Effect of Home Testing of International Normalized Ratio on Clinical Events

Matchar, David B.; Jacobson, A.; Dolor, Rowena J; Edson, Robert; Uyeda, Lauren; Phibbs, Ciaran S.; Vertrees, Julia E.; Shih, Mei‐Chiung; Holodniy, Mark; Lavori, Philip W.

doi:10.1056/nejmoa1002617

Cited by 238 publications

(235 citation statements)

References 17 publications

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“…7,14 Briefly, patients were eligible if they had atrial fibrillation, a mechanical heart valve, or both, and required chronic warfarin therapy for an indeterminate period. In part one, patients were trained to use a portable at-home INR monitoring device, and were evaluated 2 to 4 weeks later for PST competency.…”

Section: Summary Of Thinrs Designmentioning

confidence: 99%

“…7 Figure 1 outlines the differences. Five HQACM and three weekly PST patients were excluded due to incomplete HUI data.…”

Section: Study Samplementioning

confidence: 99%

“…7 These comparisons revealed a statistically significant improvement in quality-adjusted life years (QALYs), as measured by the Health Utilities Index Mark 3 (HUI), 12 for the PST group. Costs were somewhat higher in the PST group than in the HQACM group, but this difference was not statistically significant.…”

Section: Introductionmentioning

confidence: 99%

“…5 However, conventional laboratory testing of INR, as performed in both HQACM and standard clinical practice, can be inconvenient for patients who must travel to a centralized location. 6,7 In some cases, this may limit the frequency of INR testing as well as access to anticoagulation treatment. Systematic reviews have supported frequent home monitoring via patient self-testing (PST) of INR as a safe and effective alternative to standard in-clinic testing.…”

Section: Introductionmentioning

confidence: 99%

“…11 The Home INR Study (THINRS), the largest randomized controlled trial of PST (n = 2922) to date, found negligible differences in clinical outcomes between weekly PST and once-monthly in-clinic testing via HQACM. 7 In order to examine the effects of testing frequency, THINRS included a sub-study in which 234 additional patients were randomized to PST twice weekly (n = 118) or once every 4 weeks (n = 116).…”

Section: Introductionmentioning

confidence: 99%

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At-Home Versus In-Clinic INR Monitoring: A Cost–Utility Analysis from The Home INR Study (THINRS)

et al. 2016

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BACKGROUND: Effective management of patients using warfarin is resource-intensive, requiring frequent inclinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST. OBJECTIVE: To perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency. PATIENTS/INTERVENTIONS: In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly inclinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up. RESULTS: PST and HQACM participants were similar with regard to gender, age, and CHADS 2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per qualityadjusted life year gained with PST once weekly was $5566 (95 % CI, −$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions. CONCLUSION: Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.

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Section: Summary Of Thinrs Designmentioning

confidence: 99%

“…7 Figure 1 outlines the differences. Five HQACM and three weekly PST patients were excluded due to incomplete HUI data.…”

Section: Study Samplementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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At-Home Versus In-Clinic INR Monitoring: A Cost–Utility Analysis from The Home INR Study (THINRS)

et al. 2016

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Long-term Management of Venous Thromboembolism

Bauer

2011

JAMA

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Numerous randomized clinical trials have compared various durations of anticoagulant therapy with a vitamin K antagonist (ie, warfarin) for an initial episode of venous thromboembolism (VTE). Despite major advances in understanding the pathophysiology of thrombosis and its genetic basis, clinical risk factors at presentation have emerged as the primary determinant of recurrence risk. Following a minimum of 3 months of anticoagulant therapy, patients with VTE in association with transient risk factors (eg, major surgery, trauma, pregnancy) have a low annual recurrence risk, while patients without identifiable provocative risk factors have a recurrence risk of approximately 25% at 4 years with the highest annual rates occurring in the first 2 years. Extending warfarin therapy is highly effective in preventing recurrences but is associated with increased rates of major and minor bleeding. Clinical decision making therefore requires individualized assessment of recurrence and bleeding risk, coupled with patient preference. After 3 months of anticoagulant therapy for a first episode of unprovoked VTE, male sex, age older than 65 years, and an elevated D-dimer level 1 month after discontinuing anticoagulant therapy are useful parameters in identifying patients with an increased recurrence risk. The case of Ms W, a woman with unprovoked venous thromboembolism and hemorrhagic event while receiving anticoagulation, is used to illustrate clinical decision making to determine ongoing treatment.

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Long-term Clinical and Echocardiographic Outcomes in Young and Middle-aged Adults Undergoing the Ross Procedure

et al. 2021

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IMPORTANCEThere is no ideal valve substitute for young adults requiring aortic valve replacement. Multicenter data supporting use of the Ross procedure with respect to long-term postoperative valve-related mortality and reintervention, as well as function of the autograft and pulmonary homograft, are needed.OBJECTIVE To determine the long-term clinical and echocardiographic outcomes in young and middle-aged patients undergoing the Ross procedure. DESIGN, SETTING, AND PARTICIPANTSA retrospective multicenter international cohort study with a median follow-up period of 9.2 years was conducted in 5 experienced centers regularly performing the Ross procedure. Consecutive patients aged 18 to 65 years were included by each center between 1991 and 2018.MAIN OUTCOMES AND MEASURES Survival and autograft-related and homograft-related reintervention. Serial echocardiographic measurements of valve function were analyzed using mixed-effects modeling.RESULTS During the study period, 1431 patients (74.3% men; n = 1063) were operated on at a median age of 48.5 years (mean [SD], 47.7 [9.5]; range, 18.1-65; interquartile range, 42.7-54.0). Implantation techniques were root inclusion in 355 (24.9%), root replacement in 485 (34.0%), and subcoronary implantation in 587 (41.1%). Right ventricular outflow tract reconstruction was performed with homografts in 98.6% (n = 1189) and bioprostheses in 1.4% (n = 17). Ten patients (0.7%) died before discharge. Median follow-up was 9.2 years (13 015 total patient-years). Survival after 10 and 15 years was 95.1% (95% CI, 93.8%-96.5%) and 88.5% (95% CI, 85.9%-91.1%), respectively. Freedom from autograft and homograft reintervention after 15 years was 92.0% and 97.2%, respectively. Late events were autograft endocarditis in 14 patients (0.11% per patient-year), homograft endocarditis in 11 patients (0.08% per patient-year), and stroke in 37 patients (0.3% per patient-year).CONCLUSIONS AND RELEVANCE Given its excellent short-term and long-term outcome in young and middle-aged adults in this study, the Ross procedure should be considered in young and middle-aged adults who require aortic valve replacement. Patients should be referred to an experienced center with a program dedicated to the Ross procedure.

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Effect of Home Testing of International Normalized Ratio on Clinical Events

Cited by 238 publications

References 17 publications

At-Home Versus In-Clinic INR Monitoring: A Cost–Utility Analysis from The Home INR Study (THINRS)

At-Home Versus In-Clinic INR Monitoring: A Cost–Utility Analysis from The Home INR Study (THINRS)

Long-term Management of Venous Thromboembolism

Long-term Clinical and Echocardiographic Outcomes in Young and Middle-aged Adults Undergoing the Ross Procedure

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