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.).
RCT Entities:
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.).
Authors: Anne Holbrook; Sam Schulman; Daniel M Witt; Per Olav Vandvik; Jason Fish; Michael J Kovacs; Peter J Svensson; David L Veenstra; Mark Crowther; Gordon H Guyatt Journal: Chest Date: 2012-02 Impact factor: 9.410
Authors: Sireen Abdul Rahim Shilbayeh; Wejdan Ali Almutairi; Sarah Ahmed Alyahya; Nouf Hayef Alshammari; Eiad Shaheen; Alya Adam Journal: Int J Clin Pharm Date: 2017-11-30
Authors: Renato D Lopes; Richard C Becker; L Kristin Newby; Eric D Peterson; Elaine M Hylek; Christopher B Granger; Mark Crowther; Tracy Wang; Antonio C Carvalho; Otavio Berwanger; Roberto R Giraldez; Gilson Soares Feitosa; Jorge Pinto Ribeiro; Eduardo Darze; Renato A K Kalil; Marianna Andrande; Fabio Villas Boas; Jadelson Andrade; Ana Thereza Rocha; Robert A Harrington; Antonio C Lopes; David A Garcia Journal: J Thromb Thrombolysis Date: 2012-07 Impact factor: 2.300
Authors: Craig T January; L Samuel Wann; Joseph S Alpert; Hugh Calkins; Joaquin E Cigarroa; Joseph C Cleveland; Jamie B Conti; Patrick T Ellinor; Michael D Ezekowitz; Michael E Field; Katherine T Murray; Ralph L Sacco; William G Stevenson; Patrick J Tchou; Cynthia M Tracy; Clyde W Yancy Journal: Circulation Date: 2014-03-28 Impact factor: 29.690
Authors: Daniel M Witt; Robby Nieuwlaat; Nathan P Clark; Jack Ansell; Anne Holbrook; Jane Skov; Nadine Shehab; Juliet Mock; Tarra Myers; Francesco Dentali; Mark A Crowther; Arnav Agarwal; Meha Bhatt; Rasha Khatib; John J Riva; Yuan Zhang; Gordon Guyatt Journal: Blood Adv Date: 2018-11-27