Showing papers by "Manuel Monreal published in 2022"

Venous Thrombosis within 30 Days after Vaccination against SARS-CoV-2 in a Multinational Venous Thromboembolism Registry

Abstract: Background: Venous thromboembolism (VTE)—including deep vein thrombosis, pulmonary embolism, and cerebral venous sinus thrombosis (CVST)—may occur early after vaccination against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We sought to describe the site, clinical characteristics, and outcomes of VTE after vaccination against SARS-CoV-2. Methods: In a prospective study using the Registro Informatizado de Enfermedad TromboEmbólica (RIETE) platform, patients with VTE 4–30 days after vaccination against SARS-CoV-2 (1 February 2021 through 30 April 2021) were included. VTE patients recruited from the same centers into RIETE in the same months in 2018–2019 were selected as the reference group. All-cause mortality and major bleeding were the main study outcomes. Results: As of 30 April 2020, 102 patients with post-vaccination VTEs had been identified (28 after adenovirus-based vaccination [ChAdOx1 nCov-19; AstraZeneca] and 74 after mRNA-based vaccination [mRNA-1273; Moderna, and BNT162b2; Pfizer]). Compared with 911 historical controls, patients with VTE after adenovirus-based vaccination more frequently had CVST (10.7% vs. 0.4%, p < 0.001) or thrombosis at multiple sites (17.9% vs. 1.3%, p < 0.001), more frequently had thrombocytopenia (40.7% vs. 14.7%, p < 0.001), and had higher 14-day mortality (14.3% vs. 0.7%; odds ratio [OR]: 25.1; 95% confidence interval [CI]: 6.7–94.9) and major bleeding rates (10.3% vs. 1.0%, OR: 12.03, 95% CI: 3.07–47.13). The site of thrombosis, accompanying thrombocytopenia, and 14-day mortality rates were not significantly different for patients with VTE after mRNA-based vaccination, compared with historical controls. Conclusions: Compared with historical controls, VTE after adenovirus-based vaccination against SARS-CoV-2 is accompanied by thrombocytopenia, occurs in unusual sites, and is associated with worse clinical outcomes.

Efficacy and Safety Considerations With Dose-Reduced Direct Oral Anticoagulants: A Review.

Abstract: Importance Dose-reduced regimens of direct oral anticoagulants (DOACs) may be used for 2 main purposes: dose-adjusted treatment intended as full-intensity anticoagulation (eg, for stroke prevention in atrial fibrillation [AF] in patients requiring dose reduction) or low-intensity treatment (eg, extended-duration treatment of venous thromboembolism [VTE]). We reviewed randomized clinical trials (RCTs) to understand the scenarios in which dose-adjusted or low-intensity DOACs were tested and reviewed the labeled indications by regulatory authorities, using data from large registries to assess whether the use of dose-reduced DOACs in routine practice aligned with the findings of RCTs. Observations Among 4191 screened publications, 35 RCTs that used dose-adjusted DOACs were identified for dabigatran, apixaban, rivaroxaban, and edoxaban. Of these 35 RCTs, 29 were related to stroke prevention in AF. Efficacy and safety results for dose-adjusted DOACs in large RCTs of AF were similar to those found for full-dose DOACs. To our knowledge, dabigatran, apixaban, and rivaroxaban have not been studied as dose-adjusted therapy for acute VTE treatment. Low-intensity DOACs were identified in 37 RCTs. Low-intensity DOACs may be used for extended-duration treatment of VTE (apixaban and rivaroxaban), primary prevention in orthopedic surgeries (dabigatran, apixaban, and rivaroxaban), primary prevention in ambulatory high-risk cancer patients (apixaban and rivaroxaban) or (postdischarge) high-risk medical patients (rivaroxaban), in stable atherosclerotic vascular disease, or after a recent revascularization for peripheral artery disease in conjunction with aspirin (rivaroxaban). Minor variations exist between regulatory authorities in different regions regarding criteria for dose adjustment of DOACs. Data from large registries indicated that dose-reduced DOACs were used occasionally with doses or for clinical scenarios different from those studied in RCTs or recommended by regulatory authorities. Conclusions and Relevance Dose adjustment and low-intensity treatment are 2 different forms of dose-reduced DOACs. Dose adjustment is mostly relevant for AF and should be done based on the approved criteria. Dose adjustment of DOACs should not be used for acute VTE treatment in most cases. In contrast, low-intensity DOACs may be used for primary or secondary VTE prevention for studied and approved indications. Attention should be given to routine practice patterns to align the daily clinical practice with existing evidence of safety and efficacy.

