The Use of Risk Scores for Thromboprophylaxis in Medically Ill Patients-Rationale and Design of the RICO trial.

Background Venous thromboembolism (VTE) in hospitalized medically ill patients is a significant cause of morbidity and mortality. Guidelines suggest that VTE and bleeding risk assessment models (RAMs) should be integrated into the clinical decision-making process on thromboprophylaxis. However, poor evidence is available comparing the use of a RAM versus clinical judgement in evaluating VTE and bleeding occurrence. Methods Reducing Important Clinical Outcomes in hospitalized medical ill patients (RICO) is a multicenter, cluster-randomized, controlled clinical trial (ClinicalTrials.gov Identifier: NCT04267718). Acutely ill patients hospitalized in Internal Medicine wards are randomized to the use of RAMs-namely the Padua Prediction Score and the International Medical Prevention Registry on Venous Thromboembolism Bleeding Score-or to clinical judgement. The primary study outcome is a composite of symptomatic objectively confirmed VTE and major bleeding at 90-day follow-up. Secondary endpoints include the evaluation of clinical outcomes at hospital discharge and the assessment of VTE prophylaxis prescription during the study period. In order to demonstrate a 50% reduction in the primary outcome in the experimental group and assuming an incidence of the primary outcome of 3.5% in the control group at 90-day; 2,844 patients across 32 centers will be included in the study. Discussion The RICO trial is a randomized study of clinical management assessing the role of RAMs in hospitalized medical ill patients with the aim of reducing VTE and bleeding occurrence. The study has the potential to improve clinical practice since VTE still represents an important cause of morbidity and mortality in this setting.

Acute venous thromboembolism in patients with brain cancer: clinical course.

Background: Patients with brain cancer have been excluded or were underrepresented in studies on the treatment of venous thromboembolism (VTE), mainly due to the fear of intracranial hemorrhage (ICH). Objectives: The aim of this study was to provide data on the risk of ICH, recurrent VTE, and major bleeding in patients with active brain cancer. Methods: This was a multicenter, international cohort study at participating sites of the Registro Informatizado Enfermedad Tromboembólica Registry. Patients included in this study were classified as having known active brain cancer, active nonbrain cancer, or without active cancer. ICH at 3 months was the primary study outcome. Results: Overall, 98,377 patients with VTE were included: 616 with active brain cancer, 16,807 with active nonbrain cancer, and 80,954 without active cancer. At 3 months follow-up, ICH occurred in 2.8%, 0.3%, and 0.2% of the patients, respectively, and was fatal in 1.3%, 0.2%, and 0.1%, respectively. Both rates of major bleeding (3.7% vs 3.2% vs 1.5%, respectively) and recurrent VTE (3.9% vs 3.4% vs 1.1%, respectively) were higher in patients with brain or nonbrain cancer than in patients without cancer. Glioblastomas were associated with a numerically higher risk of ICH, fatal ICH, and recurrent VTE than other brain tumors. Conclusion: In patients with VTE, active brain cancer was associated with a higher risk of ICH or fatal ICH than nonbrain or no active cancer. Further studies are needed to assess the value of different treatment approaches in patients with brain cancer and VTE.

Risk factors for recurrence and major bleeding in patients with cancer-associated venous thromboembolism.

Risks of recurrence and treatment-emergent bleeding are high in patients with cancer-associated venous thromboembolism (VTE) but factors associated with these risks remain substantially undefined. The aim of this analysis in patients with cancer-associated VTE included in the Caravaggio study was to identify risk factors for recurrent VTE and major bleeding. Variables potentially predictive for recurrent VTE or major bleeding were evaluated in a Cox proportional hazard multivariable analysis with backward variable selection. Recurrent VTE occurred in 78 patients (6.8%) and major bleeding in 45 (3.9%). Independent risk factors for recurrent VTE were deep vein thrombosis (DVT) as index event (Hazard ratio (HR) 1.84, 95% CI 1.17-2.88), ECOG status of 1 or more (HR 1.95, 95% CI 1.11-3.43), pancreatic or hepatobiliary cancer site (HR 2.20, 95% CI 1.19-4.06), concomitant anti-cancer treatment (HR 1.98, 95% CI 1.03-3.81) and creatinine clearance (HR 1.10, 95% CI 1.00-1.20 for every 10 ml/min absolute increase). Independent risk factors for major bleeding were ECOG status of 2 (HR 2.31, 95% CI 1.24-4.29), genitourinary cancer site (HR 2.72, 95% CI 1.28-5.77), upper gastrointestinal cancer site (HR 3.17, 95% CI 1.22-8.23), and non-resected luminal gastrointestinal cancer (HR 2.77, 95% CI 1.38-5.56). This analysis of the Caravaggio study in patients with cancer-associated VTE who were on standardized anticoagulant treatment identified five independent predictors for recurrent VTE and four independent predictors of treatment-emergent major bleeding. Considering these risks could help clinicians to optimize the anticoagulant treatment in patients with cancer-associated VTE.

