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2. Accelerated surgery versus standard care in hip fracture (HIP ATTACK-1) : a kidney substudy of a randomized clinical trial

Author

Flavia K. Borges, P.J. Devereaux, Meaghan Cuerden, Jessica M. Sontrop, Mohit Bhandari, Ernesto Guerra-Farfán, Ameen Patel, Alben Sigamani, Masood Umer, John Neary, Maria Tiboni, Vikas Tandon, Mmampapatla Thomas Ramokgopa, Parag Sancheti, Abdel-Rahman Lawendy, Mariano Balaguer-Castro, Richard Jenkinson, Paweł Ślęczka, Aamer Nabi Nur, Gavin C.A. Wood, Robert J. Feibel, John Stephen McMahon, Bruce M. Biccard, Alessandro Ortalda, Wojciech Szczeklik, Chew Yin Wang, Jordi Tomás-Hernández, Jessica Vincent, Valerie Harvey, Shirley Pettit, Kumar Balasubramanian, Gerard Slobogean, Amit X. Garg, Laurent Veevaete, Bernard le Polain de Waroux, Patricia Lavand'homme, Olivier Cornu, Karim Tribak, Jean C. Yombi, Nassim Touil, Jigme T. Bhutia, Carol Clinckaert, Dirk De Clippeleir, Maike Reu, Leslie P. Gauthier, Victoria RA. Avram, Mitchell Winemaker, Daniel M. Tushinski, Justin de Beer, Andrew Worster, Diane L. Simpson, Kim A. Alvarado, Krysten K. Gregus, Kelly H. Lawrence, Darryl P. Leong, Philip G. Joseph, Patrick Magloire, Benjamin Deheshi, Stuart Bisland, Thomas J. Wood, David AJ. Wilson, Sandra N. Ofori, Jessica Spence, Emmanuelle Duceppe, Maria E. Tiboni, John D. Neary, Anthony Adili, David D. Cowan, Vickas Khanna, Amna Zaki, Janet C. Farrell, Anne Marie MacDonald, David Conen, Steven CW. Wong, Arsha Karbassi, Douglas S. Wright, Harsha Shanthanna, Javier Ganame, Andrew Cheung, Ryan Coughlin, Moin Khan, Spencer Wikkerink, Faraaz A. Quraishi, Waleed Kishta, Emil Schemitsch, Timothy Carey, Mark D. Macleod, David W. Sanders, Edward Vasarhelyi, Debra Bartley, George K. Dresser, Christina Tieszer, Richard J. Jenkinson, Steven Shadowitz, Jacques S. Lee, Stephen Choi, Hans J. Kreder, Markku Nousiainen, Monica R. Kunz, Ravianne Tuazon, Mopina Shrikumar, Bheeshma Ravi, David Wasserstein, David J.G. Stephen, Diane Nam, Patrick D.G. Henry, Gavin CA. Wood, Stephen M. Mann, Melanie T. Jaeger, Marco LA. Sivilotti, Christopher A. Smith, Christopher C. Frank, Heather Grant, Leone Ploeg, Jeff D. Yach, Mark M. Harrison, Aaron R. Campbell, Ryan T. Bicknell, Davide D. Bardana, Katie McIlquham, Catherine Gallant, Samantha Halman, Venkatesh Thiruganasambandamoorth, Sara Ruggiero, William J. Hadden, Brian PJ. Chen, Stephanie A. Coupal, Stephen J. McMahon, Lisa M. McLean, Hemant R. Shirali, Syed Y. Haider, Crystal A. Smith, Evan Watts, David J. Santone, Kevin Koo, Allan J. Yee, Ademilola N. Oyenubi, Aaron Nauth, Emil H. Schemitsch, Timothy R. Daniels, Sarah E. Ward, Jeremy A. Hall, Henry Ahn, Daniel B. Whelan, Amit Atrey, Amir Khoshbin, David Puskas, Kurt Droll, Claude Cullinan, Jubin Payendeh, Tina Lefrancois, Lise Mozzon, Travis Marion, Michael J. Jacka, James Greene, Matthew Menon, Robert Stiegelmahr, Derek Dillane, Marleen Irwin, Lauren Beaupre, Chad