Effect of home testing of international normalized ratio on clinical events
David B Matchar, Alan Jacobson, Rowena Dolor, Robert Edson, Lauren Uyeda, Ciaran S Phibbs, Julia E Vertrees, Mei-Chiung Shih, Mark Holodniy, Philip Lavori, THINRS Executive Committee and Site Investigators, Alan Jacobson, David Matchar, Jack E Ansell, Kathy D Boardman, Robert Edson, Michael D Ezekowitz, Stephan D Fihn, Louis Fiore, Philip W Lavori, Ciaran S Phibbs, Frederick Rickles, Alan Jacobson, David Matchar, Jack E Ansell, Rowena Dolor, Robert Edson, Freny Vaghaiwalla Mody, Ciaran S Phibbs, Julia E Vertrees, Beverly Ventura, Lori Churby, Bruce Coull, David Glidden, George Howard, John Heit, Tim Morris, Gene Sung, R Lynne Ruybalid, Diane Garrison, Meenal Patwardhan, Carol Rudo, Rosetta Corbett, Kathleen Yeager, Blanca Morales-Ratzloff, Calvin Eng, Ann Haynos, Ali Saeed, Sanjay Agarwal, Warangkana Chokesuwattanaskul, Proserfino Patacsil, Olga Sherman, Kenneth Kellick, Elongia Farrell, Lisa Samol, Kathleen Doyle, Denise Farolino, Greg Wojcik, Maurice Jones, Tara Byrd, Carol Ingle, Gina Pauskt, Peter Yunyongying, Wen Lai, Cassie Lusk, Elizabeth Price, Pintu Amratlal, Shane Huffman, Patricia Schoch, Lyndy Balderman, Pam Aakhus, Preeti Ramappa, Deepak Thatai, Elizabeth Jones, Katie Kelly Toby, Carole Adams, Rowena Dolor, Jennifer Taylor, Jennifer Cornejo, Paulette Ginier, Suzanne Venturino, Carol Schulz, Billie Jones, Abdul Choudhury, Jacolyn Jaconetty, David Oprondek, Amanda Pietrucha, Louise Corzine, Patricia Gully, Doug Geraets, Sara Miller, Jane Morse, Melody Scherubel, Angie Hoth, Michael Liston, Julie Kraemer, Talita Hill, Dorinda Sutton, Maqual Graham, Cynthia Infranca, Raynaldo Sandoval, Jose Lopez, Leonel Gallegos, Denise Duren, Mina Maquindang, Elizabeth Campbell, Ronald Fernando, Tiffany Gunneman, Barbara Howe, Myra Peterson, Carla Staresinic, Lou Ellen Williams, Mary Falls, Gerhard Johnson, Bobbie Masoud, Jean Kanter, Jeri McIntosh, John Toscano, Sheila Mailekel, Jill Nyland, Marilyn Sullivan, Udho Thadani, John Turner, Lisa Rogan, Barbara Parker, Michelle Thresher, Lars Osterberg, Elizabeth Packer, Leah Holloway, Visala Muluk, Thomas Ansell, April Bradburn, Satish Sharma, Lynn Marquis, Margaret Quillin, Linda Clifford, Ann Haynos, Susan Holly, Janet Frey, Kimberly Long, Adrienne Smith, Thomas Martin, Muhammad Isa, Jose Mendoza, Nabil Jarmukli, Tonda Yates, Allison Beck, Sherri Odat, Tammy Anthony, Karen Degre, Paul Pry, George Melnik, Judith Nicastro, Patricia Baker, Giselle Rivera, Annette Melendez, Farid Jadbabaie, Brian Abbott, Caroline Ruwet, Shannon Dyke, Luisa Sheehan, Freny Vaghaiwalla Mody, Peter Petriashvili, Negin Taher, Bita Hajzadeh, Lanille Cua, Ramyar Mahdavi, Julie Mann, Jahandar Saleh, Rosa Radbod, Ying Lu, Mark Holodniy, Javaid Sheikh, Philip Lavori, Robert Edson, Beverly Ventura, Lori Churby, Ciaran S Phibbs, Lauren Uyeda, Andres Busette, Anjali Kukde, Joanna Thorgrimsson, Pon Su, Amy Brown, Alaina Mae Difuntorum, Carole Keim, Parinaz Lajevardi, Jeff Ratto, Meredith Miller, Lenore Sheridan, Felina Roque, Briana Davis, Ryan Duffy, Michelle Mullens, Pei-Pei Woo, Chris Punzalan, Elaine Nastor, Deanne Hirshfield, Mike R Sather, Julia E Vertrees, Kathy D Boardman, Donald Conner, Bonnie Matura, Erica Copeland, Jimmy Pontzer, Dave Garnand, Charlotte Giese, Virginia Bachrach, Ward Hart, Carl Winterstein, Gregory Bates, Leon