Rate and duration of hospitalisation for acute pulmonary embolism in the real-world clinical practice of different countries : Analysis from the RIETE registry

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Outcome of Patients with Venous Thromboembolism and Factor V Leiden or Prothrombin 20210 Carrier Mutations During the Course of Anticoagulation

Background Individuals with factor V Leiden or prothrombin G20210A mutations are at a higher risk to develop venous thromboembolism. However, the influence of these polymorphisms on patient outcome during anticoagulant therapy has not been consistently explored. Methods We used the Registro Informatizado de Enfermedad TromboEmbólica database to compare rates of venous thromboembolism recurrence and bleeding events occurring during the anticoagulation course in factor V Leiden carriers, prothrombin mutation carriers, and noncarriers. Results Between March 2001 and December 2015, 10,139 patients underwent thrombophilia testing. Of these, 1384 were factor V Leiden carriers, 1115 were prothrombin mutation carriers, and 7640 were noncarriers. During the anticoagulation course, 160 patients developed recurrent deep vein thrombosis and 94 patients developed pulmonary embolism (16 died); 154 patients had major bleeding (10 died), and 291 patients had nonmajor bleeding. On multivariable analysis, factor V Leiden carriers had a similar rate of venous thromboembolism recurrence (adjusted hazard ratio [HR], 1.16; 95% confidence interval [CI], 0.82-1.64), half the rate of major bleeding (adjusted HR, 0.50; 95% CI, 0.25-0.99) and a nonsignificantly lower rate of nonmajor bleeding (adjusted HR, 0.66; 95% CI, 0.43-1.01) than noncarriers. Prothrombin mutation carriers and noncarriers had a comparable rate of venous thromboembolism recurrence (adjusted HR, 1.00; 95% CI, 0.68-1.48), major bleeding (adjusted HR, 0.75; 95% CI, 0.42-1.34), and nonmajor bleeding events (adjusted HR, 1.10; 95% CI, 0.77-1.57). Conclusions During the anticoagulation course, factor V Leiden carriers had a similar risk for venous thromboembolism recurrence and half the risk for major bleeding compared with noncarriers. This finding may contribute to decision-making regarding anticoagulation duration in selected factor V Leiden carriers with venous thromboembolism

Analysis of noncatheter-associated upper extremity deep venous thrombosis from the RIETE registry

Objective We sought to determine the risk factors for subsequent bleeding and recurrent venous thromboembolism (VTE) events following isolated noncatheter-associated upper extremity deep venous thrombosis (non-CA-UEDVT) to better inform future treatment decisions for this group of patients. Methods The RIETE registry (Registro Informatizado de Enfermedad TromboEmb\uf3lica [Computerized Registry of Patients with Venous Thromboembolism]) is a prospective international registry of patients with objectively confirmed symptomatic VTE. Patients with a symptomatic, isolated, proximal UEDVT from March 2001 through March 2015 were analyzed. Any patient with an indwelling catheter or pacemaker lead at the DVT site and at the time of thrombosis was considered to have a CA-UEDVT and was excluded. Patient and treatment characteristics such as age, gender, comorbidities, VTE risk factors, treatment drug, and duration were collected. Outcomes examined included recurrent DVT, subsequent pulmonary embolism (PE), and hemorrhage. Multivariate analysis was performed using stepwise logistic regression. Results Of the 1100 patients who met the study criteria, 580 (53%) were male. The mean age of the patients was 50 \ub1 20 years, and overall patient survival at 1 year was 85%. Recurrent VTE occurred in 59 patients (5.4%). Of these, 46 patients (4%) had recurrent DVT, 10 (0.9%) had a PE following UEDVT diagnosis, and 3 (0.3%) had both. PE was fatal in three patients (0.3%). Bleeding occurred in 50 patients (4.5%), major bleeding in 19 patients (1.7%), and fatal bleeding in 6 patients (0.5%). On multivariate analysis, malignant disease was associated with VTE recurrence (odds ratio [OR], 2.00; 95% confidence interval [CI], 1.04-3.45; P <.04), whereas hemorrhage was associated with age (OR, 1.03; 95% CI, 1.01-1.05; P =.002) and malignant disease (OR, 2.53; 95% CI, 1.34-4.76; P <.005). Hemorrhage and recurrent VTE were also significantly associated (OR, 2.79; 95% CI, 1.16-6.76; P <.03). Conclusions PE following non-CA-UEDVT is rare. Malignant disease was associated with VTE recurrence. Age and malignant disease were associated with hemorrhage, and VTE recurrence was associated with hemorrhage. Further prospective studies should be undertaken to best determine length of anticoagulation treatment for the varied populations of patients with UEDVT

