Registro Informatizado De La Enfermedad TromboEmbólica Research Articles

Cancer-Associated Thrombosis: Trends in Clinical Features, Treatment, and Outcomes From 2001 to 2020

BackgroundDespite advances in cancer and venous thromboembolism (VTE) management, the epidemiology of cancer-associated thrombosis management over time remains unclear. ObjectivesWe analyzed data from the RIETE (Registro Informatizado de la Enfermedad Trombo Embólica) registry spanning 2001 to 2020 to investigate temporal trends in clinical characteristics and treatments for cancer-associated thrombosis. MethodsUsing multivariable survival regression, we examined temporal trends in risk-adjusted rates of symptomatic VTE recurrences, major bleeding, and death within 30 days after incident VTE. ResultsAmong the 17,271 patients with cancer-associated thrombosis, there was a progressive increase in patients presenting with pulmonary embolism (from 44% in 2001-2005 to 55% in 2016-2020; P < 0.001 for trend), lung (from 12.7% to 18.1%; P < 0.001) or pancreatic cancer (from 3.8% to 5.6%; P = 0.003), and utilization of immunotherapy (from 0% to 7.4%; P < 0.001). Conversely, there was a decline in patients with prostate cancer (from 11.7% to 6.6%; P < 0.001) or carcinoma of unknown origin (from 3.5% to 0.7%; P < 0.001). At the 30-day follow-up, a reduction was observed in the proportion of patients experiencing symptomatic VTE recurrences (from 3.1% to 1.1%; P < 0.001), major bleeding (from 3.1% to 2.2%; P = 0.004), and death (from 11.9% to 8.4%; P < 0.001). Multivariable analyses revealed a decreased risk over time for VTE recurrence (adjusted subdistribution HR [asHR]: 0.94 per year; 95% CI: 0.92-0.98), major bleeding (asHR: 0.98; 95% CI: 0.96-0.99), and death (aHR: 0.97; 95% CI: 0.96-0.98). ConclusionsIn this multicenter study of cancer patients with VTE, there was a decline in thrombotic, hemorrhagic, and fatal events from 2001 to 2020. (Registro Informatizado de la Enfermedad Trombo Embólica [RIETE]; NCT02832245)

Prognostic Impact of Obstructive Sleep Apnea in Patients Presenting with Acute Symptomatic Pulmonary Embolism

In patients with pulmonary embolism (PE), there is a lack of comprehensive data on the prevalence and prognostic significance of pre-existing obstructive sleep apnea (OSA). In this study of patients with PE from the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) registry, we assessed the prevalence of OSA, and the association between pre-existing OSA and the outcomes of all-cause mortality, PE-related mortality, recurrences, and major bleeding over 30 days after initiation of PE treatment. Additionally, we also examined rates of outcomes within 90 days and 1 year following the diagnosis of PE. Of 4,153 patients diagnosed with PE, 241 (5.8%; 95% confidence interval [CI]: 5.1-6.6%) had pre-existing OSA. Overall, 166 (4.0%; 95% CI: 3.4-4.6%) died during the first 30 days of follow-up. In multivariable analysis, the OSA syndrome was not a significant predictor of death from any cause (odds ratio [OR]: 1.5; 95% CI: 0.8-2.9; p = 0.19). However, patients with pre-existing OSA had an increased PE-specific mortality (adjusted OR: 3.0; 95% CI: 1.3-6.8; p = 0.01) compared with those without OSA. OSA was not significantly associated with 30-day recurrent venous thromboembolism (adjusted OR: 0.6; 95% CI: 0.1-4.7; p = 0.65) or major bleeds (adjusted OR: 1.0; 95% CI: 0.4-2.2; p = 1.0). Findings were similar at 90-day and 1-year follow-ups. In patients presenting with PE, pre-existing OSA is relatively infrequent. Patients with OSA were at increased risk of PE-related mortality when compared with those without OSA.

