Anticoagulation and Antiplatelet Therapy for Prevention of Venous and Arterial Thrombotic Events in Critically Ill Patients With COVID-19: COVID-PACT

作者：Erin A. Bohula, David D. Berg, Mathew S. Lopes, Jean M. Connors, Ijlal Babar, Christopher F. Barnett, Sunit‐Preet Chaudhry, Amit Chopra, Wilson Ginete, Michael H. Ieong, Jason N. Katz, Edy Y. Kim, Julia Kuder, Emílio Mazza, Dalton McLean, Jarrod Mosier, Ari Moskowitz, Sabina A. Murphy, Michelle L. O’Donoghue, Jeong‐Gun Park, Rajnish Prasad, Christian T. Ruff, Mohamad N. Shahrour, Shashank S. Sinha, Stephen D. Wiviott, Sean van Diepen, Mark Zainea, Vivian M. Baird-Zars, Marc S. Sabatine, David A. Morrow, Kyung Ah Im, Retu Saxena, Brandon M. Wiley, Carina Benson, Roman Delamed, Nedaa Skeik, Ami Chopra, Marc A. Judson, Scott Beegle, Boris Shkolnik, Anupama Tiwari, Gregory F. Wu, Abhijit Raval, E. Branch, Franz Rischard, Cameron Hypes, Billie Bixby, Christian Bime, Madhan Sundaram, Nancy K. Sweitzer, Alfredo Vazquez Sandoval, Heath D. White, Katherine M. Berg, Shahzad Shaefi, Michael W. Donnino, Brett Carroll, Michael H. Ieong, Kimberly Ackerbauer, Jaime Murphy, Ankeet S. Bhatt, Alexander Blood, Siddharth Patel, Victor Luu, Shraddha Narechania, Austin Lorganger, Robert Plambeck, Ali Nayfeh, Michael Sanley, Michel Del Cor, A. J. Hegg, Winston Nara, M Snyder, Faisal Khan, Imad Shawa, Joshua Larned, Elias Collado, Mohammed Al Faiyumi, Rajeev Mehta, Sudarshan Komanapalli, Vijayadershan Muppidi, Mehul J. Desai, Casey M. Flanagan, Leonard Genovese, Tariq Haddad, Christopher R. King, Amber Peterson, Thane Htun, Elizabeth Pionk, Nicolas J. Mouawad, C. V. Nithish Kumar, Kevin Nguyen, Majid Mughal, Ryan Malek, Akarsh Parekh, Christopher Provenzano, Melissa Marie Ianitelli, Nicole Prentice-Gaytan, Adam Bykowski, Don Tait, Shelley Schendel, Varun Yalamanchili, Vasim Lala, Victor Hunyadi, Alexander Papolos, Benjamin B. Kenigsberg, Aarthi Shenoy, Thomas Stuckey, Douglas McQuaid, Praveen Mannam, Jeffrey McClung, Kent W. Nilsson, Andrew C. McKown, Jason B. Wells, David Hotchkin, Marc Jacobs, Wayne Strauss, Rick Balestra, V. Anik Sahni, R. Jeffrey Snell, Hussam Suradi, Sarah Sungurlu, J. Kuppy, Eileen Gajo, F. D. ADAMS, Abbas Shehadeh, Addi Suleiman, Harish Nandigam, Jihad Slim, Sardar Ijlal Babar, Dipti Baral, Talha Nawaz, Syed Abdullah Waheed, Randy Roth, Subhas Sitaula, S A Hayat, Jooby Babu, Jason Caberto, Victor W. Hsu, Robert W. Chang, Markian R. Bochan, Rafael Garcia‐Cortes, Hal A. Skopicki, On Chen, Lauren Pilato, Paul Richman, A. Adler, Praveen Sudhindra, Jamie Beversdorf, Ravindra Kashyap, Parth Mehta, Borna Mehrad, Ali Ataya, Jorge Lascano, Mark Brantly, Adam Austin, Eduard Koman, Thomas Galski, V Vineeth Kumar, Ayman O. Soubani, N. Harrison, Vineet Reddy, Audrey Fonkam · 发表于：Circulation · 年份：2022 · DOI：10.1161/circulationaha.122.061533 · 被引用次数：83 · 研究领域：COVID-19 Clinical Research Studies、Heparin-Induced Thrombocytopenia and Thrombosis、Venous Thromboembolism Diagnosis and Management

Background: The efficacy and safety of prophylactic full-dose anticoagulation and antiplatelet therapy in critically ill COVID-19 patients remain uncertain. Methods: COVID-PACT (Prevention of Arteriovenous Thrombotic Events in Critically-ill COVID-19 Patients Trial) was a multicenter, 2×2 factorial, open-label, randomized-controlled trial with blinded end point adjudication in intensive care unit–level patients with COVID-19. Patients were randomly assigned to a strategy of full-dose anticoagulation or standard-dose prophylactic anticoagulation. Absent an indication for antiplatelet therapy, patients were additionally randomly assigned to either clopidogrel or no antiplatelet therapy. The primary efficacy outcome was the hierarchical composite of death attributable to venous or arterial thrombosis, pulmonary embolism, clinically evident deep venous thrombosis, type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia, or clinically silent deep venous thrombosis, through hospital discharge or 28 days. The primary efficacy analyses included an unmatched win ratio and time-to-first event analysis while patients were on treatment. The primary safety outcome was fatal or life-threatening bleeding. The secondary safety outcome was moderate to severe bleeding. Recruitment was stopped early in March 2022 (≈50% planned recruitment) because of waning intensive care unit–level COVID-19 rates. Results: At 34 centers in the United States, 390 patients we...