UNASSIGNED: Many patients with atrial fibrillation (AF) discontinued oral anticoagulation (OAC) therapy after successful catheter ablation. We aimed to determine the real-world risks and consequences of discontinuing OAC use after catheter ablation for AF.
UNASSIGNED: Patients who underwent successful catheter ablation for AF from January 2004 to December 2020 were divided into continued long-term OAC (On-OAC, n = 1062) and discontinued (Off-OAC, n = 1055) groups. The long-term outcomes including thromboembolic events, major bleeding, all-cause mortality and major adverse cardiovascular events (MACE), were compared between the two groups.
UNASSIGNED: The CHA2DS2-VASc score was 3.44 ± 1.12. After a mean follow-up of 37.09 months, thromboembolism risk was higher and major bleeding risk was lower in the Off-OAC than in the On-OAC group (Both log-rank P < 0.001). CHA2DS2-VASc score-stratified subgroup analysis showed similar cumulative event rates between the two groups in men and women with scores of 2 and 3 (intermediate risk for stroke), respectively, (P > 0.05), except for a higher major bleeding rate in the On-OAC group (P = 0.002). Patients at high risk for stroke (men and women with scores ≥3 and ≥ 4) had better non-thromboembolic and non-MACE results (Both log-rank P < 0.05).
UNASSIGNED: Men with a CHA2DS2-VASc score of 2 and women with a score of 3 had a relatively low incidence of stroke events after successful catheter ablation for AF and may be safe for anticoagulation cessation. Greater benefits from long-term OAC were observed in men with CHA2DS2-VASc score ≥3 and women with score ≥4.

Nephrotic syndrome (NS) is a condition associated with hypercoagulability. Thromboembolic events are a well-recognized complication of NS. Venous thrombosis is well known, while arterial thrombosis, which is more severe, occurs less frequently and is mainly reported in children in the literature. The aim of this study was to understand these rare adult cases of NS associated with acute lower extremity arterial thrombosis and draw attention to them to prevent misdiagnosis and delayed treatment.
From January 2011 and October 2022, we conducted a retrospective study of patients with NS and arterial thrombosis. Their clinical manifestations, imaging characteristics, treatments and outcomes were analyzed and compared, and a literature review was performed.
Nine adults with NS and acute lower limb arterial thrombosis were described. In seven of these patients, six had fresh thrombi that preceded the NS diagnosis, while one had a history of NS for 14 years and previously underwent an emergency thrombectomy. Three of the seven patients eventually underwent above-knee amputations, and the other four underwent arterial revascularization with satisfactory recovery of lower-extremity perfusion. In addition to the seven patients mentioned above, the other two received successful anticoagulant treatment, as the thrombosis was present only in the popliteal artery.
Acute lower extremity arterial thrombosis is a rare but serious and potentially lethal complication in patients with NS, and early recognition and appropriate management are crucial for good patient outcomes.

Left atrial appendage closure (LAAC) proved to be noninferior to oral anticoagulation (OAC) in nonablated patients with atrial fibrillation (AF). This study aimed to compare the efficacy and safety of LAAC with those of OAC therapy in patients after AF ablation. This study included patients who underwent catheter ablation (CA) of AF between January 2016 and December 2020. The cohort was divided into CA + LAAC and CA + OAC, where propensity score matching was used to select controls, and each group contained 682 subjects. The enrolled patients\' mean age was 70.34 ± 8.32 years, and 47.3% were female; their CHA2DS2-VASc score was 3.48 ± 1.17. Baseline characteristics were similar between groups. After a 3-year mean follow-up, the incidence of thromboembolic events was 1.25 and 1.10 and that of major bleeding events was 0.65 and 1.72 per 100 patient-years in the CA + LAAC, and CA + OAC groups, respectively. The rate of thromboembolisms and major adverse cardiovascular events was similar between the 2 groups (hazard ratio [HR] 1.162, 95% confidence interval [CI] 0.665 to 2.030, p = 0.598, HR 0.711, 95% CI 0.502 to 1.005, p = 0.053); however, that of major bleeding and all-cause death was significantly reduced with LAAC (HR 0.401, 95% CI 0.216 to 0.746, p = 0.004, HR 0.528, 95% CI 0.281 to 0.989, p = 0.046). There was no significant difference in periprocedural complications (p >0.05) and the rate of AF recurrence (OAC vs LAAC: 39.44% vs 40.62%, p = 0.658). LAAC is a reasonable and safer alternative to OAC therapy in high-risk patients after AF ablation.

