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13 results on '"Carl-Magnus Wahlgren"'

1. Characteristics of traumatic major haemorrhage in a tertiary trauma center

Author

Pieter van Wyk, Marcus Wannberg, Anna Gustafsson, Jane Yan, Agneta Wikman, Louis Riddez, and Carl-Magnus Wahlgren

Subjects
Trauma, Haemorrhage, Prehospital, Blood transfusion, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

Abstract Background Major traumatic haemorrhage is potentially preventable with rapid haemorrhage control and improved resuscitation techniques. Although advances in prehospital trauma management, haemorrhage is still associated with high mortality. The aim of this study was to use a recent pragmatic transfusion-based definition of major bleeding to characterize patients at risk of major bleeding and associated outcomes in this cohort after trauma. Methods This was a retrospective cohort study including all trauma patients (n = 7020) admitted to a tertiary trauma center from January 2015 to June 2020. The major bleeding cohort (n = 145) was defined as transfusion of 4 units of any blood components (red blood cells, plasma, or platelets) within 2 h of injury. Univariate and multivariable logistic regression analyses were performed to identify risk factors for 24-hour and 30-day mortality post trauma admission. Results In the major bleeding cohort (n = 145; 145/7020, 2.1% of the trauma population), there were 77% men (n = 112) and 23% women (n = 33), median age 39 years [IQR 26–53] and median Injury Severity Score (ISS) was 22 [IQR 13–34]. Blunt trauma dominated over penetrating trauma (58% vs. 42%) where high-energy fall was the most common blunt mechanism and knife injury was the most common penetrating mechanism. The major bleeding cohort was younger (OR 0.99; 95% CI 0.98 to 0.998, P = 0.012), less female gender (OR 0.66; 95% CI 0.45 to 0.98, P = 0.04), and had more penetrating trauma (OR 4.54; 95% CI 3.24 to 6.36, P = 0.001) than the rest of the trauma cohort. A prehospital (OR 2.39; 95% CI 1.34 to 4.28; P = 0.003) and emergency department (ED) (OR 6.91; 95% CI 4.49 to 10.66, P = 0.001) systolic blood pressure 1.2 (OR 3.09; 95% CI 2.16 to 4.43; P = 0.001). Emergency damage control laparotomy was performed more frequently in the major bleeding cohort (21.4% [n = 31] vs. 1.5% [n = 106]; OR 3.90; 95% CI 2.50 to 6.08; P

Published
2024
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2. Management and outcomes of firearm-related vascular injuries

Author

Karolina Nyberger, Eva-Corina Caragounis, Pauline Djerf, and Carl-Magnus Wahlgren

Subjects
Firearm injury, Gunshot wound, Epidemiology, Vascular injury, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

Abstract Background Violence due to firearms is a major global public health issue and vascular injuries from firearms are particularly lethal. The aim of this study was to analyse population-based epidemiology of firearm-related vascular injuries. Methods This was a retrospective nationwide epidemiological study including all patients with firearm injuries from the national Swedish Trauma Registry (SweTrau) from January 1, 2011 to December 31, 2019. There were 71,879 trauma patients registered during the study period, of which 1010 patients were identified with firearm injuries (1.4%), and 162 (16.0%) patients with at least one firearm-related vascular injury. Results There were 162 patients admitted with 238 firearm-related vascular injuries, 96.9% men (n = 157), median age 26.0 years [IQR 22–33]. There was an increase in vascular firearm injuries over time (P

Published
2023
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3. A systematic review of hemorrhage and vascular injuries in civilian public mass shootings

Author

Karolina Nyberger, Lovisa Strömmer, and Carl-Magnus Wahlgren

Subjects
Civilian public mass shooting, Firearm injuries, Hemorrhage, Vascular injuries, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

Abstract Background Civilian public mass shootings (CPMSs) are a major public health issue and in recent years several events have occurred worldwide. The aim of this systematic review was to characterize injuries and mortality after CPMSs focusing on in-hospital management of hemorrhage and vascular injuries. Method A systematic review of all published literature was undertaken in Medline, Embase and Web of Science January 1st, 1968, to February 22nd, 2021, according to the PRISMA guidelines. Literature was eligible for inclusion if the CPMS included three or more people shot, injured or killed, had vascular injuries or hemorrhage. Results The search identified 2884 studies; 34 were eligible for inclusion in the analysis. There were 2039 wounded in 45 CPMS events. The dominating anatomic injury location per event was the extremity followed by abdomen and chest. The median number of operations and operated patients per event was 22 (5–101) and 10.5 (4–138), respectively. A total of 899 deaths were reported with a median mortality rate of 36.1% per event (15.9–71.4%) Thirty-eight percent (13/34) of all studies reported on vascular injuries. Vascular injuries ranged from 8 to 29%; extremity vascular injury the most frequent. Specific vascular injuries included thoracic aorta 18% (42/232), carotid arteries 6% (14/232), and abdominal aorta 5% (12/232). Vascular injuries were involved in 8.3%-10% of all deaths. Conclusion This systematic review showed an overall high mortality after CPMS with injuries mainly located to the extremities, thorax and abdomen. About one quarter of deaths was related to hemorrhage involving central large vessel injuries. Further understanding of these injuries, and structured and uniform reporting of injuries and treatment protocols may help improve evaluation and management in the future. Level of Evidence Systematic review and meta-analysis, level III.

Published
2023
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4. Platelet consumption and hyperreactivity coexist in experimental traumatic hemorrhagic model

Author

Marcus Wannberg, Xinyan Miao, Nailin Li, Agneta Wikman, and Carl-Magnus Wahlgren

Subjects
animal model, coagulopathy, hemorrhage, platelets, shock, trauma, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Introduction Platelets are critical for hemostasis, and a low platelet count predicts mortality in trauma. The role of platelet dysfunction in severe traumatic hemorrhage and coagulopathy needs to be further defined. The aim of this study was to evaluate the platelet function in a new model of experimental traumatic hemorrhage. Material and methods New Zealand white rabbits (n = 10) were subjected to tracheostomy and trauma laparotomy, and then bilateral femur fractures with 40% hemorrhage of their estimated blood volume. Arterial blood gases, standard coagulation tests, mean platelet volume, platelet aggregation using impedance aggregometry with agonist collagen, arachidonic acid (ASPI), and adenosine diphosphate (ADP), rotational thromboelastometry, and fibrinogen binding of platelets were analyzed using flow cytometry. Results After traumatic hemorrhage, there was a significant physiological response with a rise in lactate (P < .001) and a decrease in base excess (P < .001) and temperature (P < .001). Platelet count decreased from a mean of 244x109/L to 94 x109/L (P = .004) and the mean platelet volume increased from 5.1fL to 6.1fL (P = .002). Impedance aggregometry with the agonist collagen, ASPI, and ADP was all significantly decreased after hemorrhage (P = .007). However, there was an increased fibrinogen binding of ADP-activated platelets after traumatic hemorrhage analyzed by flow cytometry (P < .05). Conclusions This traumatic hemorrhage model presents two parallel pathophysiological responses of platelets; platelet consumption as evidenced by a significant decrease in platelet count and aggregation, and platelet hyperreactivity as shown by a higher mean platelet volume and enhanced platelet fibrinogen binding. Further studies are needed to characterize these different aspects of platelet function in severe traumatic hemorrhage.

