Prats, Kenneth W. Mahaffey, Harvey D. White, Deepak L. Bhatt, Kurt Huber, Valter C. Lima, Julia B. Jorgova-Makedonska, Petr Widimský, Bondo Kobulia, Peter W. Radke, Ezio Bramucci, Adam Witkowski, Evgeny Shlyakhto, Frans Van de Werf, David P. Faxon, E. Magnus Ohman, Freek W.A. Verheugt, W. Douglas Weaver, Jan G.P. Tijssen, Matthew Wilson, Stacey Mangum, Chiara Melloni, Matthew J. Brennan, Pierluigi Tricoci, Robert Harrison, Pedro Barros, Luciana Armaganijan, Monique Anderson, Akshay Bagai, Philippe Généreux, Sorin J. Brener, Laura LaSalle, Werner Benzer, Georg Delle-Karth, Franz Leisch, 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, Ivo Petrov, Boris Zehirov, Pavel Cervinka, Zdenek Coufal, Petr Hajek, David Horak, Petr Kala, Petr Kmonicek, Viktor Kocka, Jan Mrozek, Stanislav Simek, Jan Sitar, Josef Stasek, Frantisek Tousek, Gulnara Chapidze, Nodar Emukhvari, George Khabeishvili, Merab Mamatsashvili, Tamaz Shaburishvili, Steffen Behrens, Harald Darius, Martin Dissmann, Stephan Fichtlscherer, Wolfgang Franz, Tobias Geisler, Sabine Genth-Zotz, Britta Goldmann, Hubertus Heuer, Stefan Hoffmann, Andreas Mugge, Tudor Poerner, Peter Radke, Gert Richardt, Christoph Stellbrink, Nikos Werner, Stefano De Servi, Gennaro Galasso, Alberto Menozzi, Giuseppe Musumeci, Andrea Picchi, Patrizia Presbitero, Gerard Devlin, Alexander Sasse, Douglas Scott, Ralph Stewart, Szyszka Andrzej, Witold Dubaniewicz, Zbigniew Gasior, Jaroslaw Kasprzak, Andrzej Kleinrok, Zdzislawa Kornacewicz-Jach, Andrzej Rynkiewicz, Cezary Sosnowski, Radoslaw Targonski, Jaroslaw Trebacz, Elzbieta Zinka, Olga Barbarash, Yakov Dovgalevsky, Ivan Gordeev, Svetlana Kalinina, Elena Kosmachova, Valentin Markov, Prokhor Pavlov, Sergey Shalaev, Zaur Shogenov, Irina Sukmanova, Elena Vasilieva, Alexey Yakovlev, Sarana Boonbaichaiyapruck, Noppadol Chamnarnphol, Pinij Kaewsuwanna, Srun Kuanprasert, Dilok Piyayotai, Maged Amine, Dominick Angiolillo, Imran Arif, James Blankenship, Emmanouil Brilakis, Michael Chan, Joseph Cinderella, Brent Davis, Chandanreddy Devireddy, Mark Dorogy, John Douglas, Norman Ferrier, Daniel Fisher, Robert Foster, William French, John Galla, Lawrence Gimple, Harinder Gogia, Prospero Gogo, Raghava Gollapudi, Luis Gruberg, James Hermiller, Richard Heuser, Robert Iwaoka, Zubair Jafar, Carey Kimmelstiel, Scott Kinlay, James Leggett, Pierre Leimgruber, Dustin Letts, Michael Lipsitt, Reginald Low, Joaquin Martinez-Arraras, Marc Mayhew, Brent McLaurin, Paul McWhirter, Ayoub Mirza, Brian Negus, Thomas Nygaard, William O’Riordan, Richard Paulus, John Petersen, Hector Picon, Mark Picone, Ernesto Rivera, David Rizik, Arsenio Rodriguez, Jorge Saucedo, J. Christopher Scott, Virender Sethi, Adhir Shroff, Craig Siegel, Douglas Spriggs, Daniel Steinberg, Michael Stillabower, Thomas Stuckey, Jose Suarez, Jeffrey Tauth, Dogan Temizer, Mladen Vidovich, Michele Voeltz, Jonathan Waltman, Michael Wilensky, ACS - Heart failure & arrhythmias, and Cardiology

Subjects
percutaneous coronary intervention, P2Y12 receptor antagonist, Original Articles, Adenosine Monophosphate, Clopidogrel, Coronary Interventions, Treatment Outcome, myocardial infarction, Purinergic P2Y Receptor Antagonists, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Humans, Cardiology and Cardiovascular Medicine, Platelet Aggregation Inhibitors, coronary artery disease, thrombosis
Abstract