Treatment of Right Heart Thrombi Associated with Acute Pulmonary Embolism

Background Evidence-based recommendations do not adequately address the treatment of right heart thrombi in patients who present with acute symptomatic pulmonary embolism. Methods This study included patients who had acute pulmonary embolism associated with right heart thrombi and participated in the Registro Informatizado de la Enfermedad TromboEmb\uf3lica registry. We assessed the effectiveness of anticoagulation versus reperfusion treatment for the outcomes of all-cause mortality, pulmonary embolism\u2013related mortality, recurrent venous thromboembolism, and major bleeding rates through 30 days after initiation of pulmonary embolism treatment. We used propensity score matching to adjust for the likelihood of receiving reperfusion treatment. Results Of 325 patients with pulmonary embolism and right heart thrombi, 255 (78%; 95% confidence interval, 74-83) received anticoagulation and 70 (22%; 95% confidence interval, 17-26) also received reperfusion treatment. Propensity score\u2013matched pairs analyses did not detect a statistically lower risk of all-cause death (6.2% vs 14%, P = .15) or pulmonary embolism\u2013related mortality (4.7% vs 7.8%; P = .47) for reperfusion compared with anticoagulation. Of the patients who received reperfusion treatment, 6.2% had a recurrence during the study follow-up period, compared with 0% of those who received anticoagulation (P = .049). The incidence of major bleeding events was not statistically different between the 2 treatment groups (3.1% vs 3.1%; P = 1.00). Conclusions In patients with pulmonary embolism and right heart thrombi, no significant difference was found between reperfusion therapy and anticoagulant therapy for mortality and bleeding. The risk of recurrences was significantly higher for reperfusion therapy compared with anticoagulation. Right heart thrombi may not warrant riskier interventions than standard anticoagulation

Predictors of active cancer thromboembolic outcomes: RIETE experience of the Khorana score in cancer-associated thrombosis

