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Effect of Long-term Continuous Cardiac Monitoring vs Usual Care on Detection of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease

2021; American Medical Association; Volume: 325; Issue: 21 Linguagem: Inglês

10.1001/jama.2021.6470

1538-3598

Richard A. Bernstein, Hooman Kamel, Christopher B. Granger, Jonathan P. Piccini, Pramod Sethi, Jeffrey M. Katz, Carola Alfaro Vives, Paul Ziegler, Noreli Franco, Lee H. Schwamm, Indrani Acosta, Pradipkumar Jamnadas, Sushma Manda, Rizwan Alimohammad, Valerie Arias, Kristi Tempro, Kathleen Ward, Khaled Asi, Indrajit Choudhuri, Waldo R. Guerrero, Junaid Kalia, Imran Khan Niazi, Rehan Sajjad, Varoon Thavapalan, Manish D. Assar, Javier E. Banchs, James Black, Peter Y. K. Cheung, Alan Donsky, Dion Graybeal, Rashedul Hasan, Osman Mir, Claude Nguyen, Gregory Olsovsky, Jennifer Rasmussen, Sanjeev Hasabnis, Russell A. Reeves, Chris Rowley, Jitendra Sharma, Macey Smith, Kay Bonyak, Matthew C. Sackett, James Allred, Pramod Sethi, Richard Jung, Jennifer A. Lynch, Steven P. Rowe, Subasini Dash, Taya V. Glotzer, Sameer Jamal, Glauco Radoslovich, Gunjan Shukla, John Zimmerman, Haitham M. Hussein, Dennis W.X. Zhu, Kristopher Krueger, Matthew Ostrander, Darwin Ramirez, Jeffrey W. Shultz, Jay Simonson, Brett Cucchiara, Rajat Deo, David S. Frankel, Judy Jia, Scott E. Kasner, Jeanie Luciano, Steven R. Messé, Michael T. Mullen, Pasquale Santangeli, Robert D. Schaller, Qingyang Yuan, Don Bledsoe, Christian Cajavilca, David Chiu, Rajan Gadhia, Maranda Randi Grimes, Larry Katz, Stacy Moye, Tapan G. Rami, Thomas Abraham, John Volpi, Ali Al Balushi, Clara Boyd, Subbarao Choudry, Mandip S. Dhamoon, Srinivas R. Dukkipati, Davida Goltz, Qing Hao, Deborah Horowitz, Gurmeen Kaur, Jacob S. Koruth, Christeena Kurian, Marie-Noelle S. Langan, Iván Díaz, Marc L. Miller, Vivek Y. Reddy, Kara Sheinart, Laura Stein, Aaron Tansy, Stanley Tuhrim, Jesse Weinberger, William Whang, Jonathan Cross, Howard Kreger, Marc Saltzman, Kenneth Zide, Sandeep Bansal, Matthew A. Bernabei, Murray Flaster, Conor D. Barrett, Mark R. Etherton, E. Kevin Heist, Steven A. Lubitz, Robert W. Regenhardt, Richa Sharma, Scott Silverman, Kelly L. Sloane, Anand Viswanathan, Amit Doshi, William Logan, Maheen Malik, David A. Rempe, Rohan Arora, Stuart Beldner, Laurence M. Epstein, Haisam Ismail, Ram Jadonath, Jeffrey M. Katz, Richard Libman, Mohammad Moussavi, Anand Patel, Apoor Patel, Jonathan Willner, Paul Wright, Frances Caprio, Hanna Kim, Scott D. Mendelson, Rod Passman, Ilana Ruff, Mohammad Alsorogi, Gauhar Chaudhary, Kent Morris, Savannah Mullins, Nadeem Talpur, Kevin Thomas, Breehan Chancellor, Larry A. Chinitz, Andre Culpepper, Michael Fara, Koto Ishida, Kaitlyn Lillemoe, Aaron Lord, Jose Torres, Cen Zhang, Freddy Abi‐Samra, Michael L. Bernard, Jacqueline Carter, Himanshu Chokhawala, Amanda E. Downey, Samuel Khatib, Daniel P. Morin, Glenn M. Polin, Paul Rogers, Gabriel Vidal, Richard M. Zweifler, Gary Belt, Robert A. Felberg, Steve Furer, John Hanna, Angela McCall-Brown, Susan Seeger, Ramakota Reddy, Elaine Skalabrin, Diane Soik, Michael J Wilder, Michelle Kearney, Eugene LaFranchise, Brett Parker, Robert A. Pickett, Heather Bonaguidi, Douglas Gibson, Mary Kalafut, Beth Mattera, Nicholas Olson, Mary Ann Parker, John Rogers, Poulina Q. Uddin, Cherylee W. J. Chang, Sarah Graner, Joseph Kipta, Rony Salem, David J. Singh, Ahmed Al-Awwad, Bahar Beaver, Shuchi Chaudhary, Stephen Clayton, Claire Delpirou Nouh, Paul Garabelli, David Gordon, Aneesh Pakala, Bappaditya Ray, Scott Saucedo, Evgeny Sidorov, Stavros Stavrakis, Marilou Ching, Chris Deline, J. Maurice Hourihane, Amit Kandel, Chee Kim, Rakesh Magun, Ashkan Mowla, Robert G. Sawyer, Donald Switzer, Nitish Badhwar, Randall Lee, Karl Meisel, Wade S. Smith, Moayd Alkahalifah, Sushanth Aroor, Negar Asdaghi, Nirav Bhatt, Victor J. Del Brutto, George Dillon, Paul Gadient, Sebastian Koch, Litsa K. Lambrakos, Amer Malik, Erika Marulanda-Londoño, Zeeshan Memon, Iván Mendoza, Raul D. Mitrani, Gustavo Ortiz, Jose Ramano, Nicole B. Sur, L. M. Torres, James M. Daniels, Mark R. Johnson, Alejandro Magadán, Ty Shang, Nancy Mcclelland, Theodore Merriam, Karah Neisen,