Outcomes after venous thromboembolism in patients with gastric cancer: Analysis of the RIETE Registry

Gastric cancer is the fifth most common malignancy worldwide. Venous thromboembolism is an independent predictor of death among patients with gastric cancer. We aimed to describe the factors associated with mortality, thrombosis recurrence, and bleeding complications in patients with gastric cancer who develop venous thromboembolism. We included 612 patients with gastric cancer and venous thromboembolism in the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) registry from 2001 to 2018. We used Cox proportional hazard ratios and a Fine-Gray model to define factors associated with outcomes. The overall mortality at 6 months was 44.4%. Factors associated with increased 6-month mortality included immobility (HR 1.8, 95% CI 1.3-2.4; p < 0.001), anemia (HR 1.4, 95% CI 1.1-1.8; p < 0.02), and leukocytosis (HR 1.8, 95% CI 1.4-2.3; p < 0.001). Recurrent thrombosis occurred in 6.5% of patients and major bleeding complications in 8.5% of the cohort. Male sex was the main factor associated with thrombosis recurrence (HR 2.1, 95% CI 1.1-4.0; p < 0.02) and hemoglobin below 10 g/dL (HR 1.6, 95% CI 1.05-2.50; p = 0.03) the main factor associated with bleeding. In conclusion, patients with gastric cancer who develop venous thrombosis have a very high likelihood of death. Low hemoglobin in this population is associated with poor outcomes.

Venous Thromboembolism in Patients with Liver Cirrhosis: Findings from the RIETE (Registro Informatizado de la Enfermedad TromboEmbolica) Registry.

Patients with cirrhosis are not only at an increased risk of bleeding but also at risk of venous thromboembolism (VTE). We sought to determine the clinical characteristics, management, and outcomes after VTE in patients with cirrhosis. We used the data from RIETE (Registro Informatizado de la Enfermedad TromboEmbolica), an international registry of patients with VTE, to compare the outcomes in patients with and without cirrhosis. Main outcomes included all-cause mortality, pulmonary embolism (PE)-related mortality, recurrent VTE, and bleeding. Among 43,611 patients with acute VTE, 187 (0.4%) had cirrhosis. Of these, 184 (98.4%) received anticoagulation for a median of 109 days (interquartile range [IQR]: 43-201 days), most commonly with enoxaparin (median dose: 1.77 [IQR: 1.38-2.00] mg/kg/day). Compared with patients without cirrhosis, those with cirrhosis had a higher rate of all-cause mortality (10.7 vs. 3.4%; odds ratio [OR]: 3.41; 95% confidence interval [CI]: 2.03-5.46) and fatal bleeding (2.1 vs. 0.2%; OR: 13.94; 95% CI: 3.65-37.90) but similar rates of fatal PE (0.5 vs. 0.5%; OR: 1.17; 95% CI: 0.03-6.70). Patients with cirrhosis had a higher rate of all-cause mortality per 100 patient-years of follow-up (58.9 vs. 16.0; hazard ratio [HR]: 3.70; 95% CI: 2.69-4.91). One-year hazard ratio of clinically relevant bleeding (HR: 2.86; 95% CI: 1.91-4.27), fatal bleeding (HR: 8.51; 95% CI: 3.5-20.7), or recurrent VTE (HR: 2.08; 95% CI: 1.00-4.36) was higher in patients with cirrhosis. Cirrhosis is a challenging comorbidity in patients with VTE. Most patients were treated with anticoagulation and had an elevated risk of recurrence, similar risk of fatal PE, and a very high risk of bleeding including fatal bleeds.

P9. Abstract Title: Systolic Blood Pressure and Mortality in Acute Symptomatic Pulmonary Embolism

