Cessation Of Oral Anticoagulation Research Articles

Utility of transesophageal echocardiogram surveillance after watchman device placement.

In atrial fibrillation patients undergoing left atrial appendage occlusion with a Watchman device, surveillance imaging with a transesophageal echocardiogram (TEE) is typically performed at 45 days and 1 year to evaluate for device-related thrombus (DRT) and peri-device leak (PDL) before the cessation of oral anticoagulation. The incidence of these complications is relatively low, and the ideal timing and duration of surveillance is unknown. We sought to evaluate the incidence of DRT and PDL after Watchman placement at 45 days and 1 year to determine the necessity of surveillance TEEs. We retrospectively analyzed 361 patients who received a Watchman device between January 2016 and January 2020. Baseline clinical and echocardiographic data, post-procedure antithrombotic therapy, and surveillance echocardiographic data were collected from the NCDR LAAO Registry. Nested backward variable elimination regression was performed to derive independent predictors of the composite outcome of DRT and PDL. A total of 286 patients who had post-procedure TEEs were included in the analysis. At 45 days, 9 patients had DRT (3.2%) and 44 patients had PDL (15.0%). At 1 year, 5 patients had DRT (5.6%) and 8 patients had PDL (8.9%). All DRT at 45 days was treated with continued anticoagulation while no change in protocol occurred with PDL. All DRT at 1 year occurred in new patients without prior thrombus. A history of prior transient ischemic attack (TIA) and thromboembolism was significantly associated with DRT or PDL at 1 year. We identified several patients with device-related complications at 45 days and 1 year despite appropriate device sizing and adequate use of antithrombotic therapy. The incidence of DRT increased from 45 days to 1 year and occurred in patients without prior thrombus. These findings highlight the importance of surveillance imaging and suggest the potential need for extended surveillance in select patients.

Blood pressure levels and risk of haemorrhagic stroke in patients with atrial fibrillation and anticoagulants: results from a primary care cohort with hypertension

Abstract Background Haemorrhagic stroke (HS) is a serious condition that kills and debilitates many of those afflicted by it. Hypertension and oral anticoagulation (OAC) are independent risk factors for HS. Many patients with atrial fibrillation (AF) have hypertension and OAC. The concomitance of hypertension and OAC confers an even higher risk of haemorrhagic stroke, but less is known about the association between specific blood pressure levels and the risk of HS in patients with AF and OAC. Purpose To assess the risk of haemorrhagic stroke at different systolic blood pressure (SBP) levels in a primary care population with hypertension, AF and OAC. Methods We identified 3972 patients with hypertension, AF and OAC in a primary care database in southern Sweden. We followed patients from Jan 1, 2006 until a first event of HS, death, cessation of OAC or Dec 31, 2016. HS was defined as ICD-10 diagnosis codes: I60, I61, and I62. We analysed the association between SBP levels and HS by dividing SBP into five categories: <130, 130–139, 140–159, 160–179 and ≥180 mmHg. We also fitted a spline curve to visualise the relationship between SBP and HS. Hazard ratios (HR) were calculated for the SBP categories with a Cox proportional hazards model. The 130–139 group was used as a reference in the model. We identified age, sex, previous stroke, platelet inhibitor treatment, alcohol abuse and smoking as possible confounders with a directed acyclic graph and included them as co-variates in the model. Results We identified 51 cases of HS during follow-up. In the categorical analysis of SBP, point estimates of HRs for HS increased gradually from the lowest SBP category to the 160–179 category. Only the 160–179 category had a significantly different HR (3.76, CI 1.56–9.04) than the reference 130–139 category, however. See Table 1. No other co-variates were significantly associated with HS. The spline curve, Figure 1, illustrates a significantly increased HR for HS in the 140–175 SBP range. Conclusions In this real-world primary care cohort with hypertension, AF and OAC, we found that SBP in the 160–179 mmHg range was significantly associated with an increased risk of haemorrhagic stroke. Our findings emphasise the importance of blood pressure control in this patient category. Figure 1. Continuous and categorical SBP & HS risk Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): The study was financed by grants from the Swedish state under the agreement between the Swedish government and the country councils, the ALF-agreement.

