Persistence and Discontinuation of Oral Anticoagulant: Remaining Issues Not Addressed by Phase III Clinical Trials

Ayabe, Kengo; Goto, Shinichi; Goto, Shinya

doi:10.1161/jaha.116.003258

Cited by 7 publications

(6 citation statements)

References 22 publications

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Section: Methodssupporting

confidence: 65%

“…We did not identify a difference in the rate of anticoagulation use following empiric LAA closure, which is appropriate, based on current guidelines as well as published concerns regarding the completeness of exclusion of the LAA cavity from systemic circulation . However, the overall rate of anticoagulation discontinuation in both groups is a possibly troubling finding echoing previously reported concerns . Although we posited that LAA closure may influence subsequent burden of late AF as evidenced by postoperative ablations or cardioversions, event rates were low precluding statistical analysis and raising the possibility that a larger study may help to further resolve this question.…”

Section: Discussionmentioning

confidence: 84%

See 1 more Smart Citation

Evaluation of anticoagulation use and subsequent stroke in patients with atrial fibrillation after empiric surgical left atrial appendage closure: A retrospective case‐control study

Johnsrud

Melduni

Lahr

et al. 2018

Clinical Cardiology

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Background Surgical exclusion of the left atrial appendage (LAA) can be performed at the time of cardiac operation as a potential modality to decrease cardioembolic risk attributable to atrial fibrillation (AF), but it remains unclear if this decreases stroke incidence. Furthermore, it is not known whether LAA exclusion impacts the decision to discontinue anticoagulation impacting subsequent stroke risk. Hypothesis LAA exclusion does not significantly alter subsequent anticoagulation use or stroke incidence. Methods We studied 124 patients from Olmsted County with prior history of AF who underwent cardiac surgery at our institution between 1993 and 2015. Patients were divided into two groups on the basis of LAA exclusion and matched (1:1) according to 16 pretreatment variables using propensity scores obtained from a logistic regression model. Outcome data collected through chart review for survival, stroke, and the presence and duration of anticoagulation were compared between groups. Results The proportion of patients receiving anticoagulation at discharge and at 5 years was not significantly different between patients who underwent LAA exclusion and those who did not; 90% vs 81%, P = 0.156, 48% vs 49%, P = 0.722, respectively. On Kaplan‐Meier analysis there were no significant differences in time free from stroke between cases and controls. Patients discharged on oral anticoagulation (OAC) had significantly lower risk of stroke (HR = 0.19, 95% confidence interval [CI] = 0.06‐0.59, P = 0.004), independent of whether LAA closure was used. Conclusion LAA exclusion did not appear to reduce early or late stroke. Only OAC was associated with a reduction in stroke risk, underscoring the need for continued anticoagulation in high‐risk patients.

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Section: Methodssupporting

confidence: 65%

Section: Discussionmentioning

confidence: 84%

Evaluation of anticoagulation use and subsequent stroke in patients with atrial fibrillation after empiric surgical left atrial appendage closure: A retrospective case‐control study

Johnsrud

Melduni

Lahr

et al. 2018

Clinical Cardiology

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“…Approximately 23% and 29% of participants in EMPA-REG OUTCOME and CANVAS discontinued active study drug, compared to 29% and 30% for placebo, respectively (5,8). The percent discontinuation of active drug is similar to other major placebo-controlled cardiovascular outcome trials (43). Genital infections were more common with SGLT2-i vs. placebo in both EMPA-REG OUTCOME and the CANVAS Program.…”

Section: Introductionsupporting

confidence: 71%

The Changing Landscape of Diabetes Therapy for Cardiovascular Risk Reduction

Newman

Vani

Alemán

et al. 2018

Journal of the American College of Cardiology

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Type 2 diabetes mellitus (T2D) is a major risk factor for cardiovascular disease (CVD), the most common cause of death in T2D. Despite improved risk factor control, however, adults with T2D continue to experience substantial excess CVD risk. Until recently, however, improved glycemic control has not been associated with robust macrovascular benefit. The advent of two new classes of anti-hyperglycemic agents, the sodium-glucose cotransporter-2 inhibitors (SGLT2-i) and the glucagon-like peptide-1 receptor agonists (GLP-1 RA), and their respective large cardiovascular outcome trials, has led to a paradigm shift in how cardiologists and heath care practitioners conceptualize T2D treatment. Herein we will review the recent trial evidence, the potential mechanisms of action of SGLT2-i and GLP-1 RA, safety concerns, and their use for the primary prevention of CVD as well as in diabetics with impaired renal function and heart failure.

