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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The management of acute venous thromboembolism in clinical practice. Results from the European PREFER in VTE Registry

Venous thromboembolism (VTE) is a significant cause of morbidity and mortality in Europe. Data from real-world registries are necessary, as clinical trials do not represent the full spectrum of VTE patients seen in clinical practice. We aimed to document the epidemiology, management and outcomes of VTE using data from a large, observational database. PREFER in VTE was an international, non-interventional disease registry conducted between January 2013 and July 2015 in primary and secondary care across seven European countries. Consecutive patients with acute VTE were documented and followed up over 12 months. PREFER in VTE included 3,455 patients with a mean age of 60.8 ± 17.0 years. Overall, 53.0 % were male. The majority of patients were assessed in the hospital setting as inpatients or outpatients (78.5 %). The diagnosis was deep-vein thrombosis (DVT) in 59.5 % and pulmonary embolism (PE) in 40.5 %. The most common comorbidities were the various types of cardiovascular disease (excluding hypertension; 45.5 %), hypertension (42.3 %) and dyslipidaemia (21.1 %). Following the index VTE, a large proportion of patients received initial therapy with heparin (73.2 %), almost half received a vitamin K antagonist (48.7 %) and nearly a quarter received a DOAC (24.5 %). Almost a quarter of all presentations were for recurrent VTE, with >80 % of previous episodes having occurred more than 12 months prior to baseline. In conclusion, PREFER in VTE has provided contemporary insights into VTE patients and their real-world management, including their baseline characteristics, risk factors, disease history, symptoms and signs, initial therapy and outcomes

Intraperitoneal drain placement and outcomes after elective colorectal surgery: international matched, prospective, cohort study

Despite current guidelines, intraperitoneal drain placement after elective colorectal surgery remains widespread. Drains were not associated with earlier detection of intraperitoneal collections, but were associated with prolonged hospital stay and increased risk of surgical-site infections.Background Many surgeons routinely place intraperitoneal drains after elective colorectal surgery. However, enhanced recovery after surgery guidelines recommend against their routine use owing to a lack of clear clinical benefit. This study aimed to describe international variation in intraperitoneal drain placement and the safety of this practice. Methods COMPASS (COMPlicAted intra-abdominal collectionS after colorectal Surgery) was a prospective, international, cohort study which enrolled consecutive adults undergoing elective colorectal surgery (February to March 2020). The primary outcome was the rate of intraperitoneal drain placement. Secondary outcomes included: rate and time to diagnosis of postoperative intraperitoneal collections; rate of surgical site infections (SSIs); time to discharge; and 30-day major postoperative complications (Clavien-Dindo grade at least III). After propensity score matching, multivariable logistic regression and Cox proportional hazards regression were used to estimate the independent association of the secondary outcomes with drain placement. Results Overall, 1805 patients from 22 countries were included (798 women, 44.2 per cent; median age 67.0 years). The drain insertion rate was 51.9 per cent (937 patients). After matching, drains were not associated with reduced rates (odds ratio (OR) 1.33, 95 per cent c.i. 0.79 to 2.23; P = 0.287) or earlier detection (hazard ratio (HR) 0.87, 0.33 to 2.31; P = 0.780) of collections. Although not associated with worse major postoperative complications (OR 1.09, 0.68 to 1.75; P = 0.709), drains were associated with delayed hospital discharge (HR 0.58, 0.52 to 0.66; P < 0.001) and an increased risk of SSIs (OR 2.47, 1.50 to 4.05; P < 0.001). Conclusion Intraperitoneal drain placement after elective colorectal surgery is not associated with earlier detection of postoperative collections, but prolongs hospital stay and increases SSI risk

Impact of sex, age, and risk factors for venous thromboembolism on the initial presentation of first isolated symptomatic acute deep vein thrombosis

Background and aims: Sex-specific differences exist for the initial presentation of acute venous thromboembolism (VTE): men are more likely to present with proximal deep vein thrombosis (DVT) in the lower limbs (versus pulmonary embolism [PE] or isolated distal DVT [IDDVT]) than women. We studied in detail the influence of sex, age, and VTE risk factors on the initial presentation of IDDVT versus proximal DVT. Methods: A total of 24,911 patients with a first episode of objectively diagnosed acute symptomatic lower-limb DVT (without symptomatic PE) were enrolled in RIETE (years 2000–2017) and included in the present analysis. Results: A total of 4266 (17.1%) patients had IDDVT. No trend for more IDDVT diagnoses was observed over time. Women aged 40–69 had a higher proportion of IDDVT, especially between 40 and 49 years (+6.7%; 95CI +3.7%; +9.9%), whereas men had more often proximal DVT. The presenting location of first acute DVT depended on sex, age, and the prevalence and type of VTE risk factors. Recent surgery was independently associated with a diagnosis of IDDVT in both women and men, whereas active cancer and pregnancy were associated with proximal DVT. Conclusions: The interaction between age and VTE risk factors influences the presenting location (distal versus proximal) of the first acute lower-limb DVT observed in women and men. Our observations extend to IDDVT the concept that different clinical manifestations of acute VTE may not fully share the same pathophysiological mechanisms: this contributes to explain sex-specific prognostic differences

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

BACKGROUND: No 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. METHODS: We 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. RESULTS: As 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). CONCLUSIONS: Using 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

A prognostic score to identify low-risk outpatients with acute deep vein thrombosis in the lower limbs

BACKGROUND: No 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. METHODS: We used data from the Registro Informatizado de la Enfermedad TromboEmb\uf3lica (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. RESULTS: As 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). CONCLUSIONS: Using 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

Fondaparinux in the initial and long-term treatment of venous thromboembolism

Background: Even in the absence of evidence on its long-term efficacy and safety, a number of patients with venous thromboembolism (VTE) receive long-term therapy with fondaparinux alone in everyday practice. Methods: We used the Registro Informatizado de Enfermedad Tromboembólica (RIETE) registry to compare the rate of VTE recurrences and major bleeding at 10 and 90 days in patients with and without cancer. For long-term therapy, fondaparinux was compared with vitamin K antagonists (VKA) in patients without cancer and with low-molecular- weight heparin (LMWH) in those with cancer Results Of 47,378 patients recruited, 46,513 were initially treated with heparin, 865 with fondaparinux. Then, 263 patients (78 with cancer) were treated for at least 3 months with fondaparinux. After propensity-score matching, there were no differences between patients receiving initial therapy with heparin or fondaparinux. Among patients with cancer, there were no differences between fondaparinux and LMWH. Among patients without cancer, the long-term use of fondaparinux was associated with an increased risk of major bleeding (3.24 % vs. 0.95 %, p < 0.05). Conclusions: An unexpected high rate of major bleeding was observed in non-cancer patients treated with longterm fondaparinux. Our small sample does not allowto derive relevant conclusions on the use of fondaparinux in cancer patients

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&nbsp;= .15) or pulmonary embolism\u2013related mortality (4.7% vs 7.8%; P&nbsp;= .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&nbsp;= .049). The incidence of major bleeding events was not statistically different between the 2 treatment groups (3.1% vs 3.1%; P&nbsp;= 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