UNASSIGNED: More elderly patients undergo coronary artery bypass surgery (CABG) than younger patients. Whether tranexamic acid (TA) is still effective and safe in elderly patients undergoing CABG surgeries is still unclear.
UNASSIGNED: In this study, a cohort of 7,224 patients ≥70 years undergoing CABG surgery were included. Patients were categorized into the no TA group, TA group, high-dose group, and low-dose group according whether TA was administered and the dose administered. The primary endpoint was blood loss and blood transfusion after CABG. The secondary endpoints were thromboembolic events and in-hospital death.
UNASSIGNED: The blood loss at 24 and 48 h and the total blood loss after surgery in patients in the TA group were 90, 90, and 190 ml less than those in the no-TA group, respectively (p < 0.0001). The total blood transfusion was reduced 0.38-fold with TA administration compared to that without TA (OR = 0.62, 95% CI 0.56-0.68, p < 0.0001). Blood component transfusion was also reduced. High-dose TA administration reduced the blood loss by 20 ml 24 h after surgery (p = 0.032) but had no relationship with the blood transfusion. TA increased the risk of perioperative myocardial infarction (PMI) by 1.62-fold [p = 0.003, OR = 1.62, 95% CI (1.18-2.22)] but reduced the hospital stay time in patients who were administered TA compared to that of patients who did not receive TA (p = 0.026).
UNASSIGNED: We revealed that elderly patients undergoing CABG surgeries had better hemostasis after TA administration but increased the risk of PMI. High-dose TA was effective and safe compared with low-dose TA administration in elderly patients undergoing CABG surgery.

BACKGROUND: According to several studies, ROS1 rearrangement is associated with thrombotic risk in non-small cell lung cancer (NSCLC). However, there is no clear understanding of the predictors and prognostic impact of thromboembolic events (TEEs) in patients with advanced ROS1 rearrangement NSCLC.
METHODS: A total of 47 newly diagnosed advanced NSCLC patients with ROS1 rearrangement from four Chinese hospitals were retrospectively included and were evaluated for TEEs incidence, characteristics, predictors, as well as response to therapies and overall survival (OS).
RESULTS: Of the 47 enrolled patients, 23.4% (n = 11) patients developed TEEs. Among them, 7 of 11 patients (64%) developed pulmonary embolism (PE), and 5 patients (45%) experienced recurrent TEEs. In multivariate analysis, D-dimer was associated with the occurrence of TEEs in ROS1 rearranged NSCLC (HR 1.16, 95% CI 1.08-1.23, P < 0.001). Median progression-free survival (PFS) after first-line ROS1 tyrosine kinase inhibitors (TKIs) therapy was significantly longer in patients without TEEs than in those developing TEEs (26 months vs. 12 months, P = 0.0383). Furthermore, patients with TEEs had a shorter OS period than those without TEEs (29.8 months vs. not estimable, P = 0.0647).
CONCLUSIONS: The results of this multicenter study indicated that advanced NSCLC patients with ROS1 rearrangement were more likely to experience PE and TEEs recurrence. And patients with TEEs tended to have a worse prognosis. Furthermore, an elevated D-dimer level suggested a hypercoagulable state in NSCLC patients with ROS1 rearrangement.

