Interruption Of Direct Oral Anticoagulants Research Articles

DOACs vs Vitamin K Antagonists During Cardiac Rhythm Device Surgery: A Multicenter Propensity-Matched Study

BackgroundThere is a paucity of data comparing vitamin K antagonists (VKAs) to direct oral anticoagulants (DOACs) at the time of cardiac implantable electronic device (CIED) surgery. Furthermore, the best management of DOACs (interruption vs continuation) is yet to be determined. ObjectivesThis study aimed to compare the incidence of device-related bleeds and thrombotic events based on anticoagulant type (DOAC vs VKA) and regimen (interrupted vs uninterrupted). MethodsThis was an observational multicenter study. We included patients on chronic oral anticoagulation undergoing CIED surgery. Patients were matched using propensity scoring. ResultsWe included 1,975 patients (age 73.8 ± 12.4 years). Among 1,326 patients on DOAC, this was interrupted presurgery in 78.2% (n = 1,039) and continued in 21.8% (n = 287). There were 649 patients on continued VKA. The matched population included 861 patients. The rate of any major bleeding was higher with continued DOAC (5.2%) compared to interrupted DOAC (1.7%) and continued VKA (2.1%) (P = 0.03). The rate of perioperative thromboembolism was 1.4% with interrupted DOAC, whereas no thromboembolic events occurred with DOAC or VKA continuation (P = 0.04). The use of dual antiplatelet therapy, DOAC continuation, and male sex were independent predictors of major bleeding on a multivariable analysis. ConclusionsIn this large real-world cohort, a continued DOAC strategy was associated with a higher bleeding risk compared to DOAC interruption or VKA continuation in patients undergoing CIED surgery. However, DOAC interruption was associated with increased thromboembolic risk. Concomitant dual antiplatelet therapy should be avoided whenever clinically possible. A bespoke approach is necessary, with a strategy of minimal DOAC interruption likely to represent the best compromise.

Peri-procedural management and incidence of bleeding events following musculoskeletal injections or aspirations in people on oral anticoagulation and antiplatelet therapy.

Corticosteroid injections and aspirations are common interventions for managing musculoskeletal and inflammatory conditions. However, there remains limited safety evidence to support injection decisions and peri-procedural management in people on anti-thrombotics, particularly for direct oral anticoagulants (DOACs). To investigate peri-procedural management and bleeding complications following musculoskeletal injections or aspirations with anti-thrombotic medication use. A prospective observational study was undertaken (October 2018-December 2020) in Orthopaedics, Rheumatology and Radiology specialities in two large UK healthcare providers. Data collection involved weekly identification of musculoskeletal procedures, emergency attendance or admission within 30days and follow-up questionnaires sent within 2weeks post-procedure. Descriptive statistics were used to analyse anticoagulant/anti-platelet use, peri-procedural management and bleeding complications. Of 5080 procedures, 237 of 1338 responses reported antithrombotic use: warfarin (n=36), DOACs (n=75) and antiplatelets (n=126). There were no self-report or electronic identification of clinically significant bleeding events/complications. Only local bruising was reported (8.6% vs. 0.2% with non-use), and only with medication continuation or international normalised ratio (INR) levels ≥3.8 or unknown. Only 3/72 DOAC use was interrupted. In this study, no clinically significant bleeding events or complications were reported or identified following musculoskeletal injections or aspirations, with only localised bruising reported. It was not universal practice to check INR levels and DOAC interruption was uncommon. Findings add evidence that musculoskeletal procedures appear to be low risk procedures for bleeding complications with antithrombotic continuation and when INR levels within lower target range. Research on intra-articular or soft tissue iatrogenic consequences would add to risk/benefit evaluations.

The bridging conundrum: perioperative management of direct oral anticoagulants for venous thromboembolism

Most patients diagnosed with venous thromboembolism (VTE) are currently treated with direct oral anticoagulants (DOACs). Before an invasive procedure or surgery, clinicians face the challenging decision of how to best manage DOACs. Should the DOAC be held, for how long, and are there instances where bridging with other anticoagulants should be considered? Although clinical trials indicate that most patients taking DOACs for atrial fibrillation do not require bridging anticoagulation, the optimal strategy for patients with a history of VTE is undefined. In this review, we present a case-based discussion for DOAC interruption perioperatively in patients receiving anticoagulation for management of VTE.