158sinoneEven though the Khorana risk score (KRS) has been validated to predict against the development of VTE among patients with cancer, it has a low positive predictive value. It is also unknown whether the score predicts outcomes in patients with cancer with established VTE. We selected a cohort of patients with active cancer from the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry to assess the prognostic value of the KRS at inception in predicting the likelihood of VTE recurrences, major bleeding and mortality during the course of anticoagulant therapy. We analysed 7948 consecutive patients with cancer-associated VTE. Of these, 2253 (28 %) scored 0 points, 4550 (57 %) 1-2 points and 1145 (14 %) scored ≥points. During the course of anticoagulation, amongst patient with low, moderate and high risk KRS, the rate of VTE recurrences was of 6.21 (95 %CI: 4.99-7.63), 11.2 (95 %CI: 9.91-12.7) and 19.4 (95 %CI: 15.4-24.1) events per 100 patient-years; the rate of major bleeding of 5.24 (95 %CI: 4.13-6.56), 10.3 (95 %CI: 9.02-11.7) and 19.4 (95 %CI: 15.4-24.1) bleeds per 100 patient-years and the mortality rate of 25.3 (95 %CI: 22.8-28.0), 58.5 (95 %CI: 55.5-61.7) and 120 (95 %CI: 110-131) deaths per 100 patient-years, respectively. The C-statistic was 0.53 (0.50-0.56) for recurrent VTE, 0.56 (95 %CI: 0.54-0.59) for major bleeding and 0.54 (95 %CI: 0.52-0.56) for death. In conclusion, most VTEs occur in patients with low or moderate risk scores. The KRS did not accurately predict VTE recurrence, major bleeding, or mortality among patients with cancer-associated thrombosis.noneTafur A.J.; Caprini J.A.; Cote L.; Trujillo-Santos J.; del Toro J.; Garcia-Bragado F.; Tolosa C.; Barillari G.; Visona A.; Monreal M.; Adarraga M.D.; Aibar M.A.; Alfonso M.; Arcelus J.I.; Ballaz A.; Barba R.; Barron M.; Barrn-Andres B.; Bascunana J.; Blanco-Molina A.; Canas I.; Chic N.; del Pozo R.; Diaz-Pedroche M.C.; Diaz-Peromingo J.A.; Falga C.; Fernandez-Aracil C.; Fernandez-Capitan C.; Fidalgo M.A.; Font C.; Font L.; Gallego P.; Garcia I.; Garcia M.A.; Garcia-Rodenas M.; Gavin O.; Gomez C.; Gomez V.; Gonzalez J.; Grau E.; Grimon A.; Guijarro R.; Guirado L.; Gutierrez J.; Hernandez-Comes G.; Hernandez-Blasco L.; Jara-Palomares L.; Jaras M.J.; Jimenez D.; Jimenez J.; Joya M.D.; Llamas P.; Lobo J.L.; Lopez P.; Lopez-Jimenez L.; Lopez-Reyes R.; Lopez-Saez J.B.; Lorente M.A.; Lorenzo A.; Lumbierres M.; Marchena P.J.; Martin-Martos F.; Mellado M.; Nieto J.A.; Nieto S.; Nunez A.; Nunez M.J.; Otalora S.; Otero R.; Ovejero A.; Pedrajas J.M.; Perez G.; Perez-Ductor C.; Peris M.L.; Pons I.; Porras J.A.; Reig O.; Riera-Mestre A.; Riesco D.; Rivas A.; Rodriguez M.; Rodriguez-Davila M.A.; Rosa V.; Ruiz-Artacho P.; Ruiz-Gimenez N.; Sahuquillo J.C.; Sala-Sainz M.C.; Samperiz A.; Sanchez-Martinez R.; Sanz O.; Soler S.; Sopena B.; Surinach J.M.; Torres M.I.; Uresandi F.; Usandizaga E.; Valero B.; Valle R.; Vela J.; Velez-Mendizabal E.; Vidal G.; Vila M.; Villalobos A.; Xifre B.; Vanassche T.; Verhamme P.; Yoo H.H.B.; Wells P.; Hirmerova J.; Maly R.; Salgado E.; Bertoletti L.; Bura-Riviere A.; Falvo N.; Farge-Bancel D.; Hij A.; Mahe I.; Moustafa F.; Braester A.; Brenner B.; Tzoran I.; Antonucci G.; Bilora F.; Bortoluzzi C.; Brandolin B.; Bucherini E.; Candeloro G.; Cattabiani C.; Ciammaichella M.; Dentali F.; Di Micco P.; Duce R.; Giorgi-Pierfranceschi M.; Grandone E.; Imbalzano E.; Lessiani G.; Maida R.; Mastroiacovo D.; Pace F.; Parisi R.; Pellegrinet M.; Pesavento R.; Pinelli M.; Poggio R.; Prandoni P.; Quintavalla R.; Rocci A.; Tiraferri E.; Tonello D.; Tufano A.; Visona A.; Gibietis V.; Skride A.; Vitola B.; Bosevski M.; Zdraveska M.; Bounameaux H.; Mazzolai L.Tafur, A. J.; Caprini, J. A.; Cote, L.; Trujillo-Santos, J.; del Toro, J.; Garcia-Bragado, F.; Tolosa, C.; Barillari, G.; Visona, A.; Monreal, M.; Adarraga, M. D.; Aibar, M. A.; Alfonso, M.; Arcelus, J. I.; Ballaz, A.; Barba, R.; Barron, M.; Barrn-Andres, B.; Bascunana, J.; Blanco-Molina, A.; Canas, I.; Chic, N.; del Pozo, R.; Diaz-Pedroche, M. C.; Diaz-Peromingo, J. A.; Falga, C.; Fernandez-Aracil, C.; Fernandez-Capitan, C.; Fidalgo, M. A.; Font, C.; Font, L.; Gallego, P.; Garcia, I.; Garcia, M. A.; Garcia-Rodenas, M.; Gavin, O.; Gomez, C.; Gomez, V.; Gonzalez, J.; Grau, E.; Grimon, A.; Guijarro, R.; Guirado, L.; Gutierrez, J.; Hernandez-Comes, G.; Hernandez-Blasco, L.; Jara-Palomares, L.; Jaras, M. J.; Jimenez, D.; Jimenez, J.; Joya, M. D.; Llamas, P.; Lobo, J. L.; Lopez, P.; Lopez-Jimenez, L.; Lopez-Reyes, R.; Lopez-Saez, J. B.; Lorente, M. A.; Lorenzo, A.; Lumbierres, M.; Marchena, P. J.; Martin-Martos, F.; Mellado, M.; Nieto, J. A.; Nieto, S.; Nunez, A.; Nunez, M. J.; Otalora, S.; Otero, R.; Ovejero, A.; Pedrajas, J. M.; Perez, G.; Perez-Ductor, C.; Peris, M. L.; Pons, I.; Porras, J. A.; Reig, O.; Riera-Mestre, A.; Riesco, D.; Rivas, A.; Rodriguez, M.; Rodriguez-Davila, M. A.; Rosa, V.; Ruiz-Artacho, P.; Ruiz-Gimenez, N.; Sahuquillo, J. C.; Sala-Sainz, M. C.; Samperiz, A.; Sanchez-Martinez, R.; Sanz, O.; Soler, S.; Sopena, B.; Surinach, J. M.; Torres, M. I.; Uresandi, F.; Usandizaga, E.; Valero, B.; Valle, R.; Vela, J.; Velez-Mendizabal, E.; Vidal, G.; Vila, M.; Villalobos, A.; Xifre, B.; Vanassche, T.; Verhamme, P.; Yoo, H. H. B.; Wells, P.; Hirmerova, J.; Maly, R.; Salgado, E.; Bertoletti, L.; Bura-Riviere, A.; Falvo, N.; Farge-Bancel, D.; Hij, A.; Mahe, I.; Moustafa, F.; Braester, A.; Brenner, B.; Tzoran, I.; Antonucci, G.; Bilora, F.; Bortoluzzi, C.; Brandolin, B.; Bucherini, E.; Candeloro, G.; Cattabiani, C.; Ciammaichella, M.; Dentali, F.; Di Micco, P.; Duce, R.; Giorgi-Pierfranceschi, M.; Grandone, E.; Imbalzano, E.; Lessiani, G.; Maida, R.; Mastroiacovo, D.; Pace, F.; Parisi, R.; Pellegrinet, M.; Pesavento, R.; Pinelli, M.; Poggio, R.; Prandoni, P.; Quintavalla, R.; Rocci, A.; Tiraferri, E.; Tonello, D.; Tufano, A.; Visona, A.; Gibietis, V.; Skride, A.; Vitola, B.; Bosevski, M.; Zdraveska, M.; Bounameaux, H.; Mazzolai, L