BACKGROUND: Use of oral anticoagulants (OACs) among atrial fibrillation (AF) patients surviving intracranial hemorrhage (ICH) represents a challenge due to the difficult balance between thrombosis and hemorrhage.
METHODS: We performed a systematic review and meta-analysis to evaluate the effectiveness and safety of OACs resumption in AF patients with a history of ICH during long-term follow-up. The outcome measures were ischemic stroke (IS), IS or systemic embolism (SE), all-cause death, recurrent ICH and major bleeding. Meta-analyses of pooled odds ratios (ORs) were conducted with random-effects models.
RESULTS: A total of 2 randomized controlled trials (RCTs) and 9 observational studies were included, covering 18,115 patients with AF and a history of ICH. The risk of IS was not statistically different between the group of patients receiving OAC therapy and the no-OAC group (OR: 0.41, 95% CI: 0.16 to 1.0, P=0.05). The rate of IS or SE (OR: 0.42, 95% CI: 0.27 to 0.70, P=0.0008), all-cause death (OR: 0.54, 95% CI: 0.41 to 0.70, I2 =42%, P<0.00001) were significantly decreased in patients receiving OAC therapy compared to those with no-OAC therapy. The pooled OR estimates for ICH recurrence (OR: 1.46, 95% CI: 0.94 to 2.26, P=0.09) and major bleeding (OR: 1.35, 95% CI: 0.86 to 2.11, P=0.19) were not significantly increased in the OAC therapy group. There was heterogeneity between the results of observational studies and RCTs in terms of all-cause death (I2 =83.4%).
CONCLUSIONS: Considering the heterogeneity in results between observational studies and RCTs, as well as the limited number and small size of RCTs, high grade evidences are needed. Pooled analysis is required when more RCTs are completed in the future to resolve this therapeutic dilemma.

OBJECTIVE: We aimed to compare the efficacy of radiofrequency ablation (RFA) in patients undergoing mitral valve (MV) surgery with or without giant left atria.
METHODS: This retrospective, single-center, cohort study investigated patients who underwent MV surgery and concomitant RFA from 2009 to 2019. Patients were divided into non-giant left atria (diameter ≤65 mm, n = 1543) and giant left atria (diameter >65 mm, n = 241) groups. Five-year freedom from atrial tachyarrhythmia recurrence and thromboembolic event (TE) rates were assessed with death as the competing risk factor with and without propensity-score matching.
RESULTS: Patients with giant left atria had higher mortality (10.8% versus 6.2%, P = 0.008) and readmission rates for heart failure than those without (12.0% versus 6.8%, P = 0.004). Atrial tachyarrhythmia recurrence rates were higher in patients with giant left atria than in those without (49% versus 24% at 5 years, P <0.001), but the cumulative incidence of TEs before (P = 0.944) and after (P = 0.695) propensity-score matching was comparable.
CONCLUSIONS: RFA effectively prevented TEs in patients with giant left atria, despite significant atrial tachyarrhythmia recurrence. Atrial tachyarrhythmia recurrence did not increase the risk of TEs. A lower success rate should be considered when deciding whether to perform surgical ablation in patients with giant left atria.

UNASSIGNED: This study aims to evaluate the association between thromboembolic events and hemorrhagic stroke following BNT162b2 and CoronaVac vaccination.
UNASSIGNED: Patients with incident thromboembolic events or hemorrhagic stroke within 28 days of covid-19 vaccination or SARS-CoV-2 positive test during 23 February to 30 September 2021 were included. The incidence per 100,000 covid-19 vaccine doses administered and SARS-CoV-2 test positive cases were estimated. A modified self-controlled case series (SCCS) analysis using the data from the Hong Kong territory-wide electronic health and vaccination records. Seasonal effect was adjusted by month.
UNASSIGNED: A total of 5,526,547 doses of BNT162b2 and 3,146,741 doses of CoronaVac were administered. A total of 334 and 402 thromboembolic events, and 57 and 49 hemorrhagic stroke cases occurred within 28 days after BNT162b2 and CoronaVac vaccination, respectively. The crude incidence of thromboembolic events and hemorrhagic stroke per 100,000 doses administered for both covid-19 vaccines were smaller than that per 100,000 SARS-CoV-2 test positive cases. The modified SCCS detected an increased risk of hemorrhagic stroke in BNT162b2 14-27 days after first dose with adjusted IRR of 2.53 (95% CI 1.48-4.34), and 0-13 days after second dose with adjusted IRR 2.69 (95% CI 1.54-4.69). No statistically significant risk was observed for thromboembolic events for both vaccines.
UNASSIGNED: We detected a possible safety signal for hemorrhagic stroke following BNT162b2 vaccination. The incidence of thromboembolic event or hemorrhagic stroke following vaccination is lower than that among SARS-CoV-2 test positive cases; therefore, vaccination against covid-19 remains an important public health intervention.
UNASSIGNED: This study was funded by a research grant from the Food and Health Bureau, The Government of the Hong Kong Special Administrative Region (reference COVID19F01).