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“…In fact, evidence-based guidelines recommend the use of OACs but do not emphasise long-term treatment persistence. 39 Additionally, physicians’ perceptions of patient anticoagulation adherence, barriers and challenges of NVAF management may contribute to low treatment rates. Similarly, understanding patients’ perspectives on barriers associated with disease management and OAC treatment, including medication adherence/persistence and reasons for change of therapy (discontinuation/switching) and their OAC treatment experience will likely shed light on the suboptimal treatment and persistence rates observed in this study.…”

Section: Discussionmentioning

confidence: 99%

Treatment and persistence with oral anticoagulants among newly diagnosed patients with non-valvular atrial fibrillation: a retrospective observational study in a US commercially insured and Medicare Advantage population

Willey

Franchino‐Elder

et al. 2018

BMJ Open

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ObjectivesWith the approval of new non-vitamin K antagonist oral anticoagulants for stroke prevention in non-valvular atrial fibrillation (NVAF), it is anticipated that their introduction may change NVAF treatment patterns; however, there is limited supporting real-world evidence. This study investigated guideline-recommended oral anticoagulation (OAC) treatment and persistence in newly diagnosed patients with NVAF to understand demographic and clinical characteristics.DesignRetrospective observational administrative claims study in the USA.SettingPatients with NVAF with ≥1 pharmacy claim for OAC (warfarin, dabigatran, rivaroxaban or apixaban) and no atrial fibrillation diagnosis within 12 months prior to the first claim were identified in the HealthCore Integrated Research Database between 1 November 2010 and 30 November 2013.Participants45 092 patients with NVAF were included.OutcomesThe proportion of OAC-treated patients was stratified by CHADS2 score. Treatment persistence was measured from OAC initiation to discontinuation, end of eligibility or end of study period (30 November 2014), whichever occurred first.ResultsAlmost half of the patients (41.1%) received an OAC. The proportion treated differed slightly in baseline stroke risk (CHADS2<2: 39.8%; CHADS2=2 or 3: 42.4%; and CHADS2>3: 40.3%: p<0.001). Treated patients were slightly younger (70±12.2 vs 71±14.3 years; p<0.001), more likely male (59.7% vs 52.5%; p<0.001) and had a slightly elevated stroke risk (CHADS2: 2.03±1.3 vs 1.98±1.4; p<0.001) and a lower bleeding risk (HEMORR2HAGES: 2.55±1.8 vs 2.80±1.9; p<0.001) relative to untreated patients. Overall, patients with higher CHADS2 scores had higher HEMORR2HAGES scores. The mean follow-up was 2.25 years (2.25±0.85) and 72.7% of patients discontinued OACs; nearly 25% within 3 months and 55% within 12 months. The mean time to discontinuation was 255±249 days.ConclusionsThe proportion of patients with NVAF who received OAC treatment was lower than previously reported and differed slightly by stroke risk. Patients with an elevated stroke risk had a higher bleeding risk, suggesting that clinicians may incorporate both in the treatment decision.

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Persistence and Discontinuation of Oral Anticoagulant: Remaining Issues Not Addressed by Phase III Clinical Trials

Cited by 7 publications

References 22 publications

Evaluation of anticoagulation use and subsequent stroke in patients with atrial fibrillation after empiric surgical left atrial appendage closure: A retrospective case‐control study

Evaluation of anticoagulation use and subsequent stroke in patients with atrial fibrillation after empiric surgical left atrial appendage closure: A retrospective case‐control study

The Changing Landscape of Diabetes Therapy for Cardiovascular Risk Reduction

Treatment and persistence with oral anticoagulants among newly diagnosed patients with non-valvular atrial fibrillation: a retrospective observational study in a US commercially insured and Medicare Advantage population

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