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
Authors: Richard A. Bernstein, Hooman Kamel, Christopher B. Granger, Jonathan P. Piccini, Pramod P. Sethi, Jeffrey M. Katz, Carola Alfaro Vives, Paul D. Ziegler, Noreli C. Franco, Lee H. Schwamm, Indrani Acosta, Pradipkumar Jamnadas, Sushma Manda, Rizwan Alimohammad, Valerie Arias, Kristi Tempro, Kathleen Ward, Khaled Asi, Indrajit Choudhuri, Waldo Guerrero, Junaid Kalia, Imran Niazi, Rehan Sajjad, Varoon Thavapalan, Manish Assar, Javier Banchs, James Black, Peter Cheung, Alan Donsky, Dion Graybeal, Rashedul Hasan, Osman Mir, Claude Nguyen, Gregory Olsovsky, Jennifer Rasmussen, Sanjeev Hasabnis, Russell Reeves, Chris Rowley, Jitendra Sharma, Macey Smith, Kay Bonyak, Matthew Sackett, James Allred, Pramod Sethi, Richard Jung, Jennifer Lynch, Steven Rowe, Subasini Dash, Taya Glotzer, Sameer Jamal, Glauco Radoslovich, Gunjan Shukla, John Zimmerman, Haitham Hussein, Dennis Zhu, Kristopher Krueger, Matthew Ostrander, Darwin Ramirez, Jeffrey Shultz, Jay Simonson, Brett Cucchiara, Rajat Deo, David Frankel, Judy Jia, Scott Kasner, Jeanie Luciano, Steven Messe, Michael Mullen, Pasquale Santangeli, Robert Schaller, Qingyang Yuan, Don Bledsoe, Christian Cajavilca, David Chiu, Rajan Gadhia, Maranda Randi Grimes, Larry Katz, Stacy Moye, Tapan Rami, Abraham Thomas, John Volpi, Ali Al Balushi, Clara Boyd, Subbarao Choudry, Mandip Dhamoon, Srinivas Dukkipati, Davida Goltz, Qing Hao, Deborah Horowitz, Gurmeen Kaur, Jacob Koruth, Christeena Kurian, Marie-Noelle Langan, Ivan Matos Diaz, Marc Miller, Vivek Reddy, Kara Sheinart, Laura Stein, Aaron Tansy, Stanley Tuhrim, Jesse Weinberger, William Whang, Jonathan Cross, Howard Kreger, Marc Saltzman, Kenneth Zide, Sandeep Bansal, Matthew Bernabei, Murray Flaster, Conor Barrett, Mark Etherton, E. Kevin Heist, Steven Lubitz, Robert Regenhardt, Richa Sharma, Scott Silverman, Kelly Sloane, Anand Viswanathan, Amit Doshi, William Logan, Maheen Malik, David Rempe, Rohan Arora, Stuart Beldner, Laurence Epstein, Haisam Ismail, Ram Jadonath, Jeffrey Katz, Richard Libman, Mohammad Moussavi, Anand Patel, Apoor Patel, Jonathan Willner, Paul Wright, Frances Caprio, Susan Kim, Scott Mendelson, Rod Passman, Ilana Ruff, Mohammad Alsorogi, Gauhar Chaudhary, Kent Morris, Savannah Mullins, Nadeem Talpur, Kevin Thomas, Breehan Chancellor, Larry Chinitz, Andre Culpepper, Michael Fara, Koto Ishida, Kaitlyn Lillemoe, Aaron Lord, Jose Torres, Cen Zhang, Freddy Abi-Samra, Michael Bernard, Jacqueline Carter, Himanshu Chokhawala, Amanda Downey, Samuel Khatib, Daniel Morin, Glenn Polin, Paul Rogers, Gabriel Vidal, Richard Zweifler, Gary Belt, Robert Felberg, Steve Furer, John Hanna, Angela McCall-Brown, Susan Seeger, Ramakota Reddy, Elaine Skalabrin, Diane Soik, Michael Wilder, Michelle Kearney, Eugene LaFranchise, Brett Parker, Robert Andrew (Drew) Pickett, Heather Bonaguidi, Douglas Gibson, Mary Kalafut, Beth Mattera, Nicholas Olson, Mary Parker, John Rogers, Poulina Uddin, Cherylee Chang, Sarah Graner, Joseph Kipta, Rony Salem, David 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, Christopher Deline, J. Maurice Hourihane, Amit Kandel, Chee Kim, Rakesh Magun, Ashkan Mowla, Robert Sawyer, Donald Switzer, Nitish Badhwar, Randall Lee, Karl Meisel, Wade Smith, Moayd Alkahalifah, Sushanth Aroor, Negar Asdaghi, Nirav Bhatt, Victor Del Brutto, George Dillon, Paul Gadient, Sebastian Koch, Litsa Lambrakos, Amer Malik, Erika Marulanda-Londono, Zeeshan Memon, Ivan Mendoza, Raul Mitrani, Gustavo Ortiz, Jose Ramano, Nicole Sur, Luis Torres, James Daniels, Mark Johnson, Alejandro Magadan, Ty Shang, Nancy Mcclelland, Theodore Merriam, Karah Neisen
Journal: JAMA (2021)

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.