Relevance of Non-Bridging Therapy with Heparin during Temporary Interruption of Direct Oral Anticoagulants in Patients with Cancer-Associated Venous Thromboembolism.

Objectives: To evaluate the relevance of non-bridging therapy with unfractionated heparin during the temporary, pre-procedural interruption of direct oral anticoagulants (DOACs) in patients with cancer-associated venous thromboembolism (VTE).Materials and Methods: This retrospective study included 142 patients with cancer and VTE who required temporary interruption of DOACs before invasive procedures. Data, including rates of VTE recurrence, non-major bleeding, and major bleeding, were compared between patients who received or not received alternative therapy with unfractionated heparin during interruption.Results: Sixty-eight patients were prescribed heparin, while 74 were not. There were no differences in age, body mass index, white blood cell count, hemoglobin level, or platelet count between the groups. VTE recurrence was observed in four (6%) and one (1%) patient in the heparin bridging and non-bridging groups, respectively (risk ratio [RR]: 4.4, 95% confidence interval [CI]: 0.50–38.0, p=0.19). Non-major bleeding occurred in three (4%) and two (3%) patients in the bridging and non-bridging groups (RR: 1.6, 95%CI: 0.28–9.48, p=0.67), while major bleeding occurred in 0 (0%) and three patients (4%) (p=0.25), respectively.Conclusion: Our findings confirm the relevance of non-bridging therapy with unfractionated heparin for reducing VTE risk during DOAC interruption in patients with cancer.

Pocket hematoma after pacemaker or defibrillator surgery: Direct oral anticoagulants versus vitamin K antagonists.

BackgroundDirect oral anticoagulants (DOACs) are the preferred choice of oral anticoagulation in patients with atrial fibrillation (AF). Randomized trials have demonstrated the efficacy and safety of DOAC in patients undergoing a cardiac implantable electronic device procedure (CIED); however, there is limited real-world data.ObjectiveTo evaluate the outcome of patients undergoing an elective CIED procedure in a tertiary referral center with an interrupted DOAC or continued vitamin K antagonist (VKA) regimen.MethodsThis was a retrospective single-center study of consecutive patients with AF undergoing an elective CIED procedure between January 2016 and June 2019. The primary endpoint was a clinically significant pocket hematoma < 30 days after surgery. The secondary endpoint was any systemic thromboembolic complication < 30 days after surgery.ResultsOf a total of 1,033 elective CIED procedures, 283 procedures were performed in patients with AF using oral anticoagulation. One-third of the procedures were performed under DOAC (N = 81, 29%) and the remainder under VKA (N = 202, 71%). The DOAC group was younger, had less chronic renal disease, more paroxysmal AF and a lower HAS-BLED score. The VKA group more often underwent a generator change only in comparison to the DOAC group. Clinically significant pocket hematoma occurred in 5 patients (2.5%) in the VKA group and did not occur in the DOAC group (P = 0.33). There were no thromboembolic events reported.ConclusionIn patients with AF undergoing an elective CIED procedure, the risk of a pocket hematoma and a systemic thromboembolic event is comparably low when using either continued VKA or interrupted DOAC.

Management of DOAC in Patients Undergoing Planned Surgery or Invasive Procedure: Italian Federation of Centers for the Diagnosis of Thrombotic Disorders and the Surveillance of the Antithrombotic Therapies (FCSA) Position Paper.

Patients on anticoagulant treatment are constantly increasing, with an estimated prevalence in Italy of 2% of the total population. About a quarter of the anticoagulated patients require temporary cessation of direct oral anticoagulants (DOACs) or vitamin K antagonists for a planned intervention within 2 years from anticoagulation inception. Several clinical issues about DOAC interruption remain unanswered: many questions are tentatively addressed daily by thousands of physicians worldwide through an experience-based balancing of thrombotic and bleeding risks. Among possible valuable answers, the Italian Federation of Centers for the diagnosis of thrombotic disorders and the Surveillance of the Antithrombotic therapies (FCSA) proposes some experience-based suggestions and expert opinions. In particular, FCSA provides practical guidance on the following issues: (1) multiparametric assessment of thrombotic and bleeding risks based on patients' individual and surgical risk factor, (2) testing of prothrombin time, activated partial thromboplastin time, and DOAC plasma levels before surgery or invasive procedure, (3) use of heparin, (4) restarting of full-dose DOAC after high risk bleeding surgery, (5) practical nonpharmacological suggestions to manage patients perioperatively. Finally, FCSA suggests creating a multidisciplinary “anticoagulation team” with the aim to define the optimal perioperative management of anticoagulation.