Catheter-Directed Thrombolysis vs Anticoagulation in Patients With Acute Intermediate-High-risk Pulmonary Embolism: The CANARY Randomized Clinical Trial.

Abstract: Importance The optimal treatment of intermediate-high-risk pulmonary embolism (PE) remains unknown. Objective To assess the effect of conventional catheter-directed thrombolysis (cCDT) plus anticoagulation vs anticoagulation monotherapy in improving echocardiographic measures of right ventricle (RV) to left ventricle (LV) ratio in acute intermediate-high-risk PE. Design, Setting, and Participants The Catheter-Directed Thrombolysis vs Anticoagulation in Patients with Acute Intermediate-High-Risk Pulmonary Embolism (CANARY) trial was an open-label, randomized clinical trial of patients with intermediate-high-risk PE, conducted in 2 large cardiovascular centers in Tehran, Iran, between December 22, 2018, through February 2, 2020. Interventions Patients were randomly assigned to cCDT (alteplase, 0.5 mg/catheter/h for 24 hours) plus heparin vs anticoagulation monotherapy. Main Outcomes and Measures The proportion of patients with a 3-month echocardiographic RV/LV ratio greater than 0.9, assessed by a core laboratory, was the primary outcome. The proportion of patients with an RV/LV ratio greater than 0.9 at 72 hours after randomization and the 3-month all-cause mortality were among secondary outcomes. Major bleeding (Bleeding Academic Research Consortium type 3 or 5) was the main safety outcome. A clinical events committee, masked to the treatment assignment, adjudicated clinical outcomes. Results The study was prematurely stopped due to the COVID-19 pandemic after recruiting 94 patients (mean [SD] age, 58.4 [2.5] years; 27 women [29%]), of whom 85 patients completed the 3-month echocardiographic follow-up. Overall, 2 of 46 patients (4.3%) in the cCDT group and 5 of 39 patients (12.8%) in the anticoagulation monotherapy group met the primary outcome (odds ratio [OR], 0.31; 95% CI, 0.06-1.69; P = .24). The median (IQR) 3-month RV/LV ratio was significantly lower with cCDT (0.7 [0.6-0.7]) than with anticoagulation (0.8 [0.7-0.9); P = .01). An RV/LV ratio greater than 0.9 at 72 hours after randomization was observed in fewer patients treated with cCDT (13 of 48 [27.0%]) than anticoagulation (24 of 46 [52.1%]; OR, 0.34; 95% CI, 0.14-0.80; P = .01). Fewer patients assigned to cCDT experienced a 3-month composite of death or RV/LV greater than 0.9 (2 of 48 [4.3%] vs 8 of 46 [17.3%]; OR, 0.20; 95% CI, 0.04-1.03; P = .048). One case of nonfatal major gastrointestinal bleeding occurred in the cCDT group. Conclusions and Relevance This prematurely terminated randomized clinical trial of patients with intermediate-high-risk PE was hypothesis-generating for improvement in some efficacy outcomes and acceptable rate of major bleeding for cCDT compared with anticoagulation monotherapy and provided support for a definitive clinical outcomes trial. Trial Registration ClinicalTrials.gov Identifier: NCT05172115.

Clinical Presentation and Short- and Long-term Outcomes in Patients With Isolated Distal Deep Vein Thrombosis vs Proximal Deep Vein Thrombosis in the RIETE Registry.