Blood Coagulation Disorders in Heart Failure: From Basic Science to Clinical Perspectives.

Heart failure (HF) is a clinical syndrome that is divided into 3 subtypes based on the left ventricular ejection fraction. Every subtype has specific clinical characteristics and concomitant diseases, substantially increasing risk of thromboembolic complications, such as stroke, peripheral embolism and pulmonary embolism. Despite the annual prevalence of 1% and devastating clinical consequences, thromboembolic complications are not typically recognized as the leading problem in patients with HF, representing an underappreciated clinical challenge. Although the currently available data do not support routine anticoagulation in patients with HF and sinus rhythm, initial reports suggest that such strategy might be beneficial in a subset of patients at especially high thromboembolic risk. Considering the existing evidence gap, we aimed to review the currently available data regarding coagulation disorders in acute and chronic HF based on the insight from preclinical and clinical studies, to summarize the evidence regarding anticoagulation in HF in special-case scenarios and to outline future research directions so as to establish the optimal patient-tailored strategies for antiplatelet and anticoagulant therapy in HF. In summary, we highlight the top 10 pearls in the management of patients with HF and no other specific indications for oral anticoagulation therapy. Further studies are urgently needed to shed light on the pathophysiological role of platelet activation in HF and to evaluate whether antiplatelet or antithrombotic therapy could be beneficial in patients with HF. LAY SUMMARY: Heart failure (HF) is a clinical syndrome divided into 3 subtypes on the basis of the left ventricular systolic function. Every subtype has specific clinical characteristics and concomitant diseases, substantially increasing the risk of thromboembolic complications, such as stroke, peripheral embolism and pulmonary embolism. Despite the annual prevalence of 1% and devastating clinical consequences, thromboembolic complications are not typically recognized as the leading problem in patients with HF, representing an underappreciated clinical challenge. Although the currently available data do not support routine anticoagulation in patients with HF and no atrial arrhythmia, initial reports suggest that such a strategy might be beneficial in a subset of patients at especially high risk of thrombotic complications. Considering the existing evidence gap, we aimed to review the currently available data regarding coagulation problems in stable and unstable patients with HF based on the insight from preclinical and clinical studies, to summarize the evidence regarding anticoagulation in HF in specific patient groups and to outline future research directions to establish the optimal strategies for antiplatelet and anticoagulant therapy in HF, tailored to the needs of an individual patient. In summary, we highlight the top 10 pearls in the management of patients with HF and no other specific indications for oral anticoagulation therapy.

Unmet clinical needs in the prevention and treatment of cancer-associated venous thromboembolism.

Venous thromboembolism (VTE), which includes pulmonary embolism and deep vein thrombosis, is a leading cause of morbidity and mortality in patients with cancer. Based on accumulating evidence, the prophylaxis and treatment of cancer-associated VTE have been changed over the years. Recently, the introduction in clinical practice of the direct oral anticoagulants has radically changed the management of cancer-associated VTE for their easier use and non-inferior efficacy-safety profile compared to low-molecular-weight heparins. However, the heterogeneity of the cancer population in terms of site, type and stage of the malignancy, the presence of comorbidities, and the variability in cancer treatment and prognosis represent major challenges in the management of VTE in patients with cancer. In the present review, we will discuss clinical questions that represent unsolved issues in the setting of cancer-associated VTE and provide an overview on recent evidence on this topic: primary prophylaxis in ambulatory cancer patients treated with chemotherapy and in cancer surgical patients, need of long-term anticoagulation in cancer patients, treatment of VTE in cancer patients at increased bleeding risk and in special categories such as incidental VTE, splanchnic vein thrombosis or catheter-related thrombosis.

Effects of Direct Oral Anticoagulants' Nonrecommended Dose in Atrial Fibrillation: A Meta-Analysis.