P. Coles, Kelly Trask, Shelley MacDonald, J.A.I. Trenholm, William Oxner, C.G. Richardson, Niloofar Dehghan, Mehdi Sadoughi, Achal Sharma, Neil J. White, Loretta Olivieri, Stephen B. Hunt, Thomas R. Turgeon, Eric R. Bohm, Sarah Tran, Stephen M. Giilck, Tom Hupel, Pierre Guy, Peter J. O'Brien, Andrew W. Duncan, Gordon A. Crawford, Junlin Zhou, Yanrui Zhao, Yang Liu, Lei Shan, Anshi Wu, Juan M. Muñoz, Philippe Chaudier, Marion Douplat, Michel Henri Fessy, Vincent Piriou, Lucie Louboutin, Jean Stephane David, Arnaud Friggeri, Anthony Viste, Charles Hervé Vacheron, Frankie Ka Li Leung, Christian Xinshuo Fang, Dennis King Hang Yee, Parag K. Sancheti, Chetan V. Pradhan, Atul A. Patil, Chetan P. Puram, Madhav P. Borate, Kiran B. Kudrimoti, Bharati A. Adhye, Himanshu V. Dongre, Bobby John, Valsamma Abraham, Ritesh A. Pandey, Arti Rajkumar, Preetha E. George, Manesh Stephen, Nitheesh Chandran, Mohammed Ashraf, A.M. Georgekutty, Ahamad S. Sulthan, S. Adinarayanan, Deep Sharma, Satish P. Barnawal, Srinivasan Swaminathan, Prasanna U. Bidkar, Sandeep K. Mishra, Jagdish Menon, M. Niranjan, Z.K. Varghese, Santosh A. Hiremath, N.C. Madhusudhan, Abhijit Jawali, Kingsly R. Gnanadurai, Carolin E. George, Tatarao Maddipati, K.P. Mary, Vijay Sharma, Kamran Farooque, Rajesh Malhotra, Samarth Mittal, Chavi Sawhney, Babita Gupta, Purva Mathur, Shivanand Gamangati, Vijaylaxmi Tripathy, Prem H. Menon, Mandeep S. Dhillon, Devendra K. Chouhan, Sharanu Patil, Ravi Narayan, Purushotham Lal, Prashanth N. Bilchod, Surya U. Singh, Uttam V. Gattu, Ravi P. Dashputra, Prashant V. Rahate, Maurizio Turiel, Riccardo Accetta, Paolo Perazzo, Daniele Stella, Marika Bonadies, Chiara Colombo, Giuseppe De Blasio, Stefania Fozzato, Fabio Pino, Ilaria Morelli, Francesco De Donato, Eleonora Colnaghi, Vincenzo Salini, Giacomo Placella, Giuseppe Giardina, Gaetano Lombardi, Anna Marcato, Luca Guzzetti, Ilaria Rivetti, Massimiliano Greco, H.M. Khor, Hou Yee Lai, C.S. Kumar, K.H. Chee, P.S. Loh, Kit Mun Tan, Simmrat Singh, Li Lian Foo, Komella Prakasam, Sook Hui Chaw, Meng-Li Lee, Joanne HL. Ngim, Huck Wee Boon, Im Im Chin, Ydo V. Kleinlugtenbelt, Ellie BM. Landman, Elvira R. Flikweert, Herbert W. Roerdink, Roy BG. Brokelman, Hannie F. Elskamp-Meijerman, Bas Staffhorst, Jan-Hein MG. Cobben, Dilshad Begum, Anila Anjum, Pervaiz M. Hashmi, Tashfeen Ahmed, Haroon U. Rashid, Mujahid J. Khattak, Rizwan H. Rashid, Riaz H. Lakdawala, Shahryar Noordin, Naveed M. Juman, Robyna I. Khan, Muhammad M. Riaz, Syedah S. Bokhari, Ayesha Almas, Hussain Wahab, Arif Ali, Hammad N. Khan, Eraj K. Khan, Kholood A. Janjua, Sajjad H. Orakzai, Abdus S. Khan, Khawaja J. Mustafa, Mian A. Sohail, Muhammad Umar, Siddra A. Khan, Muhammad Ashraf, Muhammad K. Khan, Muhammad Shiraz, Ahmad Furgan, Piotr Dąbek, Adam Kumoń, Wojciech Satora, Wojciech Ambroży, Mariusz Święch, Jacek Rycombel, Adrian Grzelak, Ilona Nowak-Kózka, Jaroslaw Gucwa, Waldemar Machala, Mmampapatla T. Ramokgopa, Gregory