Published
2020
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5. Hypercoagulation Detected by Rotational Thromboelastometry Predicts Mortality in COVID-19: A Risk Model Based on a Prospective Observational Study

Author

Lou M. Almskog, Agneta Wikman, Jonas Svensson, Matteo Bottai, Mariann Kotormán, Carl-Magnus Wahlgren, Michael Wanecek, Jan van der Linden, and Anna Ågren

Subjects
covid-19, thromboelastometry, coagulopathy, thrombosis, mortality, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background Severe disease due to the novel coronavirus disease 2019 (COVID-19) has been shown to be associated with hypercoagulation. The aim of this study was to assess the Rotational Thromboelastometry (ROTEM) as a marker of coagulopathy in hospitalized COVID-19 patients. Methods This was a prospective, observational study where patients hospitalized due to a COVID-19 infection were eligible for inclusion. Conventional coagulation tests and ROTEM were taken after hospital admission, and patients were followed for 30 days. A prediction model, including variables ROTEM EXTEM-MCF (Maximum Clot Firmness) which in previous data has been suggested a suitable marker of hypercoagulation, age, and respiratory frequency, was developed using logistic regression to evaluate the probability of death. Results Out of the 141 patients included, 18 (13%) died within 30 days. In the final prediction model, the risk of death within 30 days for a patient hospitalized due to COVID-19 was increased with increased EXTEM-MCF, age, and respiratory frequency. Longitudinal ROTEM data in the severely ill subpopulation showed enhanced hypercoagulation. In an in vitro analysis, no heparin effect on EXTEM–coagulation time (CT) was observed, supporting a severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) effect on prolonged initiation of coagulation. Conclusion Here, we show that hypercoagulation measured with ROTEM predicts 30-day mortality in COVID-19. Longitudinal ROTEM data strengthen the hypothesis of hypercoagulation as a driver of severe disease in COVID-19. Thus, ROTEM may be a useful tool to assess disease severity in COVID-19 and could potentially guide anticoagulation therapy.

Published
2022
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6. Extracorporeal membrane oxygenation improves coagulopathy in an experimental traumatic hemorrhagic model

Author

Magnus Larsson, Jan Hultman, P. Forsman, Anders Östlund, Björn Frenckner, Agneta Wikman, P. Hedenqvist, Matteo Bottai, Carl-Magnus Wahlgren, and L. Riddez

Subjects
Male, medicine.medical_specialty, Resuscitation, medicine.medical_treatment, Hemorrhage, 030204 cardiovascular system & hematology, Shock, Hemorrhagic, Critical Care and Intensive Care Medicine, Trauma, 03 medical and health sciences, 0302 clinical medicine, Extracorporeal Membrane Oxygenation, Bleeding time, Coagulopathy, medicine, Extracorporeal membrane oxygenation, Animals, Orthopedics and Sports Medicine, Animal model, medicine.diagnostic_test, business.industry, Extracorporeal circulation, 030208 emergency & critical care medicine, Shock, Hypothermia, medicine.disease, Surgery, Thromboelastometry, Disease Models, Animal, Treatment Outcome, Anesthesia, Shock (circulatory), Emergency Medicine, Original Article, Rabbits, medicine.symptom, ECMO, business, Femoral Fractures
Abstract

Purpose Hemorrhage is the most common cause of preventable death after trauma. Coagulopathy plays a central role in uncontrolled bleeding and is caused by multiple factors. Extracorporeal Membrane Oxygenation (ECMO) is an established treatment for patients with respiratory failure and has in recent years also been used in severely injured trauma patients with cardiopulmonary failure and coexisting bleeding shock. The aim of this study was to evaluate the effect of ECMO on hypothermia, acidosis, and coagulopathy in a traumatic hemorrhagic rabbit model. Methods After anesthesia and tracheostomy, ten New Zealand White rabbits sustained laparotomy, bilateral femur fractures and were hemorrhaged 45% of their estimated blood volume. After 90 min of hemorrhagic shock they were resuscitated with a standard transfusion protocol together with venoarterial ECMO (n = 5) or with a standard transfusion protocol only (n = 5) for 60 min. No systemic heparin was administered. Results ECMO during 60 min of resuscitation significantly increased heart rate (p = 0.01), mean arterial pressure (p = 0.01), body temperature (p = 0.01) and improved the metabolic acidosis, pH (p = 0.01), and lactate (p = 0.01). ECMO also improved the coagulation capacity measured in vitro by Rotational Thromboelastometry with a significant decrease in clot formation time (p

Published
2016

7. Rivaroxaban with or without aspirin in patients with stable coronary artery disease : an international, randomised, double-blind, placebo-controlled trial