Supplemental Digital Content is available in the text., Background: Thrombotic events are reduced with cangrelor, an intravenous P2Y12 inhibitor. We sought to characterize the timing, number, and type of early events (within 2 hours of randomization) in CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). Methods: CHAMPION PHOENIX was a double-blind, placebo-controlled trial that randomized patients undergoing percutaneous coronary intervention to cangrelor or clopidogrel. For this analysis, we evaluated the efficacy of cangrelor in the first 2 hours postrandomization with regards to the primary end point (death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis). Sensitivity analyses were performed evaluating a secondary, post hoc end point (death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium definite stent thrombosis). Results: The majority of events (63%) that occurred in the trial occurred within 2 hours of randomization. The most common early event was myocardial infarction; next were stent thrombosis, ischemia driven revascularization, and death. In the first 2 hours after randomization, cangrelor significantly decreased the primary composite end point compared with clopidogrel (4.1% versus 5.4%; hazard ratio, 0.76 [95% CI, 0.64–0.90], P=0.002). Similar findings were seen for the composite end point of death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium stent thrombosis at 2 hours (0.9% versus 1.6%; hazard ratio, 0.57 [95% CI, 0.40–0.80], P=0.001). Between 2 and 48 hours, there was no difference in the primary composite end point (0.6% versus 0.5%; odds ratio, 1.17 [95% CI, 0.71–1.93]; P=0.53). Early (≤2 hours of randomization) GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) moderate or severe bleeding events were infrequent, and there was no significant difference with cangrelor compared with clopidogrel (0.2% [n=10] versus 0.1% [n=4]; adjusted odds ratio, 1.41 [95% CI, 0.37–5.40]; P=0.62). Conclusions: The reductions in ischemic events and overall efficacy seen with cangrelor in CHAMPION PHOENIX occurred early and during the period of time in which patients were being actively treated with cangrelor. These findings provide evidence that supports the importance of potent platelet inhibition during percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01156571.

Published
2021

5. 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

6. 1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry

Author

Bryan P. Yan, Deborah N. Kalkman, Muhammad Munawar, Mascot investigators, Ahmed Khashaba, Paula Tejedor, Borislav Atzev, Robert Gerber, Petr Hájek, Zdeněk Coufal, Jaya Chandrasekhar, Martin Mates, Borislav Borisov, Andrés Iñiguez, George Dangas, Martin Hudec, Jarosław Wójcik, Michael S. Lee, Houng Bang Liew, Samantha Sartori, Antonio Colombo, Petr Kala, Tiong Kiam Ong, Melissa Aquino, Usman Baber, Peter den Heijer, Roxana Mehran, Robbert J. de Winter, Hazem M. Warda, Cardiology, ACS - Atherosclerosis & ischemic syndromes, and ACS - Heart failure & arrhythmias

Subjects
Target lesion, Registry, lcsh:Diseases of the circulatory (Cardiovascular) system, medicine.medical_specialty, Anemia, 1-year, medicine.medical_treatment, COMBO, Endothelial progenitor cell capture, 030204 cardiovascular system & hematology, Dual therapy stent, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Stent, medicine, Clinical endpoint, 030212 general & internal medicine, Myocardial infarction, COMBO stent, Original Paper, business.industry, MASCOT, Incidence (epidemiology), Bleeding, PARIS bleeding risk score, Score, medicine.disease, NCT02183454, lcsh:RC666-701, PARIS, Prediction, Cardiology and Cardiovascular Medicine, business, Kidney disease
Abstract

BackgroundThe COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. ObjectiveWe analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. MethodsMASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score≤3 and intermediate-to-high (IHBR) for score>3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. Results The study included 56% (n=1270) LBR and 44% (n=1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p=0.047) driven by cardiac death (1.7% vs. 0.7%, p=0.029) with similar rates of MI (1.8% vs. 1.1%, p=0.17), TLR (1.5% vs. 1.6%, p=0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p=0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p=0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p Conclusion Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.

Published
2020

7. Corrigendum to 'Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-year final clinical outcomes from the MASCOT post-marketing registry' [Int. J. Cardiol. 283 (2019) 67–72]

Author

Andrés Iñiguez, Francesca Elmore, Kamilia Moalem, Peter den Heijer, Deborah Morrell, Samantha Sartori, Borislav Atzev, Jaya Chandrasekhar, Clayton Snyder, Melissa Aquino, Borislav Borisov, Martin Mates, Antonio Colombo, Martin Hudec, Zdenek Coufal, Usman Baber, Roxana Mehran, Stephen M. Rowland, Mascot investigators, Michael S. Lee, Petr Hájek, and Tiong Kiam Ong

Subjects
medicine.medical_specialty, Mascot, business.industry, medicine.medical_treatment, Emergency medicine, Conventional PCI, Cohort, medicine, Stent, Cardiology and Cardiovascular Medicine, business
Published
2019

8. Lenticulostriate Artery Aneurysm Presenting as Subarachnoid Haemorrhage

Author

Borislav Atzev, Trilochan Srivastava, Raghavendra Bakki Sannegowda, Bhawna Sharma, and Tarun Mathur

Subjects
medicine.medical_specialty, Internal capsule, business.industry, medicine.disease, Lenticulostriate artery, Surgery, medicine.anatomical_structure, Aneurysm, Rare case, cardiovascular system, medicine, Subarachnoid haemorrhage, cardiovascular diseases, Radiology, Moyamoya disease, Vasculitis, business, Artery
Abstract

Lenticulostriate perforating artery aneurysms are rare [1]. Lenticulostriate artery (LSA) aneurysms are endarteries, small and fragile and supply internal capsule and basal ganglia and LSA aneurysms may be saccular or fusiform and commonly present with basal ganglia hemorrhage [1,2]. They can be associated with conditions like moyamoya disease, hypertension, vasculitis and arterio-venous malformations (AVMs) [1-4]. LSA aneurysms which by itself is an uncommon entity usually presents with intraparenchymal haemorrhages [3,5]. Rarely LSA aneurysms presents with subarachnoid haemorrhage (SAH) or primary intraventricular haemorrhage PIVH [1-3,5,6]. We report a rare case of LSA aneurysm presenting with SAH who was successfully managed conservatively.

Published
2014

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