BACKGROUND: The efficacy and safety profiles of nonrecommended direct oral anticoagulant (DOAC) doses in patients with nonvalvular atrial fibrillation (NVAF) are still undefined. SUMMARY: We searched for randomized controlled trials and observational studies that compared nonrecommended versus recommended doses of DOACs, published up to December 2021. Primary study outcomes were ischemic stroke/transient ischemic attack/systemic embolism (IS/TIA/SE) and major bleeding (MB). All-cause mortality was a secondary outcome. We determined pooled odds ratios (ORs) between groups of patients with a random-effect model. Twenty-three studies with 175,801 patients were included. Nonrecommended doses were associated with a higher risk of IS/TIA/SE and all-cause mortality, but not of MB as compared to recommended doses of DOACs (OR 1.25 [95% CI: 1.14-1.38], OR 1.69 [95% CI: 1.31-2.18] and OR 1.10 [95% CI: 0.93-1.31], respectively). The nonrecommended low dose was associated with an increased risk of IS/TIA/SE and all-cause death (OR 1.21 [95% CI: 1.05-1.39] and OR 1.66 [95% CI: 1.18-2.35], respectively) but not of MB (OR 1.01 [95% CI: 0.83-1.22] as compared to recommended doses. Subgroup analysis of nonrecommended low doses of DOACs showed a nonsignificant increase in IS/TIA/SE in Asians (OR 1.17 [95% CI: 0.89-1.54] vs. non-Asian (OR 1.21 [95% CI: 1.07-1.36]). KEY MESSAGES: Compared with recommended doses, nonrecommended low doses of DOACs increase the risk of ischemic events without decreasing the risk of bleeding. For Asians, the efficacy of DOACs seemed preserved despite the nonrecommended low-dose prescription. Clinicians should carefully adhere to recommended DOAC prescription advice in managing NVAF patients.

ICH in primary or metastatic brain cancer patients with or without anticoagulant treatment: a systematic review and meta-analysis.

Anticoagulant treatment in patients with primary and metastatic brain cancer is a concern due to risk of intracranial hemorrhage (ICH). We performed a systematic review and meta-analysis to evaluate the risk of ICH in patients with primary or metastatic brain cancer treated with or without anticoagulants. Articles on ICH in patients with primary or metastatic brain cancer treated with or without anticoagulants published up to September 2021 were identified by searching PubMed, EMBASE, and Cochrane Library databases. The primary outcome of this analysis was ICH. Thirty studies were included. Rate of ICH was 13.0% in 1009 patients with metastatic brain cancer and 6.4% in 2353 patients with primary brain cancer (relative risk [RR], 3.26; 95% confidence interval [CI], 2.69-3.94; I2 = 92.8%). In patients with primary brain cancer, ICH occurred in 12.5% and 4.4% of patients treated with or without anticoagulants, respectively (11 studies, 659 treated and 1346 not treated patients; RR, 2.63; 95% CI, 1.48-4.67; I2 = 49.6%). In patients with metastatic brain cancer, ICH occurred in 14.7% and 15.4% (5 studies, 265 treated and 301 not treated patients; RR, 0.92; 95% CI, 0.43-1.93; I2 = 0%). ICH occurred in 8.3% of 172 treated with direct oral anticoagulants (DOACs) and in 11.7% of 278 treated with low-molecular weight heparin (LMWH) (5 studies; RR, 0.44; 95% CI, 0.25-0.79; I2 = 0%). Patients with metastatic brain cancer have a particularly high risk of ICH. Patients with primary brain cancer have an increased risk of ICH during anticoagulation. DOACs are associated with a lower risk of ICH than LMWH.

Recurrent Ischemic Stroke and Bleeding in Patients With Atrial Fibrillation Who Suffered an Acute Stroke While on Treatment With Nonvitamin K Antagonist Oral Anticoagulants: The RENO-EXTEND Study.