B. Firth, Mwalimu Karera, Maria Fourtounas, Virsen Singh, Anna Biscardi, Muhammad N. Iqbal, Ryan J. Campbell, Matimba L. Maluleke, Carien Moller, Lerato Nhlapo, Sithombo Maqungo, Margot Flint, Marcin B. Nejthardt, Sean Chetty, Stephen Venter, Ernesto Guerra-Farfan, Jordi Tomas-Hernandez, Yaiza Garcia-Sanchez, Miriam Garrido Clua, Vicente Molero-Garcia, Jordi Teixidor-Serra, Maria del Mar Villar-Casares, Jordi Selga Marsa, Juan A. Porcel-Vazquez, Jose-Vicente Andres- Peiro, Jaume Mestre-Torres, Patricia Guilabert, M Luisa Paños Gozalo, Luis Abarca, Nuria Martin, Gemma Usua, Pilar Lalueza-Broto, Judith Sanchez-Raya, Jorge Nuñez Camarena, Antoni Fraguas-Castany, Carlos Piedra Calle, Diego Soza Leiva, Maria Garcia Carrasco, Montsant Jornet-Gibert, Montserrat Monfort-Mira, Alfons Gasset-Teixidor, Francesc Antoni Marcano-Fernández, Isabel Simó- Sánchez, Begoña Mari-Alfonso, Christian Yela-Verdú, Raúl Pellejero-García, Júlia Casas-Codina, Ruben Iglesias- Sanjuan, Pau Balcells-Nolla, Oriol Vila-Sánchez, Mercè Bertrana de Bustos, Pablo Castillón, Martí Bernaus, Saioa Quintas, Olga Gómez, Jordi Salvador, Javier Abarca, Cristina Estrada, Marga Novellas, Francesc Anglès, Alfred Dealbert, Oscar Macho, Alexia Ivanov, Esther Valldosera, Marta Arroyo, Borja Pey, Antoni Yuste, Llorenç Mateo, Julio De Caso, Rafael Anaya, J.L. Higa-Sansone, Angelica Millan, Victoria Baños, Sergio Herrera-Mateo, Hector J. Aguado, Virginia García-Virto, Clarisa Simón-Pérez, Sergio Chavez, María Bragado, María Plata, Enrique Guerado, Encarnacion Cruz, Juan R. Cano, Jose M. Bogallo, Paphon Sa-ngasoongsong, Noratep Kulachote, Norachart Sirisreetreerux, Nachapan Pengrung, Theerawat Chalacheewa, Vanlapa Arnuntasupakul, Teerapat Yingchoncharoen, Bundit Naratreekoon, Miriam A. Kadry, Surendini Thayaparan, Victor Babu, Arash Aframian, Souad Bentoumi, Amrinder Sayan, Ihab Abdlaziz, Marcela P. Vizcaychipi, Patricia Correia, Shashank Patil, Kevin Haire, Amy SE. Mayor, Sally Dillingham, Laura Nicholson, Ben T. Brooke, Joby John, Shashi K. Nanjayan, Martyn J. Parker, Susan O'Sullivan, Meir T. Marmor, Amir Matityahu, Robert T. McClellan, Curt Comstock, Anthony Ding, Paul Toogood, Robert O’Toole, Marcus Sciadini, Jason Nascone, Nathan O’Hara, Scott P. Ryan, Molly E. Clark, Charles Cassidy, Konstantin Balonov, Tristan Weaver, Laura S. Phieffer, Sergio D. Bergese, Andrew J. Marcantonio, Shrikant I. Bangdiwala, Michael H. McGillion, Sanela Dragic-Taylor, Chelsea Maxwell, Sarah Molnar, Jennifer R. Wells, Patrice Forget, Paul Landais, Giovanni Landoni, Ekaterine Popova, Iain K. Moppett, Robin Roberts, null Chairperson, Finlay McAlister, David Sackett, James Wright, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, UCL - SSS/IREC/NMSK - Neuro-musculo-skeletal Lab, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'anesthésiologie, UCL - (SLuc) Service d'orthopédie et de traumatologie de l'appareil locomoteur, and UCL - (SLuc) Service de médecine interne générale