Correction to: Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism (Internal and Emergency Medicine, (2019), 14, 7, (1101-1112), 10.1007/s11739-019-02077-5)

In the original publication, part of the conflict of statement was incorrectly published as “Dr. Bikdeli reports that he was approached by lawyers on behalf of plaintiffs in litigation related to IVC filters”. The correct statement should read as “Dr. Bikdeli reports that he is a consulting expert (on behalf of the plaintiff) for litigation related to a specific type of IVC filters”. In addition, the affiliation of first author was incorrectly published. The corrected affiliation is given in this erratum

Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism

The association between inferior vena cava filter (IVC) use and outcome in patients presenting with major bleeding during anticoagulation for venous thromboembolism (VTE) has not been thoroughly investigated. We used the RIETE registry to compare the 30-day outcomes (death, major re-bleeding or VTE recurrences) in VTE patients who bled during the first 3 months of therapy, regarding the insertion of an IVC filter. A propensity score matched (PSM) analysis was performed to adjust for potential confounders. From January 2001 to September 2016, 1065 VTE patients had major bleeding during the first 3 months of anticoagulation (gastrointestinal 370; intracranial 124). Of these, 122 patients (11%) received an IVC filter. Patients receiving a filter restarted anticoagulation later (median, 4 vs. 2 days) and at lower doses (95\u2009\ub1\u200952 IU/kg/day vs. 104\u2009\ub1\u200955 of low-molecular-weight heparin) than those not receiving a filter. During the first 30 days after bleeding (after excluding 246 patients who died within the first 24 h), 283 patients (27%) died, 63 (5.9%) had non-fatal re-bleeding and 19 (1.8%) had recurrent pulmonary embolism (PE). In PSM analysis, patients receiving an IVC filter (n\u2009=\u2009122) had a lower risk for all-cause death (HR 0.49; 95% CI 0.31-0.77) or fatal bleeding (HR 0.16; 95% CI 0.07-0.49) and a similar risk for re-bleeding (HR 0.55; 95% CI 0.23-1.40) or PE recurrences (HR 1.57; 95% CI 0.38-6.36) than those not receiving a filter (n\u2009=\u2009429). In VTE patients experiencing major bleeding during the first 3 months, use of an IVC filter was associated with reduced mortality rates.Clinical Trial Registration NCT02832245