Influence of peri-procedural management of direct oral anticoagulants on the incidence of pocket hematoma in patients undergoing cardiac rhythm device implantation – The StimAOD study

Direct oral anticoagulants (DOAC) are commonly used in patients undergoing rhythm device implantation, exposing to an increased risk of pocket hematoma. However, the optimal perioperative strategy for DOAC management remains unclear. We performed a multicentre prospective observational study of patients receiving DOAC and undergoing pacemaker or defibrillator implantation. The primary endpoint was clinically relevant hematoma (CRH) within 30 ± 5 days after implantation. Any hematoma included CRH and non-clinically relevant hematoma. We aimed to describe practices, assess the impact of DOAC interruption before and after the procedure and identify predictors of CRH. In total, 789 patients were included, median age 80 [30–102], 36.4% women. CHA 2 DS 2 -VASc score was 4 [0–8] and 16.5% had a history of stroke. Defibrillators were implanted in one fifth. Antiplatelet therapy accounted for 18.5%. Overall DOAC were interrupted 40.8 ± 45.3 h prior the procedure and resumed 38.8 ± 40.3 h later. Pre- and post-procedural heparin bridging were observed in 8.2% and 3.9%, and shortened anticoagulation interruption (32.1 ± 48.8 vs. 55.8 ± 45.5 h, P < 0.001 and 22 ± 26.2 vs. 39.5 ± 40.6 h, P < 0.001, respectively). Postoperative bridging increased by 4.1 the risk of any hematoma up to 5.9 when associated with preoperative bridging. CRH occurred in 3.3%. In multivariate analysis dual antiplatelet therapy, defibrillator implantation and CHA 2 DS 2 -VASc score 0-1 were strong predictors of CRH ( Table 1 ). Among CHA 2 DS 2 -VASc score 0-1, postoperative anticoagulation was resumed earlier in those with a hematoma (29.6 ± 15.1 vs. 65.7 ± 70.5 hours, P = 0.007). Finally, thromboembolic events were low (0.63%). Dual antiplatelet therapy, defibrillator and CHA 2 DS 2 -VASc score 0-1 majored the risk of CRH. Timing of DOAC interruption and resumption were not predictive of CHR, however postoperative period seemed to be at high-risk of hematoma especially when bridging is performed. These findings have strong impact for clinical practice.

Risk of stroke and other thromboembolic complications after interruption of DOAC therapy compared with warfarin therapy in patients with atrial fibrillation: a retrospective cohort analysis

Direct oral anticoagulants (DOACs) have become the treatment of choice in thromboembolism prophylaxis for non-valvular atrial fibrillation, surpassing warfarin. While interruption of DOAC therapy for various reasons is a common...

Comparison of temporary interruption with continuation of direct oral anticoagulants for low bleeding risk procedures

IntroductionLimited data is available on the rates of bleeding and thromboembolic events for patients undergoing low bleeding risk procedures while taking direct oral anticoagulants (DOAC). MethodsAdults taking DOAC in the Michigan Anticoagulation Quality Improvement Initiative (MAQI2) database who underwent a low bleeding risk procedure between May 2015 and Sep 2019 were included. Thirty-day bleeding (of any severity), thromboembolic events, and death were compared between DOAC temporarily interrupted and continued uninterrupted groups. Adverse event rates were compared using an inverse probability weighting propensity score. ResultsThere were 820 patients who underwent 1412 low risk procedures. DOAC therapy was temporarily interrupted in 371 (45.2%) patients (601 [42.6%] procedures) and continued uninterrupted in 449 (54.8%) patients (811 [57.4%] procedures). DOAC patients with temporary interruptions were more likely to have diabetes, prior stroke or TIA, prior bleeding, higher CHA2DS2-VASc, and higher modified HAS-BLED scores. DOAC interruption was common for gastrointestinal endoscopy, electrophysiology device implantation, and cardiac catheterization while it was less common for cardioversion, dermatologic procedures, and subcutaneous injection. After propensity score adjustment, bleeding risk was lower in the DOAC temporary interruption group (OR 0.62, 95% CI 0.41–0.95) as compared to the group with continuous DOAC use. Rates of thromboembolic events and death did not differ significantly between the two groups. ConclusionsDOAC-treated patients undergoing low bleeding risk procedures may experience lower rates of bleeding when DOAC is temporarily interrupted. Prospective studies focused on low bleeding risk procedures are needed to identify the safety DOAC management strategy.

