Risultati per: Colite ulcerosa negli adulti: review

Circulation, Volume 146, Issue Suppl_1, Page A12439-A12439, November 8, 2022. Introduction:Mitral annular calcification (MAC) is a common chronic degenerative process of the mitral valve. Thrombus formation on MAC is a rare complication that is poorly understood and likely contributes to the increased risk of thromboembolic events. We performed a systematic review (PROSPERO 2022 CRD42022299281) to understand the management and outcomes of patients with thrombus on MAC.Methods:Medline, Embase, and Cochrane databases (inception to December 2021) were searched to identify studies with MAC thrombus. Patients with prior mitral valve intervention or prosthesis were excluded. The outcomes of interest were treatment, mortality, and thromboembolic events.Results:Fifteen studies with 22 cases of MAC thrombus were included (Table 1). The average age at diagnosis was 69.1±14.8 years and 82% were female. Most patients presented with stroke or transient ischemic event (68%) or myocardial infarction (18%). All patients were diagnosed with either transthoracic (82%) or transesophageal (18%) echocardiography. Seventy-seven percent of patients were treated with anticoagulation alone and 23% required surgery. The most common indication for surgery was prevention of recurrent embolization (14%). No mortality was reported. Thromboembolic events after diagnosis occurred in 27%. For those treated with anticoagulation alone, 23% had persistent thrombus with or without embolization.Conclusions:This is the first systematic review examining the management and outcomes of patients with MAC thrombus. In patients with MAC who present with a thromboembolic event, careful echocardiographic assessment of MAC to exclude the presence of thrombus should be performed. While most patients can be managed with anticoagulation alone, a significant number will require surgery. Persistent thrombus despite anticoagulation and recurrent embolization are common. Larger studies are needed to elucidate the optimal long-term care for these patients.

Circulation, Volume 146, Issue Suppl_1, Page A12322-A12322, November 8, 2022. Introduction:Observational studies show inconsistent associations of red meat consumption with cardiovascular disease (CVD) and diabetes. Moreover, red meat consumption varies by sex, whether the associations vary by sex remains unclear.Methods:This systematic review and meta-analysis was performed to summarize the evidence concerning the association of unprocessed and processed red meat consumption with CVD, coronary heart disease (CHD), stroke, type 2 diabetes (T2DM), and gestational diabetes mellitus (GDM). Two researchers independently searched PubMed, Web of Science, Embase, and the Cochrane Library for observational studies and randomized controlled trials (RCTs) published before September 2021.Results:A total of 44 observational studies (N=4,857,244) for CVD and 28 observational studies (N=1,897,591) for diabetes were included. Red meat consumption was positively associated with risk of CVD [relative risk (RR) 1.11, 95% confidence interval (CI) 1.05 to 1.17 for unprocessed red meat; RR 1.15, 95% CI 1.09 to 1.22) for processed red meat], CHD and stroke, with no clear sex disparity. Both unprocessed and processed red meat consumption were related to a higher risk of T2DM, and unprocessed red meat consumption was related to risk of GDM. The associations with T2DM were more evident in men than in women, and in western countries.Conclusions:Our study suggests that unprocessed and processed red meat consumption are both associated with higher risk of CVD, CHD, stroke, and diabetes, with a more obvious association in women for diabetes. These findings highlight the need for a better understanding of the mechanisms to facilitate improving cardiometabolic health.

