Long-term Oral Anticoagulation Research Articles

Tissue Oedema Following Pulsed Field Ablation Recognized during a Concomitant Left Atrial Appendage Closure Procedure. A Case Report

Abstract Background In patients with non-valvular atrial fibrillation (AF), at high stroke risk and who are ineligible for long-term oral anticoagulation the left atrial appendage closure (LAAC) could be an alternative to anticoagulation. Pulsed field ablation (PFA) is a new nonthermal method for cardiac ablation modality based on high-voltage electrical energy for irreversible electroporation. We first report a case of a concomitant PFA pulmonary vein isolation and LAAC. Case Summary A 74-year-old female patient was referred to our department for pulmonary vein isolation (PVI) for persistent AF (CHA2DS2-VASc Score 5). A concomitant percutaneous LAAC was proposed because of a history of previous cerebellar transient ischemic attack despite continuous oral anticoagulation therapy. PVI was achieved with a pentaspline PFA catheter, LAAC performed with a WATCHMAN FLXTM device (Boston Scientific, Plymouth, MN, USA). After PVI, a swelling of the left atrial ridge was observed, yet a 27 mm LAAC device was successfully implanted. The follow-up transesophageal echo (TEE) after 6 weeks showed complete resolution of the oedema, no device related thrombus but a slight proximal tilting of the LAAC device without leakage could be observed. The 6-month follow-up demonstrated a stable sinus rhythm, no stroke or bleeding events were recorded. Discussion In this case of synchronous PFA-PVI procedure in AF and Watchman FLXTM device implantation, the electroporation created an acute oedema at the ridge level which at the TEE follow-up after 6 weeks was resolved. This resulted in a slightly tilted Watchman device position which was nevertheless stable and showed no leakage.

Effect Of Long-Term Use Of Antithrombotics And Statins On COVID-19 Mortality And Clinical Severity

Objective: Coronavirus Disease-2019 (COVID-19), has affected the whole world and is still an important disease with its mutations. In our study, we aimed to evaluate the effects of antithrombotic agents [acetylsalicylic acid (ASA), P2Y12 inhibitors, oral anticoagulants (OACs)] and statin treatments used before hospitalization on COVID-19 mortality and clinical severity. Methods: A retrospective study was conducted on 5577 patients hospitalized with positive swab tests or findings consistent with COVID-19 on computed tomography. The 6-month mortality, in-hospital mortality, need for intensive care and intubation, and recurrent hospitalization outcomes of patients receiving chronic ASA (n=1210), P2Y12 inhibitors (n=357), OACs (n=1192), and statin (n=607) treatment were evaluated. Results: The 6-month mortality rate was 13.5% (n=754), in-hospital mortality rate was 11.2% (n=627), the rate of admission to the intensive care unit was 16.1% (n=897), the need for intubation was 8.8% (n=493), and the rate of recurrent hospitalization was 10.4% (n=579). ASA and OACs reduced all outcomes. P2Y12 inhibitors provided benefit in other endpoints except intubation. Statins used before hospitalization did not provide a statistically significant decrease in 6-month mortality (p: 0.06), but were associated with a decrease in the rates of in-hospital mortality, need for intensive care, recurrent hospitalization, and intubation. Conclusion: We found that long-term ASA, P2Y12 inhibitors, OACs and statin treatments used before hospitalization in patients hospitalized with COVID-19, reduced COVID-19 mortality and clinical severity. We think that these treatments may be beneficial in selected patient groups where post-COVID effects are observed.

De-escalation to ticagrelor monotherapy versus 12 months of dual antiplatelet therapy in patients with and without acute coronary syndromes: a systematic review and individual patient-level meta-analysis of randomised trials