BACKGROUND: In patients with atrial fibrillation who suffered an ischemic stroke while on treatment with nonvitamin K antagonist oral anticoagulants, rates and determinants of recurrent ischemic events and major bleedings remain uncertain. METHODS: This prospective multicenter observational study aimed to estimate the rates of ischemic and bleeding events and their determinants in the follow-up of consecutive patients with atrial fibrillation who suffered an acute cerebrovascular ischemic event while on nonvitamin K antagonist oral anticoagulant treatment. Afterwards, we compared the estimated risks of ischemic and bleeding events between the patients in whom anticoagulant therapy was changed to those who continued the original treatment. RESULTS: After a mean follow-up time of 15.0±10.9 months, 192 out of 1240 patients (15.5%) had 207 ischemic or bleeding events corresponding to an annual rate of 13.4%. Among the events, 111 were ischemic strokes, 15 systemic embolisms, 24 intracranial bleedings, and 57 major extracranial bleedings. Predictive factors of recurrent ischemic events (strokes and systemic embolisms) included CHA2DS2-VASc score after the index event (odds ratio [OR], 1.2 [95% CI, 1.0-1.3] for each point increase; P=0.05) and hypertension (OR, 2.3 [95% CI, 1.0-5.1]; P=0.04). Predictive factors of bleeding events (intracranial and major extracranial bleedings) included age (OR, 1.1 [95% CI, 1.0-1.2] for each year increase; P=0.002), history of major bleeding (OR, 6.9 [95% CI, 3.4-14.2]; P=0.0001) and the concomitant administration of an antiplatelet agent (OR, 2.8 [95% CI, 1.4-5.5]; P=0.003). Rates of ischemic and bleeding events were no different in patients who changed or not changed the original nonvitamin K antagonist oral anticoagulants treatment (OR, 1.2 [95% CI, 0.8-1.7]). CONCLUSIONS: Patients suffering a stroke despite being on nonvitamin K antagonist oral anticoagulant therapy are at high risk of recurrent ischemic stroke and bleeding. In these patients, further research is needed to improve secondary prevention by investigating the mechanisms of recurrent ischemic stroke and bleeding.

Risk factors and one-year mortality in patients with direct oral anticoagulant-associated gastrointestinal bleeding.

BACKGROUND AND AIM: Risk factors and mortality in patients with DOACs-associated gastrointestinal bleeding (GIB) are not completely defined. Aims of this study were to identify risk factors for bleeding and evaluate one-year mortality in patients with DOACs-associated GIB. METHODS: We conducted a case-control study. Cases were patients with DOACs-associated GIB admitted to the Perugia Hospital, Italy between 2013 and 2019. Controls were derived from the prospective database of patients with DOACs referred to the ambulatory service. Cases and controls were matched by a 1:2 ratio for type and dose of DOAC, indication for anticoagulation and gender. Univariate and multivariable analyses were performed to identify risk factors. Hazard Ratio with 95% confidence interval was used to calculate mortality. RESULTS: We included 324 patients, of which 108 with DOACs-associated GIB. Mean age was 81.9 ± 7.2 years and 78.9 ± 8.7 years, respectively. The most frequent indication for anticoagulation was atrial fibrillation. Reduced doses of DOACs were prescribed in 186 patients (56.4%). At multivariable analysis, active cancer (OR:7.26; 95%CI 3.10-16.96), renal impairment (OR:4.26; 95%CI 1.98-9.17), bleeding predisposition (OR:3.66; 95%CI 2.00-6.68), COPD (OR:2.12; 95%CI 1.08-4.16) and uncontrolled hypertension (OR:1.86; 95%CI 1.07-3.23) were found to be predictors for DOACs-associated GIB. Adjusted one-year mortality was significantly higher in patients who experienced GIB compared with those who did not experience GIB (OR: 7.04; 95%CI 3.82-14.31). CONCLUSIONS: Predictors of DOACs-associated GIB included active cancer, renal impairment, bleeding predisposition, COPD and uncontrolled hypertension. The adjusted one-year-mortality was significantly increased in patients with DOACs-associated GIB in comparison to DOACs patients without GIB.

Vascular events with immune checkpoint inhibitors in melanoma or non-small cell lung cancer: A systematic review and meta-analysis.