Management of Patients Receiving Direct Oral Anticoagulants Scheduled for Radical Prostatectomy: An Update of a Prospective Assessment

BackgroundIn the perioperative setting, temporary interruption of direct oral anticoagulants (DOACs) is mandatory. However, the safety of these recommendations is largely based on nonurological surgical experiences. ObjectiveTo verify the safety of these recommendations in patients undergoing radical prostatectomy (RP). Design, setting, and participantsA total of 5317 patients underwent RP in our tertiary care centre between December 2017 and February 2020. Of them, 107 consecutive patients had DOACs in standard preoperative medication. DOAC intake was stopped 2–3 d before RP. Postoperatively, patients received weight- and risk-adapted low-molecular-weight heparin (LMWH). DOAC intake was restarted, and administration of LMWH was stopped the 3rd day after surgery. For comparison, we performed 1:2 propensity-score matching (DOAC:non-DOAC), which resulted in 321 consecutive patients. Outcome measurements and statistical analysisPerioperative outcomes and 30-d morbidity were compared between both cohorts. The Wilcoxon rank sum test and the Pearson’s chi-square test were used. Results and limitationsThe median age of patients with DOACs was 68 yr. Sixty-six patients (61.7%) stopped DOAC intake 48 h and 41 patients (38.3%) 72 h before RP. In comparison with the matching cohort, the median blood loss during RP, median duration of surgery, and median duration of hospitalisation did not differ in a statistically significant fashion. Similarly, there was no significant difference in 30-d morbidity between groups. Importantly, the rate of bleeding and thromboembolic complications did likewise not differ significantly, though it is a nonrandomised and retrospective study. ConclusionsStandardised perioperative management of DOACs is important to minimise bleeding and thromboembolic complications. RP can be performed with a low perioperative complication risk if patients are adherent to our presented algorithm. Patient summaryWe looked at peri- and postoperative complications and compared direct oral anticoagulant (DOAC) and non-DOAC patients. We found no significant difference in thromboembolic and bleeding complications between the groups. We conclude that our regime is safe.

Abstract 13721: Is Single Dose Interruption of Direct Oral Anticoagulants Necessary Before Atrial Fibrillation Ablation? A Systematic Review and Meta-analysis

Background: In patients with atrial fibrillation taking direct oral anticoagulants (DOACS) and undergoing catheter ablation, it is unclear if interruption of a single dose of DOAC before the procedure is necessary. We assessed the peri-procedural adverse events between uninterrupted vs single-dose interrupted DOACS. Methods: A systematic review of Medline and EMBASE was conducted and all randomized controlled trials (RCTs) and observational studies that compared uninterrupted versus interrupted DOACS were included. Random effects model was used and risk ratios (RR) with 95% confidence intervals (CI) were reported using Mantel Haenszel method. All studies defined dose interruption as holding a single dose of DOAC before ablation. Separate analyses were conducted for RCTs and observational studies. Results: Eight RCTs with 2656 patients and 4 observational studies with 834 patients were included. In RCT restricted analysis, no significant difference was seen in major bleeding [RR 0.65 (CI 0.30-1.42)], minor bleeding [RR 0.98 (0.68-1.40)], stroke/transient ischemic attack/thromboembolism [RR 0.90 (CI 0.27-2.98)] and silent cerebral infarction [RR 0.51 (CI 0.14-1.89)]. In observational study restricted analysis, no significant difference was seen in major bleeding [RR 3.04 (CI 0.13-74.07)], minor bleeding [RR 0.88 (0.46-1.69)], stroke/transient ischemic attack/thromboembolism [RR 0.98 (CI 0.12-7.91)] and a statistically significant lower silent cerebral infarction [RR 0.45 (CI 0.31-0.67)]. Conclusion: Uninterrupted DOACS are safe for patients undergoing AF ablation and logistically easier for patients. Figure 1: Forest plot showing outcomes with uninterrupted vs interrupted direct oral anticoagulants in patients undergoing ablation for atrial fibrillation in randomized controlled trials.