Rochester, William B Bronson, Susan Levenberg, Steve Malone, Cora Scheel, Chaplain Ed Bastille, Robert M Cardelli, William R Blythe, Lyndel Monroe, Byron W Brown Jr, Paul Lachetti, Virginia Shahrok, William L Fong, Father Te Van Nguyen, Timothy O'Leary, Brian Schuster, John Feussner, Grant D Huang, Kenneth Mahaffey, Patty Connolly, Diana McFarron, Sheila Dickerson, Meredith Smith, Gregg Stashenko, Jennifer Vergara, Chira Melloni, Pierluigi Triccoci, Michael Felker, Michael Gharacholou, Willie Hester, Adrian Hernandez, Matt Brennan, Manesh Patel, Lynda Szczech, Matthew Roe, John Alexander, Patrick Pun, Bimal Shah, Rujuta Patel, Sana Al-Khatib, Kristin Newby, David B Matchar, Alan Jacobson, Rowena Dolor, Robert Edson, Lauren Uyeda, Ciaran S Phibbs, Julia E Vertrees, Mei-Chiung Shih, Mark Holodniy, Philip Lavori, THINRS Executive Committee and Site Investigators, Alan Jacobson, David Matchar, Jack E Ansell, Kathy D Boardman, Robert Edson, Michael D Ezekowitz, Stephan D Fihn, Louis Fiore, Philip W Lavori, Ciaran S Phibbs, Frederick Rickles, Alan Jacobson, David Matchar, Jack E Ansell, Rowena Dolor, Robert Edson, Freny Vaghaiwalla Mody, Ciaran S Phibbs, Julia E Vertrees, Beverly Ventura, Lori Churby, Bruce Coull, David Glidden, George Howard, John Heit, Tim Morris, Gene Sung, R Lynne Ruybalid, Diane Garrison, Meenal Patwardhan, Carol Rudo, Rosetta Corbett, Kathleen Yeager, Blanca Morales-Ratzloff, Calvin Eng, Ann Haynos, Ali Saeed, Sanjay Agarwal, Warangkana Chokesuwattanaskul, Proserfino Patacsil, Olga Sherman, Kenneth Kellick, Elongia Farrell, Lisa Samol, Kathleen Doyle, Denise Farolino, Greg Wojcik, Maurice Jones, Tara Byrd, Carol Ingle, Gina Pauskt, Peter Yunyongying, Wen Lai, Cassie Lusk, Elizabeth Price, Pintu Amratlal, Shane Huffman, Patricia Schoch, Lyndy Balderman, Pam Aakhus, Preeti Ramappa, Deepak Thatai, Elizabeth Jones, Katie Kelly Toby, Carole Adams, Rowena Dolor, Jennifer Taylor, Jennifer Cornejo, Paulette Ginier, Suzanne Venturino, Carol Schulz, Billie Jones, Abdul Choudhury, Jacolyn Jaconetty, David Oprondek, Amanda Pietrucha, Louise Corzine, Patricia Gully, Doug Geraets, Sara Miller, Jane Morse, Melody Scherubel, Angie Hoth, Michael Liston, Julie Kraemer, Talita Hill, Dorinda Sutton, Maqual Graham, Cynthia Infranca, Raynaldo Sandoval, Jose Lopez, Leonel Gallegos, Denise Duren, Mina Maquindang, Elizabeth Campbell, Ronald Fernando, Tiffany Gunneman, Barbara Howe, Myra Peterson, Carla Staresinic, Lou Ellen Williams, Mary Falls, Gerhard Johnson, Bobbie Masoud, Jean Kanter, Jeri McIntosh, John Toscano, Sheila Mailekel, Jill Nyland, Marilyn Sullivan, Udho Thadani, John Turner, Lisa Rogan, Barbara Parker, Michelle Thresher, Lars Osterberg, Elizabeth Packer, Leah Holloway, Visala Muluk, Thomas Ansell, April Bradburn, Satish Sharma, Lynn Marquis, Margaret Quillin, Linda Clifford, Ann Haynos, Susan Holly, Janet Frey, Kimberly Long, Adrienne Smith, Thomas Martin, Muhammad Isa, Jose Mendoza, Nabil Jarmukli, Tonda Yates, Allison Beck, Sherri Odat, Tammy Anthony, Karen Degre, Paul Pry, George Melnik, Judith Nicastro, Patricia Baker, Giselle Rivera, Annette Melendez, Farid Jadbabaie, Brian Abbott, Caroline Ruwet, Shannon Dyke, Luisa Sheehan, Freny Vaghaiwalla Mody, Peter Petriashvili, Negin Taher, Bita Hajzadeh, Lanille Cua, Ramyar Mahdavi, Julie Mann, Jahandar Saleh, Rosa Radbod, Ying Lu, Mark Holodniy, Javaid Sheikh, Philip