Thromboembolic Risk of Cessation of Oral Anticoagulation Post Catheter Ablation in Patients With and Without Atrial Fibrillation Recurrence

Cessation of oral anticoagulation (OAC) is common after the first 3 months of catheter ablation of atrial fibrillation (AF); however, thromboembolic risk has not been defined in patients with and without AF recurrence (RAF vs NRAF) post ablation. We identified 796 patients who discontinued OAC at 3 months post AF ablation from January 2015 to May 2018 in our center. Regular follow-up was performed to detect RAF, collect medication management and thromboembolic and major bleeding events. CHA2DS2-VASc score was 1.79 ± 1.50; 547 (68.7%) patients were at intermediate and high risk (i.e., CHA2DS2-VASc score ≥1 in male patients, or ≥2 in female patients); 169 (21.2%) were RAF. During 29.2±12.2 months follow-up, the incidence rate of thromboembolism was 1.62 per 100 patient-year (7 in 431 years) in RAF, 0.33 per 100 patient-year (5 in 1,503 years) in NRAF. After adjusting for potential confounding factors, RAF was associated with more 3.5-fold higher rate of thromboembolism compared with NRAF (adjusting HR, 4.488; 95% CI, 1.381 to 14.586). Rate of thromboembolism was even higher in patients with intermediate and high risk (2.16 per 100 patient-year [7 in 323 years] vs 0.38 per 100 patient-year [4 in 1,043 years], aHR, 5.807; 95% CI, 1.631 to 20.671). In multivariate logistic regression analysis, RAF was the only independent predictor of thromboembolism (4.837 [1.498 to 15.621], p = 0.008). In conclusion, cessation of OAC in NRAF may be reasonable, especially for patients with the contraindications for continuing OAC; however, cessation of OAC appeared unsafe in RAF with a high-risk stroke profile because of high incidence rate of thromboembolism.

The cessation of oral anticoagulation following left atrial appendage surgery.

Atrial fibrillation is associated with a significantly increased risk of stroke, and oral anticoagulation is the mainstay of preventative treatment. Scenarios arise where the risks of treatment with oral anticoagulation may outweigh the benefits, most commonly when there is an elevated risk of bleeding. Studies of percutaneous closure of the left atrial appendage have strongly implicated this structure in the etiology of stroke in atrial fibrillation, and provide some rationale for the discontinuation of oral anticoagulation following percutaneous closure device implantation. A common clinical concern is the safety of cessation of oral anticoagulation after surgical closure of the left atrial appendage in patients with a history of atrial fibrillation. Here, we review the evidence guiding this management decision and draw comparison with data on percutaneous closure.

Cessation of oral anticoagulants in antiphospholipid syndrome.

Objective To study the outcome of patients with antiphospholipid syndrome (APS) after oral anticoagulant treatment cessation. Methods We performed a retrospective study of patients with APS experiencing cessation of oral anticoagulant and enrolled in a French multicentre observational cohort between January 2014 and January 2016. The main outcome was the occurrence of recurrent thrombotic event after oral anticoagulation cessation. Results Forty four APS patients interrupted oral anticoagulation. The median age was 43 (27-56) years. The median duration of anticoagulation was 21 (9-118) months. Main causes of oral anticoagulant treatment cessation were switch from vitamin K antagonists to aspirin in 15 patients, prolonged disappearance of antiphospholipid antibodies in ten, bleeding complications in nine and a poor therapeutic adherence in six. Eleven (25%) patients developed a recurrent thrombotic event after oral anticoagulation cessation, including three catastrophic APS and one death due to lower limb ischemia. Antihypertensive treatment required at time of oral anticoagulants cessation seems to be an important factor associated with recurrent thrombosis after oral anticoagulant cessation (15.2% in patients with no relapse versus 45.5% in patients with recurrent thrombosis, p = 0.038). Oral anticoagulant treatment was re-started in 18 (40.9%) patients. Conclusion The risk of a new thrombotic event in APS patients who stopped their anticoagulation is high, even in those who showed a long lasting disappearance of antiphospholipid antibodies. Except for the presence of treated hypertension, this study did not find a particular clinical or biological phenotype for APS patients who relapsed after anticoagulation cessation. Any stopping of anticoagulant in such patients should be done with caution.

Cessation of oral anticoagulation is an important risk factor for stroke and mortality in atrial fibrillation patients.