Author

Stuart J Connolly, John W Eikelboom, Jackie Bosch, Gilles Dagenais, Leanne Dyal, Fernando Lanas, Kaj Metsarinne, Martin O'Donnell, Anthony L Dans, Jong-Won Ha, Alexandr N Parkhomenko, Alvaro A Avezum, Eva Lonn, Liu Lisheng, Christian Torp-Pedersen, Petr Widimsky, Aldo P Maggioni, Camilo Felix, Katalin Keltai, Masatsugu Hori, Khalid Yusoff, Tomasz J Guzik, Deepak L Bhatt, Kelley R H Branch, Nancy Cook Bruns, Scott D Berkowitz, Sonia S Anand, John D Varigos, Keith A A Fox, Salim Yusuf, JORGELINA SALA, LUIS CARTASEGNA, MARISA VICO, MIGUEL ANGEL HOMINAL, EDUARDO HASBANI, ALBERTO CACCAVO, CESAR ZAIDMAN, DANIEL VOGEL, ADRIAN HRABAR, PABLO OMAR SCHYGIEL, CARLOS CUNEO, HUGO LUQUEZ, IGNACIO J. MACKINNON, RODOLFO ANDRES AHUAD GUERRERO, JUAN PABLO COSTABEL, INES PALMIRA BARTOLACCI, OSCAR MONTANA, MARIA BARBIERI, OSCAR GOMEZ VILAMAJO, RUBEN OMAR GARCIA DURAN, LILIA BEATRIZ SCHIAVI, MARCELO GARRIDO, ADRIAN INGARAMO, ANSELMO PAULINO BORDONAVA, MARIA JOSE PELAGAGGE, LEONARDO NOVARETTO, JUAN PABLO ALBISU DI GENNERO, LUZ MARIA IBANEZ SAGGIA, MOIRA ALVAREZ, NESTOR ALEJANDRO VITA, STELLA MARIS MACIN, RICARDO DARIO DRAN, MARCELO CARDONA, LUIS GUZMAN, RODOLFO JUAN SARJANOVICH, JESUS CUADRADO, SEBASTIAN NANI, MARCOS RAUL LITVAK BRUNO, CAROLINA CHACON, LAURA ELENA MAFFEI, DIEGO GRINFELD, NATALIA VENSENTINI, CLAUDIO RODOLFO MAJUL, HECTOR LUCAS LUCIARDI, PATRICIA DEL CARMEN GONZALEZ COLASO, FREDY ANTONI FERRE PACORA, PAUL VAN DEN HEUVEL, PETER VERHAMME, BAVO ECTOR, PHILIPPE DEBONNAIRE, PHILIPPE VAN DE BORNE, JEAN LEROY, HERMAN SCHROE, PASCAL VRANCKX, IVAN ELEGEERT, ETIENNE HOFFER, KARL DUJARDIN, CLARISSE INDIO DO BRASIL, DALTON PRECOMA, JOSE ANTONIO ABRANTES, EULER MANENTI, GILMAR REIS, JOSE SARAIVA, LILIA MAIA, MAURO HERNANDES, PAULO ROSSI, FABIO ROSSI DOS SANTOS, SERGIO LUIZ ZIMMERMANN, RAFAEL RECH, EDUARDO ABIB JR, PAULO LEAES, ROBERTO BOTELHO, OSCAR DUTRA, WEIMAR SOUZA, MARIA BRAILE, NILO IZUKAWA, JOSE CARLOS NICOLAU, LUIZ FERNANDO TANAJURA, CARLOS VICENTE SERRANO JUNIOR, CESAR MINELLI, LUIZ ANTONIO NASI, LIVIA OLIVEIRA, MARCELO JOSE DE CARVALHO CANTARELLI, RICHARD TYTUS, SHEKHAR PANDEY, EVA LONN, JAMES CHA, SAUL VIZEL, MOHAN BABAPULLE, ANDRE LAMY, KEVIN SAUNDERS, JOSEPH BERLINGIERI, BOB KIAII, RAKESH BHARGAVA, PRAVINSAGAR MEHTA, LAURIE HILL, DAVID FELL, ANDY LAM, FAISAL AL-QOOFI, CRAIG BROWN, ROBERT PETRELLA, JOSEPH A RICCI, ANTHONY GLANZ, NICOLAS NOISEUX, KEVIN BAINEY, FATIMA MERALI, MICHAEL HEFFERNAN, ANTHONY DELLA SIEGA, GILLES R DAGENAIS, FRANCOIS DAGENAIS, STEEVE BRULOTTE, MICHEL NGUYEN, MICHAEL HARTLEIB, RANDOLPH GUZMAN, RONALD BOURGEOIS, DENNIS RUPKA, YAARIV KHAYKIN, GILBERT GOSSELIN, THAO HUYNH, CLAUDE PILON, JEAN CAMPEAU, FRANCIS PICHETTE, ARIEL DIAZ, JAMES JOHNSTON, PRAVIN SHUKLE, GREGORY HIRSCH, PAUL RHEAULT, WLODZIMIERZ CZARNECKI, ANNIE ROY, SHAH NAWAZ, STEPHEN FREMES, DINKAR SHUKLA, GABRIEL JANO, JORGE LEONARDO COBOS, RAMON CORBALAN, MARCELO MEDINA, LEONARDO NAHUELPAN, CARLOS RAFFO, LUIS PEREZ, SERGIO POTTHOFF, BENJAMIN STOCKINS, PABLO SEPULVEDA, CHRISTIAN PINCETTI, MARGARITA VEJAR, HONGYAN TIAN, XUESI WU, YUANNAN KE, KAIYING JIA, PENGFEI YIN, ZHAOHUI WANG, LITIAN YU, SHULIN WU, ZONGQUI WU, SHAO WEN LIU, XIAO JUAN BAI, YANG ZHENG, PING YANG, YUN MEI YANG, JIWEI ZHANG, JUNBO GE, XIAO PING CHEN, JUNXIA LI, TAO HONG HU, RUIYAN ZHANG, ZHE ZHENG, XIN CHEN, LIANG TAO, JIANPING LI, WEIJIAN HUANG, GUOSHENG FU, CHUNJIAN LI, YUGANG DONG, CHUNSHENG WANG, XINMIN ZHOU, YE KONG, ARISTIDES SOTOMAYOR, JOSE LUIS ACCINI MENDOZA, HENRY CASTILLO, MIGUEL URINA, GUSTAVO AROCA, MARITZA PEREZ, DORA INES MOLINA DE SALAZAR, GREGORIO SANCHEZ VALLEJO, MANZUR J FERNANDO, HENRY GARCIA, LUIS HERNANDO GARCIA, EDGAR ARCOS, JUAN GOMEZ, FRANCISCO CUERVO MILLAN, FREDY ALBERTO TRUJILLO DADA, BORIS VESGA, GUSTAVO ADOLFO MORENO SILGADO, EVA ZIDKOVA, JEAN-CLAUDE LUBANDA, MARKETA KALETOVA, RADIM KRYZA, GABRIEL MARCINEK, MAREK RICHTER, JINDRICH SPINAR, JIRI MATUSKA, MARTIN TESAK, ZUZANA MOTOVSKA, MARIAN BRANNY, JIRI MALY, MARTIN MALY, MARTIN WIENDL, LENKA FOLTYNOVA CAISOVA, JOSEF SLABY, PETR VOJTISEK, JAN PIRK, LENKA SPINAROVA, MIROSLAVA BENESOVA, JULIA CANADYOVA, MIROSLAV HOMZA, JINDRICH FLORIAN, ROSTISLAV POLASEK, ZDENEK COUFAL, VLADIMIRA SKALNIKOVA, RADIM BRAT, MIROSLAV BRTKO, PETR JANSKY, JAROSLAV LINDNER, PAVEL MARCIAN, ZBYNEK STRAKA, MARTIN TRETINA, YAN CARLOS DUARTE, FREDDY POW CHON LONG, MAYRA SANCHEZ, JOSE LOPEZ, CARMITA PERUGACHI, RICARDO MARMOL, FREDDY TRUJILLO, PABLO TERAN, JAAKKO TUOMILEHTO, HENRI TUOMILEHTO, MARJA-LEENA TUOMINEN, ILKKA KANTOLA, GABRIEL STEG, VICTOR ABOYANS, FLORENCE LECLERCQ, EMILE FERRARI, FRANCK BOCCARA, EMMANUEL MESSAS, PATRICK MISMETTI, MARIE ANTOINETTE SEVESTRE, GUILLAUME CAYLA, PASCAL MOTREFF, STEFAN STOERK, HANS-DIRK DUENGEN, CHRISTOPH STELLBRINK, OSMAN GUEROCAK, CHRISTOPH KADEL, RUEDIGER BRAUN-DULLAEUS, MICHAEL JESERICH, CHRISTIAN OPITZ, HANS-FRIEDRICH VOEHRINGER, KARL-FRIEDRICH APPEL, BERNHARD WINKELMANN, THOMAS DORSEL, SIGRID NIKOL, HARALD DARIUS, JURGEN RANFT, SEBASTIAN SCHELLONG, WOLFGANG JUNGMAIR, PIROZE DAVIERWALA, MARC VORPAHL, LASZLO BAJNOK, ZOLTAN LASZLO, EBRAHIM NOORI, GABOR VERESS, ANDRAS VERTES, ANDRAS ZSARY, ERNO KIS, LASZLO KORANYI, JUDIT BAKAI, ZOLTAN BODA, FERENC POOR, ZOLTAN JARAI, VENDEL KEMENY, JOHN BARTON, BRENDAN MCADAM, ANDREW MURPHY, PETER CREAN, NIALL MAHON, RONAN CURTIN, BRIAIN MACNEILL, SEAN DINNEEN, MAJDI