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1. A sub-study of the POISE-3 randomized trial examined effects of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury

Author

Garg, Amit X., Marcucci, Maura, Cuerden, Meaghan S., Sontrop, Jessica M., Painter, Thomas W., Lomivorotov, Vladimir, Sessler, Daniel I., Chan, Matthew T.V., Borges, Flavia K., Leslie, Kate, Duceppe, Emmanuelle, Parikh, Chirag R., Roshanov, Pavel, Martínez-Zapata, María José, Wang, Chew Yin, Xavier, Denis, Efremov, Sergey, Landoni, Giovanni, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Meyhoff, Christian S., Short, Timothy G., Amir, Mohammed, Torres, David, Wittmann, Maria, Patel, Ameen, Ruetzler, Kurt, Parlow, Joel L., Jayaram, Raja, Polanczyk, Carisi A., Fleischmann, Edith, Tandon, Vikas, Astrakov, Sergey V., Conen, David, Kei Wu, William Ka, Cheong, Chao Chia, Ayad, Sabry, Kirov, Mikhail, de Nadal, Miriam, Likhvantsev, Valery V., Paniagua, Pilar, Aguado, Hector J., Ofori, Sandra N., Vincent, Jessica, Copland, Ingrid, Balasubramanian, Kumar, Biccard, Bruce M., Srinathan, Sadeesh, Ismoilov, Samandar, Wang, Michael Ke, Kurz, Andrea, Belley-Cote, Emilie P., Bhatt, Keyur, Eikelboom, John, Gross, Peter, Lamy, Andre, McGillion, Michael, McIntyre, William, Richards, Toby, Spence, Jessica, Van Helder, Thomas, Whitlock, Richard, and Devereaux, P.J.

Published
2024
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2. Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

Author

Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Martínez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.

Published
2022
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3. Working conditions of medical workers during the COVID-19 pandemic in 2020–2021 in Novosibirsk

Author

Shpagina, Lyubov A., primary, Kotova, Olga S., additional, Likhenko-Logvinenko, Kristina V., additional, Astrakov, Sergey V., additional, Kalinichenko, Aleksander V., additional, Gerasimenko, Oksana N., additional, Karmanovskaya, Svetlana A., additional, Chebykin, Dmitry V., additional, Kuzmina, Lyudmila P., additional, and Bukhtiyarov, Igor V., additional

Published
2023
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4. Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery: An International Randomized Controlled Trial

Author

Marcucci, Maura, Painter, Thomas W, Conen, David, Lomivorotov, Vladimir, Sessler, Daniel I, Chan, Matthew T V, Borges, Flavia K, Leslie, Kate, Duceppe, Emmanuelle, Martínez-Zapata, María José, Wang, Chew Yin, Xavier, Denis, Ofori, Sandra N, Wang, Michael Ke, Efremov, Sergey, Landoni, Giovanni, Kleinlugtenbelt, Ydo V, Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X, Short, Timothy G, Wittmann, Maria, Meyhoff, Christian S, Amir, Mohammed, Torres, David, Patel, Ameen, Ruetzler, Kurt, Parlow, Joel L, Tandon, Vikas, Fleischmann, Edith, Polanczyk, Carisi A, Lamy, Andre, Jayaram, Raja, Astrakov, Sergey V, Wu, William Ka Kei, Cheong, Chao Chia, Ayad, Sabry, Kirov, Mikhail, de Nadal, Miriam, Likhvantsev, Valery V, Paniagua, Pilar, Aguado, Hector J, Maheshwari, Kamal, Whitlock, Richard P, McGillion, Michael H, Vincent, Jessica, Copland, Ingrid, Balasubramanian, Kumar, Biccard, Bruce M, Srinathan, Sadeesh, van Lier, Felix, and Anesthesiology

Abstract

BACKGROUND: Among patients having noncardiac surgery, perioperative hemodynamic abnormalities are associated with vascular complications. Uncertainty remains about what intraoperative blood pressure to target and how to manage long-term antihypertensive medications perioperatively. OBJECTIVE: To compare the effects of a hypotension-avoidance and a hypertension-avoidance strategy on major vascular complications after noncardiac surgery. DESIGN: Partial factorial randomized trial of 2 perioperative blood pressure management strategies (reported here) and tranexamic acid versus placebo. (ClinicalTrials.gov: NCT03505723). SETTING: 110 hospitals in 22 countries. PATIENTS: 7490 patients having noncardiac surgery who were at risk for vascular complications and were receiving 1 or more long-term antihypertensive medications. INTERVENTION: In the hypotension-avoidance strategy group, the intraoperative mean arterial pressure target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld and the other long-term antihypertensive medications were administered only for systolic blood pressures 130 mm Hg or greater, following an algorithm. In the hypertension-avoidance strategy group, the intraoperative mean arterial pressure target was 60 mm Hg or greater; all antihypertensive medications were continued before and after surgery. MEASUREMENTS: The primary outcome was a composite of vascular death and nonfatal myocardial injury after noncardiac surgery, stroke, and cardiac arrest at 30 days. Outcome adjudicators were masked to treatment assignment. RESULTS: The primary outcome occurred in 520 of 3742 patients (13.9%) in the hypotension-avoidance group and in 524 of 3748 patients (14.0%) in the hypertension-avoidance group (hazard ratio, 0.99 [95% CI, 0.88 to 1.12]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term. LIMITATION: Adherence to the assigned strategies was suboptimal; however, results were consistent across different adherence levels. CONCLUSION: In patients having noncardiac surgery, our hypotension-avoidance and hypertension-avoidance strategies resulted in a similar incidence of major vascular complications. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong.