<h3>Importance</h3> The optimal cut-off for systolic blood pressure (SBP) to define high-risk pulmonary embolism (PE) remains to be defined. <h3>Objectives</h3> To evaluate the relationship between SBP on admission and short-term mortality and other cardiovascular events in patients with acute symptomatic PE. <h3>Design, Setting and Participants</h3> The Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) Registry is an ongoing, multi-center, international, prospective registry of consecutive patients with symptomatic, objectively confirmed, acute venous thromboembolism (VTE). The current study included 39,257 patients from RIETE with acute symptomatic PE between 2001 and 2018. <h3>Main Outcomes and Measures</h3> Primary outcomes included all-cause and PE-specific 30-day mortality. Secondary outcomes included major bleeding and recurrent venous thromboembolism (VTE). <h3>Results</h3> There was a linear inverse relationship between admission SBP and 30-day all-cause and PE-related mortality that persisted after multivariable adjustment. Patients in the lower SBP strata had higher rates of all-cause death (reference: SBP 120-129 mmHg) (adjusted odds ratio [OR] 2.9, 95% confidence interval [CI] 2.0-4.2 for SBP <70 mmHg, and OR 1.7, 95% CI 1.4-2.1 for SBP 70-89 mmHg). The findings for 30-day PE-related mortality were similar (adjusted OR 4.4, 95% CI 2.7-7.2 for SBP <70 mmHg, and OR 2.6, 95% CI 1.9-3.4 for SBP 70-89 mmHg). After adjustment for all covariates, we did not find a significant relationship between admission SBP and recurrence or bleeding. <h3>Conclusions</h3> In patients with acute symptomatic PE, a low SBP portends an increased risk of all-cause and PE-related mortality. The highest mortality was observed in patients with SBP <70 mmHg.

Hospital volume and outcomes for acute pulmonary embolism: multinational population based cohort study

ObjectivesTo evaluate the association between experience in the management of acute pulmonary embolism, reflected by hospital case volume, and mortality.DesignMultinational population based cohort study using data from the Registro Informatizado...

Prediction of short‐term prognosis in elderly patients with acute pulmonary embolism: validation of the RIETE score

Introduction The Registro Informatizado de la Enfermedad TromboEmbolica (RIETE) score was derived to identify patients with pulmonary embolism (PE) at low risk of overall complications. Objective To externally validate the RIETE score and compare its prognostic performance with the Pulmonary Embolism Severity Index (PESI), its simplified version (sPESI) and the Geneva Prognostic Score (GPS). Methods In a prospective multicenter cohort, we studied 687 elderly patients with acute PE. The primary outcome was 10-day overall complications (death, recurrent PE or major bleeding); the secondary outcome was 30-day overall mortality. We compared complications and mortality in low-risk vs. higher-risk patients and the area under the receiver operating characteristic (ROC) curve across scores. Results Overall, 27 patients (3.9%) had complications within 10 days and 22 (3.2%) died within 30 days. The RIETE score classified a smaller proportion of patients as low risk (31%) than the PESI (35%), sPESI (36%) and the GPS (90%). The proportion of low-risk patients based on the RIETE score, PESI, sPESI and GPS who had complications was 1.9%, 1.7%, 1.6% and 2.9%, respectively. The RIETE score had a lower area under the ROC curve (0.60) for predicting complications than the PESI (0.67), sPESI (0.65) and GPS (0.72). The area under the ROC curve for predicting mortality was similar (0.76-0.78) for all scores. Conclusion The RIETE score classified fewer patients as low risk than the other scores. It accurately identified patients at low risk of mortality but was not superior to other scores in predicting 10-day overall complications. http://clinicaltrials.gov. Identifier: NCT00973596.

Outcomes Associated With Inferior Vena Cava Filters Among Patients With Thromboembolic Recurrence During Anticoagulant Therapy.

The aim of this study was to assess the effectiveness of inferior vena cava (IVC) filter use among patients who develop recurrent symptomatic venous thromboembolism (VTE) on anticoagulant therapy. There is a lack of efficacy evidence of IVC filter therapy in patients with VTE recurrence on anticoagulant therapy. In this cohort study of patients with acute VTE identified from the RIETE (Registro Informatizado de la Enfermedad Tromboembólica) registry, the associations between IVC filter placement for VTE recurrence in the first 3months of anticoagulant therapy and the outcomes of all-cause mortality, pulmonary embolism (PE)-related mortality, second recurrent VTE, and major bleeding rates through 30 days after diagnosis of recurrence were assessed. Among 17 patients treated with filters and 49 matched patients treated without filters for VTE recurrence that presented as deep vein thrombosis, propensity score-matched groups showed no significant differences in death for filter insertion compared with no insertion (17.7% vs. 12.2%; p= 0.56). Among 48 patients treated with filters and 91 matched patients treated without filters for VTE recurrence that presented as PE, propensity score-matched groups showed a significant decrease in all-cause death for filter insertion compared with no insertion (2.1% vs. 25.3%; p= 0.02). The PE-related mortality rate was not significantly lower for filter insertion than no insertion (2.1% vs. 17.6%; p= 0.08), though the point estimates markedly differed. Among patients with VTE recurrence during the first 3 months of anticoagulant therapy, IVC filter insertion was not associated with a survival benefit in patients who recurred with deep vein thrombosis, although it was associated with a lower risk for all-cause death in patients who recurred with PE.