HALABI, REUVEN ZIMLICHMAN, DAVID ZELTSER, YOAV TURGEMAN, ELIEZER KLAINMAN, BASIL LEWIS, AMOS KATZ, SHAUL ATAR, EUGENIA NIKOLSKY, STEFANO BOSI, MONICA NALDI, POMPILIO FAGGIANO, DEBORA ROBBA, LUCIO MOS, GIANFRANCO SINAGRA, FRANCO COSMI, LUIGI OLTRONA VISCONTI, DE MATTEIS CARMINE, GIUSEPPE DI PASQUALE, MATTEO DI BIASE, SARA MANDORLA, MARINO BERNARDINANGELI, GIOVANNI CARLO PICCINNI, MICHELE MASSIMO GULIZIA, MARCELLO GALVANI, FLAVIO VENTURI, GIORGIO MOROCUTTI, MARIA GRAZIA BALDIN, CARLO OLIVIERI, GIAN PIERO PERNA, VINCENZO CIRRINCIONE, TAKAYASU KANNO, HIROYUKI DAIDA, YUKIO OZAKI, NAOMASA MIYAMOTO, SHINICHI HIGASHIUE, HIROSHI DOMAE, SHINOBU HOSOKAWA, HIROO KOBAYASHI, TAKEHIKO KURAMOCHI, KENSHI FUJII, KAZUAKI MIZUTOMI, KEIJIRO SAKU, KAZUO KIMURA, YOSHIHARU HIGUCHI, MITSUNORI ABE, HARUHITO OKUDA, TOSHIYUKI NODA, TERUAKI MITA, ATSUSHI HIRAYAMA, HARUHIKO ONAKA, MORIAKI INOKO, MITSUGU HIROKAMI, MUNENORI OKUBO, YUTAKA AKATSUKA, MIZUHO IMAMAKI, HARUO KAMIYA, MAMORU MANITA, TOSHIHARU HIMI, HIDEKI UENO, YUJI HISAMATSU, JUNYA AKO, YASUHIRO NISHINO, HIDEO KAWAKAMI, YUTAKA YAMADA, YUKIHIRO KORETSUNE, TAKAHISA YAMADA, TETSURO YOSHIDA, HIDEKI SHIMOMURA, NORIYUKI KINOSHITA, AKIHIKO TAKAHASHI, KHALID YUSOFF, WAN AZMAN WAN AHMAD, MUHAMMAD RADZI ABU HASSAN, SAZZLI KASIM, AIZAI AZAN ABDUL RAHIM, DIMON MOHD ZAMRIN, MASAHARU MACHIDA, YORIHIKO HIGASHINO, NORIAKI UTSU, AKIHIKO NAKANO, SHIGERU NAKAMURA, TETSUO HASHIMOTO, KENJI ANDO, TOMOHIRO SAKAMOTO, F.J. PRINS, DIRK LOK, JOHANNES GERT-JAN MILHOUS, ERIC VIERGEVER, FRANK WILLEMS, HENK SWART, MARCO ALINGS, ROB BREEDVELD, KEES-JAN DE VRIES, ROGER VAN DER BORGH, FANNY OEI, STIENEKE ZOET-NUGTEREN, HANS KRAGTEN, JEAN PAUL HERRMAN, PAUL VAN BERGEN, MARCEL GOSSELINK, EDUARD HOEKSTRA, ERWIN ZEGERS, EELKO RONNER, FRANK DEN HARTOG, GERARD BARTELS, PETER NIEROP, COEN VAN DER ZWAAN, JACOB VAN ECK, EDWIN VAN GORSELEN, BJORN GROENEMEIJER, PIETER HOOGSLAG, MARC ROBERT DE GROOT, ALDRIN LOYOLA, DENNIS JOSE SULIT, NANNETTE REY, MARIA TERESA ABOLA, DANTE MORALES, ELLEN PALOMARES, MARC EVANS ABAT, GREGORIO ROGELIO, PHILIP CHUA, JOSE CARLO DEL PILAR, JOHN DENNIS ALCARAZ, GERALDINE EBO, LOUIE TIRADOR, JOSEFINA CRUZ, JOHN ANONUEVO, ARTHUR PITARGUE, MARIANNA JANION, TOMASZ GUZIK, GRZEGORZ GAJOS, MACIEJ ZABOWKA, ANDRZEJ RYNKIEWICZ, MARLENA BRONCEL, ANDRZEJ SZUBA, DANUTA CZARNECKA, PAWEL MAGA, IRINA STRAZHESKO, YURY VASYUK, ZHANNA SIZOVA, YURY POZDNYAKOV, OLGA BARBARASH, MIKHAIL VOEVODA, TATIANA POPONINA, ALEXEY REPIN, IRINA OSIPOVA, ANNA EFREMUSHKINA, NINA NOVIKOVA, OLEG AVERKOV, DMITRY ZATEYSHCHIKOV, ARKADIY VERTKIN, AZA AUSHEVA, PATRICK COMMERFORD, SAADIYA SEEDAT, LOUIS VAN ZYL, JAN ENGELBRECHT, ELLEN MAKONLI MAKOTOKO, CATHARINA ELIZABETH PRETORIUS, ZAID MOHAMED, ADRIAN HORAK, THOMAS MABIN, ERIC KLUG, JANG-HO BAE, CHEOLHO KIM, CHONG-JIN KIM, DONG-SOO KIM, YONG JIN KIM, SEUNGJAE JOO, JONG-WON HA, CHUL SOO PARK, JANG YOUNG KIM, YOUNG-KWON KIM, CHRISTINA JARNERT, THOMAS MOOE, MIKAEL DELLBORG, INGEMAR TORSTENSSON, PER ALBERTSSON, LARS JOHANSSON, FARIS AL-KHALILI, HENRIK ALMROTH, TOMMY ANDERSSON, EMIL PANTEV, BENGT-OLOV TENGMARK, BO LIU, GUNDARS RASMANIS, CARL-MAGNUS WAHLGREN, TIZIANO MOCCETTI, ALEXANDER PARKHOMENKO, VIRA TSELUYKO, VOLODYMYR VOLKOV, OLENA KOVAL, LYUDMYLA KONONENKO, OLEKSANDR PROKHOROV, VALERIY VDOVYCHENKO, ANDRIY BAZYLEVYCH, LEONID RUDENKO, VADYM VIZIR, OLEKSANDR KARPENKO, YAROSLAV MALYNOVSKY, VALENTYNA KOVAL, BORYS STOROZHUK, JAMES COTTON, ASOK VENKATARAMAN, ANDREW MORIARTY, DEREK CONNOLLY, PATRICK DAVEY, ROXY SENIOR, INDERPAUL BIRDI, JOHN CALVERT, PATRICK DONNELLY, JASPER TREVELYAN, JUSTIN CARTER, AARON PEACE, DAVID AUSTIN, NEVILLE KUKREJA, THOMAS HILTON, SUNNY SRIVASTAVA, RONALD WALSH, RONALD FIELDS, JOSEPH HAKAS, EDWARD PORTNAY, HARINDER GOGIA, ABRAHAM SALACATA, JOHN J. HUNTER, J MICHAEL BACHARACH, NICOLAS SHAMMAS, DAMODHAR SURESH, RICKY SCHNEIDER, PAUL GURBEL, SUBHASH BANERJEE, PAUL GRENA, NOEL BEDWELL, STEPHEN SLOAN, STEVEN LUPOVITCH, ANAND SONI, KATHLEEN GIBSON, RENEE SANGRIGOLI, RAJENDRA MEHTA, PETER I-HSUAN TSAI, EVE GILLESPIE, STEPHEN DEMPSEY, GLENN HAMROFF, ROBERT BLACK, ELLIS LADER, JOHN B. KOSTIS, VERA BITTNER, WILLIAM MCGUINN, KELLEY BRANCH, VINAY MALHOTRA, STEPHEN MICHAELSON, MICHAEL VACANTE, MATTHEW MCCORMICK, RALUCA ARIMIE, ALAN CAMP, GEORGE DAGHER, N. MATHEW KOSHY, STEPHEN THEW, FREDERICK COSTELLO, MARK HEIMAN, ROBERT CHILTON, MICHAEL MORAN, FREDRIC ADLER, ANTHONY COMEROTA, ANDREW SEIWERT, WILLIAM FRENCH, HARVEY SEROTA, ROBERT HARRISON, FAISAL BAKAEEN, SHUAB OMER, LOKESH CHANDRA, ALAN WHELAN, ANDREW BOYLE, PHILIP ROBERTS-THOMSON, JAMES ROGERS, PATRICK CARROLL, DAVID COLQUHOUN, JAMES SHAW, PETER BLOMBERY, JOHN AMERENA, CHRIS HII, ALISTAIR ROYSE, BHUWAN SINGH, JOSEPH SELVANAYAGAM, SHIRLEY JANSEN, WINGCHI LO, CHRISTOPHER HAMMETT, ROHAN POULTER, SESHASAYEE NARASIMHAN, HENRIK WIGGERS, HENRIK NIELSEN, GUNNAR GISLASON, LARS KOBER, KIM HOULIND, VIBEKE BOENELYKKE SOERENSEN, ULRIK DIXEN, JENS REFSGAARD, ELISABETH ZEUTHEN, PETER SOEGAARD, MARIAN HRANAI, LUDOVIT GASPAR, DANIEL PELLA, KATARINA HATALOVA, ERIKA DROZDAKOVA, IOAN COMAN, DOINA DIMULESCU, DRAGOS VINEREANU, MIRCEA CINTEZA, CRINA SINESCU, CATALINA ARSENESCU, IMRE BENEDEK, ELENA BOBESCU, DAN DOBREANU, DAN GAITA, ADRIAN IANCU, ADRIANA ILIESIU, DANIEL LIGHEZAN, LUCIAN PETRESCU, OCTAVIAN PIRVU, IULIA TEODORESCU, DAN TESLOIANU, MARIUS MARCIAN VINTILA, and OVIDIU CHIONCEL

