Dataset Information

Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin Following WATCHMAN in High-Risk Patients.

ABSTRACT:

Background

In the pivotal WATCHMAN trials, warfarin was used exclusively for postprocedural anticoagulation following left atrial appendage closure. We sought to investigate the safety and efficacy of direct oral anticoagulants (DOACs) in high-risk patients with atrial fibrillation who underwent left atrial appendage closure with WATCHMAN.

Methods

This was a retrospective study of 318 patients who underwent the WATCHMAN procedure in a tertiary referral center (June 2016-September 2020). We compared the outcomes of patients who were discharged on DOACs versus warfarin after the WATCHMAN procedure. The primary outcome was the composite of any bleeding, thromboembolism, or cardiovascular death through 7 days and 45 days after the procedure.

Results

The final analysis included 301 patients, of whom 82.4% (248/301) were discharged on DOACs and 17.6% (53/301) were discharged on warfarin. The mean CHA₂DS₂-VASc and HAS-BLED scores were 4.9 ± 1.6 and 2.9 ± 0.9, respectively. The primary composite outcome was similar between the DOAC and warfarin groups through 7 days (3.2% vs 5.6%; adjusted odds ratio [OR], 0.65; 95% confidence interval [CI], 0.13-3.17; P = .59) and 45 days after procedure (10.1% vs 11.3%; adjusted OR, 1.18; 95% CI, 0.41-3.45; P = .76). Major bleeding (5.2% vs 9.5%; P = .34) and all-cause readmission (12.5% vs 16.9%; P = .85) at 45 days were comparable between the DOAC and warfarin groups. The overall incidence of device-related thrombus and significant peri-device flow at 45 days were low (<0.5%).

Conclusions

In high-risk patients with atrial fibrillation, the primary composite outcome of any bleeding, thromboembolism, or cardiovascular death through 7 days and 45 days following WATCHMAN implantation was similar in patients receiving DOACs versus warfarin.

SUBMITTER: Tan BE

PROVIDER: S-EPMC11307383 | biostudies-literature | 2022 May-Jun

REPOSITORIES: biostudies-literature

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Publications

Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin Following WATCHMAN in High-Risk Patients.

Tan Bryan E-Xin BE Rao Mohan M Baibhav Bipul B Chuprun Dmitry D Shah Abrar A Bhatt Deepak L DL Depta Jeremiah P JP

Journal of the Society for Cardiovascular Angiography & Interventions 20220420 3

<h4>Background</h4>In the pivotal WATCHMAN trials, warfarin was used exclusively for postprocedural anticoagulation following left atrial appendage closure. We sought to investigate the safety and efficacy of direct oral anticoagulants (DOACs) in high-risk patients with atrial fibrillation who underwent left atrial appendage closure with WATCHMAN.<h4>Methods</h4>This was a retrospective study of 318 patients who underwent the WATCHMAN procedure in a tertiary referral center (June 2016-September ...[more]

PMID: 39131954

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Project description:BackgroundWhile clinical guidelines recommend direct-acting oral anticoagulants (DOAC) over warfarin to treat isolated nonvalvular atrial fibrillation, guidelines are silent regarding nonvalvular atrial fibrillation treatment among individuals with cancer, reflecting the paucity of evidence in this setting. We quantified relative risk of ischemic stroke or systemic embolism and major bleeding (primary outcomes), and all-cause and cardiovascular death (secondary outcomes) among older individuals with cancer and nonvalvular atrial fibrillation comparing DOACs and warfarin.MethodsThis retrospective cohort study used Surveillance, Epidemiology, and End Results cancer registry and linked US Medicare data from 2010 through 2016, and included individuals diagnosed with cancer and nonvalvular atrial fibrillation who newly initiated DOAC or warfarin. We used inverse probability of treatment weighting to control confounding. We used competing risk regression for primary outcomes and cardiovascular death, and Cox proportional hazard regression for all-cause death.ResultsAmong 7675 individuals included in the cohort, 4244 (55.3%) received DOACs and 3431 (44.7%) warfarin. In the inverse probability of treatment weighting analysis, there was no statistically significant difference among DOAC and warfarin users in the risk of ischemic stroke or systemic embolism (1.24 versus 1.19 events per 100 person-years, adjusted hazard ratio 1.41 [95% CI, 0.92-2.14]), major bleeding (3.08 versus 4.49 events per 100 person-years, adjusted hazard ratio 0.90 [95% CI, 0.70-1.17]), and cardiovascular death (1.88 versus 3.14 per 100 person-years, adjusted hazard ratio 0.82 [95% CI, 0.59-0.1.13]). DOAC users had significantly lower risk of all-cause death (7.09 versus 13.3 per 100 person-years, adjusted hazard ratio 0.81 [95% CI, 0.69-0.94]) compared to warfarin users.ConclusionsOlder adults with cancer and atrial fibrillation exposed to DOACs had similar risks of stroke and systemic embolism and major bleeding as those exposed to warfarin. Relative to warfarin, DOAC use was associated with a similar risk of cardiovascular death and a lower risk of all-cause death.