Published
2023

5. Tranexamic Acid in Patients Undergoing Noncardiac Surgery

Author

UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, Devereaux, P.J., Marcucci, Maura, Painter, Thomas W., Conen, David, Lomivorotov, Vladimir, Sessler, Daniel I., Chan, Matthew T.V., Borges, Flavia K., Martínez-Zapata, María J., Wang, Chew Yin, Xavier, Denis, Ofori, Sandra N., Wang, Michael K., Efremov, Sergey, Landoni, Giovanni, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurt, Parlow, Joel L., Tandon, Vikas, Fleischmann, Edith, Polanczyk, Carisi A., Lamy, Andre, Astrakov, Sergey V., Rao, Mangala, Wu, William K.K., Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery V., Paniagua, Pilar, Aguado, Hector J., Whitlock, Richard P., McGillion, Michael H., Prystajecky, Michael, Vincent, Jessica, Eikelboom, John, Copland, Ingrid, Balasubramanian, Kumar, Turan, Alparslan, Bangdiwala, Shrikant I., Stillo, David, Gross, Peter L., Cafaro, Teresa, Alfonsi, Pascal, Roshanov, Pavel S., Belley-Côté, Emilie P., Spence, Jessica, Richards, Toby, VanHelder, Tomas, McIntyre, William, Guyatt, Gordon, Yusuf, Salim, Leslie, Kate, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, Devereaux, P.J., Marcucci, Maura, Painter, Thomas W., Conen, David, Lomivorotov, Vladimir, Sessler, Daniel I., Chan, Matthew T.V., Borges, Flavia K., Martínez-Zapata, María J., Wang, Chew Yin, Xavier, Denis, Ofori, Sandra N., Wang, Michael K., Efremov, Sergey, Landoni, Giovanni, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurt, Parlow, Joel L., Tandon, Vikas, Fleischmann, Edith, Polanczyk, Carisi A., Lamy, Andre, Astrakov, Sergey V., Rao, Mangala, Wu, William K.K., Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery V., Paniagua, Pilar, Aguado, Hector J., Whitlock, Richard P., McGillion, Michael H., Prystajecky, Michael, Vincent, Jessica, Eikelboom, John, Copland, Ingrid, Balasubramanian, Kumar, Turan, Alparslan, Bangdiwala, Shrikant I., Stillo, David, Gross, Peter L., Cafaro, Teresa, Alfonsi, Pascal, Roshanov, Pavel S., Belley-Côté, Emilie P., Spence, Jessica, Richards, Toby, VanHelder, Tomas, McIntyre, William, Guyatt, Gordon, Yusuf, Salim, and Leslie, Kate

Abstract

BACKGROUND Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The pri- mary safety outcome was myocardial injury after noncardiac surgery, nonhemor- rhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular out- come, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confi- dence interval [CI], 0.67 to 0.87; absolute difference, −2.6 percentage points; 95% CI, −3.8 to −1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 per- centage points; 95% CI, −1.1 to 1.7; one-sided P=0.04 for noninferiority). CONCLUSIONS Among patients undergoing noncardiac surgery, the incidence of the com

Published
2022

6. Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3):a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

Author

Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T.V., Borges, Flavia K., Martínez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K.K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, Devereaux, P. J., Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T.V., Borges, Flavia K., Martínez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K.K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.

