International Normalized Ratio Targets for Left-Sided Mechanical Valve Replacement

Gupta, Saurabh; Belley‐Côté, Emilie P.; Sarkaria, A.; Pandey, Arjun; Spence, Jessica; McClure, Ghyslaine; Panchal, Puru; Jaffer, Iqbal H.; An, Kevin R.; Eikelboom, John W.; Whitlock, Richard

doi:10.1055/s-0038-1637755

Cited by 14 publications

(2 citation statements)

References 36 publications

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“… 27 Further, evidence suggests that a lower therapeutic range might yield a net benefit to patients with a MHV, because it may be easier to reach and maintain, and potentially reduces bleeding. 32 33 34 This is particularly important as contemporary implants might be less thrombogenic than historical devices. In our study, the rate of thrombotic outcomes was lower than we had anticipated, even in the group with poorest anticoagulation control while the risk of bleeding was more concerning, especially in the poorer TTR groups.…”

Section: Discussionmentioning

confidence: 99%

Outcomes of Patients with a Mechanical Heart Valve and Poor Anticoagulation Control on Warfarin

Johansson,

Benz,

Kovalova

et al. 2023

Thromb Haemost

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Background Patients with a mechanical heart valve (MHV) require oral anticoagulation. Poor anticoagulation control is thought to be associated with adverse outcomes, but data are limited. Objective To assess the risks of clinical outcomes in patients with a MHV and poor anticoagulation control on warfarin. Patients/Methods We conducted a retrospective study of consecutive patients undergoing MHV implantation at a tertiary care center (2010–2019). Primary outcome was a composite of ischemic stroke, systemic embolism, or prosthetic valve thrombosis. Major bleeding and death were key secondary outcomes. We constructed multivariable regression models to assess the association between time in therapeutic range (TTR) on warfarin beyond 90 days after surgery with outcomes. Results We included 671 patients with a MHV (80.6% in aortic, 14.6% in mitral position; mean age 61 years, 30.3% female). Median follow-up was 4.9 years, mean TTR was 62.5% (14.5% TTR <40%, 24.6% TTR 40–60%, and 61.0% TTR >60%). Overall rates of the primary outcome, major bleeding, and death were 0.73, 1.41, and 1.44 per 100 patient-years. Corresponding rates for patients with TTR <40% were 1.31, 2.77, and 3.22 per 100 patient-years. In adjusted analyses, every 10% decrement in TTR was associated with a 31% increase in hazard for the primary outcome (hazard ratio [HR]: 1.31, 95% confidence interval [CI]: 1.13–1.52), 34% increase in major bleeding (HR: 1.34, 95% CI: 1.17–1.52), and 32% increase in death (HR: 1.32, 95% CI: 1.11–1.57). Conclusion In contemporary patients with a MHV, poor anticoagulation control on warfarin was associated with increased risks of thrombotic events, bleeding, and death.

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Section: Discussionmentioning

confidence: 99%

Outcomes of Patients with a Mechanical Heart Valve and Poor Anticoagulation Control on Warfarin

Johansson,

Benz,

Kovalova

et al. 2023

Thromb Haemost

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“…11 We recently demonstrated in patients with mechanical heart valves treated with warfarin that targeting lower INR ranges did not compromise efficacy for prevention of thromboembolic complications and was associated with a lower risk of bleeding. 12 Here, we report the results of a systematic review and meta-analysis of randomized trials comparing different intensities of anticoagulation with VKAs in patients with AF. Our specific objectives were to compare the effects of lower versus standard INR ranges on clinical outcomes and to assess whether the results varied based on the region of origin (East Asian vs. Western) of the studies.…”

Section: Introductionmentioning

confidence: 99%

Lower versus Standard INR Targets in Atrial Fibrillation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Pandey

Zhang

et al. 2020

Thromb Haemost

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Background Western guidelines recommend an international normalized ratio (INR) range of 2 to 3 when using warfarin for stroke prevention in atrial fibrillation (AF), but lower INR ranges are frequently used in East Asia. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) in AF patients comparing the effect of lower versus standard INR targets on thromboembolism, major bleeding, and mortality. Methods We searched Western databases including Cochrane CENTRAL, Medline, and Embase as well as Chinese databases including SinoMed, CNKI, and Wanfang Data. We pooled risk ratios (RRs) using random-effects model. We grouped INR targets in two ways: (1) any study-specific lower versus standard targets and (2) INR ranges of approximately 1.5 to 2 versus 2 to 3. Results Seventy-nine RCTs (n = 12,928) met eligibility criteria: 74 (n = 11,322) from East Asia and 5 (n = 1,606) from Western countries. Compared with standard targets, lower INR ranges were associated with higher rates of thromboembolism (76 RCTs, n = 12,577: 7.1% vs. 4.4%, RR 1.50, 95% confidence interval [CI] 1.29–1.74, I 2 = 0%), lower rates of major bleeding (61 RCTs, n = 10,815: 2.2% vs. 4.4%, RR 0.54, 95% CI 0.44–0.67, I 2 = 0%), and similar mortality (32 RCTs, n = 7,327: 4.8% vs. 5.2%, RR 1.00, 95% CI 0.85–1.19, I 2 = 0%). Results were similar when comparing target ranges of approximately 1.5 to 2 versus 2 to 3. Conclusion Moderate quality evidence suggests lower INR targets reduce bleeding but increase thromboembolism in AF. The data are dominated by East-Asian studies, limiting generalizability to Western populations. Until higher quality data demonstrate otherwise, an INR range of 2 to 3 should remain standard for thromboembolic prophylaxis in AF.

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Mechanical Prosthetic Valves

Henn

Moon

2020

Cardiac Surgery

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International Normalized Ratio Targets for Left-Sided Mechanical Valve Replacement

Abstract: In patients with mechanical valves, higher INR targets are not supported by current evidence, which is of very low quality. In fact, our systematic review suggests that lower INR targets offer significantly lower bleeding risks with no significant difference in thromboembolic risk.

Cited by 14 publications

References 36 publications

Outcomes of Patients with a Mechanical Heart Valve and Poor Anticoagulation Control on Warfarin

Outcomes of Patients with a Mechanical Heart Valve and Poor Anticoagulation Control on Warfarin

Lower versus Standard INR Targets in Atrial Fibrillation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Mechanical Prosthetic Valves

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