The incidence of venous and arterial thromboembolic events in advanced cancer patients treated with immune checkpoint inhibitors (ICIs) has been sporadically reported. We performed a systematic review and meta-analysis to assess the rate of vascular events in patients with melanoma and non-small cell lung cancer (NSCLC) treated with ICIs. A systematic search of MEDLINE and EMBASE was performed to identify randomized clinical trials and prospective studies. The main outcomes were venous thromboembolism (VTE), stroke or systemic embolism (SE) and myocardial infarction (MI). Secondary outcomes were fatal VTE, fatal stroke or SE and fatal MI. Pooled proportions with 95% confidence intervals (CI) were calculated using random-effects models. A total of 59 trials, 25 in 5,578 patients with melanoma and 34 in 6,543 patients with NSCLC were included. In patients with melanoma, rates of VTE, stroke or SE and MI were 1.5% (95% CI 0.8-2.8), 1.7% (95% CI 0.8-3.7) and 0.4% (95% CI 0.2-0.9), respectively. In patients with NSCLC, corresponding rates were 1.9% (95% CI 1.2-3.2), 1.2% (95% CI 0.6-2.5), and 1.1% (95% CI 0.5-2.1), respectively. Rates of fatal VTE and MI were similar in melanoma and NSCLC patients. Rates of fatal stroke or SE were 1.9% (95% CI 0.4-9.5) and 0.7% (95% CI 0.2-2.3) in melanoma and NSCLC patients, respectively. Rates of VTE (3.1% vs. 1.1%) and myocardial infarction (3.4% Vs. 0.5%) were numerically higher in NSCLC patients treated with combined-ICIs vs mono-ICIs. Our study shows a not negligible rate of vascular events in patients with melanoma or NSCLC treated with ICIs.

Clinical characteristics and outcomes of incidental venous thromboembolism in cancer patients: Insights from the Caravaggio study.

BACKGROUND: Clinical guidelines advise similar anticoagulant treatment for symptomatic and incidental cancer-associated venous thromboembolism (VTE). We investigated clinical features and outcomes of cancer patients with incidental or symptomatic VTE randomized in the Caravaggio study. OBJECTIVES: We performed a predefined sub-analysis of the Caravaggio study in order to investigate the clinical features and outcomes of incidental and symptomatic VTE in patients with cancer. The relative efficacy and safety of apixaban and dalteparin in patients with incidental and symptomatic VTE was also assessed. METHODS: The Caravaggio study compared apixaban to dalteparin for the 6-month treatment of cancer-associated VTE. The primary efficacy and safety outcomes were recurrent VTE and major bleeding. RESULTS: Two hundred thirty patients (20%) had incidental and 925 (80%) symptomatic VTE. Pulmonary embolism with or without deep vein thrombosis as index event, colorectal cancer, Eastern Cooperative Oncology Group (ECOG) score of 0, and locally advanced or metastatic cancer were more frequent in patients with incidental VTE. Deep vein thrombosis as index event, hematological cancer, and ECOG score of 2 were more frequent in patients with symptomatic VTE. Ten patients (4.3%) with incidental and 68 (7.4%) with symptomatic VTE had recurrent VTE (hazard ratio [HR] 0.57, 95% confidence interval [CI] 0.29-1.10). Major bleeding occurred in 12 (5.2%) patients with incidental VTE and in 33 (3.6%) patients with symptomatic VTE (HR 1.43, 95% CI 0.74-2.77). When comparing apixaban to dalteparin in patients with symptomatic and incidental VTE, the HR for recurrence was 0.73 (95% CI 0.45-1.19) and 0.41 (95% CI 0.11-1.56), respectively, and the HR for major bleeding 0.93 (95% CI 0.47-1.83) and 0.96 (95% CI 0.31-2.96), respectively. CONCLUSIONS: Compared to cancer patients with symptomatic VTE, those with incidental VTE have different clinical features at presentation, with a numerically lower incidence of recurrent VTE and a numerically higher incidence of major bleeding.

Coagulopathy and sepsis: Pathophysiology, clinical manifestations and treatment.

Sepsis is a complex syndrome with a high incidence, increasing by 8.7% annually over the last 20 years. Coagulopathy is a leading factor associated with mortality in patients with sepsis and range from slight thrombocytopenia to fatal disorders, such as disseminated intravascular coagulation (DIC). Platelet reactivity increases during sepsis but prospective trials of antiplatelet therapy during sepsis have been disappointing. Thrombocytopenia is a known predictor of worse prognosis during sepsis. The mechanisms underlying thrombocytopenia in sepsis have yet to be fully understood but likely involves decreased platelet production, platelet sequestration and increased consumption. DIC is an acquired thrombohemorrhagic syndrome, resulting in intravascular fibrin formation, microangiopathic thrombosis, and subsequent depletion of coagulation factors and platelets. DIC can be resolved with treatment of the underlying disorder, which is considered the cornerstone in the management of this syndrome. This review presents the current knowledge on the pathophysiology, diagnosis, and treatment of sepsis-associated coagulopathies.

Thromboembolic Complications in Covid-19: From Clinical Scenario to Laboratory Evidence.