Thrombotic complications with interruption of direct oral anticoagulants in dermatologic surgery

Direct oral anticoagulants (DOACs), such as apixaban, rivaroxaban, and dabigatran, are increasingly being used to provide prophylaxis and treatment for arterial and venous thromboembolism. Multiple procedural subspecialties have implemented guidelines detailing time frames for perioperative DOAC interruption; however, the impact of perioperative DOAC interruption in patients undergoing dermatologic surgery is currently unknown, and evidence-based guidelines are lacking. To assess the 30-day postoperative rate of thrombotic complications (ischemic stroke, transient ischemic attack, systemic embolism, deep vein thrombosis [DVT] and pulmonary embolism) in patients with nonvalvular atrial fibrillation (AF) or a history of DVT who underwent perioperative DOAC interruption during dermatologic surgery. A retrospective medical record review was performed of all patients with AF or a history of DVT who underwent perioperative DOAC interruption during dermatologic surgery at Advanced Dermatologic Surgery and the University of Kansas Medical Center between January 1, 2016, and August 31, 2020. Among 806 operations, comprising 750 Mohs micrographic operations (93.1%) and 56 excisions (6.9%), 1 patient (0.14% of patients with AF) sustained a transient ischemic attack and 2 patients (0.25% of all patients) sustained minor bleeding complications during the 30-day postoperative period. Perioperative DOAC interruption appears to be safe and efficacious in dermatologic surgery.

Postpolypectomy bleeding of colorectal polyps in patients with continuous warfarin and short-term interruption of direct oral anticoagulants

Postpolypectomy bleeding (PPB) is the most common adverse event after colorectal polypectomy. Use of anticoagulants is an important risk factor for PPB. This study aimed to evaluate PPB in patients receiving treatment with warfarin and direct oral anticoagulants (DOACs). Between August 2017 and July 2019, 5449 patients with 12,601 polyps who underwent endoscopic snare resection of colorectal polyps were enrolled. Endoscopic snare resection was performed in patients receiving continuous warfarin (C-warfarin) and in patients who experienced 1 day cessation of (O-) of DOACs in accordance with the Japanese Gastroenterological Endoscopy Society guidelines. The PPB rate in the group receiving anticoagulants was statistically higher than that in the group without anticoagulants (8.5% [33/387] vs 1.2% [63/5,062], respectively; P< .001). By multivariate logistic regression analysis, male gender (odds ratio [OR], 2.17; P= .007), warfarin (OR, 4.64; P< .001), DOACs (OR, 6.59; P< .001), and multipolyp removal (OR, 1.77; P= .007) were significant risk factors for PPB. PPB was observed in 9 and 21 patients in the C-warfarin and O-DOACs groups, respectively: C-warfarin (8.0% [9/113]), O-dabigatran (6.1% [2/33]), O-rivaroxaban (14.8% [9/61]), O-apixaban (9.8% [9/92]), and O-edoxaban (1.8% [1/56]). The PPB rate with the O-edoxaban group was significantly lower than that with the O-rivaroxaban group (P< .05). Use of anticoagulant therapy was an independent risk factor for PPB. The rates of PPB in patients receiving C-warfarin and O-DOACs were also higher than those in patients not receiving anticoagulants. Edoxaban may be safe through short-term withdrawal in patients undergoing endoscopic snare resection of colorectal polyps.

Predictors of Bleeding in the Perioperative Anticoagulant Use for Surgery Evaluation Study.