Dual antiplatelet therapy (DAPT) for 12 months is the standard of care after coronary stenting in patients with acute coronary syndrome (ACS). The aim of this individual patient-level meta-analysis was to summarise the evidence comparing DAPT de-escalation to ticagrelor monotherapy versus continuing DAPT for 12 months after coronary drug-eluting stent implantation. A systematic review and individual patient data (IPD)-level meta-analysis of randomised trials with centrally adjudicated endpoints was performed to evaluate the comparative efficacy and safety of ticagrelor monotherapy (90 mg twice a day) after short-term DAPT (from 2 weeks to 3 months) versus 12-month DAPT in patients undergoing percutaneous coronary intervention with a coronary drug-eluting stent. Randomised trials comparing P2Y12 inhibitor monotherapy with DAPT after coronary revascularisation were searched in Ovid MEDLINE, Embase, and two websites (www.tctmd.com and www.escardio.org) from database inception up to May 20, 2024. Trials that included patients with an indication for long-term oral anticoagulants were excluded. The risk of bias was assessed using the revised Cochrane risk-of-bias tool. The principal investigators of the eligible trials provided IPD by means of an anonymised electronic dataset. The three ranked coprimary endpoints were major adverse cardiovascular or cerebrovascular events (MACCE; a composite of all-cause death, myocardial infarction, or stroke) tested for non-inferiority in the per-protocol population; and Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding and all-cause death tested for superiority in the intention-to-treat population. All outcomes are reported as Kaplan-Meier estimates. The non-inferiority was tested using a one-sided α of 0·025 with the prespecified non-inferiority margin of 1·15 (hazard ratio [HR] scale), followed by the ranked superiority testing at a two-sided α of 0·05. This study is registered with PROSPERO (CRD42024506083). A total of 8361 unique citations were screened, of which 610 records were considered potentially eligible during the screening of titles and abstracts. Of these, six trials that randomly assigned patients to ticagrelor monotherapy or DAPT were identified. De-escalation took place a median of 78 days (IQR 31-92) after intervention, with a median duration of treatment of 334 days (329-365). Among 23 256 patients in the per-protocol population, MACCE occurred in 297 (Kaplan-Meier estimate 2·8%) with ticagrelor monotherapy and 332 (Kaplan-Meier estimate 3·2%) with DAPT (HR 0·91 [95% CI 0·78-1·07]; p=0·0039 for non-inferiority; τ2<0·0001). Among 24 407 patients in the intention-to-treat population, the risks of BARC 3 or 5 bleeding (Kaplan-Meier estimate 0·9% vs 2·1%; HR 0·43 [95% CI 0·34-0·54]; p<0·0001 for superiority; τ2=0·079) and all-cause death (Kaplan-Meier estimate 0·9% vs 1·2%; 0·76 [0·59-0·98]; p=0·034 for superiority; τ2<0·0001) were lower with ticagrelor monotherapy. Trial sequential analysis showed strong evidence of non-inferiority for MACCE and superiority for bleeding among the overall and ACS populations (the z-curve crossed the monitoring boundaries or the required information size without crossing the futility boundaries or approaching the null). The treatment effects were heterogeneous by sex for MACCE (p interaction=0·041) and all-cause death (p interaction=0·050), indicating a possible benefit in women with ticagrelor monotherapy, and by clinical presentation for bleeding (p interaction=0·022), indicating a benefit in ACS with ticagrelor monotherapy. Our study found robust evidence that, compared with 12 months of DAPT, de-escalation to ticagrelor monotherapy does not increase ischaemic risk and reduces the risk of major bleeding, especially in patients with ACS. Ticagrelor monotherapy might also be associated with a mortality benefit, particularly among women, which warrants further investigation. Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale.

Patient-reported treatment burden: comparison between vitamin-K antagonist and non-vitamin K antagonist oral anticoagulants

Abstract Introduction Treatment burden (TB) is defined as the overall workload that maintenance or improvement of their functioning and well-being poses on patients with chronic medical conditions. A high patient-reported TB has been associated with lower adherence to treatment and increased risk of major adverse events including death. We explored the differences in patient-reported TB value and prevalence of unacceptably high TB score (≥59 points) between patients receiving vitamin K antagonist oral anticoagulants (VKA) and non-vitamin K antagonist oral anticoagulants (NOAC). Furthermore, we explored contributory factors associated with TB and the relationship between TB and quality of life (QoL) in these patients. Methods A single-centre study included consecutive adult in- and outpatients on long-term oral anticoagulation, seen at a university clinical centre a from April to June 2019, who were willing to complete the Treatment Burden Questionnaire encompassing 13 items assessing the TB associated with taking medicine, self-monitoring, laboratory assessments, medical consultations, organisational and administrative requirements, adherence to dietary and physical activity recommendations, as well as the social repercussions of the treatment. Results Of 320 enroled patients, 206 (64.4%) were taking a VKA. Atrial fibrillation was the most common indication for long-term oral anticoagulation (n=299, 93.4%). The mean TB score was significantly higher in patients on VKA versus those taking a NOAC (48.8 ±26.5 vs. 41.8 ±19.7, P= 0.014), mostly owing to significantly higher TB values for questions related to self-monitoring, including the International Normalized Ratio (INR) control (3.85±3.32 vs. 1.62±1.38, P&amp;lt;0.001) and diet restrictions (3.98±3.43 vs. 2.48±2.49, P&amp;lt;0.001) in patients taking VKA (Figure 1). In addition, these patients significantly more often reported an unacceptably high TB of ≥59 points compared with those taking NOAC (30.1% vs 18.4%, P= 0.024). Multivariable regression analysis of predictors of TB in patients taking a VKA or NOAC are presented in Table 1. Conclusion In our study, patients receiving a VKA reported significantly higher TB compared to those using NOAC, especially regarding the questions about self-monitoring (including INR control) and diet restrictions. An unacceptably high TB was also more prevalent among patients receiving a VKA. Our findings suggest that prescribing NOACs in preference to VKAs could help in decreasing the self-reported TB in patients who need oral anticoagulant therapy.