Circulation, Volume 146, Issue Suppl_1, Page A11139-A11139, November 8, 2022. Introduction:Trials evaluating the role of esophageal cooling in the prevention of esophageal injury in patients undergoing atrial fibrillation (AF) catheter ablation have yielded mixed results. The aim of our study is to evaluate the efficacy of esophageal cooling in the prevention of esophageal injury in patients undergoing AF catheter ablation.Methods:Comprehensive search of MEDLINE, EMBASE, and Cochrane databases through April 2022 for randomized controlled trials (RCTs) evaluating the role of esophageal cooling compared with control in the prevention of esophageal injury during AF catheter ablation. The study’s primary outcome was the incidence of total esophageal injury. Secondary outcomes included the incidence of severe esophageal injury, the incidence of mild to moderate esophageal injury, procedural duration, posterior wall duration, total radiofrequency (RF) time, acute reconnection incidence, and ablation index.Results:The meta-analysis included 4 RCTs with total of 294 patients. There was no significant difference in the incidence of total esophageal injury between esophageal cooling and control (15% vs. 19%; Relative Risk [RR] 0.86; 95% confidence interval [CI] 0.31 – 2.41; I2= 63%). However, compared with control, esophageal cooling showed lower risk of severe esophageal injury (0.01% vs. 0.09%; RR 0.21; 95% CI 0.05 – 0.80). There were no significant differences among the two groups in mild to moderate esophageal injury (13.6% vs. 12.1%; RR 1.09; 95% CI 0.28 – 4.23), procedure duration (standardized mean difference [SMD] -0.03; 95% CI -0.36 – 0.30), posterior wall duration (SMD 0.27; 95% CI -0.04 – 0.58), total RF time (SMD -0.50; 95% CI -1.15 – 0.16), acute reconnection incidence (RR 0.93; 95% CI 0.02 – 36.34), and ablation index (SMD 0.16; 95% CI -0.33 – 0.66).Conclusions:Among patients undergoing AF catheter ablation, esophageal cooling did not show a significant difference in the incidence of total esophageal injury. However, it has shown a significant decrease in the risk of severe esophageal injury without affecting the ablation process. This can help decrease the progression to atrial-esophageal fistula. Further large RCTs are needed to better evaluate the role of esophageal cooling in the prevention of esophageal injury.

Circulation, Volume 146, Issue Suppl_1, Page A15681-A15681, November 8, 2022. Introduction:Although heart failure (HF) guidelines emphasized dietary sodium restriction, the recommendation was based on limited evidence. We analyzed the impact of dietary sodium restriction on HF outcomes and quality of life (QoL) by systematically reviewing the available literature to-date.Methods:MEDLINE and SCOPUS were queried from inception till April 2022 for randomized controlled trials (RCTs) and observational studies with sodium restriction (≤1500-3000mg) as an intervention/comparator and assessing its impact (or association) on HF outcomes. Data about HF-related hospitalizations, all-cause mortality and QoL (via the Kansas City Cardiomyopathy Questionnaire) was extracted, pooled and analyzed. Forest plots were created based on random effects model.Results:Twelve studies (n= 4637 patients) were included in our analysis with a median follow-up time of 6 months. The pooled analysis demonstrated no difference in HF hospitalizations between the sodium-restricted and unrestricted groups (OR = 1.30 [0.81-2.10] P

Circulation, Volume 146, Issue Suppl_1, Page A12549-A12549, November 8, 2022. Introduction:Evaluating the efficacy of newer medical therapies in black patients with heart failure with reduced ejection fraction (HFrEF) remains an important and unanswered question. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) in HFrEF to compare outcomes in black versus non-black patients with a specific focus on new therapies, namely ARNIs and SGLT2 inhibitors.Methods:Medline, Embase and Cochrane CENTRAL were searched from inception until May 2022. Pairs of reviewers independently identified RCTs that 1) compared either an SGLT2 inhibitor or an ARNI to placebo/standard of care in HFrEF patients and 2) reported outcomes stratified by race. Outcomes were pooled using the Generic Inverse Variance or Mantel-Haenszel models, and risk of bias was assessed using the Cochrane tool.Results:Four RCTs (n=17,797; 6.6% black) were identified, all of which were published in the past decade. In the placebo/control arm, black patients had a higher rate of heart failure hospitalization or cardiovascular death compared to non-black/white patients (OR: 1.52, 95% CI: 1.26, 1.84; absolute difference: 81, [95% CI: 43, 124] more events per 1,000 patients). In two RCTs, there was a trend towards a greater reduction in the composite of cardiovascular death or heart failure hospitalization with SGLT2 inhibitors in black patients (n=483; RR: 0.61, 95% CI: 0.45, 0.83) compared to white patients (n=6,445; RR: 0.84, 95% CI: 0.75, 0.95; p-interaction=0.06). In two RCTs, treatment with an ARNI was associated with reductions in the composite of cardiovascular death or heart failure hospitalization in both black patients (n=744; HR: 0.67, 95% CI: 0.40, 1.11) and non-black/white patients (n=6,109; HR: 0.80, 95% CI: 0.72, 0.89; p-interaction= p=0.49).Conclusions:Black patients are poorly represented in contemporary heart failure trials, and have worse outcomes compared with non-black patients. Newer therapies such as ARNIs and SGLT2 inhibitors are efficacious in black patients. SGLT2 inhibitors may afford greater risk reduction in black compared to non-black patients.