SARS-Cov-2 infection, a pandemic disease since March 2020, is associated with a high percentage of cardiovascular complications mainly of a thromboembolic (TE) nature. Although clinical patterns have been described for the assessment of patients with increased risk, many TE complications occur in patients with apparently moderate risk. Notably, a recent statement from the European Society of Cardiology (ESC) atherosclerosis and vascular biology working group pointed out the key role of vascular endothelium for the recruitment of inflammatory and thrombotic pathways responsible for both disseminated intravascular coagulation and cardiovascular complications. Therefore, a better understanding of the pathophysiological process linking infection to increased TE risk is needed in order to understand the pathways of this dangerous liaison and possibly interrupt it with appropriate treatment. In this review, we describe the histological lesions and the related blood coagulation mechanisms involved in COVID-19, we define the laboratory parameters and clinical risk factors associated with TE events, and propose a prophylactic anticoagulation treatment in relation to the risk category. Finally, we highlight the concept that a solid risk assessment based on prospective multi-center data would be the challenge for a more precise risk stratification and more appropriate treatment.

Sex-specific differences in the presentation, clinical course, and quality of life of patients with acute venous thromboembolism according to baseline risk factors. Insights from the PREFER in VTE.

INTRODUCTION: Sex and the presence of specific provoking risk factors, along with age, influence the presentation and prognosis of venous thromboembolism (VTE). We investigated the presentation, course and quality of life in women and men with acute VTE classified according to their VTE provoking factors. METHODS: PREFER in VTE is an international, non-interventional registry of patients with a first episode of acute symptomatic VTE. Baseline provoking factors were classified as follows: major transient, minor transient, active cancer, and none identifiable. The primary outcome was recurrent VTE. Quality of life and treatment satisfaction were secondary outcomes. RESULTS: Of 3,455 patients with acute VTE, 1,623 (47%) were women. The mean age at the time of VTE was 61 (SD 18) in women, 60 (SD 15) in men. The distribution of provoking risk factors was similar between sexes, despite a tendency for higher frequency of minor and major transient risk factors in women, and cancer or unprovoked VTE in men. At 12-month follow-up, VTE recurrence was reported in 74 (6.5%) women and 80 (6.4%) men (absolute risk difference -0.1%, 95% CI -1.9%; +2.1%). In patients with unprovoked VTE, the VTE recurrence rate was 38/612 (6.2%) in women and 53/798 (6.6%) in men (absolute risk difference -0.4, 95% CI -3.0; +2.1%). Multivariable Cox regressions confirmed the absence of sex differences. Quality of life and treatment satisfaction scores one year after VTE were lower in women than in men irrespective of the provoking risk factors (p<0.001 for both scores). CONCLUSIONS: Despite differences in the provoking risk factors for VTE, women and men had a similar rate VTE recurrence at one year. After acute VTE, women had lower quality of life and treatment satisfaction scores.

Risk Factors for Intracerebral Hemorrhage in Patients With Atrial Fibrillation on Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention.

[Figure: see text].

Safety of catheter ablation of atrial fibrillation in cancer survivors.

PURPOSE: In patients with cancer, the safety of catheter ablation for non-valvular atrial fibrillation (AF) has not been evaluated, yet. The aim of this study was to assess the safety of AF ablation in cancer survivors. METHODS: Consecutively recruited patients undergoing catheter ablation of non-valvular AF at our center between March 2015 and March 2017 were evaluated. The primary outcome of the study was clinically relevant bleedings occurred within 30 ± 5 days after the procedure. Patients with cancer were propensity matched to patients without cancer in a 1:3 and 1:6 ratio after stratification by baseline clinical features. RESULTS: Overall, 184 patients were included in the study. Of them, 21 (11%) were cancer survivors. Cancer site was more frequently gastrointestinal (36%), breast (23%), and genitourinary (18%). At 30 ± 5 days, clinically relevant bleedings occurred in 14 patients. Crude odds ratio (OR) for clinically relevant bleedings was 3.60 (95% CI 1.02-12.7) higher in cancer than in non-cancer patients. This trend remained after propensity score-matched population (OR 3.48, 95% CI 0.76-15.90 for matched 1:3, OR 4.95, 95% CI 1.2-20.2 for matched 1:6). Type of anticoagulation was not associated with bleedings. CONCLUSIONS: Preliminary results suggest that clinically relevant bleeding after catheter ablation for AF is more frequent in cancer survivors than in patients without cancer. Further studies are required to confirm the present data.