Right heart thrombi in pulmonary embolism.

There is a lack of comprehensive data on the prevalence, predictors and prognostic significance of right heart thrombi (RHT) in pulmonary embolism.In this study of patients with pulmonary embolism from the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) registry, we assessed the prevalence and predictors of RHT, and the association between the presence of RHT and the outcomes of all-cause mortality, pulmonary embolism-related mortality, recurrences, and major bleeding through 30 days after initiation of pulmonary embolism treatment.Of 12 441 patients with pulmonary embolism and baseline echocardiographic data, 2.6% had RHT. The following increased the risk of RHT: younger age, previous bleeding, congestive heart failure, cancer, syncope, systolic blood pressure <100 mmHg, and arterial oxyhaemoglobin saturation <90%. Patients with RHT were significantly more likely to die from any cause (adjusted OR 2.50 (95% CI 1.62-3.84); p<0.001) and from pulmonary embolism (adjusted OR 4.29 (95% CI 2.45-7.48); p<0.001) during follow-up. RHT was associated with an increased risk of recurrence during follow-up (1.8% versus 0.7%; p=0.04). Major bleeding was similar in patients with and without RHT.In patients presenting with pulmonary embolism, RHT is relatively infrequent. Patients with RHT had a worse outcome when compared with those without RHT.

Recurrence of venous thromboembolism in patients with recent gestational deep vein thrombosis or pulmonary embolism: Findings from the RIETE Registry

IntroductionThe aim of this study was to investigate the recurrence rate of venous thromboembolism (VTE) and the prevalence of major bleeding or death in patients with previous VTE in pregnancy and puerperium. Risk factors for VTE recurrence were also assessed. Materials and methodsWe evaluated a cohort of patients enrolled in the international, multicenter, prospective Registro Informatizado de la Enfermedad Trombo-Embólica (RIETE) registry with objectively confirmed VTE. ResultsIn the registry, 607 women were presenting with VTE that occurred during pregnancy or puerperium. The 2-year VTE recurrence rate was 3.3% (CI: 95 1.5–5.0%) and the recurrent VTE incidence rate was 2.28events/100 patients-year. Among the 16 cases of VTE recurrence 11 cases appeared during drug treatment while only five cases were diagnosed after therapy discontinuation. No significant difference was found in treatment duration among these two subgroups of VTE recurrence cases and women without recurrence. Furthermore, the use of thrombolytics and inferior vena cava filter in initial treatment was associated to an increased risk of VTE recurrence. ConclusionsThe current study provides new insights on VTE recurrence rate in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) that occurred in pregnancy or postpartum period. These findings can contribute to risk assessment of thrombotic burden, thereby allowing for better decision making regarding antithrombotic management in this clinical setting.

Identification of Low-Risk Patients with Acute Symptomatic Pulmonary Embolism for Outpatient Therapy.