Circulation, Volume 146, Issue Suppl_1, Page A11186-A11186, November 8, 2022. Introduction:The association of the COVID-19 vaccination with myocarditis has been reported in adolescents. However, evidence of myocarditis after COVID-19 vaccination among adolescents is scarce compared to adults. We aimed to investigate the clinical features and outcomes of COVID-19 mRNA vaccination-related myocarditis in adolescents.Methods:PubMed and EMBASE were searched through April 2022 to investigate the characteristics of vaccine-associated myocarditis in adolescent patients (aged 12-20 years) through observational studies, case series, and correspondence according to PRISMA guidelines. Data regarding patient characteristics, the type, and dose of the vaccine, laboratory data, imaging studies, mortality, and treatments were extracted from each article. One-group meta-analysis in a random-effects model was performed.Results:22 observational studies were identified, including 861 cases of vaccine-associated myocarditis. The mean age was 16.0 (95%CI, 15.5-16.5), and the male was predominant at 90.8%. Three-quarters of myocarditis occurred after the second dose (78.2%, 95% CI, 62.4- 94.0). The incident rate was higher after the second dose (12.7 -118.7 per million persons) than the first dose (0.6-10.0 per million persons). Chest pain (85.2%) was the common presenting symptom. Although 16.0% of patients (51/302) had left ventricular (LV) systolic dysfunction (LV ejection fraction [EF] < 55%), most of the cases (40/289) were mildly reduced LVEF as 45-54% (12.0% of total patients). Interestingly, cardiac magnetic resonance imaging revealed late gadolinium enhancement in 80.5% (95% CI, 65.7-95.2) of the cases. Overall, 92.8% of patients required hospitalization, and 14.7% required intensive care unit admission. However, no in-hospital mortality was observed (0/230), and the length of stay at the hospital was less than 5 days.Conclusions:This systematic review and meta-analysis demonstrate a low incident rate and largely favorable outcomes of COVID-19 vaccine-associated myocarditis in adolescents. Our findings would help better understand myocarditis following COVID-19 mRNA vaccination among adolescents and decision-making for parents with vaccine hesitancy.

Circulation, Volume 146, Issue Suppl_1, Page A11195-A11195, November 8, 2022. Introduction:The safety and clinical outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) among solid organ transplant patients are not well documented.Objective:This study aimed to evaluate the clinical outcomes of TAVR and SAVR among patients with a history of solid organ transplantation.Method:We performed a systematic literature search of databases for relevant articles from inception until April 20, 2022.Result:A total of 342 studies were identified, resulting in 7 studies with a total of 6,128 patients included in the final analysis. The odds of in-hospital mortality (OR 0.29, 95% CI 0.16-0.52, p < 0.0001), blood transfusion (OR 0.30, 95% CI 0.22-0.40 p < 0.00001), postoperative bleeding (OR 0.40, 95% CI 0.33-0.48 p < 0.00001), acute kidney injury (OR 0.50, 95% CI 0.38-0.67 p < 0.00001), and sepsis or infection (OR 0.37, 95% CI 0.25-0.56, p < 0.00001) were significantly lower in patients undergoing TAVR compared to SAVR. Permanent pacemaker implantation was significantly higher in patients who underwent SAVR (OR 2.96, 95% CI 1.98-4.44, p =