Subjects
Hip Fractures, Nephrology, Humans, Pelvic Bones, Kidney
Abstract

To the Editor: Acute kidney injury (AKI) is a lesser-known complication of hip fracture that may come about owing to decreased kidney perfusion and heightened inflammation from trauma, pain, bleeding, and fasting. Approximately 15%-20% of patients undergoing surgery for a hip fracture develop AKI, with 0.5%-1.8% receiving dialysis. [...]

Published
2022

3. Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death

Author

Rikke M. Dahl, Joel L. Parlow, Emmanuelle Duceppe, Rajendra K. Premchand, Jesús Álvarez-García, Reitze N. Rodseth, Kate Leslie, S. A. Walker, Daniel I. Sessler, Alexandre Biasi Cavalcanti, Prashant V. Rahate, Manfred D. Seeberger, Guangmei Mao, Christian S. Meyhoff, P. J. Devereaux, Fernando Botto, Nicole M. Zimmerman, Skarlet M. Vásquez, Bruno Gossetti, and Packianathaswamy Balaji

Subjects
medicine.medical_specialty, Mean arterial pressure, Heart disease, business.industry, 030208 emergency & critical care medicine, Perioperative, medicine.disease, Comorbidity, law.invention, 03 medical and health sciences, 0302 clinical medicine, Anesthesiology and Pain Medicine, Randomized controlled trial, 030202 anesthesiology, law, Anesthesia, Anesthesiology, Internal medicine, Cohort, Cardiology, Medicine, Myocardial infarction, business
Abstract

Background The relative contributions of intraoperative and postoperative hypotension to perioperative morbidity remain unclear. We determined the association between hypotension and a composite of 30-day myocardial infarction and death over three periods: (1) intraoperative, (2) remaining day of surgery, and (3) during the initial four postoperative days. Methods This was a substudy of POISE-2, a 10,010-patient factorial-randomized trial of aspirin and clonidine for prevention of myocardial infarction. Clinically important hypotension was defined as systolic blood pressure less than 90 mmHg requiring treatment. Minutes of hypotension was the exposure variable intraoperatively and for the remaining day of surgery, whereas hypotension status was treated as binary variable for postoperative days 1 to 4. We estimated the average relative effect of hypotension across components of the composite using a distinct effect generalized estimating model, adjusting for hypotension during earlier periods. Results Among 9,765 patients, 42% experienced hypotension, 590 (6.0%) had an infarction, and 116 (1.2%) died within 30 days of surgery. Intraoperatively, the estimated average relative effect across myocardial infarction and mortality was 1.08 (98.3% CI, 1.03, 1.12; P < 0.001) per 10-min increase in hypotension duration. For the remaining day of surgery, the odds ratio was 1.03 (98.3% CI, 1.01, 1.05; P < 0.001) per 10-min increase in hypotension duration. The average relative effect odds ratio was 2.83 (98.3% CI, 1.26, 6.35; P = 0.002) in patients with hypotension during the subsequent four days of hospitalization. Conclusions Clinically important hypotension—a potentially modifiable exposure—was significantly associated with a composite of myocardial infarction and death during each of three perioperative periods, even after adjustment for previous hypotension.

Published
2018

4. Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE) : an international, randomised, placebo-controlled trial