Lavori, Robert Edson, Beverly Ventura, Lori Churby, Ciaran S Phibbs, Lauren Uyeda, Andres Busette, Anjali Kukde, Joanna Thorgrimsson, Pon Su, Amy Brown, Alaina Mae Difuntorum, Carole Keim, Parinaz Lajevardi, Jeff Ratto, Meredith Miller, Lenore Sheridan, Felina Roque, Briana Davis, Ryan Duffy, Michelle Mullens, Pei-Pei Woo, Chris Punzalan, Elaine Nastor, Deanne Hirshfield, Mike R Sather, Julia E Vertrees, Kathy D Boardman, Donald Conner, Bonnie Matura, Erica Copeland, Jimmy Pontzer, Dave Garnand, Charlotte Giese, Virginia Bachrach, Ward Hart, Carl Winterstein, Gregory Bates, Leon Rochester, William B Bronson, Susan Levenberg, Steve Malone, Cora Scheel, Chaplain Ed Bastille, Robert M Cardelli, William R Blythe, Lyndel Monroe, Byron W Brown Jr, Paul Lachetti, Virginia Shahrok, William L Fong, Father Te Van Nguyen, Timothy O'Leary, Brian Schuster, John Feussner, Grant D Huang, Kenneth Mahaffey, Patty Connolly, Diana McFarron, Sheila Dickerson, Meredith Smith, Gregg Stashenko, Jennifer Vergara, Chira Melloni, Pierluigi Triccoci, Michael Felker, Michael Gharacholou, Willie Hester, Adrian Hernandez, Matt Brennan, Manesh Patel, Lynda Szczech, Matthew Roe, John Alexander, Patrick Pun, Bimal Shah, Rujuta Patel, Sana Al-Khatib, Kristin Newby
Abstract
Background: Warfarin anticoagulation reduces thromboembolic complications in patients with atrial fibrillation or mechanical heart valves, but effective management is complex, and the international normalized ratio (INR) is often outside the target range. As compared with venous plasma testing, point-of-care INR measuring devices allow greater testing frequency and patient involvement and may improve clinical outcomes.
Methods: We randomly assigned 2922 patients who were taking warfarin because of mechanical heart valves or atrial fibrillation and who were competent in the use of point-of-care INR devices to either weekly self-testing at home or monthly high-quality testing in a clinic. The primary end point was the time to a first major event (stroke, major bleeding episode, or death).
Results: The patients were followed for 2.0 to 4.75 years, for a total of 8730 patient-years of follow-up. The time to the first primary event was not significantly longer in the self-testing group than in the clinic-testing group (hazard ratio, 0.88; 95% confidence interval, 0.75 to 1.04; P=0.14). The two groups had similar rates of clinical outcomes except that the self-testing group reported more minor bleeding episodes. Over the entire follow-up period, the self-testing group had a small but significant improvement in the percentage of time during which the INR was within the target range (absolute difference between groups, 3.8 percentage points; P<0.001). At 2 years of follow-up, the self-testing group also had a small but significant improvement in patient satisfaction with anticoagulation therapy (P=0.002) and quality of life (P<0.001).
Conclusions: As compared with monthly high-quality clinic testing, weekly self-testing did not delay the time to a first stroke, major bleeding episode, or death to the extent suggested by prior studies. These results do not support the superiority of self-testing over clinic testing in reducing the risk of stroke, major bleeding episode, and death among patients taking warfarin therapy. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT00032591.).
Source: PubMed