Patients with acute symptomatic pulmonary embolism (PE) deemed to be at low risk for early complications might be candidates for partial or complete outpatient treatment. To develop and validate a clinical prediction rule that accurately identifies patients with PE and low risk of short-term complications and to compare its prognostic ability with two previously validated models (i.e., the Pulmonary Embolism Severity Index [PESI] and the Simplified PESI [sPESI]) Multivariable logistic regression of a large international cohort of patients with PE prospectively enrolled in the RIETE (Registro Informatizado de la Enfermedad TromboEmbólica) registry. All-cause mortality, recurrent PE, and major bleeding up to 10 days after PE diagnosis were determined. Of 18,707 eligible patients with acute symptomatic PE, 46 (0.25%) developed recurrent PE, 203 (1.09%) bled, and 471 (2.51%) died. Predictors included in the final model were chronic heart failure, recent immobilization, recent major bleeding, cancer, hypotension, tachycardia, hypoxemia, renal insufficiency, and abnormal platelet count. The area under receiver-operating characteristic curve was 0.77 (95% confidence interval [CI], 0.75-0.78) for the RIETE score, 0.72 (95% CI, 0.70-0.73) for PESI (P < 0.05), and 0.71 (95% CI, 0.69-0.73) for sPESI (P < 0.05). Our RIETE score outperformed the prognostic value of PESI in terms of net reclassification improvement (P < 0.001), integrated discrimination improvement (P < 0.001), and sPESI (net reclassification improvement, P < 0.001; integrated discrimination improvement, P < 0.001). We built a new score, based on widely available variables, that can be used to identify patients with PE at low risk of short-term complications, assisting in triage and potentially shortening duration of hospital stay.

A Prognostic Score to Identify Low-risk Outpatients with Acute Deep Vein Thrombosis in the Lower Limbs

BackgroundNo prior studies have identified which patients with deep vein thrombosis in the lower limbs are at a low risk for adverse events within the first week of therapy. MethodsWe used data from the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) to identify patients at low risk for the composite outcome of pulmonary embolism, major bleeding, or death within the first week. We built a prognostic score and compared it with the decision to treat patients at home. ResultsAs of December 2013, 15,280 outpatients with deep vein thrombosis had been enrolled. Overall, 5164 patients (34%) were treated at home. Of these, 12 (0.23%) had pulmonary embolism, 8 (0.15%) bled, and 4 (0.08%) died. On multivariable analysis, chronic heart failure, recent immobility, recent bleeding, cancer, renal insufficiency, and abnormal platelet count independently predicted the risk for the composite outcome. Among 11,430 patients (75%) considered to be at low risk, 15 (0.13%) suffered pulmonary embolism, 22 (0.19%) bled, and 8 (0.07%) died. The C-statistic was 0.61 (95% confidence interval [CI], 0.57-0.65) for the decision to treat patients at home and 0.76 (95% CI, 0.72-0.79) for the score (P = .003). Net reclassification improvement was 41% (P < .001). Integrated discrimination improvement was 0.034 for the score and 0.015 for the clinical decision (P < .001). ConclusionsUsing 6 easily available variables, we identified outpatients with deep vein thrombosis at low risk for adverse events within the first week. These data may help to safely treat more patients at home. This score, however, should be validated.

Home versus in-hospital treatment of outpatients with acute deep venous thrombosis of the lower limbs

Some physicians are still concerned about the safety of treatment at home of patients with acute deep venous thrombosis (DVT). We used data from the RIETE (Registro Informatizado de la Enfermedad TromboEmbólica) registry to compare the outcomes in consecutive outpatients with acute lower limb DVT according to initial treatment at home or in the hospital. A propensity score-matching analysis was carried out with a logistic regression model. As of December 2012, 13,493 patients had been enrolled. Of these, 4456 (31%) were treated at home. Patients treated at home were more likely to be male and younger and to weigh more; they were less likely than those treated in the hospital to have chronic heart failure, lung disease, renal insufficiency, anemia, recent bleeding, immobilization, or cancer. During the first week of anticoagulation, 27 patients (0.20%) suffered pulmonary embolism (PE), 12 (0.09%) recurrent DVT, and 51 (0.38%) major bleeding; 80 (0.59%) died. When only patients treated at home were considered, 12 (0.27%) had PE, 4 (0.09%) had recurrent DVT, 6 (0.13%) bled, and 4 (0.09%) died (no fatal PE, 3 fatal bleeds). After propensity analysis, patients treated at home had a similar rate of venous thromboembolism recurrences and a lower rate of major bleeding (odds ratio, 0.4; 95% confidence interval, 0.1-1.0) or death (odds ratio, 0.2; 95% confidence interval, 0.1-0.7) within the first week compared with those treated in the hospital. In outpatients with DVT, home treatment was associated with a better outcome than treatment in the hospital. These data may help safely treat more DVT patients at home.