Abstract

Background: For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. Methods: The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the ta

Published
2022

7. Tranexamic Acid in Patients Undergoing Noncardiac Surgery

Author

Devereaux, P.J., primary, Marcucci, Maura, additional, Painter, Thomas W., additional, Conen, David, additional, Lomivorotov, Vladimir, additional, Sessler, Daniel I., additional, Chan, Matthew T.V., additional, Borges, Flavia K., additional, Martínez-Zapata, María J., additional, Wang, Chew Yin, additional, Xavier, Denis, additional, Ofori, Sandra N., additional, Wang, Michael K., additional, Efremov, Sergey, additional, Landoni, Giovanni, additional, Kleinlugtenbelt, Ydo V., additional, Szczeklik, Wojciech, additional, Schmartz, Denis, additional, Garg, Amit X., additional, Short, Timothy G., additional, Wittmann, Maria, additional, Meyhoff, Christian S., additional, Amir, Mohammed, additional, Torres, David, additional, Patel, Ameen, additional, Duceppe, Emmanuelle, additional, Ruetzler, Kurt, additional, Parlow, Joel L., additional, Tandon, Vikas, additional, Fleischmann, Edith, additional, Polanczyk, Carisi A., additional, Lamy, Andre, additional, Astrakov, Sergey V., additional, Rao, Mangala, additional, Wu, William K.K., additional, Bhatt, Keyur, additional, de Nadal, Miriam, additional, Likhvantsev, Valery V., additional, Paniagua, Pilar, additional, Aguado, Hector J., additional, Whitlock, Richard P., additional, McGillion, Michael H., additional, Prystajecky, Michael, additional, Vincent, Jessica, additional, Eikelboom, John, additional, Copland, Ingrid, additional, Balasubramanian, Kumar, additional, Turan, Alparslan, additional, Bangdiwala, Shrikant I., additional, Stillo, David, additional, Gross, Peter L., additional, Cafaro, Teresa, additional, Alfonsi, Pascal, additional, Roshanov, Pavel S., additional, Belley-Côté, Emilie P., additional, Spence, Jessica, additional, Richards, Toby, additional, VanHelder, Tomas, additional, McIntyre, William, additional, Guyatt, Gordon, additional, Yusuf, Salim, additional, and Leslie, Kate, additional

Published
2022
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8. Additional file 9 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

Author

Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.

Abstract

Additional file 9. POISE-3 informed consent form template (English).

Published
2022
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9. Additional file 7 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

Author

Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.

Abstract

Additional file 7. POISE-3 interim analyses.

Published
2022
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10. Additional file 10 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

Author

Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.

Subjects
ComputingMilieux_THECOMPUTINGPROFESSION, Data_FILES, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries)
Abstract

Additional file 10. List of investigators and committees.

Published
2022
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11. Additional file 8 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

Author

Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.

Abstract

Additional file 8. POISE-3 organizational structure and oversight of trial conduct.

Published
2022
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12. Additional file 5 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

Author

Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.

Abstract

Additional file 5. POISE-3 tertiary outcomes.

Published
2022
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13. Additional file 3 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

Author

Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.

Abstract

Additional file 3. Rationale for POISE-3 study dosing regimen of tranexamic acid.

Published
2022
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14. Additional file 6 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

Author

Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.

Abstract

Additional file 6. POISE-3 outcome definitions.

Published
2022
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16. Tranexamic Acid in Patients Undergoing Noncardiac Surgery

Author

P J, Devereaux, Maura, Marcucci, Thomas W, Painter, David, Conen, Vladimir, Lomivorotov, Daniel I, Sessler, Matthew T V, Chan, Flavia K, Borges, María J, Martínez-Zapata, Chew Yin, Wang, Denis, Xavier, Sandra N, Ofori, Michael K, Wang, Sergey, Efremov, Giovanni, Landoni, Ydo V, Kleinlugtenbelt, Wojciech, Szczeklik, Denis, Schmartz, Amit X, Garg, Timothy G, Short, Maria, Wittmann, Christian S, Meyhoff, Mohammed, Amir, David, Torres, Ameen, Patel, Emmanuelle, Duceppe, Kurt, Ruetzler, Joel L, Parlow, Vikas, Tandon, Edith, Fleischmann, Carisi A, Polanczyk, Andre, Lamy, Sergey V, Astrakov, Mangala, Rao, William K K, Wu, Keyur, Bhatt, Miriam, de Nadal, Valery V, Likhvantsev, Pilar, Paniagua, Hector J, Aguado, Richard P, Whitlock, Michael H, McGillion, Michael, Prystajecky, Jessica, Vincent, John, Eikelboom, Ingrid, Copland, Kumar, Balasubramanian, Alparslan, Turan, Shrikant I, Bangdiwala, David, Stillo, Peter L, Gross, Teresa, Cafaro, Pascal, Alfonsi, Pavel S, Roshanov, Emilie P, Belley-Côté, Jessica, Spence, Toby, Richards, Tomas, VanHelder, William, McIntyre, Gordon, Guyatt, Salim, Yusuf, Kate, Leslie, Erin, Hittesdorf, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, Devereaux, P J, Marcucci, Maura, Painter, Thomas W, Conen, David, Lomivorotov, Vladimir, Sessler, Daniel I, Chan, Matthew T V, Borges, Flavia K, Martínez-Zapata, María J, Wang, Chew-Yin, Xavier, Deni, Ofori, Sandra N, Wang, Michael K, Efremov, Sergey, Landoni, Giovanni, Kleinlugtenbelt, Ydo V, Szczeklik, Wojciech, Schmartz, Deni, Garg, Amit X, Short, Timothy G, Wittmann, Maria, Meyhoff, Christian S, Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurt, Parlow, Joel L, Tandon, Vika, Fleischmann, Edith, Polanczyk, Carisi A, Lamy, Andre, Astrakov, Sergey V, Rao, Mangala, Wu, William K K, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery V, Paniagua, Pilar, Aguado, Hector J, Whitlock, Richard P, Mcgillion, Michael H, Prystajecky, Michael, Vincent, Jessica, Eikelboom, John, Copland, Ingrid, Balasubramanian, Kumar, Turan, Alparslan, Bangdiwala, Shrikant I, Stillo, David, Gross, Peter L, Cafaro, Teresa, Alfonsi, Pascal, Roshanov, Pavel S, Belley-Côté, Emilie P, Spence, Jessica, Richards, Toby, Vanhelder, Toma, Mcintyre, William, Guyatt, Gordon, Yusuf, Salim, Leslie, Kate, and Anesthesiology