Abstract: Importance Insufficient data exist about the clinical presentation, short-term, and long-term outcomes of patients with isolated distal deep vein thrombosis (IDDVT), that is, thrombosis in infrapopliteal veins without proximal extension or pulmonary embolism (PE). Objective To determine the clinical characteristics, short-term, and 1-year outcomes in patients with IDDVT and to compare the outcomes in unadjusted and multivariable adjusted analyses with patients who had proximal DVT. Design, Setting, and Participants This was a multicenter, international cohort study in participating sites of the Registro Informatizado Enfermedad Tromboembólica (RIETE) registry conducted from March 1, 2001, through February 28, 2021. Patients included in this study had IDDVT. Patients with proximal DVT were identified for comparison. Patients were excluded if they had a history of asymptomatic DVT, upper-extremity DVT, coexisting PE, or COVID-19 infection. Main Outcomes and Measures Primary outcomes were 90-day and 1-year mortality, 1-year major bleeding, and 1-year venous thromboembolism (VTE) deterioration, which was defined as subsequent development of proximal DVT or PE. Results A total of 33 897 patients were identified with isolated DVT (without concomitant PE); 5938 (17.5%) had IDDVT (mean [SD] age, 61 [17] years; 2975 male patients [50.1%]), and 27 959 (82.5%) had proximal DVT (mean [SD] age, 65 [18] years; 14 315 male patients [51.2%]). Compared with individuals with proximal DVT, those with IDDVT had a lower comorbidity burden but were more likely to have had recent surgery or to have received hormonal therapy. Patients with IDDVT had lower risk of 90-day mortality compared with those with proximal DVT (odds ratio [OR], 0.47; 95% CI, 0.40-0.55). Findings were similar in 1-year unadjusted analyses (hazard ratio [HR], 0.52; 95% CI, 0.46-0.59) and adjusted analyses (HR, 0.72; 95% CI, 0.64-0.82). Patients with IDDVT had a lower 1-year hazard of VTE deterioration (HR, 0.83; 95% CI, 0.69-0.99). In 1-year adjusted analyses of patients without an adverse event within the first 3 months, IDDVT was associated with lower risk of VTE deterioration (adjusted HR, 0.48; 95% CI, 0.24-0.97). By 1-year follow-up, symptoms or signs of postthrombotic syndrome were less common in patients with IDDVT (47.6% vs 60.5%). Conclusions and Relevance Results of this cohort study suggest that patients with IDDVT had a less ominous prognosis compared with patients with proximal DVT. Such differences were likely multifactorial, including the differences in demographics, risk factors, comorbidities, particularly for all-cause mortality, and a potential association of thrombus location with VTE deterioration and postthrombotic syndrome. Randomized clinical trials are needed to assess the optimal long-term management of IDDVT.

Enoxaparin versus dalteparin or tinzaparin in patients with cancer and venous thromboembolism: The RIETECAT study

Abstract: Venous thromboembolism (VTE) is a frequent complication in patients with cancer and a leading cause of morbidity and death.

[Translated article] Multidisciplinary consensus for the management of pulmonary thromboembolism.

Abstract: We have updated recommendations on 12 controversial topics that were published in the 2013 National Consensus on the diagnosis, risk stratification and treatment of patients with pulmonary embolism (PE). A comprehensive review of the literature was performed for each topic, and each recommendation was evaluated in two teleconferences. For diagnosis, we recommend against using the Pulmonary Embolism Rule Out Criteria (PERC) rule as the only test to rule out PE, and we recommend using a d-dimer cutoff adjusted to age to rule out PE. We suggest using computed tomography pulmonary angiogram as the imaging test of choice for the majority of patients with suspected PE. We recommend using direct oral anticoagulants (over vitamin K antagonists) for the vast majority of patients with acute PE, and we suggest using anticoagulation for patients with isolated subsegmental PE. We recommend against inserting an inferior cava filter for the majority of patients with PE, and we recommend using full-dose systemic thrombolytic therapy for PE patients requiring reperfusion. The decision to stop anticoagulants at 3 months or to treat indefinitely mainly depends on the presence (or absence) and type of risk factor for venous thromboembolism, and we recommend against thrombophilia testing to decide duration of anticoagulation. Finally, we suggest against extensive screening for occult cancer in patients with PE.

Rate of Recurrence After Discontinuing Anticoagulation Therapy in Patients With COVID-19-Associated Venous Thromboembolism.