Oral anticoagulation (OAC) is highly effective preventing stroke and mortality in AF, but withdrawal is common in the elderly, when high bleeding risk and when are difficulties achieving an optimal time in therapeutic range (TTR). We analysed the rate of OAC cessation, predisposing factors to cessation and the relation to clinical outcomes in a large 'real world' cohort of AF patients over a long follow-up period. Consecutive non-valvular AF outpatients clinically stables for six months were recruited. Rates of cardiovascular events, major bleeding and mortality were recorded and related to OAC cessation. We included 1361 patients (48.7 % male; aged 76, IQR 71-81), followed-up for a median of 6.5 years. During follow-up, 244 patients suffered thrombotic events, 250 suffered from major bleeding and 551 patients died. 10 % of patients stopped OAC. After OAC withdrawal, there were 36 thromboembolic events (22 strokes), 10 major bleedings and 75 deaths. OAC cessation was independently associated with adverse cardiovascular events (HR 1.45; 95 % CI 1.01-2.08), stroke/TIA (HR 1.85; 1.17-2.94) and all-cause mortality (HR 1.30; 1.02-1.67). Independent predictors of OAC cessation were age ≥80 (HR 2.29; 1.60-3.29), previous coronary artery disease (HR 0.32; 0.15-0.71), major bleeding (HR 5.00; 3.49-7.15), heart failure (HR 2.38; 1.26-4.47), cancer (HR 5.24; 3.25-8.44) and renal impairment developed during follow-up (HR 2.70; 1.26-5.75). In conclusion, in non-valvular AF patients, cessation of OAC was independently associated with the risk of stroke, adverse cardiovascular events and mortality. Bleeding events and some variables associated with higher bleeding risk are responsible for OAC cessation.

Comparison of Efficacy and Safety of Left Atrial Appendage Occlusion in Patients Aged

Left atrial appendage occlusion (LAAO) is emerging as a promising alternative to oral anticoagulation. Because aged patients present a greater risk of not only cardioembolic events but also major bleeding, LAAO might represent a valid alternative as this would allow oral anticoagulation cessation while keeping cardioembolic protection. The objective of the study was to explore the safety and efficacy of LAAO in elderly patients. Data from the AMPLATZER Cardiac Plug multicenter registry were analyzed. The cohort was categorized in 2 groups (<75 vs ≥ 75 years). A total of 1,053 subjects were included in the registry. Of them, 219 were excluded because of combined procedures. As a result, 828 subjects were included (54.6% ≥ 75 years). Procedural success was high and similar in both groups (97.3%). Acute procedural major adverse events were not statistically different among groups (3.2% in <75 years vs 5.1%; p = 0.17) although stratified analysis showed a higher incidence of cardiac tamponade in elderly patients (0.5% vs 2.2%; p = 0.04). With a median follow-up of 16.8 months, no significant differences in stroke/TIA (1.9% vs 2.3%; p = 0.89) and major bleeding (1.7% vs 2.6%; p = 0.54) were observed. In conclusion, LAAO was associated with similar procedural success in patients aged <75 and ≥ 75 years although older patients had a higher incidence of cardiac tamponade. At follow-up, stroke and major bleeding rates were similar among groups.

Long-term oral anticoagulation for patients after successful catheter ablation of atrial fibrillation: is it necessary?

Catheter ablation for atrial fibrillation is an effective rhythm-control therapy for selected patients. Currently, it is unknown whether maintenance of sinus rhythm after atrial fibrillation ablation can reduce one's stroke risk. If so, this may potentially obviate the need to treat patients with long-term oral anticoagulation (OAC). This article reviews the available evidence and areas of uncertainty pertaining to this question. To date, no randomized trial data exist on this topic. Analyses from health administrative databases and observational registries suggested that atrial fibrillation patients who underwent catheter ablation had lower risk of stroke when compared with those who did not. Among patients who maintained sinus rhythm after ablation, low rates of stroke (<0.7% per year) were observed even after discontinuation of OAC therapy. These findings raise the possibility that successful catheter ablation may lower one's stroke risk to a point at which long-term OAC therapy is not obligatory. Whether successful atrial fibrillation ablation reduces one's stroke risk is unknown. Low stroke risks were reported by observational studies in patients who maintained sinus rhythm after ablation despite OAC cessation. High-quality, randomized trial data are needed to provide clarity on this key unanswered question.