Circulation, Volume 146, Issue Suppl_1, Page A10489-A10489, November 8, 2022. Introduction:The optimal transfusion strategy for patients with ACS is unclear. Current data are inconclusive and there is a paucity of long term data; therefore, we performed a subgroup analysis of patients with AMI in the Transfusion Thresholds in Cardiac Surgery (TRICS-III) randomized controlled trial (RCT) to add evidence addressing this important clinical question, and interpret the results in the context of a systematic review and meta-analysis.Methods:The TRICS-III trial randomized patients undergoing cardiac surgery on cardiopulmonary bypass with a moderate-to-high risk of death to restrictive transfusion (transfuse at hemoglobin

Circulation, Volume 146, Issue Suppl_1, Page A13502-A13502, November 8, 2022. Introduction:In patients with acute myocardial infraction (AMI), multivessel coronary artery disease (CAD) is associated with worse prognosis than single-vessel CAD. Several observational studies have reported worse clinical outcomes in AMI patients with non-infarct-related artery chronic total occlusion (n-IRA CTO). We performed a systematic review and meta-analysis to evaluate the prognostic significance of n-IRA CTO in patients with AMI.Methods:Systematic review was performed querying PubMed, Google Scholar, Cochrane and clinicaltrials.gov from Inception through May 2022. Studies comparing AMI patients with and without n-IRA CTO were included. Outcomes included in-hospital, 30-day and long-term mortality, cardiac mortality, major adverse cardiovascular events (MACE), and major bleeding. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated using random effects models.Results:Five prospective, eight retrospective and 3 subgroup analyses of randomized control trials (RCTs) (n-IRA CTO n=2,521, no CTO n=18,397) were identified. Presence of n-IRA CTO was associated with higher in-hospital (RR 2.86, 95% CI 1.77-4.62, p

Circulation, Volume 146, Issue Suppl_1, Page A12471-A12471, November 8, 2022. Introduction:Ventricular tachycardia (VT) poses a significant risk in patients with ischemic cardiomyopathy. Antiarrhythmic drugs (AAD) and catheter ablation are the 2 strategies employed to reduce the risk of future VT episodes. It is not established if one strategy is superior to the other.Hypothesis:Recently, randomized trials have been published comparing the efficacy and safety of both strategies for VT management. Unfortunately, most of these trials included a relatively small number of patients and had different outcomes or composite of outcomes limiting their utility.Methods:We performed a meta-analysis of randomized clinical trials comparing these treatment modalities for VT management. Criteria for appropriate studies were the inclusion of outcome data for both ablation and AAD arms, history of documented VT or ICD therapy before enrollments, and use of ICD to reliably monitor the incidence. Due to recent advances in substrate-based VT ablation and changes in ICD algorithms we limited our search for studies published in last 10 years. We identified four studies that met our inclusion and exclusion criteria.Results:Our included studies randomized 609 patients, 303 in ablation, and 310 in AAD groups. All-cause mortality data were available for all included studies. The cumulative odds ratio (OR) for all-cause mortality for VT ablation compared to AADs was 0.88, 95% confidence interval [0.56-1.39], p-value 0.58. Cumulative OR for cardiac death was 0.81 [95% CI 0.47-1.38], p-value 0.44, OR for ICD shocks was 0.82[0.57-1.18], p-value 0.29 and the OR for heart failure or cardiac rehospitalization was 0.82 [95% CI 0.53-1.25] p-value 0.35. Treatment-related complications were reported in only two studies with cumulative OR 0.31 [95% CI 0.19-0.51] p