Subjects
Male, medicine.medical_treatment, Myocardial Infarction, Coronary Artery Disease, 030204 cardiovascular system & hematology, Stroke/epidemiology, Coronary artery disease, 0302 clinical medicine, Rivaroxaban, Hemorrhage/chemically induced, Carotid artery disease, 030212 general & internal medicine, Myocardial infarction, Cardiovascular Diseases/mortality, Aspirin, Atrial fibrillation, General Medicine, Stroke, ORAL RIVAROXABAN, Cardiovascular Diseases, Factor Xa Inhibitors/administration & dosage, Cardiology, Female, Drug Therapy, Combination, medicine.drug, medicine.medical_specialty, Rivaroxaban/administration & dosage, Coronary Artery Disease/drug therapy, Hemorrhage, Drug Administration Schedule, 03 medical and health sciences, Double-Blind Method, Internal medicine, Journal Article, Myocardial Infarction/epidemiology, medicine, Humans, Aspirin/administration & dosage, Platelet Aggregation Inhibitors/administration & dosage, Aged, Dose-Response Relationship, Drug, business.industry, Unstable angina, Percutaneous coronary intervention, medicine.disease, PREVENTION, Morbidity, business, Platelet Aggregation Inhibitors, Factor Xa Inhibitors
Abstract