Abstract: This cohort study assesses the rate of recurrence of venous thromboembolism (VTE) in patients with COVID-19–associated VTE who discontinued anticoagulation therapy.

Outcome of cancer-associated venous thromboembolism is more favorable among patients with hematologic malignancies than in those with solid tumors.

Abstract: BACKGROUND The natural history of patients with hematologic cancer and venous thromboembolism (VTE) has not been consistently evaluated. We aimed to compare the rates of symptomatic recurrent VTE, major bleeding or death during anticoagulant therapy in patients with VTE associated to hematologic vs. solid cancers. METHODS Consecutive patients with active cancer recruited in RIETE were evaluated. Their baseline characteristics, treatments and outcomes during the course of anticoagulation were compared. Univariate and multivariate competing-risk analysis were performed. RESULTS As of December 2020, 16,694 patients with cancer and VTE were recruited. Of these, 1,062 (6.4%) had hematologic cancers. Hematologic patients were less likely to initially present with pulmonary embolism (48% vs. 63%) and more likely with upper-extremity deep vein thrombosis (25% vs. 18%). They also were more likely to have severe thrombocytopenia at baseline (5.6% vs. 0.7%) or to receive chemotherapy (67% vs. 41%). During the course of anticoagulation (median, 150 vs. 127 days), 1,071 patients (6.4%) developed VTE recurrences, 806 (4.8%) suffered major bleeding and 4,136 (24.8%) died. Patients with hematologic cancers had lower rates of recurrent VTE (rate ratio [RR]: 0.73; 95% confidence interval [CI]: 0.56-0.95), major bleeding (RR: 0.72; 95%CI: 0.53-0.98) or all-cause death (RR: 0.49; 95%CI: 0.41-0.57) than those with solid cancers. Patients with multiple myeloma showed the best outcomes. CONCLUSIONS Patients with hematologic cancers, particularly multiple myeloma, and VTE had better outcomes than those with solid cancers. These findings are relevant for the interpretation of previous clinical trials and the design of future studies.

How well do European patients understand cancer-associated thrombosis? A patient survey.

Abstract: Ongoing concerns regarding the morbidity and mortality from cancer-associated thrombosis led the European Cancer Patient Coalition (ECPC), the voice of cancer patients across Europe, to create a pan-European cancer-associated awareness patient survey to assess cancer-associated thrombosis (CAT) knowledge among a large population of patients with cancer. The ECPC survey represents the largest of its kind among patients/caregivers with CAT. It identified significant gaps in patient awareness and knowledge of CAT as well as a need for educational CAT-related discussions and interventions between healthcare professionals and patients with cancer and their caregivers. The aim of this paper is to highlight these gaps and to provide awareness of what/when information should be shared with patients/caregivers. Notably, the importance of providing information on how to reduce their risk of CAT, the role of anticoagulant prophylaxis and treatment (short- and long-term) including possible side-effects, and finally how to identify CAT symptoms early. Here we outline what type of information should be provided, as well as when and how to best discuss CAT with our oncology patients and their caregivers along the cancer care continuum, to reduce the risk of CAT and associated complications with a goal of improving patient outcomes.

Venous thromboembolism in patients with autoimmune disorders: a comparison between bleeding complications during anticoagulation and recurrences after its discontinuation

Abstract: The ideal duration of anticoagulation therapy in patients with autoimmune disorders and venous thromboembolism (VTE) is controversial. We used the Registro Informatizado de Enfermedad TromboEmbólica (RIETE) database to compare the incidence rate of major bleeding during anticoagulation versus the incidence rate of VTE recurrences after its discontinuation. We included 1061 patients with autoimmune disorders and VTE followed‐up after discontinuing anticoagulant therapy: rheumatoid arthritis, 321; polymyalgia rheumatica, 159; ulcerative colitis, 134; Crohn’s disease, 111; systemic lupus erythematosus (SLE), 82; giant cell arteritis, 58; ankylosing spondylitis, 39; Behcet disease, 17; other vasculitides, 140. During anticoagulation (median, 183 days), 64 patients had major bleeding. After discontinuing anticoagulation (median, 190 days), 112 patients developed symptomatic VTE recurrences. In most subgroups, the incidence rate of major bleeding during therapy was similar to the incidence rate of VTE recurrences after its discontinuation. However, in patients with SLE (10.0 major bleeds, 95% confidence interval [CI] 4.07–20.9) per 100 patient‐years vs. 3.62 VTE recurrences, 95% CI 1.15–8.74) or ankylosing spondylitis (10.9 major bleeds [95% CI 3.47–26.3] vs. 4.69 VTE recurrences, 95% CI 1.19–12.8) the incidence rates of major bleeding during anticoagulation were over twofold higher than the incidence rates of VTE recurrences after its discontinuation.