Circulation, Volume 146, Issue Suppl_1, Page A12239-A12239, November 8, 2022. Introduction:Physical activity (PA) decreases the risk of cardiovascular events, but to what degree this is related to effects on surrogate markers of subclinical cardiovascular disease (CVD) is unclear. Clarifying the relationship between objectively measured PA and subclinical CVD would provide justification for using measures of subclinical CVD in clinical trials of PA interventions.Hypothesis:We hypothesized that higher levels of objectively measured PA are associated with less subclinical CVD.Methods:We performed a systematic review using Medline, Embase, CINAHL and Cochrane (January 1, 2000 – January 12, 2022). Studies of adult populations that examined the relationship between objectively measured PA (accelerometry) and subclinical CVD were included. Markers for subclinical CVD included: ankle brachial index (n=4 studies); arterial stiffness (n=31); carotid artery plaque/stenosis and intima media thickness (n=9); coronary artery atherosclerosis (n=4); endothelial function (n=8); measures of cardiac structure and function (n=4); and eight studies included multiple of the aforementioned outcomes. For those studies, we considered results on each outcome separately. Risk of bias was also assessed.Results:PA was inversely associated with subclinical CVD in 60 of 78 included analyses (76.9%). Of these, five studies (6.4%) found only an association with higher levels of PA. In six studies (7.7%), PA was no longer associated with subclinical CVD after adjustment for confounders. Seven analyses (9.0%) demonstrated mixed results but demonstrated an inverse relationship between PA and subclinical CVD in specific circumstances. Only 18 studies (23.1%) suggested that PA was not associated with decreased subclinical CVD.Conclusions:Increased PA is associated with less subclinical CVD across diverse populations. Interventions to increase PA have the potential to reduce the burden of subclinical CVD and, therefore, clinical CVD events.

Circulation, Volume 146, Issue Suppl_1, Page A12256-A12256, November 8, 2022. Rivaroxaban is a direct oral anticoagulant that works by inhibiting factor Xa. Direct anticoagulants have largely replaced direct vitamin K inhibitors (VKAs) due to the increased risk of major hemorrhages and the need for regular monitoring and dose adjustments. However, there have been multiple reports of elevated international normalized ratio (INR) and incidents of bleeding in patients on rivaroxaban, which brings into question the potential need for monitoring. The purpose of this review is to differentiate the patients that may benefit from regular monitoring and to propose future directions for implementation of monitoring. Here we report a case of an INR of 4.8 in a patient who presented with a gastrointestinal bleed and a drop of five gm/dL in hemoglobin four days after starting rivaroxaban following right femoral popliteal bypass graft stenting. The patient had no liver or kidney abnormalities and was not taking any medication or consuming any foods that could introduce any significant drug interaction. Additionally, we conducted a systematic review of similar reports in the literature with the goal of identifying the factors that could influence rivaroxaban’s levels in the blood or its influence on the INR. We reviewed PubMed using keywords including; “rivaroxaban”, “anti-Xa”, “DOAC”, “elevated”, “INR”, “bleeding”, “hemorrhage”, “pharmacology”, and “pharmacokinetics”. The literature revealed reports of INRs up to 5.2. Reviewing the pharmacokinetics of rivaroxaban indicated possibly higher drug levels in Caucasians, patients with a low body mass index (BMI), and patients with polymorphisms in the genes coding for CYP3A4, CYP2J2, or p-glycoprotein, assuming no renal or liver disease and no significant drug-drug or drug-food interactions. INR can be falsely normal if the thromboplastin reagent used to monitor the INR on warfarin is not sensitive to the changes in INR due to rivaroxaban. We suggest finding a thromboplastin reagent that is sensitive to INR changes with rivaroxaban, which could yield clinically relevant INRs on rivaroxaban allowing for accurate monitoring. We then suggest conducting studies to evaluate the cost effectiveness of regular monitoring in at-risk patients.