Incidence and outcome of periinterventional atrial fibrillation in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention

Abstract Background Peri-interventional atrial fibrillation (AF) may be detected in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). Data on the thromboembolic risk and long-term clinical outcome in patients with AF limited to the peri-interventional period is scarce. Purpose To assess the incidence and impact on long-term clinical outcome of peri-interventional de-novo AF in STEMI patients. Methods and Results This retrospective single-center cohort study included all patients who underwent PCI between January 2016 and November 2020 (n=491) due to STEMI. Patients were stratified to three cohorts of AF status: Pre-existing AF: n=42 [8.6%], newly diagnosed peri-interventional AF: n=56 [11.4%] and no AF: n=393 [80.0%]. Patients with newly diagnosed peri-interventional AF as well as patients with pre-existing AF had in median a mild-moderately reduced left ventricular ejection fraction (LVEF), patients in sinus rhythm in median a normal LVEF. During the average follow-up time of 4.7 years (min. 2 years, max. 7 years) the rate for readmission for AF or occurrence of AF without hospital admission was increased in patients with peri-interventional de-novo AF or pre-existing AF (n=6 [10.7%], n=10 [23.8%]) compared to those in sinus rhythm n=22 [5.6%] (p&amp;lt;0,001) The occurrence of ischemic stroke was higher in patients with peri-interventional de-novo AF (n=2 [3.6%] or with pre-existing AF (n=2 [4.8%]) compared to those in sinus rhythm (n=6 [1.5%]. (p=0.256) The risk of cardiovascular death was significantly higher in patients with newly diagnosed peri- interventional AF compared to patients with pre-existing or no AF (n=13 [23.2%], n=5 [11.9%], n= 37 [9.4%]) (p=0.009). In the patient group with peri-interventional de-novo AF, only 25.0% (n=13) received long-term oral anticoagulation therapy (OAK). The rate of stroke in patients who received OAK after peri- interventional de-novo AF was 7.7% (n=1) compared to those without OAK 2.6% (n=1). Conclusion Peri-interventional AF is a frequent finding in STEMI patients undergoing primary PCI. Patients with peri-interventional AF had a significantly increased risk for an adverse cardiovascular outcome. Optimal secondary prophylactic measures appear mandatory in this patient population. The significance of long-term OAK therapy is to be determined.

Left atrial appendage clipping during hybrid atrial fibrillation ablation: a very long-term, single-center experience