Blood Pressure and Hypertension Studies

Patients with ischemic stroke attributed to large- or small-vessel disease are not considered at high risk for atrial fibrillation (AF), and the AF incidence rate in this population is unknown.To determine whether long-term cardiac monitoring is more effective than usual care for AF detection in patients with stroke attributed to large- or small-vessel disease through 12 months of follow-up.The STROKE-AF trial was a randomized (1:1), multicenter (33 sites in the US) clinical trial that enrolled 496 patients between April 2016 and July 2019, with primary end point follow-up through August 2020. Eligible patients were aged 60 years or older or aged 50 to 59 years with at least 1 additional stroke risk factor and had an index stroke attributed to large- or small-vessel disease within 10 days prior to insertable cardiac monitor (ICM) insertion.Patients randomized to the intervention group (n = 242) received ICM insertion within 10 days of the index stroke; patients in the control group (n = 250) received site-specific usual care consisting of external cardiac monitoring, such as 12-lead electrocardiograms, Holter monitoring, telemetry, or event recorders.Incident AF lasting more than 30 seconds through 12 months.Among 492 patients who were randomized (mean [SD] age, 67.1 [9.4] years; 185 [37.6%] women), 417 (84.8%) completed 12 months of follow-up. The median (interquartile range) CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score was 5 (4-6). AF detection at 12 months was significantly higher in the ICM group vs the control group (27 patients [12.1%] vs 4 patients [1.8%]; hazard ratio, 7.4 [95% CI, 2.6-21.3]; P < .001). Among the 221 patients in the ICM group who received an ICM, 4 (1.8%) had ICM procedure-related adverse events (1 site infection, 2 incision site hemorrhages, and 1 implant site pain).Among patients with stroke attributed to large- or small-vessel disease, monitoring with an ICM compared with usual care detected significantly more AF over 12 months. However, further research is needed to understand whether identifying AF in these patients is of clinical importance.ClinicalTrials.gov Identifier: NCT02700945.