BACKGROUND: Coronary artery disease is a major cause of morbidity and mortality worldwide, and is a consequence of acute thrombotic events involving activation of platelets and coagulation proteins. Factor Xa inhibitors and aspirin each reduce thrombotic events but have not yet been tested in combination or against each other in patients with stable coronary artery disease.METHODS: In this multicentre, double-blind, randomised, placebo-controlled, outpatient trial, patients with stable coronary artery disease or peripheral artery disease were recruited at 602 hospitals, clinics, or community centres in 33 countries. This paper reports on patients with coronary artery disease. Eligible patients with coronary artery disease had to have had a myocardial infarction in the past 20 years, multi-vessel coronary artery disease, history of stable or unstable angina, previous multi-vessel percutaneous coronary intervention, or previous multi-vessel coronary artery bypass graft surgery. After a 30-day run in period, patients were randomly assigned (1:1:1) to receive rivaroxaban (2·5 mg orally twice a day) plus aspirin (100 mg once a day), rivaroxaban alone (5 mg orally twice a day), or aspirin alone (100 mg orally once a day). Randomisation was computer generated. Each treatment group was double dummy, and the patients, investigators, and central study staff were masked to treatment allocation. The primary outcome of the COMPASS trial was the occurrence of myocardial infarction, stroke, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS: Between March 12, 2013, and May 10, 2016, 27 395 patients were enrolled to the COMPASS trial, of whom 24 824 patients had stable coronary artery disease from 558 centres. The combination of rivaroxaban plus aspirin reduced the primary outcome more than aspirin alone (347 [4%] of 8313 vs 460 [6%] of 8261; hazard ratio [HR] 0·74, 95% CI 0·65-0·86, pINTERPRETATION: In patients with stable coronary artery disease, addition of rivaroxaban to aspirin lowered major vascular events, but increased major bleeding. There was no significant increase in intracranial bleeding or other critical organ bleeding. There was also a significant net benefit in favour of rivaroxaban plus aspirin and deaths were reduced by 23%. Thus, addition of rivaroxaban to aspirin has the potential to substantially reduce morbidity and mortality from coronary artery disease worldwide.FUNDING: Bayer AG.

Published
2018
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8. Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry

Author

Raman Uberoi, Carlo Setacci, Mario Lescan, Antonio Lorido, David Murray, Zoltán Szeberin, Tomasz Zubilewicz, Vincent Riambau, Angsu Chartrungsan, Jörg Tessarek, Marek Iłżecki, Hartmuth Gortz, Matthias Thenholt, Maher Fattoum, Semih Buz, Piergiorgio Cao, Domenico Benevento, Giancarlo Palasciano, Feras Abdallah, John Boyle, S. Llagostera Pujol, Carlos Esteban, Nilo Mosquera, Enrique Aracil Sanus, Ignacio Iglesias Negreira, J.T.F.J. Raymakers, Joost van Herwaarden, Georgios Pitoulias, Theodoros Kratimenos, Carl Magnus Wahlgren, Claes Forssell, Greg Fulton, Lars Lonn, Gustav Pedersen, Jorge Vergara, Manuel Espindola Silva, Stephen Wing-Keung Cheng, Phan Minh Anh, Carlos David Calderas, and Patrick Bohan

Subjects
Male, Time Factors, medicine.medical_treatment, 030204 cardiovascular system & hematology, 030230 surgery, registry, Endovascular aneurysm repair, endovascular aneurysm repair, 0302 clinical medicine, Postoperative Complications, Endovascular Aortic Repair, Risk Factors, Occlusion, 80 and over, Prospective Studies, Registries, Aged, 80 and over, Endovascular Procedures, endograft, Middle Aged, Abdominal aortic aneurysm, Aortic Aneurysm, Product Surveillance, Postmarketing, Treatment Outcome, Female, Stents, Cardiology and Cardiovascular Medicine, Adult, medicine.medical_specialty, Adolescent, endoleak, occlusion, Prosthesis Design, Risk Assessment, 03 medical and health sciences, Blood Vessel Prosthesis Implantation, Young Adult, abdominal aortic aneurysm, medicine, Product Surveillance, Postmarketing, Humans, Radiology, Nuclear Medicine and imaging, Abdominal, cardiovascular diseases, mortality, reintervention, stent-graft, Aged, Aortic Aneurysm, Abdominal, Blood Vessel Prosthesis, business.industry, Stent, medicine.disease, Surgery, business, Follow-Up Studies
Abstract

Purpose: To evaluate the safety and performance of the Treovance stent-graft. Methods: The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. Results: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. Conclusion: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.

Published
2018

9. Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial

Author

Paul Sidhu, Jan Blankensteijn, Jonas Malmstedt, Martin M Brown, Angel Chamorro, Jeroen Hendriks, Karl-olof Lovblad, David Doig, Barry Beiles, Tim McGahan, Gerard Stansby, Lorenz Hirt, Stefan Engelter, Christophe Bonvin, Sami Curtze, Dick Zeilstra, Juan Miguel Macho Fernandez, Geert Vanhooren, Gary A Ford, Carl Magnus Wahlgren, Leo Bonati, Petra Ijäs, Jonathan Tibballs, Bonvin, Christophe, Kalangos, Afksendiyos, Lövblad, Karl-Olof, Sztajzel, Roman, Halliday, A, ACS - Amsterdam Cardiovascular Sciences, Surgery, Neurology, Radiology and Nuclear Medicine, and ANS - Amsterdam Neuroscience

Subjects
PROTOCOL, Male, medicine.medical_specialty, Time Factors, medicine.medical_treatment, ddc:616.0757, Modified Rankin Scale, Angioplasty, medicine, media_common.cataloged_instance, Humans, Carotid Stenosis, Functional ability, cardiovascular diseases, European union, ANGIOPLASTY, Stroke/etiology/mortality/prevention & control, Stroke, media_common, Endarterectomy, Aged, Endarterectomy, Carotid, Intention-to-treat analysis, ddc:617, business.industry, ARTERY STENOSIS, Articles, General Medicine, Recovery of Function, Middle Aged, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], medicine.disease, equipment and supplies, 3. Good health, Surgery, ddc:616.8, surgical procedures, operative, Treatment Outcome, cardiovascular system, Female, Stents, Carotid stenting, business, STROKE, Carotid Stenosis/complications/mortality/therapy, Follow-Up Studies
Abstract