Cellular Indices and Outcome in Patients with Acute Venous Thromboembolism

Abstract: Background Cellular indices provide integrative information about systemic inflammation status which is readily available from routine laboratory parameters. This study aimed to evaluate the prognostic role of three cellular indices in patients with venous thromboembolism (VTE). Methods The RIETE registry database was used to determine the association between the baseline neutrophil-to-lymphocyte-ratio (NLR), platelet-to-lymphocyte-ratio (PLR) and systemic-immune-inflammation-index (SII) for 90-day adverse outcomes in patients with acute VTE. Results From January 2020 to April 2021, 4487 patients with acute VTE were recruited in the RIETE registry. Of these, 2683 presented with symptomatic pulmonary embolism (PE); 283 with incidental PE; 1129 with lower-limb deep vein thrombosis (DVT); 175 with upper-limb DVT; 69 with splanchnic vein thrombosis; 142 with superficial vein thrombosis and 20 with retinal vein thrombosis. Mean values were: NLR 5.9 ± 7.1, PLR 190 ± 158 and SII 1459 ± 2028. During the first 90-days, 38 patients (0.8%) developed recurrent DVT, 45 (1.0%) had recurrent PE, 152 (3.4%) suffered major bleeding, and 484 (11%) died. On multivariable analysis, patients with NLR >4.41 were at an increased risk for major bleeding and patients with NLR >4.96 were at the risk of death, while those with SII >1134.5 were at increased risk for death. Conclusions This study reports the results of a large cohort to date which evaluate the prognostic value of three cellular indices simultaneously in patients with acute VTE. Results support that none of the three baseline cellular indices were sufficient for prediction of VTE recurrences in acute VTE patients. The patients with higher baseline NLR values were at an increased risk of major bleeding or death, those with high SII values were only at an increased risk for mortality.

Developing Validated Tools to Identify Pulmonary Embolism in Electronic Databases: Rationale and Design of the PE-EHR+ Study

Abstract: Abstract Background Contemporary pulmonary embolism (PE) research, in many cases, relies on data from electronic health records (EHRs) and administrative databases that use International Classification of Diseases (ICD) codes. Natural language processing (NLP) tools can be used for automated chart review and patient identification. However, there remains uncertainty with the validity of ICD-10 codes or NLP algorithms for patient identification. Methods The PE-EHR+ study has been designed to validate ICD-10 codes as Principal Discharge Diagnosis, or Secondary Discharge Diagnoses, as well as NLP tools set out in prior studies to identify patients with PE within EHRs. Manual chart review by two independent abstractors by predefined criteria will be the reference standard. Sensitivity, specificity, and positive and negative predictive values will be determined. We will assess the discriminatory function of code subgroups for intermediate- and high-risk PE. In addition, accuracy of NLP algorithms to identify PE from radiology reports will be assessed. Results A total of 1,734 patients from the Mass General Brigham health system have been identified. These include 578 with ICD-10 Principal Discharge Diagnosis codes for PE, 578 with codes in the secondary position, and 578 without PE codes during the index hospitalization. Patients within each group were selected randomly from the entire pool of patients at the Mass General Brigham health system. A smaller subset of patients will also be identified from the Yale-New Haven Health System. Data validation and analyses will be forthcoming. Conclusions The PE-EHR+ study will help validate efficient tools for identification of patients with PE in EHRs, improving the reliability of efficient observational studies or randomized trials of patients with PE using electronic databases.