Circulation, Volume 146, Issue Suppl_1, Page A11832-A11832, November 8, 2022. Introduction:Angiotensin receptor-neprilysin inhibitors (ARNI) like sacubitril-valsartan reduce morbidity and mortality in heart failure with reduced ejection fraction (HFrEF). However, its higher cost relative to other guideline-directed medical therapy(GDMT) may ultimately limit access for patients, especially those impacted by social determinants of health (SDOH).Methods:A retrospective review of all patients at Allegheny General Hospital with HFrEF taking sacubitril-valsartan between January 1, 2016 and January 1, 2022 was conducted. Logistic regression was used to study the impact of various SDOH (Income, Employment, Transportation, Insurance) on medication adherence.Results:Out of 201 patients who met the inclusion criteria, ARNI was discontinued in 47 (23.4%) patients. Common reasons for discontinuation included cost/insurance coverage in 10 patients (21.3%), hypotension in 18 patients (38.3%), hyperkalemia (4.3%) and worsening renal function (10.6%). Lower income (OR:0.75 [95% CI 0.58 to 0.98] p = 0.03) and greater distance from clinic (OR:1.25 [95% CI 1.03 to 1.51] p = 0.02) was associated with higher odds of discontinuing ARNI. Discontinuation was observed more frequently in retired patients (55.3% vs 43.5%) compared to those actively employed. Compared to those with Medicare, Medicaid or no insurance, ARNI was continued more frequently in patients with private insurance.Conclusions:Patients with HFrEF live longer when treated with appropriate GDMT. However, given costs associated with novel agents, clinicians must acknowledge that SDOH substantially impact a patient’s ability to fill such expensive prescriptions regularly.

Circulation, Volume 146, Issue Suppl_1, Page A12314-A12314, November 8, 2022. Introduction:Chronic total occlusion (CTO) percutaneous intervention (PCI) is an evolving challenge within interventional cardiology. Anticoagulation during percutaneous intervention remains part of the standard of care for patients undergoing PCI to prevent thrombotic complications peri-procedurally. Unfractionated heparin (UFH) is a commonly used for CTO PCI-related anticoagulation. However, bivalirudin (BV), a synthetic, reversible, direct thrombin inhibitor, has been utilized as an alternative to UFH in CTO patients undergoing PCI. This meta-analysis aims to investigate the efficacy and safety of bivalirudin versus UFH for CTO PCI.Methods:We performed a comprehensive literature search using PubMed, Embase, and Cochrane Library databases through May 2022 for all studies evaluating efficacy and safety of bivalirudin versus UFH in CTO patients undergoing PCI. The primary outcome was mortality. Secondary outcomes were major adverse cardiac events (MACE), major bleeding events, peri-procedure myocardial infarction (MI), in-stent thrombosis, and unplanned revascularization. Pooled risk ratio (RR) and 95% confidence intervals (CIs) were obtained by the Mantel-Haenszel method within a random-effects model. Heterogeneity was assessed by I2 statistic.Results:A total of 5 studies containing 1347 patients with CTO undergoing PCI on anticoagulation (631 BV versus 716 UFH) were included. No significant difference existed between BV and UFH regarding mortality [RR: 0.54 (95% CI: 0.19-1.56); P 0.26 , I2 0%]. Major bleeding events were significantly lower in BV compared with UFH [RR: 0.33 (95% CI: 0.19-0.66); P 0.001, I2 0%]. MACE [RR: 0.75 (95% CI: 0.55-1.00); P 0.05, I2 2%], peri-procedure MI [RR: 0.80 (95% CI: 0.56-1.15); P 0.24, I2 0%], in-stent thrombosis [RR: 0.68 (95% CI: 0.19-2.39); P 0.55, I2 17%] and unplanned revascularization [OR: 0.77 (95% CI: 0.29-2.07); P 0.61, I2 0%] were similar between the two groups.Conclusions:BV seems to be safer than UFH in preventing major bleeding in anticoagulated patients with CTO undergoing PCI; there is no significant difference between groups in terms of mortality, MACE, peri-procedure MI, in-stent thrombosis, or unplanned revascularization. Future randomized controlled trials are needed.