Author

P J Devereaux, Emmanuelle Duceppe, Gordon Guyatt, Vikas Tandon, Reitze Rodseth, Bruce M Biccard, Denis Xavier, Wojciech Szczeklik, Christian S Meyhoff, Jessica Vincent, Maria Grazia Franzosi, Sadeesh K Srinathan, Jason Erb, Patrick Magloire, John Neary, Mangala Rao, Prashant V Rahate, Navneet K Chaudhry, Bongani Mayosi, Miriam de Nadal, Pilar Paniagua Iglesias, Otavio Berwanger, Juan Carlos Villar, Fernando Botto, John W Eikelboom, Daniel I Sessler, Clive Kearon, Shirley Pettit, Mukul Sharma, Stuart J Connolly, Shrikant I Bangdiwala, Purnima Rao-Melacini, Andreas Hoeft, Salim Yusuf, P.J. Devereaux, Shrikant I. Bangdiwala, Stuart Connolly, John Eikelboom, Janice Pogue, Daniel I. Sessler, Sara Di Diodato, Zora Gasic, Louise J. Mastrangelo, Sarah H. Molnar, Jennifer L. Swanson, Makayla L. Tosh, Jennifer R. Wells, Rafael Diaz, Clara K. Chow, Beatriz Gonzales, Skarlet Vásquez, Petr Jansky, Radovan Dušek, Christian S. Meyhoff, Pierre Coriat, Maria Wittmann, Gerald Yonga, Nandini Mathur, Elena Seletti, German Malaga, Bernadette A. Tumanan-Mendoza, Maria Pamela A. Tagle, Bruce M. Biccard, Pablo Alonso-Coello, Ekaterine Popova, Martin Shields, Yannick Le Manach, Paul Moayyedi, Sander van Zanten, Edith Fleischmann, Amit Garg, Kamilu Karaye, Edward McFalls, Alben Sigamani, Emilie Belley-Côté, Grzegorz Biedroń, Flavia Borges, Steffan Frosi Stella, Christian Haarmark Nielsen, Darryl P. Leong, Jessica Spence, Allen Tran, Katarzyna Wawrzycka-Adamczyk, Stephen S. Yang, Terence Yung, D. George Wyse, Davy Cheng, David E. Johnstone, George A. Wells, Philip Joseph, Ameen Patel, Krysten Gregus, Kelly Lawrence, Lindsay Doharris, David Conen, Jason Cheung, Jim Douketis, Douglas Wright, Spencer Wikkerink, William Dechert, Mohamed Panju, Khalid Azzam, Theodore Rapanos, Tomas Van Helder, Anjali Shroff, Jacqueline Hare, Biniam Kidane, Thang Nguyen, Larissa Leydier, Vanessa Bayaraa, Joel Parlow, Deborah A. DuMerton, Amar Thakrar, Jessica Shelley, Benoit Deligne, Roberta Daila Carling, Marko Mrkobrada, George K. Dresser, Michael J. Jacka, David Hornstein, Gerrit B. Winkelaar, Zoeb Hussain Haider, Pravina Prashant Lanjewar, Valsamma Varughese, Rajneesh Calton, Hemani Ahuja, Preetha George, Ambika Sharma, Keyur Sureshchandra Bhatt, Dhaval Odhavajibhai Mangukiya, Karshan Vira Nandaniya, Viral Vasantrai Parekh, Ashok Bhaskaran Pillai, Vidya P. Menon, Sanjay Channappa Desai, Ravinder Singh Sidhu, Sandeep Kumar Gupta, Robbie K. George, T.R. Gurunath, Leanne W. Drummond, Alexandra M. Torborg, Belinda S. Küsel, Prebashini Naidoo, Datshana P. Naidoo, Chantal Rajah, Zane Farina, Richard Peter von Rahden, Simphiwe Gumede, Chishala Chishala, Ettienne Coetzee, Robert A. Dyer, Johan Diedericks, Piotr Bielański, Bogusz Kaczmarek, Dorota Studzińska, Maciej Zaniewski, Marek Józef Libura, Tomasz Mikołaj Zacharias-Nalichowski, Aurelia A.S. Sega, Jakub Salwa, Mateusz Kózka, Jacek Górka, Anna Wludarczyk, Ilona Nowak-Kózka, Paweł Szczepan Grudzień, Jaroslaw W. Gucwa, Michał Piotr Słowiaczek, Paweł P.D. Dobosz, Ismail Gögenur, Jens Ravn Eriksen, Tine Borup, Tove Kirkegaard, Dan Isbye, Asger Sonne, Lars S. Rasmussen, Sofie Pedersen, Hannibal Troensegaard, Camilla L. Duus, Benedikte M. Halle, Ossian N. Gundel, Katrine F. Bernholm, Kristian Rønsholt Martinsen, Søren Pedersen, Theis S. Itenov, Elena Camio, Carles Vázquez, Silvia Matarin, Esther Cano, Jesús Álvarez-García, Inmaculada India, Aránzazu González-Osuna, Marc Vives, Elena Rosselló, Ana B. Serrano, Maurizio Turiel, Lorenzo Drago, Chiara Colombo, Federica Marra, Lucio Mos, Franco Arteni, Rosalba Lembo, Alessandro Ortalda, Simonetta Passarani, Zhirajr Mokini, Estevao Lanna Figueiredo, Gustavo Fonseca Werner, Joao Luiz Petriz, Lilia Nigro Maia, Ricardo R. Bergo, Dalton Bertolim Precoma, José Francisco Kerr Saraiva, Oscar Gomez Vilamajo, Eduardo Allegrini, Mariano Benzadón, Maria Leonor Parody, Ernesto A. Duronto, Adrián C. Ingaramo, Gustavo Adolfo Parra, Danny Novoa, Scott A. Miller, Sabu Thomas, Sudhakar P. Karlapudi, Mohamad H. Bourji, Subhash Banerjee, Anita Gupta, Isaac O. Opole, Michal Fischer, Victor Lecaros Mendoza, Eugenio Borja Reyes, Richard J. Pierson, Martin O. Shields, Vincent Piriou, Kai Zacharowski, Aida Rotta-Rotta, Main Paper, Sadeesh K. Srinathan, Prashant Rahate, Navneet Chaudhry, Bogani Mayosi, and Mike Sharma