No difference in outcome between therapeutic and preventive anticoagulation in patients with superficial vein thrombosis involving the saphenous–femoral junction

Abstract: Following the demonstration that thrombosis involving the superficial veins of the lower extremities (SVT) is a less benign disease than previously thought,1 several controlled studies have consistently shown that fondaparinux in preventive doses, low-molecular-weight heparins (LMWHs) in intermediate doses, and rivaroxaban in preventive doses are effective and safe strategies for preventing extension or recurrence of the disease, as well as progression to the deep vein system and migration to the pulmonary circulation.2-6 In all these clinical trials, patients with the thrombus head within 3 cm from the saphenous–femoral junction were not eligible for recruitment, as they were perceived as being at a higher risk of venous thromboembolic complications in the absence of an active drug, nor were they in studies addressing the treatment of deep vein thrombosis (DVT) because of the lack of involvement of the deep vein system. Accordingly, which is the most proper therapeutic conduct in these patients is unknown. International guidelines are elusive in this regard.7,8 Although most physicians end up managing these patients with therapeutic doses of anticoagulants because of the feared risk of progression to the deep vein system, as far as we know there is no evidence of treatment failure coming from the long-term follow-up of patients managed with lower doses. Here we report the findings from an international registry. The Computerized Registry of Patients with Venous Thromboembolism (RIETE) (ClinicalTrials.gov Identifier: NCT02832245) is a large prospective registry that has been enrolling patients with objectively confirmed VTE since 2001.9 The main objective of RIETE is to provide information to help physicians to improve their knowledge on the natural history of thromboembolic disease, including epidemiologic, diagnostic, prophylactic, and therapeutic information. All enrollees provide written or verbal informed consent according to the local ethics protocols of enrolling centers. The institutional review board at each enrolling center approves participation in RIETE for the site investigators and allows the entry of de-identified patient information into the RIETE database. Out of 1320 patients with isolated SVT (i.e., without simultaneous involvement of the deep venous system, as assessed by systematic bilateral ultrasonography) who were enrolled in the RIETE registry between March 2015 and June 2021, 374 (28.3%) had a thrombosis involving the most proximal tract of the greater saphenous with the thrombus head being within 3 cm from the saphenous–femoral junction. Of these patients, 227 (60.7%) were managed with full-dose LMWH or therapeutic doses of fondaparinux overlapped with and/or followed by vitamin K antagonists or direct oral anticoagulants. The remaining 147 patients (39.3%) were managed with preventive doses of fondaparinux or intermediate-dose LMWH. Table 1 illustrates the main demographic and clinical characteristics of the recruited patients, as well as the main risk factors of thrombosis, which were fully comparable between the two study No difference in outcome between therapeutic and preventive anticoagulation in patients with superficial vein thrombosis involving the saphenous–femoral junction

[Translated article] Prognostic Significance of Findings on CTPA Supporting an Alternative Diagnosis to PE Among Patients Hospitalized for an Exacerbation of COPD: Predefined Subanalysis of the SLICE Trial.

Abstract: Among patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD), the SLICE trial showed that the addition of an active diagnostic strategy for pulmonary embolism (PE) to usual care compared with usual care alone did not improve a composite set of health outcomes. The objective of this subanalysis was to determine the frequency and prognostic significance of findings on computed tomography pulmonary angiogram (CTPA) supporting an alternative diagnosis to PE.We analyzed all patients randomized to the intervention in the SLICE trial who received a CTPA that did not show PE. We used multivariable logistic regression to assess the independent association between findings supporting an alternative diagnosis to PE and a composite of readmission for COPD or death within 90 days after randomization.Among the 746 patients who were randomized, this subanalysis included 175 patients in the intervention group who received a CTPA that did not show PE. Eighty-four (48.0%) patients had acute bronchial infection, 13 (7.4%) had lung cancer, 10 (5.7%) had congestive heart failure, 8 (4.6%), 18 (10.3%) had other diagnoses, and 42 (24.0%) had a normal CTPA. In multivariable analysis, findings supporting an alternative diagnosis to PE were not significantly associated with the primary outcome (odds ratio: 0.64; 95% confidence interval: 0.30-1.38; P=0.26).Among patients hospitalized for an exacerbation of COPD, CTPA identified an alternative diagnosis in 76% of the patients. However, specific management of these patients was not associated with improved outcomes within 90 days after randomization.