Background Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain. We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments. Methods Patients with symptomatic carotid stenosis were randomly assigned 1:1 to open treatment with stenting or endarterectomy at 50 centres worldwide. Randomisation was computer generated centrally and allocated by telephone call or fax. Major outcomes were assessed by an independent endpoint committee unaware of treatment assignment. The primary endpoint was fatal or disabling stroke in any territory after randomisation to the end of follow-up. Analysis was by intention to treat ([ITT] all patients) and per protocol from 31 days after treatment (all patients in whom assigned treatment was completed). Functional ability was rated with the modified Rankin scale. This study is registered, number ISRCTN25337470. Findings 1713 patients were assigned to stenting (n=855) or endarterectomy (n=858) and followed up for a median of 4·2 years (IQR 3·0–5·2, maximum 10·0). Three patients withdrew immediately and, therefore, the ITT population comprised 1710 patients. The number of fatal or disabling strokes (52 vs 49) and cumulative 5-year risk did not differ significantly between the stenting and endarterectomy groups (6·4% vs 6·5%; hazard ratio [HR] 1·06, 95% CI 0·72–1·57, p=0·77). Any stroke was more frequent in the stenting group than in the endarterectomy group (119 vs 72 events; ITT population, 5-year cumulative risk 15·2% vs 9·4%, HR 1·71, 95% CI 1·28–2·30, p Interpretation Long-term functional outcome and risk of fatal or disabling stroke are similar for stenting and endarterectomy for symptomatic carotid stenosis. Funding Medical Research Council, Stroke Association, Sanofi-Synthélabo, European Union.

Published
2015

10. Effect of white-matter lesions on the risk of periprocedural stroke after carotid artery stenting versus endarterectomy in the International Carotid Stenting Study (ICSS): a prespecified analysis of data from a randomised trial

Author

Jan Blankensteijn, Jonas Malmstedt, Kirsten Krohg-Sørensen, Hans Rolf Jäger, Martin M Brown, Jeroen Hendriks, Peter Gillgren, Karl-olof Lovblad, Lorenz Hirt, Stefan Engelter, Christophe Bonvin, Geert Vanhooren, Markku Kaste, Carl Magnus Wahlgren, Leo Bonati, Petra Ijäs, Amsterdam Cardiovascular Sciences, Surgery, Neurology, Radiology and Nuclear Medicine, Amsterdam Neuroscience, Cras, Patrick, Hendriks, Jeroen, van Schil, Paul, and ICSS Investigators

Subjects
Male, Risk, medicine.medical_specialty, medicine.medical_treatment, Clinical Neurology, Cerebral Revascularization, Carotid endarterectomy, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Postoperative Complications, Leukoencephalopathies, Internal medicine, Angioplasty, medicine, media_common.cataloged_instance, Humans, Carotid Stenosis, Single-Blind Method, cardiovascular diseases, European union, Stroke, Endarterectomy, media_common, Cardiovascular diseases [DCN MP - Plasticity and memory NCEBP 14], Aged, Aged, 80 and over, Endarterectomy, Carotid, business.industry, Cardiovascular diseases Tissue engineering and pathology [NCEBP 14], Articles, Middle Aged, medicine.disease, 3. Good health, Surgery, Stenosis, Treatment Outcome, Cardiology, Female, Stents, Human medicine, Neurology (clinical), Carotid stenting, business, Cardiovascular diseases Aetiology, screening and detection [NCEBP 14], 030217 neurology & neurosurgery
Abstract

Item does not contain fulltext BACKGROUND: Findings from randomised trials have shown a higher early risk of stroke after carotid artery stenting than after carotid endarterectomy. We assessed whether white-matter lesions affect the perioperative risk of stroke in patients treated with carotid artery stenting versus carotid endarterectomy. METHODS: Patients with symptomatic carotid artery stenosis included in the International Carotid Stenting Study (ICSS) were randomly allocated to receive carotid artery stenting or carotid endarterectomy. Copies of baseline brain imaging were analysed by two investigators, who were masked to treatment, for the severity of white-matter lesions using the age-related white-matter changes (ARWMC) score. Randomisation was done with a computer-generated sequence (1:1). Patients were divided into two groups using the median ARWMC. We analysed the risk of stroke within 30 days of revascularisation using a per-protocol analysis. ICSS is registered with controlled-trials.com, number ISRCTN 25337470. FINDINGS: 1036 patients (536 randomly allocated to carotid artery stenting, 500 to carotid endarterectomy) had baseline imaging available. Median ARWMC score was 7, and patients were dichotomised into those with a score of 7 or more and those with a score of less than 7. In patients treated with carotid artery stenting, those with an ARWMC score of 7 or more had an increased risk of stroke compared with those with a score of less than 7 (HR for any stroke 2.76, 95% CI 1.17-6.51; p=0.021; HR for non-disabling stroke 3.00, 1.10-8.36; p=0.031), but we did not see a similar association in patients treated with carotid endarterectomy (HR for any stroke 1.18, 0.40-3.55; p=0.76; HR for disabling or fatal stroke 1.41, 0.38-5.26; p=0.607). Carotid artery stenting was associated with a higher risk of stroke compared with carotid endarterectomy in patients with an ARWMC score of 7 or more (HR for any stroke 2.98, 1.29-6.93; p=0.011; HR for non-disabling stroke 6.34, 1.45-27.71; p=0.014), but there was no risk difference in patients with an ARWMC score of less than 7. INTERPRETATION: The presence of white-matter lesions on brain imaging should be taken into account when selecting patients for carotid revascularisation. Carotid artery stenting should be avoided in patients with more extensive white-matter lesions, but might be an acceptable alternative to carotid endarterectomy in patients with less extensive lesions. FUNDING: Medical Research Council, the Stroke Association, Sanofi-Synthelabo, the European Union Research Framework Programme 5.