Abstract Background/introduction Epicardial left atrial appendage (LAA) clipping is an effective strategy for stroke prophylaxis in high thromboembolic (TE) and bleeding risk patients with atrial fibrillation (AF). In addition to LAA exclusion from systemic circulation, clipping promotes concomitant appendage isolation, which might have positive impacts on arrhythmia control. Purpose The aim of this study was to report safety, success rate, and the long-term clinical outcomes of LAA clipping in a large cohort of AF patients undergoing concomitant hybrid ablation. Methods Consecutive patients undergoing hybrid AF ablation between 2013 and 2023 were enrolled. Hybrid ablation was performed in a one-step procedure consisting of thoracoscopic epicardial radiofrequency (RF) ablation followed by endocardial mapping and ablation, if needed. Ablation lesion set included pulmonary vein (PV) and posterior wall (PW) isolation, as well as RF applications to the LAA/posterolateral ridge. LAA clipping was performed via Atriclip exclusion system (Atricure, Inc., The Nederlands) after epicardial ablation. Additional endocardial lesions were performed in case of incomplete epicardial ablation or at physician’s discretion. Results A total of 130 patients were included (mean age: 65±9.4; 72.3% males); among them, 19.2% and 55.4% had persistent or long-standing persistent AF, respectively. Mean CHA2DS2-VASC and HAS-BLED were 3.1±1.1 and 2.3+-0.5. Five patients (3.8 %) had absolute contraindication to long-term oral anticoagulation, 3 (2.3%) had previous life-threatening bleeding events, 17 (13.1%) had a previous TE event. The final clip size was 35mm in 90.7% cases. Acute success was achieved in 97.7%; failure was due to LAA size (n=1), proximity to phrenic nerve (n=1), or bypass graft (n=1). One patient had incomplete occlusion due to a large secondary lobe, which required a second clip. No periprocedural complications related to clipping were documented. At a mean follow-up of 51±35 months, one (0.8%) patient had a stroke and 3 (2.3%) a transient ischemic attack (4 events per 552 patient/years; 0.7%). One patient had a microreentrant tachycardia mapped from the area near the LAA clipping. Conclusion In a large cohort undergoing hybrid AF ablation, epicardial LAA clipping was safe and highly successful. Acute failure was rare and due to LAA morphology or proximity to phrenic nerve and bypass graft. Thromboembolic event rate was very low.

Efficacy and outcomes of antiplatelet therapy versus oral anticoagulants in patients undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis.

Recent guidelines suggest that antiplatelet therapy (APT) is the standard of care in the absence of long-term oral anticoagulation (OAC) indications in patients post-transcatheter aortic valve replacement (TAVR). The superiority of one method over the other remains controversial. Several databases, including MEDLINE, Google Scholar, and EMBASE, were electronically searched. The primary endpoint was the all-cause mortality (ACM) rate. Secondary endpoints included cardiovascular death, myocardial infarction (MI), stroke/TIA, haemorrhagic stroke, bleeding events, systemic embolism, and valve thrombosis in post-TAVR patients receiving APT and oral anticoagulants (OACs). Forest plots were generated using Review Manager version 5.4, with a p value less than 0.05 indicating statistical significance. Subgroup analysis was performed to explore potential sources of heterogeneity. Twelve studies were selected. No significant differences were observed in APT and OAC group for ACM [risk ratio (RR): 0.67; 95% CI:0.45-1.01; P=0.05], cardiovascular death [RR:0.91; 95% CI:0.73-1.14; P=0.42], MI [RR:1.69; 95% CI:0.43-6.72; P=0.46], Stroke/TIA [RR:0.79; 95% CI:0.58-1.06; P=0.12], ischaemic stroke [RR:0.83; 95% CI:0.50-1.37; P=0.47], haemorrhagic stroke [RR:1.08; 95% CI: 0.23-5.15; P=0.92], major bleeding [RR:0.79; 95% CI:0.51-1.21; P=0.28], minor bleeding [RR:1.09; 95% CI: 0.80-1.47; P=0.58], life-threatening bleeding [RR:0.85; 95% CI:0.55-1.30; P=0.45], any bleeding [RR:0.98; 95% CI:0.83-1.15; P=0.78], and systemic embolism [RR:0.87; 95% CI:0.44-1.70; P=0.68]. The risk of valve thrombosis was higher in patients receiving APT than in those receiving OAC [RR:2.61; 95% CI:1.56-4.36; P =0.0002]. Although the risk of valve thrombosis increased in patients receiving APT, the risk of other endpoints was comparable between the two groups.