Low-molecular-weight or Unfractionated Heparin in Venous Thromboembolism: The Influence of Renal Function

BackgroundIn patients with acute venous thromboembolism and renal insufficiency, initial therapy with unfractionated heparin may have some advantages over low-molecular-weight heparin. MethodsWe used the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) Registry data to evaluate the 15-day outcome in 38,531 recruited patients. We used propensity score matching to compare patients treated with unfractionated heparin with those treated with low-molecular-weight heparin in 3 groups stratified by creatinine clearance levels at baseline: >60 mL/min, 30 to 60 mL/min, or <30 mL/min. ResultsPatients initially receiving unfractionated heparin therapy (n = 2167) more likely had underlying diseases than those receiving low-molecular-weight heparin (n = 34,665). Propensity score-matched groups of patients with creatinine clearance levels >60 mL/min (n = 1598 matched pairs), 30 to 60 mL/min (n = 277 matched pairs), and <30 mL/min (n = 210 matched pairs) showed an increased 15-day mortality for unfractionated heparin compared with low-molecular-weight heparin (4.5% vs 2.4% [P = .001], 5.4% vs 5.8% [P = not significant], and 15% vs 8.1% [P = .02], respectively), an increased rate of fatal pulmonary embolism (2.8% vs 1.2% [P = .001], 3.2% vs 2.5% [P = not significant], and 5.7% vs 2.4% [P = .02], respectively), and a similar rate of fatal bleeding (0.3% vs 0.3%, 0.7% vs 0.7%, and 0.5% vs 0.0%, respectively). Multivariate analysis confirmed that patients treated with unfractionated heparin were at increased risk for all-cause death (odds ratio, 1.8; 95% confidence interval, 1.3-2.4) and fatal pulmonary embolism (odds ratio, 2.3; 95% confidence interval, 1.5-3.6). ConclusionsIn comparison with low-molecular-weight heparin, initial therapy with unfractionated heparin was associated with a higher mortality and higher rate of fatal pulmonary embolism in patients with creatinine clearance levels >60 mL/min or <30 mL/min, but not in those with levels between 30 and 60 mL/min.

Effects of age on the risk of dying from pulmonary embolism or bleeding during treatment of deep vein thrombosis

The risk of patients dying of pulmonary embolism (PE) or bleeding during the treatment of deep vein thrombosis (DVT), and whether these risks are influenced by patient age, has not been thoroughly studied. We used data from the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) to assess the risk of fatal PE and fatal bleeding in 16,199 patients with lower limb DVT (without symptomatic PE at the time of inclusion) during the 3 months after diagnosis, with patients categorized according to age. During the 3 months of anticoagulant treatment, there were 31 fatal PEs (0.19%) and 83 fatal hemorrhages (0.51%). During the first 7 days of therapy, the frequency of fatal PEs was similar to that of fatal bleeding (12 vs 14 deaths, respectively; odds ratio [OR], 0.86; 95% confidence interval [CI], 0.39-1.87). However, from days 8 to 90, the frequency of fatal bleeding was greater than that of fatal PE (69 vs 19 deaths; OR, 3.64; 95% CI, 2.22-6.20). The higher frequency of fatal bleeding compared with fatal PE from days 8 to 90 appeared to be confined to patients who were aged ≥ 60 years. Multivariate analysis showed that patient age was independently associated with an increased risk of death from bleeding during the first 3 months: every 10 years the OR increased by 1.37 (95% CI, 1.12-1.67). During the first week of treatment, the risk of fatal bleeding and fatal PE were similar. Then, particularly in patients who were aged ≥ 60 years, the risk of dying from bleeding exceeded the risk of dying from PE.