Published
2013

11. Vorapaxar in the secondary prevention of atherothrombotic events

Author

Jose Nicolau, Andrzej Rynkiewicz, Keith Fox, Vahid Mansouri, Fausto Miranda Junior, Jose Antônio Marin-Neto, Carlos Tauil, Yves Samson, Giovanni ESPOSITO, David Morrow, Wojciech Sobiczewski, James Spratt, Jacek Kubica, Miguel Urina, STEFANO CARUGO, Majken Karoline Jensen, Frans Van de Werf, Stavros Konstantinides, Oscar Ayo-Martin, Lucia Mazzolai, Isabella TRITTO, ERIC HERNANDEZ-TRIANA, Philip Bath, Diana Gorog, Graeme Hankey, Juhani Airaksinen, Marco Vatrano, Jose Faria Neto, Peter Sinnaeve, Roman Herzig, Serge Timsit, Urszula Fiszer, Attila Csányi, Marcia Chaves, Robert Mikulik, Marek Roik, Mónica Jaramillo, Michel GALINIER, Helle Klingenberg Iversen, Bassem A. Samad, Philippe Gabriel STEG, Elizabeth Coetsee, Guillermo Isasti, Domenico Scrutinio, Silvia Reverté Villarroya, Malcolm Robert Macleod, Michael Lim, Amos Katz, Meyer ELBAZ, Derek Chew, Hanne Christensen, Markus Theurl, Simona Marcheselli, Patricia Simal, Michal Bar, Isabelle Quere, Geert Vanhooren, Piotr Ponikowski, Xavier Garcia-Moll, Elena Corrada, Robert Welsh, Helge Wuttig, Philip Aylward, Carl Magnus Wahlgren, Marco Stramba-Badiale, Fernando Manzur, LAURENT SUISSA, Thierry Moulin, Giancarlo Marenzi, Gian Battista Danzi, Bogumił Ramotowski, Caitrin McDonough, Afanasiev Stanislav, RAUL CARLOS REY, Emilia Solinas, Cardiovascular Division (SZG), Brigham and Women's Hospital [Boston], Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia [Buenos Aires] (FLENI), FLENI, Milpark Hospital (Milpark Hospital), Milpark Hospital, Division of Cardiovascular Research (EDINBURGH - DCVR), University of Edinburgh, Heart Institute (SAO PAULO - Heart Institute), University of São Paulo Medical School, Canisius-Wilhelmina Hospital [Nijmegen, The Netherlands], Instituto de Investigaciones Clinicas Rosario (CIC ROSARIO), CIC ROSARIO, University Hospital Brno, Montreal Heart Institute (MONTREAL HEART INSTITUTE), Service de Neurologie [Brest], Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Morrow, DA, Braunwald, E, Bonaca, MP, Ameriso, SF, Dalby, AJ, Fish, MP, Fox, KA, Lipka, LJ, Liu, X, Nicolau, JC, Ophuis, AJ, Paolasso, E, Scirica, BM, Spinar, J, Theroux, P, Wiviott, SD, Strony, J, Murphy, SA, Novo, s, Morrow, Da, Bonaca, Mp, Ameriso, Sf, Dalby, Aj, Fish, Mp, Fox, Kaa, Lipka, Lj, Nicolau, Jc, Ophuis, Ajo, Scirica, Bm, Theroux, P., Wiviott, Sd, Strony, J., Murphy, Sa, Esposito, Giovanni, TRA 2P TIMI 50 Steering Comm, Inves, Diener, Hans Christoph (Beitragende*r), Equipe NEMESIS - Centre de Recherches de l'Institut du Cerveau et de la Moelle épinière (NEMESIS-CRICM), Centre de Recherche de l'Institut du Cerveau et de la Moelle épinière (CRICM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), UCL - SSS/IONS/NEUR - Clinical Neuroscience, UCL - (MGD) Service de neurologie, Morrow David, A., Braunwald, Eugene, Bonaca Marc, P., Ameriso Sebastian, F., Dalby Anthony, J., Fish Mary, Polly, Fox Keith, A. A., Lipka Leslie, J., Liu, Xuan, Nicolau Jose, Carlo, Ophuis A. J., Oude, Paolasso, Ernesto, Scirica Benjamin, M., Spinar, Jindrich, Theroux, Pierre, Wiviott Stephen, D., Strony, John, Murphy Sabina, A., Golino, Paolo, and Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)

Subjects
Male, Pyridines, [SDV]Life Sciences [q-bio], Myocardial Infarction, Medizin, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Brain Ischemia, Lactones, 0302 clinical medicine, MESH: Peripheral Arterial Disease, Secondary Prevention, MESH: Double-Blind Method, 030212 general & internal medicine, Myocardial infarction, Stroke, Vorapaxar, MESH: Aged, Aspirin, MESH: Middle Aged, MESH: Risk, Cardiovascular diseases [NCEBP 14], MESH: Secondary Prevention, Hazard ratio, MESH: Brain Ischemia, General Medicine, Middle Aged, Clopidogrel, 3. Good health, MESH: Receptor, PAR-1, MESH: Myocardial Infarction, vorapaxar, secondary prevention, atherothrombotic events, Cardiovascular Diseases, MESH: Platelet Aggregation Inhibitors, Anesthesia, Retreatment, Platelet aggregation inhibitor, Female, Intracranial Hemorrhages, MESH: Hemorrhage, MESH: Intracranial Hemorrhages, MESH: Lactones, circulatory and respiratory physiology, medicine.drug, Risk, ISQUEMIA CEREBRAL, Hemorrhage, Placebo, MESH: Stroke, Peripheral Arterial Disease, 03 medical and health sciences, Double-Blind Method, [INFO.INFO-IM]Computer Science [cs]/Medical Imaging, medicine, Humans, Receptor, PAR-1, MESH: Retreatment, MESH: Kaplan-Meier Estimate, Aged, MESH: Humans, business.industry, MESH: Pyridines, MESH: Cardiovascular Diseases, medicine.disease, Settore MED/11 - Malattie Dell'Apparato Cardiovascolare, MESH: Male, business, MESH: Female, Platelet Aggregation Inhibitors
Abstract

BACKGROUND: Thrombin potently activates platelets through the protease-activated receptor PAR-1. Vorapaxar is a novel antiplatelet agent that selectively inhibits the cellular actions of thrombin through antagonism of PAR-1. METHODS: We randomly assigned 26,449 patients who had a history of myocardial infarction, ischemic stroke, or peripheral arterial disease to receive vorapaxar (2.5 mg daily) or matching placebo and followed them for a median of 30 months. The primary efficacy end point was the composite of death from cardiovascular causes, myocardial infarction, or stroke. After 2 years, the data and safety monitoring board recommended discontinuation of the study treatment in patients with a history of stroke owing to the risk of intracranial hemorrhage. RESULTS:At 3 years, the primary end point had occurred in 1028 patients (9.3%) in the vorapaxar group and in 1176 patients (10.5%) in the placebo group (hazard ratio for the vorapaxar group, 0.87; 95% confidence interval [CI], 0.80 to 0.94; P

Published
2012
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