BackgroundIn the PAUSE (Perioperative Anticoagulant Use for Surgery Evaluation) Study, a simple, standardized, perioperative interruption strategy was provided for patients with nonvalvular atrial fibrillation taking direct oral anticoagulants (DOACs). Our objective was to define the factors associated with perioperative bleeding.Methods and ResultsWe analyzed bleeding as the composite of major and clinically relevant nonmajor bleeding. Putative predictors of bleeding, and preoperative DOAC level were prospectively collected during recruitment. We used stratified logistic regression models for analysis. All statistical analyses were performed in R version 3.6.0. There were 3007 patients requiring perioperative DOAC interruption. More than one third of the included patients underwent a high bleeding risk procedure. The 30‐day rates of major and clinically relevant nonmajor bleeding were 3.02% in apixaban (n=1257), 2.84% in dabigatran (n=668), and 4.16% for rivaroxaban (n=1082). Multivariate analysis stratified by region found more bleeding for hypertension (odds ratio [OR], 1.79; 95% CI 1.07‐2.99; P=0.027), and prior bleeding (OR, 1.71; 95% CI, 1.08‐2.71; P=0.021). Surgical bleed risk classification (high‐ versus low‐risk) as a predictor of bleeding was only significant in the univariate analysis. The prediction model for major and clinically relevant nonmajor bleeding had an area under the curve of 0.71, and the preoperative DOAC level did not improve the area under the curve of the model.ConclusionsIn patients treated with DOACs who required an elective surgery/procedure and were managed with standardized DOAC interruption and resumption, there we did not find reversible risk factors for bleeding, suggesting that adjustment of the PAUSE management protocol to mitigate against bleeding is not needed.

A Survey of Direct Oral Anticoagulant Cessation in General Surgery and Outcomes in Patients with Nonvalvular Atrial Fibrillation.

There is little data on management and outcomes of atrial fibrillation (AF) patients on direct oral anticoagulants (DOAC) undergoing general surgery.We retrospectively assessed 98 surgeries in 85 nonvalvular AF patients aged 73 ± 8 (59 men) receiving DOACs. Cardiac, emergency, and minimally invasive surgeries were excluded.The CHA2DS2-VASc score ranged from 0 to 8. The DOACs being given were: dabigatran, 16; rivaroxaban, 25; apixaban, 28; and edoxaban, 16. While the DOACs were not suspended in 11 cases, they were interrupted for a median of 2.0 days before surgery and restarted at a median of 3.0 days after surgery. There were 9 complications (9.2%), 3 instances of thromboembolism and 6 bleeding. Thromboembolism occurred at a mean of 3.0 postoperative days, all of which occurred before resumption of DOACs, while bleeding events occurred at a mean of 4.0 postoperative days. Two of the 3 patients with thromboembolism went into cardiopulmonary arrest during the event, but were resuscitated. There were significantly more patients with congestive heart failure or combined antiplatelets in the patients with complications. The complication group had a significantly higher HAS-BLED score and lower preoperative hemoglobin level. There were no significant differences in the management of DOAC interruption between those with complications and without.The perioperative complication rate in nonvalvular AF patients undergoing elective surgery treating with DOACs was 9.2%. Patients with congestive heart failure, receiving combined therapy with antiplatelets, a higher HAS-BLED score, or lower preoperative hemoglobin level were at higher risk. Further studies evaluating the ideal perioperative DOAC protocol are warranted.

Remaining activity of temporary interrupted direct oral anticoagulants and its impact on intra-ablation heparinization in patients with atrial fibrillation: Comparisons across four drugs and two dose regimens.

Atrial fibrillation (AF) ablation with minimally interrupted direct oral anticoagulants (DOACs) may raise a concern about their remaining activity. We tested the residual activity of four different DOACs and its impact on intraprocedural heparinization in patients undergoing AF ablation. We measured the anti-factor Χa activity for rivaroxaban, apixaban, and edoxaban, and serum DOAC concentration for rivaroxaban, apixaban, and dabigatran, 24 hours after the last intake in patients undergoing AF ablation treated with standard or reduced doses of DOACs. The heparin requirement during the procedure was also measured. We enrolled 34 patients with rivaroxaban, 35 with apixaban, 32 with edoxaban, and 31 with dabigatran, and among them, 30 were treated with reduced doses. The anti-factor Χa activity was the highest in the apixaban group among the patients with standard doses. The DOAC concentration was paradoxically lower in patients with standard doses than in those with reduced doses among the patients with rivaroxaban (34.3 ± 19.8 vs 56.6 ± 7.7 ng/mL; P = .01) and dabigatran (12.6 ± 10.6 vs 23.4 ± 14.7 ng/mL; P = .03). The total heparin requirement per body surface area had significant correlations with the anti-factor Χa activity (r = -.36) and DOAC concentration (r = -.32). Two different multiple linear regression models (adjusted R2 = 0.56 and 0.6, respectively) revealed that the anti-factor Χa activity (β = -.28; P = .002) and DOAC concentration (β = -.38; P < .001) were independent determinants of the total heparin requirement. Factors determining residual DOAC activity may include its type and dose regimen, and it may influence the heparin requirement during AF ablation.