Subjects
Male, medicine.medical_specialty, Myocardial Infarction, Placebo-controlled study, Hemorrhage, 030204 cardiovascular system & hematology, Placebo, Antithrombins, Dabigatran, law.invention, Peripheral Arterial Disease, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, 030202 anesthesiology, law, Internal medicine, medicine, Humans, Perioperative Period, Stroke, Aged, Aged, 80 and over, business.industry, Hazard ratio, Proton Pump Inhibitors, Thrombosis, Venous Thromboembolism, General Medicine, Perioperative, Placebo Effect, medicine.disease, Troponin, Clinical trial, Treatment Outcome, Female, business, Omeprazole, medicine.drug
Abstract

Summary Background Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. Methods In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. Findings Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55–0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55–1·53; p=0·76). Interpretation Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication. Funding Boehringer Ingelheim and Canadian Institutes of Health Research.

Published
2018

5. Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial

Author

Daniel I, Sessler, Christian S, Meyhoff, Nicole M, Zimmerman, Guangmei, Mao, Kate, Leslie, Skarlet M, Vásquez, Packianathaswamy, Balaji, Jesús, Alvarez-Garcia, Alexandre B, Cavalcanti, Joel L, Parlow, Prashant V, Rahate, Manfred D, Seeberger, Bruno, Gossetti, S A, Walker, Rajendra K, Premchand, Rikke M, Dahl, Emmanuelle, Duceppe, Reitze, Rodseth, Fernando, Botto, and P J, Devereaux

Subjects
Male, Postoperative Complications, Surgical Procedures, Operative, Myocardial Infarction, Humans, Female, Comorbidity, Hypotension, Intraoperative Complications, Aged
Abstract

The relative contributions of intraoperative and postoperative hypotension to perioperative morbidity remain unclear. We determined the association between hypotension and a composite of 30-day myocardial infarction and death over three periods: (1) intraoperative, (2) remaining day of surgery, and (3) during the initial four postoperative days.This was a substudy of POISE-2, a 10,010-patient factorial-randomized trial of aspirin and clonidine for prevention of myocardial infarction. Clinically important hypotension was defined as systolic blood pressure less than 90 mmHg requiring treatment. Minutes of hypotension was the exposure variable intraoperatively and for the remaining day of surgery, whereas hypotension status was treated as binary variable for postoperative days 1 to 4. We estimated the average relative effect of hypotension across components of the composite using a distinct effect generalized estimating model, adjusting for hypotension during earlier periods.Among 9,765 patients, 42% experienced hypotension, 590 (6.0%) had an infarction, and 116 (1.2%) died within 30 days of surgery. Intraoperatively, the estimated average relative effect across myocardial infarction and mortality was 1.08 (98.3% CI, 1.03, 1.12; P0.001) per 10-min increase in hypotension duration. For the remaining day of surgery, the odds ratio was 1.03 (98.3% CI, 1.01, 1.05; P0.001) per 10-min increase in hypotension duration. The average relative effect odds ratio was 2.83 (98.3% CI, 1.26, 6.35; P = 0.002) in patients with hypotension during the subsequent four days of hospitalization.Clinically important hypotension-a potentially modifiable exposure-was significantly associated with a composite of myocardial infarction and death during each of three perioperative periods, even after adjustment for previous hypotension.

Published
2017

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