Subjects
BLOOD-TRANSFUSION, HEMORRHAGE, Canada, Tranexamic Acid, MORTALITY, Surgical Procedures, Operative, BIMS, Humans, Hemorrhage, Thrombosis, General Medicine, Antifibrinolytic Agents
Abstract

BACKGROUND Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The pri- mary safety outcome was myocardial injury after noncardiac surgery, nonhemor- rhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular out- come, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confi- dence interval [CI], 0.67 to 0.87; absolute difference, −2.6 percentage points; 95% CI, −3.8 to −1.4; two-sided P

Published
2022

17. Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery : An International Randomized Controlled Trial.

Author

Marcucci M, Painter TW, Conen D, Lomivorotov V, Sessler DI, Chan MTV, Borges FK, Leslie K, Duceppe E, Martínez-Zapata MJ, Wang CY, Xavier D, Ofori SN, Wang MK, Efremov S, Landoni G, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Ruetzler K, Parlow JL, Tandon V, Fleischmann E, Polanczyk CA, Lamy A, Jayaram R, Astrakov SV, Wu WKK, Cheong CC, Ayad S, Kirov M, de Nadal M, Likhvantsev VV, Paniagua P, Aguado HJ, Maheshwari K, Whitlock RP, McGillion MH, Vincent J, Copland I, Balasubramanian K, Biccard BM, Srinathan S, Ismoilov S, Pettit S, Stillo D, Kurz A, Belley-Côté EP, Spence J, McIntyre WF, Bangdiwala SI, Guyatt G, Yusuf S, and Devereaux PJ

Subjects
Humans, Antihypertensive Agents therapeutic use, Postoperative Complications epidemiology, Canada, Hypotension etiology, Hypotension prevention & control, Hypertension drug therapy
Abstract

Background: Among patients having noncardiac surgery, perioperative hemodynamic abnormalities are associated with vascular complications. Uncertainty remains about what intraoperative blood pressure to target and how to manage long-term antihypertensive medications perioperatively., Objective: To compare the effects of a hypotension-avoidance and a hypertension-avoidance strategy on major vascular complications after noncardiac surgery., Design: Partial factorial randomized trial of 2 perioperative blood pressure management strategies (reported here) and tranexamic acid versus placebo. (ClinicalTrials.gov: NCT03505723)., Setting: 110 hospitals in 22 countries., Patients: 7490 patients having noncardiac surgery who were at risk for vascular complications and were receiving 1 or more long-term antihypertensive medications., Intervention: In the hypotension-avoidance strategy group, the intraoperative mean arterial pressure target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld and the other long-term antihypertensive medications were administered only for systolic blood pressures 130 mm Hg or greater, following an algorithm. In the hypertension-avoidance strategy group, the intraoperative mean arterial pressure target was 60 mm Hg or greater; all antihypertensive medications were continued before and after surgery., Measurements: The primary outcome was a composite of vascular death and nonfatal myocardial injury after noncardiac surgery, stroke, and cardiac arrest at 30 days. Outcome adjudicators were masked to treatment assignment., Results: The primary outcome occurred in 520 of 3742 patients (13.9%) in the hypotension-avoidance group and in 524 of 3748 patients (14.0%) in the hypertension-avoidance group (hazard ratio, 0.99 [95% CI, 0.88 to 1.12]; P  = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term., Limitation: Adherence to the assigned strategies was suboptimal; however, results were consistent across different adherence levels., Conclusion: In patients having noncardiac surgery, our hypotension-avoidance and hypertension-avoidance strategies resulted in a similar incidence of major vascular complications., Primary Funding Source: Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong., Competing Interests: Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-3157.

Published
2023
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