P469Minimally interrupted versus uninterrupted non-vitamin K anticoagulants for atrial fibrillation ablation. a meta-analysis of randomized controlled trials

Abstract Introduction More and more patients undergoing atrial fibrillation (AF) ablation are anticoagulated with direct oral anticoagulants (DOAC). In order to balance the peri-procedural risk of bleeding with the risk of stroke, an important clinical question is whether to continue an interrupted DOAC administration or minimal interrupt by skipping the last one or two doses before the procedure. Dealing with rare events, the randomized controlled trials (RCTs) looking at this question have not been sufficiently powered to give a definitive answer. Purpose To do a systematic review of the literature comparing an uninterrupted DOAC strategy to minimally interrupted (1-2 doses) strategy in the setting of AF ablation in terms of peri-procedural stroke and bleeding. Methods PubMed, EMBASE, and Cochrane databases were searched for RCTs comparing a strategy of uninterrupted versus minimally interrupted DOAC administration for atrial fibrillation ablation. The primary endpoint was a composite of clinically significant adverse events: ischemic stroke, transient ischemic attack (TIA), systemic embolism, and major or minor bleeding events. A random-effects meta-analysis was performed on the resulting trials. The systematic review protocol was pre-registered in the PROSPERO database. The study selection process followed the PRISMA statement. Results After checking and removing duplicates, 188 articles were screened by reading the title and abstract. 8 of them were selected for a full text screening. Because 3 were not randomized, finally, 5 RCTs met the inclusion criteria. A total of 1 769 patients were included in the meta-analysis, and the sample size of the individual RCTs ranged from 97 to 846 patients. The overall prevalence of paroxysmal AF varied from 54% to 100%. The mean age of patients ranged from 63,5 to 70 years, and 21,6% to 32,8% of the trial populations were women. Comorbidities, such as hypertension, dyslipidemia, and diabetes, were common. Most patients had CHA2DS2-VASc &amp;lt; 3; range from 1,7 to 2,7We found consistently low rates of strokes, TIAs, systemic embolisms and bleedings across all trials and both arms (RR = 0.98, 95% CI 0.69 – 1.38, I-squared = 0%, p = 0.874). Conclusion We found no evidence in favor of a difference between uninterrupted and interrupted administration of NOACs regarding the primary outcome of clinical thromboembolic and bleeding. Abstract Figure. Meta-analysis of the primary outcome

Perioperative antithrombotic management of patients who receive direct oral anticoagulants during gastroenterological surgery.

AimWe investigated the effect of perioperative management of direct oral anticoagulants (DOACs) on bleeding and thromboembolic complications during gastroenterological (GE) surgery.MethodsA total of 334 patients receiving anticoagulants and undergoing elective GE surgery between 2012 and 2018 were enrolled. The patients were divided into three groups: patients receiving warfarin (WF, n = 231), patients receiving DOACs with heparin bridging (DOAC‐HB, n = 34), and patients receiving DOAC without heparin bridging (DOAC‐NHB, n = 69). Outcome variables were compared between the groups and the risk factors of postoperative bleeding were assessed using logistic multivariate analysis.ResultsNo significant differences were observed in background characteristics between the groups. There were similarities between the groups in surgical blood loss (P = .772) and rate of intraoperative transfusion (P = .952). Thromboembolic complications only occurred in two patients in the WF group (0.9%), and no thromboembolism occurred in the DOAC groups. The incidence of major postoperative bleeding was significantly higher in DOAC‐HB group than in the other groups (14.7% vs 4.8% vs 1.4%, P = .011). Multivariate analysis showed DOAC with heparin bridging to be the most significant risk factor of major postoperative bleeding (odds ratio = 11.60, P = .028).ConclusionsElective GE surgery can be safely performed in patients receiving DOACs without heparin bridging. Perioperative heparin bridging during DOAC interruption is not recommended even for patients undergoing major GE surgery due to increased postoperative bleeding.