Clinical presentation and outcome of venous thromboembolism in COPD

Chronic obstructive pulmonary disease (COPD) is a moderate risk factor for venous thromboembolism (VTE), but neither the clinical presentation nor the outcome of VTE in COPD patients is well known. The clinical presentation of VTE, namely pulmonary embolism (PE) or deep venous thrombosis (DVT), and the outcome at 3 months (death, recurrent VTE or bleeding) were compared between 2,984 COPD patients and 25,936 non-COPD patients included in the RIETE (Registro Informatizado de la Enfermedad TromboEmbólica) registry. This ongoing international, multi-centre registry includes patients with proven symptomatic PE or DVT. PE was the more frequent VTE presentation in COPD patients (n = 1,761, 59%). PE presentation was more significantly associated with COPD patients than non-COPD patients (OR 1.64, 95% CI 1.49-1.80). During the 3-month follow-up, mortality (10.8% versus 7.6%), minor bleeding (4.5% versus 2.3%) or first VTE recurrences as PE (1.5% versus 1.1%) were significantly higher in COPD patients than in non-COPD patients. PE was the most common cause of death. COPD patients presented more frequently with PE than DVT. It may explain the worse prognosis of COPD patients, with a higher risk of death, bleeding or VTE recurrences as PE compared with non-COPD patients. Further therapeutic options are needed.

Haemodynamically unstable pulmonary embolism in the RIETE Registry: systolic blood pressure or shock index?

Patients with acute pulmonary embolism (PE) presenting with haemodynamic instability have the worst prognosis. However, what is understood by haemodynamic instability has not been clearly defined. The Registro Informatizado de la Enfermedad Tromboembólica (RIETE) is an ongoing registry of consecutive patients with symptomatic, objectively confirmed, acute deep vein thrombosis or PE. The present authors compared the predictive value of a systolic blood pressure (SBP) value of <100 mmHg and <90 mmHg and the shock index (cardiac frequency divided by SBP) on 30-day mortality in consecutive patients with PE. As of May 2006, 6,599 patients with PE were enrolled in the study. Of these, 417 (6.3%) died within 30 days: 153 of the initial PE, 29 of recurrent PE and 235 due to other causes. Of the 417 individuals who died, 127 (30%) had a positive shock index, 60 (14%) had SBP <100 mmHg and 33 (7.9%) had SBP <90 mmHg. On multivariate analysis any of the three parameters were independently associated with an increased mortality. The shock index had a higher sensitivity (30.5 versus 14.4 and 7.9% for SBP <100 mmHg and <90 mmHg, respectively) but lower specificity (86.3 versus 93.0 and 96.6). All three measures of haemodynamic instability are independent predictors of 30-day mortality. However, while the shock index had the highest sensitivity, a systolic blood pressure value <90 mmHg had the highest specificity.

D-dimer levels correlate with mortality in patients with acute pulmonary embolism: Findings from the RIETE registry

Few studies have addressed the prognostic implications of D-dimer in patients with pulmonary embolism. The aim of this study was to investigate the correlation between D-dimer levels and mortality in patients with pulmonary embolism. Observational study. Hospitals participating in the Registro Informatizado de la Enfermedad Tromboembólica (RIETE). A total of 588 consecutive patients with symptomatic pulmonary embolism who were included in the RIETE between March 2001 and December 2004. Quantitative D-dimer measurement was performed on admission using an automated latex agglutination test (IL Test D-dimer). All patients underwent clinical follow-up for 3 months. Overall mortality rate was 10.5%. The cause of death was pulmonary embolism in 18 patients (3.0%), fatal bleeding in one patient (0.2%), and other causes in 43 patients (7.3%). There were 28 (4.8%) nonfatal venous thromboembolism recurrences and 35 (6.0%) nonfatal bleeding episodes. The incidence of D-dimer 500-2499 ng/mL, D-dimer 2500-4999 ng/mL, and D-dimer >or=5000 ng/mL was 47.8%, 26.0%, and 20.4%, respectively. Compared with patients with D-dimer 500-2499 ng/mL, the relative risk (odds ratio) of overall mortality was 1.91 (95% confidence interval 0.91-4.09) and 2.94 (95% confidence interval 1.42-6.25) in patients with D-dimer 2500-4999 ng/mL and D-dimer >or= 5000 ng/mL, respectively (p = .032). Patients with D-dimer >or=5000 ng/mL showed higher risk of death from fatal pulmonary embolism (odds ratio 4.4, 95% confidence interval 0.5-33.0) than death from other causes (odds ratio 2.1, 95% confidence interval 0.7-6.0). Elevated D-dimer levels were associated with more severe disease, as assessed by clinical features. In patients who present with pulmonary embolism, D-dimer concentration is an independent predictive factor associated with all-cause and pulmonary embolism-related death. D-dimer >or=5000 ng/mL occurs in about one in five patients and is associated with a 2.9-fold increased risk of overall mortality. These results suggest that D-dimer quantification could be a useful biomarker and help determine initial therapies.