Cessation of oral anticoagulation in relation to mortality and the risk of thrombotic events in patients with atrial fibrillation

Bleeding risk (often perceived, rather than actual) is a common reason for cessation of oral anticoagulation with Vitamin K antagonists (VKA). We investigate clinical outcomes in a consecutive population of VKA naïve atrial fibrillation (AF) patients, who initiated VKA therapy in our clinic. We included consecutive VKA-naïve patients with non valvular AF, initiated on VKA therapy in our anticoagulation outpatient clinic in 2009. During follow-up, adverse events [thrombotic/vascular events (stroke, acute coronary syndrome, acute heart failure and cardiac death), major bleeding and death], and VKA cessation were recorded. At the end of the follow-up, we determined time within therapeutic range (TTR), using a linear approximation (Rosendaal method). We studied 529 patients (49% male, median age 76), median follow-up 835 days (IQR 719-954). During this period 114 patients stopped VKA treatment. 63 patients suffered a thrombotic/cardiovascular event (5.17%/year, 27 thrombotic/ischaemic strokes), 51 major bleeding (4.19%/year) and 48 died (3.94%/year). Median TTR was 54% (34-57). On multivariate analysis (adjusted by CHA₂DS₂-VASc score), VKA cessation was associated with death [Hazard Ratio (HR) 3.43; p<0.001], stroke [4.21; p=0.001] and thrombotic/cardiovascular events [2.72; p<0.001]. Independent risk factors for major bleeding were age [1.08; p<0.001], previous stroke [1.85; p=0.049], and TTR [0.97; p=0.001], but not VKA cessation. In conclusion, in AF patients AF, VKA cessation is independently associated with mortality stroke and cardiovascular events. Specifically, VKA cessation independently increased the risk of stroke, even after adjusting for CHA₂DS₂-VASc score. TTR was an independent risk factor for major bleeding following initiation of VKA therapy.

Very Low Risk of Thromboembolic Events in Patients Undergoing Successful Catheter Ablation of Atrial Fibrillation With a CHADS 2 Score ≤3

Background— Long-term cessation of oral anticoagulation (OAC) after catheter ablation of atrial fibrillation (AF) has been deemed controversial. The safety of this management strategy in patients without recurrent AF and with historically elevated risks for thromboembolism remains largely unknown. In this study, we sought to evaluate the long-term results of OAC cessation after successful catheter ablation of AF. Methods and Results— OAC and antiarrhythmic drugs (AADs) were discontinued irrespective of AF type or baseline CHADS 2 (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack) risk score in 327 patients (mean age, 63±13 years; 79% men) with drug-refractory AF after catheter ablation (mean CHADS 2 score, 1.89±0.95; median, 2.0). Patients with a CHADS 2 score of 2 (45.4%) and 3 (23.2%) accounted for 68.8% of this cohort. In patients with a high risk of recurrence or prior thromboembolic complications, OAC was continued for up to 6 to 12 months postablation and antiplatelet therapy was administered to all patients who maintained sinus rhythm upon OAC interruption. After a follow-up of 46±17 months (range, 13–82 months), 82% remained AF free (off AADs). Significant predictors of late AF recurrence ( P &lt;0.05) were nonparoxysmal AF (hazard ration [HR], 1.83), female sex (HR, 2.19), age ≥60 years (HR, 1.81), left atrial size &gt;40 mm (HR, 3.52), CHADS 2 score ≥2 (HR, 1.81), and early recurrences (HR, 5.52). No symptomatic ischemic cerebrovascular events were detected during follow-up despite interruption of OAC in 298 (91%) patients and AADs in 293 (89%) patients. Conclusions— No significant thromboembolic-related morbidity is observed when AADs and OAC are discontinued after successful catheter ablation of AF in patients with a CHADS 2 score ≤3 who are maintained on antiplatelet therapy during long-term follow-up.