Periprocedural Direct Oral Anticoagulant Management: The RA-ACOD Prospective, Multicenter Real-World Registry.

Introduction There is scarce real-world experience regarding direct oral anticoagulants (DOACs) perioperative management. No study before has linked bridging therapy or DOAC-free time (pre-plus postoperative time without DOAC) with outcome. The aim of this study was to investigate real-world management and outcomes. Methods RA-ACOD is a prospective, observational, multicenter registry of adult patients on DOAC treatment requiring surgery. Primary outcomes were thrombotic and hemorrhagic complications. Follow-up was immediate postoperative (24–48 hours) and 30 days. Statistics were performed using a univariate and multivariate analysis. Data are presented as odds ratios (ORs [95% confidence interval]). Results From 26 Spanish hospitals, 901 patients were analyzed (53.5% major surgeries): 322 on apixaban, 304 on rivaroxaban, 267 on dabigatran, 8 on edoxaban. Fourteen (1.6%) patients suffered a thrombotic event, related to preoperative DOAC withdrawal (OR: 1.57 [1.03–2.4]) and DOAC-free time longer than 6 days (OR: 5.42 [1.18–26]). Minor bleeding events were described in 76 (8.4%) patients, with higher incidence for dabigatran (12.7%) versus other DOACs (6.6%). Major bleeding events occurred in 17 (1.9%) patients. Bridging therapy was used in 315 (35%) patients. It was associated with minor (OR: 2.57 [1.3–5.07]) and major (OR: 4.2 [1.4–12.3]) bleeding events, without decreasing thrombotic events. Conclusion This study offers real-world data on perioperative DOAC management and outcomes in a large prospective sample size to date with a high percentage of major surgery. Short-term preprocedural DOAC interruption depending on the drug, hemorrhagic risk, and renal function, without bridging therapy and a reduced DOAC-free time, seems the safest practice.

Perioperative interruption of direct oral anticoagulants and vitamin K antagonists in patients with atrial fibrillation: A comparative analysis

BackgroundThere is a paucity of studies comparing postoperative thromboembolic and major bleeding complications following perioperative interruption of the direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs). Objective/MethodsWe conducted a retrospective cohort study to compare postoperative thromboembolic and major bleeding outcomes following perioperative interruption of DOACs and VKAs in patients with atrial fibrillation. The primary efficacy and safety outcomes were the 30‐day postoperative rates of arterial thromboembolic events (ATEs) and major bleeding, respectively. The secondary outcomes included the 30‐day rates of clinically relevant nonmajor bleeding (CRNMB) and overall mortality. Thromboembolic, major bleeding, and mortality outcomes were independently adjudicated. Multivariable mixed‐effects logistic‐regression models were used to adjust for potential confounding variables between the DOAC and VKA cohorts. ResultsA total of 325 DOAC patients undergoing 351 procedures and 199 VKA patients undergoing 221 procedures were included. The 30‐day ATE rate was 0.57% (95% confidence interval [CI], 0.27‐0.8) in the DOAC cohort. There were no ATEs in the VKA cohort. The 30‐day rates of major bleeding were 0.57% (95% CI, 0.27‐0.8) and 3.62% (95% CI, 0‐7.3) in the DOAC and the VKA cohorts, respectively. There were significantly more postoperative major bleeding events in the VKA cohort. The 30‐day rate of CRNMB was 4.27% (95% CI, 4.15‐4.42) in the DOAC cohort and 4.52% (95% CI, 3.67‐5.38) in the VKA cohort. There were 2 deaths in the VKA cohort, one of which was deemed to be a fatal nonsurgical bleeding event. ConclusionsThe perioperative interruption of VKAs may be associated with higher postoperative major bleeding rates as compared to DOACs. Careful postoperative reinitiation and monitoring of VKA anticoagulation may be warranted following surgical procedures.