Reduced dementia risk in patients with optimized anticoagulation therapy undergoing atrial fibrillation ablation

BackgroundAtrial fibrillation (AF) is associated with the development of dementia, and observational studies have shown that oral anticoagulation and catheter ablation reduce dementia risk. However, such studies did not consistently report on periprocedural anticoagulation and long-term oral anticoagulation coverage, for which reason the separate effect of AF ablation on dementia risk could not be established. ObjectiveWe evaluated the protective effect of AF ablation in a large cohort of patients who received optimized anticoagulation and compared them with patients who were managed medically. MethodsWe retrospectively included 5912 consecutive patients who underwent first-time catheter ablation for AF between 2008 and 2018 and compared them with 52,681 control individuals from the Swedish Patient Register. Propensity score matching produced 2 cohorts of equal size (n = 3940) with similar baseline characteristics. Dementia diagnosis was identified by International Classification of Diseases codes from the patient register. ResultsMost propensity score–matched patients were taking an oral anticoagulant at the start (94.5%) and end (75.0%) of the study. Mean follow-up was 4.9 ± 2.8 years. Catheter ablation was associated with lower risk for the dementia diagnosis compared with the control group (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.22–0.86; P = .017). The result was similar when including patients with a stroke diagnosis before inclusion (HR, 0.50; 95% CI, 0.28–0.89; P = .019) and after adjustment for the competing risk of death (HR, 0.41; 95% CI, 0.20–0.86; P = .018). ConclusionCatheter ablation of AF in patients with optimized oral anticoagulation therapy was associated with a reduction in dementia diagnosis, even after adjustment for potential confounders and for competing risk of death.

A real-world multicenter study on left atrial appendage occlusion: The Italian multi-device experience

BackgroundTranscatheter left atrial appendage occlusion (LAAO) has emerged as an alternative treatment for stroke prevention in patients with atrial fibrillation (AF) at high risk of thromboembolism, who cannot tolerate long-term oral anticoagulation (OAC). Questions persist regarding effectiveness and safety of this treatment and the optimal post-interventional antithrombotic regimen after LAAO. MethodsWe retrospectively gathered data from 428 patients who underwent percutaneous LAAO in 6 Italian high-volume centres, aimed at describing the real-world utilization, safety, and effectiveness of LAAO procedures, also assessing the clinical outcomes associated with different antithrombotic strategies. ResultsAmong the entire population, 20 (4.7 %) patients experienced a combination of pericardial effusion and periprocedural major bleeding: 8 (1.9 %) pericardial effusion, 1 (0.3 %) fatal bleeding, and 3 (0.7 %) non-fatal procedural major bleeding. Patients were discharged with different antithrombotic regimens: dual (DAPT) (27 %) or single (SAPT) (26 %) antiplatelet therapy, OAC (27 %), other antithrombotic regimens (14 %). Very few patients were not prescribed with antithrombotic drugs (6 %). At a medium 523 ± 58 days follow-up, 14 patients (3.3 %) experienced all-cause death, 6 patients (1.4 %) cardiovascular death, 3 patients (0.7 %) major bleeding, 10 patients (2.6 %) clinically relevant non-major bleeding, and 3 patients (0.7 %) ischemic stroke. At survival analysis, with DAPT as the reference group, OAC therapy was associated with better outcomes. ConclusionsOur findings confirm that LAAO is a safe procedure. Different individualized post-discharge antithrombotic regimens are now adopted, likely driven by the perceived thrombotic and hemorrhagic risk. The incidence of both ischemic and bleeding events tends to be low.

First report of chronic portal vein thrombosis successfully managed with splenectomy and long-term direct oral anticoagulants

First report of chronic portal vein thrombosis successfully managed with splenectomy and long-term direct oral anticoagulants

A decade of experience in over 300 surgically treated spine patients with long-term oral anticoagulation: a propensity scorematched cohort study.

The aim of this study was to investigate the risks and outcomes of patients with long-term oral anticoagulation (OAC) undergoing spine surgery. All patients on long-term OAC who underwent spine surgery between 01/2005 and 06/2015 were included. Data were prospectively collected within our in-house Spine Surgery registry and retrospectively supplemented with patient chart and administrative database information. A 1:1 propensity score-matched group of patients without OAC from the same time interval served as control. Primary outcomes were post-operative bleeding, wound complications and thromboembolic events up to 90days post-surgery. Secondary outcomes included intraoperative blood loss, length of hospital stay, death and 3-month post-operative patient-rated outcomes. In comparison with the control group, patients with OAC (n = 332) had a 3.4-fold (95%CI 1.3-9.0) higher risk for post-operative bleeding, whereas the risks for wound complications and thromboembolic events were comparable between groups. The higher bleeding risk was driven by a higher rate of extraspinal haematomas (3.3% vs. 0.6%; p = 0.001), while there was no difference in epidural haematomas and haematoma evacuations. Risk factors for adverse events among patients with OAC were mechanical heart valves, posterior neck surgery, blood loss > 1000mL, age, female sex, BMI > 30kg/m2 and post-operative PTT levels. At 3-month follow-up, most patients reported favourable outcomes with no difference between groups. Although OAC patients have a higher risk for complications after spine surgery, the risk for major events is low and patients benefit similarly from surgery.

LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry.

Interventional left atrial appendage occlusion (LAAO) mitigates the risk of thromboembolic events in nonvalvular atrial fibrillation (AF) patientswith contraindication for long-term oral anticoagulation (OAC). Patients with prior stroke have a relevantly increased risk of recurrent stroke, so the effectiveness of LAAO could be reduced in this specific very high-risk patient group. This sub-study of the LAARGE registry investigates the effectiveness and safety of LAAO for secondary prevention in nonvalvularAF patients with a history of stroke. LAARGE is a prospective, non-randomised registry on the clinical reality of LAAO. The current sub-study employs data from index procedure and 1-year follow-up. Effectiveness and safety were assessed by documentation of all-cause mortality, non-fatal thromboembolism, procedure-related complications, and bleeding events. A total of 638 patients were consecutively included from 38 hospitals in Germany and divided into two groups: 137 patients with a history of stroke (21.5%) and 501 patients without. Successful implantation was consistent between both groups (98.5% vs. 97.4%, p = NS), while peri-procedural MACCE and other complications were rare (0% vs. 0.6% and 4.4% vs. 4.0%, respectively; each p = NS). Kaplan-Meier estimate showed no significant difference in primaryeffectiveness outcome measure (freedom from all-cause death or non-fatal stroke) between both groups at follow-up (87.8% vs. 87.7%, p = NS). The incidence of transient ischemic attack or systemic embolism at follow-up was low (0% vs. 0.5% and 0.9% vs. 0%, respectively; each p = NS). Severe bleeding events after hospitaldischarge were rare (0% vs. 0.7%, p = NS). Patients with prior stroke demonstrated similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OACfor secondary stroke prevention in this selected group of nonvalvular AF patients. NCT02230748.

Unraveling effort thrombosis: a comprehensive case report on page-schroetter syndrome

Background: Page-Schroetter Syndrome (PSS) is a rare variant of thoracic outlet syndrome which requires early intervention to prevent formation of deep vein thrombosis in the upper limbs. Development of PSS depends on risk factors such as young-aged athletes, typically of male sex, who exercises using repetitive arm movements such as swimming, muscle building exercises, and handball, aggravating microtrauma to venous intima leading to activation of coagulation cascade. Case Presentation: A case of 33-year-old Saudi male was presented to the emergency department on an acute onset of right arm swelling, redness, and pain. Following calisthenics exercises where he was doing push-ups on an open door. The patient was hemodynamically stable, negative for signs and symptoms of pulmonary embolism, and he denied any history of thrombus-forming events. The patient was diagnosed with PSS after detecting filling defect on Doppler ultrasound, and severe stenosis of the right subclavian vein on venogram. The patient was treated accordingly and was discharged on long-term oral direct anticoagulants. Conclusion: PSS is easily missed due to scarce number of reported cases, and unfamiliarity from the medical personnel with the approach to detect and treat upper limb deep vein thrombosis.

Pulmonary embolism in cancer patients. Effectiveness of vitamin K antagonists and direct oral anticoagulants in long-term therapy.

Patients with cancer are prone to develop pulmonary embolism (PE) in the course of cancer-associated thrombosis. These patients have increased risk of both recurrent venous thromboembolism and major bleeding. Pulmonary embolism treatment in the cancer patient group is challenging. Selection of anticoagulants, duration of anticoagulation, decision of adjuvant therapy, and adjustment of the regimen in special situations are the major problems that need to be considered in the treatment of cancer-associated PE. Current first line treatment in long-term therapy following an episode of PE is low molecular weight heparin (LMWH), with direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) listed as viable alternatives. This study aims to explore long-term oral anticoagulation therapy for cancer patients. Both VKAs and DOACs are compared to LMWH, which serves as a gold standard in anticoagulation therapy for cancer patients and has proven to be effective.