Abstract 13807: Sex Differences in Patients Characteristics, Risk Factors, and Symptomatology in Older Adults With Pulmonary Embolism: Findings From the SERIOUS-PE Study

Abstract: Background: Biological sex is linked with pulmonary embolism (PE) disease presentation in young patients, such as the risk incurred by pregnancy. Whether sex differences exist in PE presentation, co-morbidities, risk factors, and symptomatology in older adults, the age group in which most of these events occur, remains unknown. Methods: We identified older adults (aged ≥65 years) with PE in a large international PE registry that is replete with granular clinical information about clinical characteristics and PE symptoms (RIETE registry, 2001-2021). To provide national data from the USA, we assessed sex differences in risk factors and clinical characteristics of US Medicare beneficiaries with PE (2001-2019). Results: The majority of older adults with PE in RIETE (19,294/ 33,462, 57.7%) and in Medicare database (551,492/ 948,823, 58.7%) were women (Panel A). Compared with men, women with PE less frequently had atherosclerotic diseases, obstructive lung disease, cancer, or unprovoked PE, but more frequently had a varicose veins, depression, prolonged immobility, or history of hormonal therapy (P<0.001 for all, Panel B). Compared with men, women less often presented with chest pain (37.3% vs 40.6%) or with hemoptysis (2.4% vs 5.6%), but more often presented with dyspnea (84.6% vs 80.9%) (P<0.001 for all). The proportions of patients with syncope (16.4% vs 15.9%) and patients with simplified Pulmonary Embolism Severity Index >0 (76.3% vs 75.0%) were comparable. Conclusions: In routine practice, elderly women constitute the largest proportion of patients with PE. Sex differences exist in risk factors and clinical presentation of older adults with PE, with cancer and cardiovascular disease being more common in men; and transient provoking factors such as immobility or hormone therapy being more common in women. Whether such differences correlate with disparities in treatment, or differences in short- or long-term clinical outcomes warrant further investigation.

Differences in patients with pulmonary embolism according to in-hospital or home therapy: findings in the RIETE registry

Abstract: Introduction: The aim was to analyze the clinical and prognostic differences between patients with PE with home and hospital treatment. Methods: The RIETE registry included 18145 and 1166 PE patients treated at hospital and at home. The clinical features were compared according to the treatment regimen. Results: Patients with home therapy were younger than patients treated at hospital (59.0±16.4 vs 66.8±17.2 years, p<0.001), presented less immobilization (15% vs 19%, OR 0.75, 95%CI 0.64-0.88) and had less unprovoked PE (50% vs 55%, OR 0.80, 95%CI 0.71-0.90), had more subsegmental PE (17% vs 4.6%, OR 4.17, 95%CI 3.42-5.09) and less proximal PE (16% vs 43%), OR 0.26, 95%CI 0.21-0.31), and had less heart affectation (7.6% vs 19%, OR 0.36, 95%CI 0.21-0.62). More proportion of patients without admission had PESI<65 (36% vs 19%, OR 2.45, 95%CI 2.16-2.78). At 7 days, patients treated at home presented less major bleeding (0.1% vs 0.8%, OR 0.11, 95%CI 0.02-0.78), less mortality (0.1% vs 1.6%, OR 0.05, 95%CI 0.01-0.38) and less event composed by recurrent PE, major bleeding and death (0.3% vs 2.4%, OR 0.14, 95%CI 0.05-0.38). Risk factors for the composite event were history of myocardial infarction (HR 1.38, 95%CI 1.01-1.90), chronic heart failure (HR 1.51, 95%CI 1.12-2.04), recent bleeding (HR 2.16, 95%CI 1.35-3.44), active cancer (HR 1.47, 95%CI 1.13-1.92), having transient risk factors (HR 1.67, 95%CI 1.33-2.11) and hospital admission (HR 4.24, 95%CI 1.56-11.57). Conclusion: PE patients treated at home were younger, less severe and less complicated than patients treated at hospital. Risk factors for the composite event were heart disease, bleeding, cancer and hospital admission.