Clinical Syndromes and Clinical Outcome in Patients With Pulmonary Embolism: Findings From the RIETE Registry

<h3>Introduction</h3> The influence of the clinical syndromes of pulmonary embolism (PE) on clinical outcome has not been evaluated. <h3>Patients and methods</h3> The Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) is an ongoing registry of consecutive patients with acute venous thromboembolism. In this study, all enrolled patients with acute PE without preexisting cardiac or pulmonary disease were classified into three clinical syndromes: pulmonary infarction, isolated dyspnea, or circulatory collapse. Their clinical characteristics, laboratory findings, and 3-month outcomes were compared. <h3>Results</h3> As of January 2005, 4,145 patients with acute, symptomatic, objectively confirmed PE have been enrolled in RIETE. Of them, 3,391 patients (82%) had no chronic lung disease or heart failure: 1,709 patients (50%) had pulmonary infarction, 1,083 patients (32%) had isolated dyspnea, and 599 patients (18%) had circulatory collapse. Overall, 149 patients (4.4%) died during the first 15 days of therapy: 2.5% with pulmonary infarction, 6.2% with isolated dyspnea (odds ratio [OR], 2.6; 95% confidence interval [CI], 1.7 to 3.8), and 6.5% with circulatory collapse (OR, 2.7; 95% CI, 1.7 to 4.2). From days 16 to 90, 31 patients had recurrent PE; 5 of 14 patients (36%) with pulmonary infarction died of their new PE, compared with 5 of 10 patients (50%) with isolated dyspnea, and all 7 patients (100%) with circulatory collapse. <h3>Conclusions</h3> PE patients with pulmonary infarction (50% of the whole series) had a significantly lower mortality rate both during initial therapy and after discharge.

Pulmonary Embolism in Patients with Chronic Obstructive Pulmonary Disease or Congestive Heart Failure

Background The diagnosis of pulmonary embolism (PE) is often unreliable in patients with chronic obstructive pulmonary disease (COPD) or congestive heart failure (CHF). Subjects and Methods Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) is an ongoing registry of consecutive patients with acute venous thromboembolism. In this study, the clinical characteristics, laboratory findings, and clinical outcomes of all enrolled patients with acute PE, with or without underlying cardiopulmonary diseases, were compared and contrasted. In addition, the performance of 2 clinical models for the diagnosis of PE was retrospectively evaluated. Results As of January 2005, 4444 patients with symptomatic PE have been enrolled in RIETE. Of those, 632 patients (14%) had COPD and 422 (9.5%) had CHF. Significant differences were found in clinical presentation and 3-month outcomes among the 3 groups. With the Geneva model, there was a lower percentage of PE patients with COPD (relative risk [RR] 0.82; 95% confidence interval [CI], 0.66-1.02) or CHF (RR 0.73; 95% CI, 0.56-0.95) who fell into the low pretest probability category, compared with patients with neither. Besides, the percentage of patients with high probability of PE was similar among the 3 patient groups. The frequency of COPD (61%) and CHF (72%) patients with a high pretest probability for PE increased when using the Pisa score, but the percentage of COPD patients into the high probability group was lower (RR 0.60; 95% CI, 0.51-0.71). Conclusions Significant differences exist in PE patients with and without underlying cardiopulmonary diseases. The performance of the 2 clinical prediction models varied according to the presence or absence of underlying COPD or CHF.