Novel Oral Anticoagulants in Cardiovascular Practice

In the recent era of medicine, Novel Oral Anticoagulants (Apixaban, Dabigatran, Edoxaban, and Rivaroxaban) have become the preferred drugs for long-term anticoagulation therapy in the majority of cardiovascular conditions, along with non-cardiac co-morbid conditions with few necessary exceptions. This preference is based on their easy availability, therapeutic efficacy, all-cost effectiveness, safety profile, and more convenient usage for both patients and clinicians. Novel Oral Anticoagulants (NOACs) have different pharmacokinetics and pharmacodynamics than oral vitamin K antagonists. This article highlights the basic pharmacology, common complications, available antidotes, and the utility of NOACs in different common cardiovascular diseases requiring long-term oral anticoagulation, including stroke prevention in valvular and non-valvular atrial fibrillation, coronary artery disease, myocardial infarction, left ventricular thrombus and cerebrovascular attacks. NOACs are still underutilized in cardiovascular practice because the concomitant co-morbid conditions hinder a clinician from prescribing these drugs confidently. This manuscript will provide a brief critical overview to help clinicians prescribe NOACs more conveniently.

Choosing Appropriate Candidates for Left Atrial Appendage Occlusion.

Atrial fibrillation (AF) is one the most prevalent arrhythmias globally and is associated with a significantly higher risk of morbidity and mortality, including an up to five-fold increase in risk of stroke. While oral anticoagulation therapy remains the standard approach for stroke prevention in nonvalvular AF, left atrial appendage occlusion (LAAO) has emerged as a viable alternative for patients who are intolerant to long-term oral anticoagulation therapy. However, selecting appropriate candidates for LAAO requires a comprehensive evaluation that considers various clinical factors, although this presents a challenge in clinical practice. This review aims to provide an overview of the current recommendations for patient selection in LAAO procedures and the key factors that need to be considered both before and after the procedure, as well as the ongoing advancements in this field that may facilitate the selection of patients for LAAO.

DAPT Is Comparable to OAC Following LAAC With WATCHMAN FLX: A National Registry Analysis.

Left atrial appendage occlusion (LAAO) is an approved alternative for stroke prevention in atrial fibrillation for patients with an "appropriate rationale" to avoid long-term oral anticoagulation (OAC). Many patients undergoing LAAO are at high risk of bleeding. This study sought to investigate whether dual antiplatelet therapy (DAPT) is a safe alternative to OAC (direct oral anticoagulation [DOAC] or warfarin) with aspirin after LAAO. Using National Cardiovascular Data Registry LAAO registry data, patients undergoing Watchman FLX (Boston Scientific) implantation (August 5, 2020-September 30, 2021) were included in 1:1 propensity-matched analyses comparing discharge medication regimens (DAPT, DOAC/aspirin, or warfarin/aspirin). A composite endpoint (death, stroke, major bleeding, and systemic embolism), its components, and device-related thrombus between discharge and 45days were evaluated. In 49,968 patients implanted with the Watchman FLX during the study period, the mean age was 77 years, and 40% were women. Postimplant DOAC/aspirin was prescribed in 24,497 patients, warfarin/aspirin in 3,913, and DAPT in 4,155. DAPT patients had more comorbid conditions than patients receiving OAC/aspirin. After propensity score matching, the 45-day composite endpoint rates were similar among the groups (DAPT=3.44% vs DOAC/aspirin: 4.06%; P = 0.13 and DAPT=3.23% vs warfarin/aspirin: 3.08%; P = 0.75). Death, stroke, and device-related thrombus were also similar; major bleeding was slightly increased in DOAC/aspirin patients (DAPT=2.48% vs DOAC/aspirin=3.25%; P = 0.04 and DAPT=2.25% vs warfarin/aspirin=2.22%; P = 0.93). In a large registry, DAPT had a similar safety profile compared with current Food and Drug Administration-approved postimplant drug regimens of OAC with aspirin following LAAO with the Watchman FLX. Shared decision making for nonpharmacologic stroke prevention should include a discussion of postprocedure medical therapy options.