Noninterruption of Warfarin Therapy is Safe and Does not Compromise Outcome in Patients Undergoing Endovenous Laser Therapy (EVLT)

To assess the need for cessation of oral anticoagulation with warfarin for patients undergoing endovenous laser therapy (EVLT). Between September 2004 and July 2010, 518 patients underwent 770 EVLT procedures on the lower extremity, at our institution. Of these patients, 5 underwent a total of 12 separate lower extremity EVLT procedures for the treatment of symptomatic reflux without interruption of warfarin therapy. No bleeding complications were observed during the procedure or in early follow-up. None of the patients developed a deep venous thrombosis. Complete ablation of the target vessel was observed in all patients on follow-up Duplex ultrasounds at 1 and 8 weeks postintervention. Endovenous laser therapy can be safely performed and does not compromise target vessel ablation in patients receiving oral anticoagulation warfarin therapy. Warfarin therapy should not be routinely interrupted in patients undergoing this procedure.

Continuing warfarin therapy is superior to interrupting warfarin with or without bridging anticoagulation therapy in patients undergoing pacemaker and defibrillator implantation

Current guidelines recommend stopping oral anticoagulation and starting bridging anticoagulation with intravenous heparin or subcutaneous enoxaparin when implanting a pacemaker or defibrillator in patients at moderate or high risk for thromboembolic events. A limited body of literature suggests that device surgery without cessation of oral anticoagulation may be feasible. The purpose of this study was to evaluate the safety of device surgery in orally anticoagulated patients without interrupting warfarin therapy. We performed a retrospective study of 459 consecutive patients on chronic warfarin therapy who underwent device surgery from April 2004 to September 2008. Warfarin was continued in 222 patients during the perioperative period. Warfarin was temporarily held and bridging therapy administered in 123 patients. Warfarin was temporarily held without bridging therapy in 114 patients. There were no significant differences with regard to age, sex, or risk factors for thromboembolism in the three groups. Patients who continued taking warfarin had a lower incidence of pocket hematoma (P = .004) and a shorter hospital stay (P <.0001) than did patients in the bridging group. Holding warfarin without bridging is associated with a higher incidence of transient ischemic attacks (P = .01). Temporarily interrupting anticoagulation is associated with increased thromboembolic events, whereas cessation of warfarin with bridging anticoagulation is associated with a higher rate of pocket hematoma and a longer hospital stay. Continuing warfarin with a therapeutic international normalized ratio appears to be a safe and cost-effective approach when implanting a pacemaker or defibrillator in patients with moderate to high thromboembolic risk.

Bridge or continue Coumadin for device surgery: a randomized controlled trial rationale and design

Many patients requiring cardiac arrhythmia device surgery are on chronic oral anticoagulation therapy. The periprocedural management of their anticoagulation presents a dilemma to physicians, particularly in the subset of patients with moderate-to-high risk of arterial thromboembolic events. Physicians have responded by treating patients with bridging anticoagulation while oral anticoagulation is temporarily discontinued. However, there are a number of downsides to bridging anticoagulation around device surgery; there is a substantial risk of significant device pocket hematoma with important clinical sequelae; bridging anticoagulation may lead to more arterial thromboembolic events and bridging anticoagulation is expensive. In response to these issues, a number of centers have explored the option of performing device surgery without cessation of oral anticoagulation. The observational data suggest a greatly reduced hematoma rate with this strategy. Despite these encouraging results, most physicians are reluctant to move to operating on continued Coumadin in the absence of confirmatory data from a randomized trial. We have designed a prospective, single-blind, randomized, controlled trial to address this clinical question. In the conventional arm, patients will be bridged. In the experimental arm, patients will continue on oral anticoagulation and the primary outcome is clinically significant hematoma. Our study has clinical relevance to at least 70 000 patients per year in North America.

Intravitreale Injektionen bei Antikoagulation

The number of intravitreal injections has increased steadily over the past few years. The aim of this prospective study was to evaluate the safety of intravitreal injections in patients under concurrent oral anticoagulation or antiplatelet therapy. 57 patients who underwent consecutively 80 intravitreal injections of Ranibizumab, Bevacizumab or triamcinolone were included in the study. The majority of the patients was treated with Ranibizumab and received antiplatelet therapy. Post-injection intra- or extraocular haemorrhages were documented. Small subconjunctival haemorrhages were noted in 45 % of the eyes. No patient experienced a subtotal subconjunctival or vitreous haemorrhage. There was no difference between patients who received oral anticoagulation and those with antiplatelet therapy. This study suggests that intravitreal injections can be performed without cessation of oral anticoagulation or antiplatelet therapy.