Project description:BackgroundResearch comparing direct-acting oral anticoagulants (DOACs) to warfarin has excluded nursing home residents, a vulnerable and high-risk population.ObjectiveTo compare the safety and effectiveness of DOACs versus warfarin.DesignNew-user cohort study (2011-2016).PatientsUS nursing home residents aged > 65 years with non-valvular atrial fibrillation enrolled in fee-for-service Medicare for > 6 months.ExposuresInitiators of DOACs (2881 apixaban, 1289 dabigatran, 3735 rivaroxaban) were 1:1 propensity matched to warfarin initiators.Main measuresOutcomes included ischemic stroke or transient ischemic attack (i.e., ischemic cerebrovascular event), bleeding (extracranial or intracranial), other vascular events, death, and a composite of all outcomes. Absolute rate differences (RD) and cause-specific hazard ratios (HR) with 95% confidence intervals (CI) were estimated. Subgroup analyses were performed by alignment of DOAC dosing with labeling.Key resultsMedian age (84 years), CHA2DS2-Vasc (5), and ATRIA risk scores (3) were similar across medications. Clinical outcome rates were similar for dabigatran and rivaroxaban users versus warfarin users. However, ischemic cerebrovascular event rates were higher among dabigatran and rivaroxaban users that received reduced dosages without an indication. Overall, apixaban users had higher ischemic cerebrovascular event rates (HR 1.86; 95% CI 1.00-3.45) and lower bleeding rates (HR 0.66; 95% CI 0.49-0.88), but outcome rates varied by dosing alignment. Mortality rates (per 100 person-years) were lower for apixaban (RDs - 9.30; 95% CI - 13.18 to - 5.42), dabigatran (RDs - 10.79; 95% CI - 14.98 to - 6.60), and rivaroxaban (RDs - 8.92; 95% CI - 12.01 to - 5.83) versus warfarin; composite outcome findings were similar.ConclusionsAmong US nursing home residents, the DOACs were each associated with lower mortality versus warfarin. Misaligned DOAC dosing was common in nursing homes and was associated with clinical and mortality outcomes. Overall, DOAC users had lower rates of adverse outcomes including mortality compared with warfarin users.

Project description:We examined a large community-based sample of patients with atrial fibrillation (AF) and valvular heart disease (VHD) (excluding prosthetic valves) with a goal to compare outcomes among patients with AF, with and without VHD, taking warfarin, dabigatran, and rivaroxaban. We identified Medicare beneficiaries enrolled in Medicare Part D benefit plan from 2011 to 2013 with newly diagnosed AF (18 137 patients with VHD [dabigatran, 1979; rivaroxaban, 2027; warfarin, 14 131] and 85 596 patients without VHD [dabigatran, 13 522; rivaroxaban, 14 257; warfarin, 57 817]). Primary outcomes of all-cause mortality, ischemic strokes, major bleeding, and myocardial infarction were compared across the 3 anticoagulants using 3-way propensity-matched samples. After propensity matching, a total of 5871 patients with VHD and 40 221 patients without VHD and AF were studied. Both dabigatran and rivaroxaban were associated with significantly lower risk of death in patients with VHD with AF (dabigatran versus warfarin: hazard ratio, 0.71; 95% confidence interval, 0.52-0.98; P=0.038; rivaroxaban versus warfarin: hazard ratio, 0.68; 95% confidence interval, 0.49-0.95; P=0.022). Nongastrointestinal bleeding was significantly reduced with dabigatran and rivaroxaban versus warfarin in those with VHD (dabigatran versus warfarin: hazard ratio, 0.17; 95% confidence interval, 0.06-0.49; P=0.001; rivaroxaban versus warfarin: hazard ratio, 0.37; 95% confidence interval, 0.17-0.84; P=0.017). Ischemic stroke and gastrointestinal bleeding rates did not differ between rivaroxaban, dabigatran, and warfarin in patients with VHD. The effects of the 3 anticoagulants on outcomes were comparable in patients with and without VHD and with AF. In this cohort of Medicare beneficiaries with VHD (excluding patients with prosthetic valves) and new-onset AF between 2011 and 2013, novel oral non-vitamin K anticoagulants were safe and effective options for prevention of systemic thromboembolism.

Project description:BackgroundClinical trials of direct oral anticoagulants (DOAC) are scarce and inconclusive in patients who are receiving dialysis, for whom DOAC are not labelled in Europe. In a French nationwide registry study of patients on chronic dialysis, we compared the effectiveness and safety of off-label DOAC use vs approved vitamin K antagonist (VKA).MethodsData on patients on dialysis were extracted from the French Renal Epidemiology and Information Network (REIN) registry and merged with data from the French national healthcare system database (Système National des Données de Santé, SNDS). Patients on dialysis who had initiated treatment with an oral anticoagulant between 1 January 2012 and 31 December 2020, were eligible for inclusion. The primary safety outcome was the occurrence of major bleeding events and the primary effectiveness outcome was the occurrence of thrombotic events. Using propensity score-weighted cause-specific Cox regression, we compared the safety and effectiveness outcomes for DOAC and VKA.ResultsA total of 8954 patients received an oral anticoagulant (483 DOAC and 8471 VKA) for the first time after the initiation of dialysis. Over a median (interquartile range) follow-up period of 1.7 (0.8-3.2) years, 2567 patients presented a first thromboembolic event and 1254 patients had a bleeding event. After propensity score adjustment, the risk of a thromboembolic event was significantly lower in patients treated with a DOAC than in patients treated with a VKA {weighted hazard ratio (wHR) [95% confidence interval (CI)] 0.66 (0.46; 0.94)}. A non-significant trend toward a lower risk of major bleeding events was found in DOAC-treated patients, relative to VKA-treated patients [wHR (95% CI) 0.68 (0.41; 1.12)]. The results were consistent across subgroups and in sensitivity analyses.ConclusionsIn a large group of dialysis patients initiating an oral anticoagulant, the off-label use of DOACs was associated with a significantly lower risk of thromboembolic events and a non-significantly lower risk of bleeding, relative to VKA use. This provides reassurance regarding the off-label use of DOACs in people on dialysis.

Dataset Information

Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin Following WATCHMAN in High-Risk Patients.

Background

Methods

Results

Conclusions

Publications

Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin Following WATCHMAN in High-Risk Patients.

Similar Datasets

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