Rationale and design of Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial

BackgroundDespite the wide implementation of transcatheter aortic valve implantation (TAVI), the optimal antithrombotic therapy after TAVI has not been established yet. Owing to the accumulating evidence supporting the efficacy and safety of single antiplatelet therapy (SAPT) over dual antiplatelet therapy, the latest guideline recommends life-long SAPT. However, there is scarce evidence supporting SAPT compared with non-antithrombotic therapy. Given the vulnerability of patients undergoing TAVI in terms of high bleeding risk, the benefit of SAPT may be canceled out by its potential increased bleeding risk. Study design and objectivesNon-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial is a prospective, randomized controlled, open-label blinded endpoint multicenter trial conducted in Japan, testing the non-inferiority of non-antithrombotic therapy compared with aspirin monotherapy in patients who underwent TAVI and had no indications for long-term oral anticoagulation therapy (OAC). Patients who successfully underwent trans-femoral TAVI for severe aortic stenosis with either balloon-expandable or self-expandable valves are eligible for inclusion. Key exclusion criteria are (i) occurrence of perioperative complications (ii) indications of taking antithrombotic drugs for other reasons; (iii) eGFR <30 ml/min/1.73 m2 or hemodialysis or peritoneal dialysis. A total of 360 patients will be randomized (1:1) to aspirin monotherapy vs. non-antithrombotic therapy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, and bleeding. All bleeding events based on the Valve Academic Research Consortium 3 are included as a component of the primary outcome. ConclusionThe NAPT trial will determine the non-inferiority of a non-antithrombotic therapy compared with aspirin monotherapy after TAVI.

1- or 3-Month DAPT in Patients With HBR With or Without Oral Anticoagulant Therapy After PCI

BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients on long-term oral anticoagulation (OAC) therapy is still uncertain. ObjectivesThe aim of this analysis was to assess the effects of 1- vs 3-month DAPT in patients with and those without concomitant OAC included in the XIENCE Short DAPT program. MethodsThe XIENCE Short DAPT program enrolled patients with high bleeding risk who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. DAPT was discontinued at 1 or 3 months in patients free from ischemic events and adherent to treatment. The effect of 1- vs 3-month DAPT was compared in patients with and those without OAC using propensity score stratification. The primary endpoint was all-cause death or any myocardial infarction (MI). The key secondary endpoint was Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding. Outcomes were assessed from 1 to 12 months after index PCI. ResultsAmong 3,364 event-free patients, 1,462 (43%) were on OAC. Among OAC patients, the risk for death or MI was similar between 1- and 3-month DAPT (7.4% vs 8.8%; adjusted HR: 0.74; 95% CI: 0.49-1.11; P = 0.139), whereas BARC types 2 to 5 bleeding was lower with 1-month DAPT (adjusted HR: 0.71; 95% CI: 0.51-0.99; P = 0.046). These effects were consistent in patients with and those without OAC (P for interaction = NS). ConclusionsBetween 1 and 12 months after PCI, 1-month compared with 3-month DAPT was associated with similar rates of all-cause death or MI and a reduced rate of BARC types 2 to 5 bleeding, irrespective of OAC treatment.

Comparative Bleeding Risk in Patients with Atrial Fibrillation with Cancer versus Without Cancer from Nationwide Prospective Cohort.

Comparison of the bleeding risk for long-term oral anticoagulation (OAC) in patients with nonvalvular atrial fibrillation (AF) with and without cancers has been inconsistent. This study aimed to clarify the differences in the bleeding risk in patients with AF with cancers and those without cancers during the long-term OAC.The CODE-AF prospective registry enrolled 5,902 consecutive patients treated for AF at 10 tertiary referral centers in Korea. Of the enrolled patients, 464 (7.8%) were diagnosed with cancers and were followed for all stroke and bleeding events (net composite events).The age, CHA2DS2-VASC, and HAS-BLED scores were similar between AF patients with and without cancers. Male population greatly comprised patients with AF with cancers. They were equally prescribed with direct OAC compared to those without cancers. The incidence rate for clinically relevant nonmajor (CRNM) bleeding events was higher in the patients with AF with cancers than in those without cancers (4.4 per 100 person-years versus 2.8 per 100 person-years, P = 0.023), and net composite events were also more frequent in patients with AF with cancers than in those without cancers (6.4 per 100 person-years versus 4.0 per 100 person-years, P = 0.004). Patients with AF with cancers showed a significantly higher rate of CRNM bleeding (hazard ratio [HR] 1.54, confidence interval [CI] 1.05-2.25, P = 0.002) than those without cancers.Based on the AF cohort, AF with cancers could face a significantly higher risk for CRNM bleeding events in the long-term OAC than those without cancers.