Comparison of seven prognostic tools to identify low-risk pulmonary embolism in patients aged <50 years

In young patients with acute pulmonary embolism (PE), the predictive value of currently available prognostic tools has not been evaluated. Our objective was to compare prognostic value of 7 available tools (GPS, PESI, sPESI, Prognostic Algorithm, PREP, shock index and RIETE) in patients aged &lt;50 years. We used the RIETE database, including PE patients from 2001 to 2017. The major outcome was 30-day all-cause mortality. Of 34,651 patients with acute PE, 5,822 (17%) were aged &lt;50 years. Of these, 83 (1.4%) died during the first 30 days. Number of patients deemed low risk with tools was: PREP (95.9%), GPS (89.6%), PESI (87.2%), Shock index (70.9%), sPESI (59.4%), Prognostic algorithm (58%) and RIETE score (48.6%). The tools with a highest sensitivity were: Prognostic Algorithm (91.6%; 95% CI: 85.6\u201397.5), RIETE score (90.4%; 95%CI: 84.0\u201396.7) and sPESI (88%; 95% CI: 81\u201395). The RIETE, Prognostic Algorithm and sPESI scores obtained the highest overall sensitivity estimates for also predicting 7- and 90-day all-cause mortality, 30-day PE-related mortality, 30-day major bleeding and 30-day VTE recurrences. The proportion of low-risk patients who died within the first 30 days was lowest using the Prognostic Algorithm (0.2%), RIETE (0.3%) or sPESI (0.3%) scores. In PE patients less 50 years, 30-day mortality was low. Although sPESI, RIETE and Prognostic Algorithm scores were the most sensitive tools to identify patients at low risk to die, other tools should be evaluated in this population to obtain more efficient results

Outcomes during anticoagulation in patients with symptomatic vs. incidental splanchnic vein thrombosis

Introduction: Current guidelines recommend the use of anticoagulant therapy in patients with symptomatic splanchnic vein thrombosis (SVT) and suggest no routine anticoagulation in those with incidental SVT. Methods: We used the RIETE (Registro Informatizado Enfermedad Trombo Emb\uf3lica) registry to assess the rate and severity of symptomatic venous thromboembolism (VTE) recurrences and major bleeding events appearing during the course of anticoagulation in patients with symptomatic or incidental SVT. Results: In March 2017, 521 patients with SVT were recruited. Of them, 212 (41%) presented with symptomatic SVT and 309 had incidental SVT. Most (93%) patients received anticoagulant therapy (median, 147 days). During the course of anticoagulation, 20 patients developed symptomatic VTE recurrences (none died) and 26 had major bleeding (fatal bleeding, 5). On multivariable analysis, patients with incidental SVT had a non-significantly higher risk for symptomatic VTE recurrences (adjusted hazard ratio [HR]: 2.04; 95%CI: 0.71\u20135.88) and a similar risk for major bleeding (HR: 1.12; 95%CI: 0.47\u20132.63) than those with symptomatic SVT. Active cancer was associated with at increased risk for VTE recurrences (HR: 3.06; 95%CI: 1.14\u20138.17) and anaemia (HR: 4.11; 95%CI: 1.45\u201311.6) or abnormal prothrombin time (HR: 4.10; 95%CI: 1.68\u201310.1) were associated with at increased risk for major bleeding. Conclusions: The rates of recurrent SVT and major bleeding were similar between patients with incidental or symptomatic SVT. Because the severity of bleeding complications during anticoagulation may outweigh the severity of VTE recurrences in both groups, further studies should identify those SVT patients who benefit from anticoagulant therapy