Long-Term Prospective Study of Recurrent Venous Thromboembolism in Patients Younger than 50 Years

Long-term incidence of recurrent venous thromboembolism (VTE) in patients younger than 50 years, not affected by a malignancy or chronic diseases, are poorly characterized. After the initial episode of VTE and cessation of oral anticoagulation, 98 patients, mean age 32.2 ± 9.2 years were followed for a median of 117 months (range 6–165). Congenital risk factors for VTE were present in 36% of patients, acquired persistent (positive antiphospholipid antibodies during the whole follow-up) in 19%, and acquired transitory in 44%. Thirty episodes of recurrent VTE were documented. The cumulative incidence of VTE after 1 year of follow-up was 5.1%, 9.8% after 2 years, 14% after 4 years, and 34.2% after 8 years. In the univariate analysis, the relative risk of recurrent VTE was 2.66 [95% confidence interval (CI) 1.03–6.90] for congenital risk factors, 4.97 (95% CI 1.75–14.0) for persistent acquired (antiphospholipid antibodies), 2.64 (95% CI 1.23–5.66) for male gender and 2.27(1.00–5.15) for body mass index >30 kg/m². In the multivariate analysis, male gender [hazard ratio (HR) 4.23, 95% CI 1.88–9.77) the presence of congenital factors (HR 3.28, 95% CI 1.25–8.63) and acquired persistent factors (HR 8.50, 95% CI 2.84–25.50) were independent risk factors for recurrent VTE. In patients under 50 years of age without malignancy or underlying chronic disease, hospitalized for an acute thromboembolic event, the presence of antiphospholipid antibodies, congenital defects of coagulation, male sex, and obesity were risk factors for recurrent VTE. These data raise the possibility that selected patients with VTE may require prolonged anticoagulation to prevent recurrent disease.

Outpatient Management of the Chronically Anticoagulated Patient for Elective Surgery

With the appropriate use of preadmission clinics, "hospital in the home" programs, and alternatives to intravenous heparin, the majority of chronically anticoagulated patients can be managed as outpatients prior to elective surgery. The preoperative management depends on the original indication for long-term anticoagulation, the interval since the last thromboembolic event, and the extent and type of surgery planned. Only patients who are undergoing major surgery, and who have a high risk of recurrent thrombosis or embolism, require preoperative admission to hospital and conversion to an intravenous heparin regimen. Patients undergoing minor surgery may require no change to their oral anticoagulation. The remainder require cessation of oral anticoagulation and alternative thromboprophylaxis preoperatively, which can be achieved on an outpatient basis using low molecular weight heparin. Outpatient anticoagulation management requires a clear protocol that is understood and agreed to by all parties involved in the care of surgical patients perioperatively.

Rebound after cessation of oral anticoagulant therapy: the biochemical evidence.

The existence of a phenomenon of rebound hypercoagulability after cessation of oral anticoagulant therapy is controversial. The sensitive procoagulant markers for in vivo thrombin and fibrin formation are potential tools for the reassessment of the presence of each a phenomenon. We examined 19 patients anticoagulated for 6 +/- 2 months (SD, range 3-12) because of venous thromboembolism or myocardial infarction as follows: twice during stable, oral anticoagulation (INR 3.1-3.7) and then on days 1, 2, 3, 4, 5, 7, 9, 11, 13, 15, and > 30 after cessation of oral anticoagulation. Thrombin-antithrombin III complexes (TAT) and fibrinopeptide A (FPA) were measured in addition to the prothrombin times and factors II, V, VII, and X. None of the 19 patients developed clinically manifest thromboembolism within the following 9-18 months. However, the patients' TAT levels increased transiently: rising from 1.5 +/- 0.1 ng/ml (SEM) to 3.0 +/- 0.2 ng/ml on day 4 (P < 0.001), and returned to 1.7 +/- 0.1 ng/ml after day 30 (normals 1.8 +/- 0.33). 17/19 patients showed TAT peak levels above the upper limit of normal between days 3 and 11 (average: day 4), which normalized again after 30 d. 8/19 patients also had transient FPA levels above the upper normal limits ( < 1.81). We conclude that our patients increased their thrombin and fibrin formation transiently and that a subpopulation reached values consistent with a prethrombotic state.