As a new type of drug developed rapidly in recent years, Janus kinase inhibitors (JAKinibs) have caused controversy due to possible adverse reactions of thromboembolism. The aim of this study was to analyse and evaluate the association between thromboembolic events and the use of JAKinibs, on the base of the latest data in the Food and Drug Administration\'s Adverse Event Reporting System.
A disproportionality analysis was conducted, utilizing data from 1 January 2012 to 30 September 2021 in the FAERS. For each drug-adverse event pair, reporting odds ratio (ROR) and information components (IC) were calculated.
A total of 15 positive safety signals were detected within the FAERS: ruxolitinib was significantly associated with portal vein thrombosis (ROR025  = 3.49, IC025  = 1.50); tofacitinib immediate release with pulmonary embolism (ROR025  = 2.09, IC025  = 1.02) and thrombosis (ROR025  = 1.15, IC025  = 0.18); tofacitinib extended release with pulmonary embolism (ROR025  = 1.27, IC025  = 0.26) and thrombosis (ROR025  = 1.29, IC025  = 0.33); baricitinib with deep vein thrombosis (ROR025  = 8.27, IC025  = 3.00), portal vein thrombosis (ROR025  = 1.97, IC025  = 0.63), pulmonary embolism (ROR025  = 7.90, IC025  = 2.94), thrombosis (ROR025  = 2.04, IC025  = 0.93) and venous thrombosis (ROR025  = 2.15, IC025  = 0.81); upadacitinib with pulmonary embolism (ROR025  = 1.25, IC025  = 0.25), pulmonary thrombosis (ROR025  = 5.32, IC025  = 2.33) and thrombosis (ROR025  = 2.72, IC025  = 1.39); and filgotinib with pulmonary embolism (ROR025  = 4.83, IC025  = 2.10). In the analysis of the time to onset of thromboembolic events, no obviously recognizable pattern was found. Several safety signals with embolic and thrombotic events (Standardised MedDRA Query) were found in the study.
This pharmacovigilance study covered 8 types of JAKinib that are already on the market, and provided new safety signals based on past safety information. Some of these signals still need more medical evidence.

OBJECTIVE: To investigate the clinical characteristics and risk factors for thromboembolic events in patients with idiopathic inflammatory myopathy (IIM).
METHODS: We retrospectively analyzed 1144 consecutive patients with IIM for arterial and venous thromboses and compared them with age- and sex-matched IIM patients without thrombosis. Logistic regression analysis was used to analyze risk factors for thrombosis.
RESULTS: Twenty-four (2.1%) patients had arterial or venous thromboses (mean age, 62.6 ± 11.6 years; range, 33-81 years). Thromboembolic events occurred in 54.2% (13/24) of patients within 6 months before or after IIM diagnosis. Thrombosis patients had a higher Cutaneous Dermatomyositis Disease Area and Severity Index score (p = 0.028), higher myositis disease activity assessment visual analogue scale score (MYOACT) (p < 0.001), and a greater proportion of them had varicose veins (p = 0.001), surgical history in the past 3 months (p = 0.039), malignancy (p = 0.018), and infection (p < 0.001). The manual muscle test 8 score (p < 0.001) and albumin level (p = 0.003) were lower in thrombosis patients. There was no significant difference between the two groups in glucocorticoid pulse therapy; however, intravenous immunoglobulin therapy was more commonly used in thrombosis patients (p = 0.04). In multivariable regression models, malignancy, infection, longer duration of glucocorticoid treatment, and higher MYOACT were risk factors for thrombosis. The cumulative survival time of IIM patients with thrombosis was significantly shorter than that of controls.
CONCLUSIONS: Malignancy, infection, longer duration of glucocorticoid use, and increased myositis disease activity are risk factors for thrombosis. Patients with these risk factors should undergo screening for thrombosis. Key Points • To investigate the clinical characteristics and risk factors for thromboembolism events in patients with IIM, we performed a retrospective study with IIM patients who experienced a thromboembolic event. • We found that malignancy, infection, longer duration of glucocorticoid treatment, and a higher level of myositis disease activity were risk factors for thrombosis. • The results suggest that patients with the above risk factors should undergo screening for thrombosis.