Circulation, Volume 146, Issue Suppl_1, Page A11823-A11823, November 8, 2022. Background:Besides hard medical outcomes in patients with inherited cardiac conditions (ICC). it is crucial to focus on the patient-reported outcomes (PRO) as well. These patients may have a disease-specific need due to ICC-related distress concerning family members and reproductive choices. We evaluated which PRO scales are currently used in cardiogenetics.Methods:From three datasets (PubMed, PsychINFO, and Web of Science), eligible studies published between 2008-2022 were selected as described in the review protocol (PROSPERO 2021 CRD42021271384). The quality of studies was assessed (https://pubmed.ncbi.nlm.nih.gov/27082055 ) and analyzed for the primary outcome variable of patient-reported outcomes.Results:Eighteen out of 232 articles were selected for data extraction; 9 studies used a cross-sectional design, and population characteristics and outcome measures varied. The risk of bias was high or unclear in 77% of the studies. All studies mainly used two questionnaires in combination or alone: the short form of medical outcomes survey (SF-36), a generic PROM that reports on health status and the Hospital Anxiety and Depression Scale (HADS), a standard measure of psychological well-being. Thirteen studies using SF-36 showed lower scores on the mental health component in patients with ICC versus population norms. Ten studies using HADS showed a prevalence of clinically significant anxiety (17-47%) and depression (8.3% to 28%) which are higher than the population norm (8.3% and 6.3%).Conclusion:Our results from only a few published studies indicate that although psychological morbidity in ICC patients is high, measurements are non-specific, variable, and generic and address overall health, instead of addressing factors specific to ICC, such as heritability. We propose to develop a disease-specific PROM for cardiogenetics to evaluate the heritability factor in patients with ICC to implement in the care pathway and optimize patient-centred care.

Circulation, Volume 146, Issue Suppl_1, Page A12596-A12596, November 8, 2022. Introduction:The efficacy and safety of direct oral anticoagulants (DOACs) as treatment alternatives for patients with thrombotic antiphospholipid syndrome (APS) remain controversial.Methods:We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) that compared the efficacy and safety of DOACs with vitamin-K antagonists (VKAs) in patients with thrombotic APS. We searched PubMed, EMBASE and Cochrane Central Register of Controlled Trials through April 9, 2022. Main efficacy outcomes were a composite of arterial thrombotic events, and a composite of venous thromboembolic events (VTE). The main safety outcome was major bleeding according to the International Society on Thrombosis and Hemostasis (ISTH) criteria. A random effects model with inverse variance was used for the primary analysis. Risk of bias was assessed using the Cochrane Collaboration criteria.Results:Our search retrieved 253 studies. Four RCTs involving 474 patients were included (Figure). All four RCTs were open-label but had proper random sequence generation and adequate allocation concealment. The DOACs used were rivaroxaban (3 trials) and apixaban (1 trial). The mean percent time in therapeutic range in the warfarin arm among the four studies was 60%. Overall, use of DOACs compared with VKAs was associated with increased odds of composite of arterial thrombotic events (OR 5.64, 95% confidence interval [CI] 1.96-16.27,p=0.001, I2= 0%). The odds of subsequent VTE events (OR 1.19, 95% CI 0.31-4.53,p=0.80, I2= 0%), or major bleeding (OR 1.02, 95% CI 0.42-2.47,p=0.97, I2= 0%) were not significantly different between the two groups.Conclusions:Patients with thrombotic APS randomized to DOACs compared to VKAs appear to have increased risk for arterial thrombosis. No significant differences were observed between patients randomized to DOACs vs VKAs in the risk of subsequent VTE or major bleeding.