Ruiz-Artacho, P. (Pedro)
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- Hospital volume and outcomes for acute pulmonary embolism: multinational population based cohort study(BMJ, 2019) Quezada, A. (Andrés); Bikdeli, B. (Behnood); Monreal, M. (Manuel); Muriel, A. (Alfonso); Ruiz-Artacho, P. (Pedro); Jiménez, D. (David); Yusen, R.D. (Roger D.); Miguel-Diez, J. (Javier) de; Jara-Palomares, L. (Luis); Lobo, J.L. (José Luis)Objectives To evaluate the association between experience in the management of acute pulmonary embolism, reflected by hospital case volume, and mortality. Design Multinational population based cohort study using data from the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) registry between 1 January 2001 and 31 August 2018. Setting 353 hospitals in 16 countries. Participants 39 257 consecutive patients with confirmed diagnosis of acute symptomatic pulmonary embolism. Main outcome measure Pulmonary embolism related mortality within 30 days after diagnosis of the condition. Results Patients with acute symptomatic pulmonary embolism admitted to high volume hospitals (>40 pulmonary embolisms per year) had a higher burden of comorbidities. A significant inverse association was seen between annual hospital volume and pulmonary embolism related mortality. Admission to hospitals in the highest quarter (that is, >40 pulmonary embolisms per year) was associated with a 44% reduction in the adjusted odds of pulmonary embolism related mortality at 30 days compared with admission to hospitals in the lowest quarter (<15 pulmonary embolisms per year; adjusted risk 1.3% v 2.3%; adjusted odds ratio 0.56 (95% confidence interval 0.33 to 0.95); P=0.03). Results were consistent in all sensitivity analyses. All cause mortality at 30 days was not significantly reduced between the two quarters (adjusted odds ratio 0.78 (0.50 to 1.22); P=0.28). Survivors showed little change in the odds of recurrent venous thromboembolism (odds ratio 0.76 (0.49 to 1.19)) or major bleeding (1.07 (0.77 to 1.47)) between the low and high volume hospitals. Conclusions In patients with acute symptomatic pulmonary embolism, admission to high volume hospitals was associated with significant reductions in adjusted pulmonary embolism related mortality at 30 days. These findings could have implications for management strategies.
- Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial(2020) Rauch-Kroehnert, U. (Ursula); Bonacchini, L. (Luca); Schmidtmann, I. (Irene); Genth-Zotz, S. (Sabine); Manolis, A. (Athanasios); Harjola, V.P. (Veli-Pekka); Konstantinides, S.V. (Stavros V.); Schellong, S. (Sebastian); Becattini, C. (Cecilia); Schwaiblmair, M. (Martin); Beyer-Westendorf, J. (Jan); Ruiz-Artacho, P. (Pedro); Bauersachs, R.M. (Rupert M.); Wild, P.S. (Philipp S.); Jiménez, D. (David); Brachmann, J. (Johannes); Ageno, W. (Walter); Held, M. (Matthias); Stahrenberg, R. (Raoul); Iogna-Prat, L. (Lorenzo); Duerschmied, D. (Daniel); Empen, K. (Klaus); Ficker, J.H. (Joachim H.); Lankeit, M. (Mareike); Fonseca, C. (Candida); Bernardi, E. (Enrico); Espinola-Klein, C. (Christine); Westerweel, P.E. (Peter); Meyer, A. (Andreas); Lange, T.J. (Tobias J.); Mustonen, P. (Pirjo); Czihal, M. (Michael); Christ, M. (Michael)Aims To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. Methods and results We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for >_3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of a = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%). Conclusion Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.
- Therapeutic versus prophylactic bemiparin in hospitalized patients with nonsevere covid-19 pneumonia (bemicop study): an open-label, multicenter, randomized, controlled trial(2022) Marcos-Jubilar, M. (María); Carmona-Torre, F. (Francisco de A.); Vidal, R. (Rosa); Ruiz-Artacho, P. (Pedro); Filella, D. (David); Carbonell, C. (Cristina); Jiménez-Yuste, V. (Víctor); Schwartz, J. (Juana); Llamas, P. (Pilar); Alegre, F. (Félix); Sadaba, B. (Belén); Nuñez-Cordoba, J.M. (Jorge M.); Yuste, J.R. (José Ramón); Fernández-García, J. (Javier); Lecumberri, R. (Ramón)Thromboprophylaxis with low molecular weight heparin in hospitalized patients with COVID-19 is mandatory, unless contraindicated. Given the links between inflammation and thrombosis, the use of higher doses of anticoagulants could improve outcomes. We conducted an open-label, multicenter, randomized, controlled trial in adult patients hospitalized with nonsevere COVID-19 pneumonia and elevated D-dimer. Patients were randomized to therapeutic-dose bemiparin (115 IU/kg daily) versus standard prophylaxis (bemiparin 3,500 IU daily), for 10 days. The primary efficacy outcome was a composite of death, intensive care unit admission, need of mechanical ventilation support, development of moderate/severe acute respiratory distress, and venous or
- Management and outcomes of cancer patients with venous thromboembolism presenting with thrombocytopenia(Elsevier, 2020) Lecumberri, R. (Ramón); Ruiz-Artacho, P. (Pedro); Trujillo-Santos, J. (Javier); Brenner, B. (Benjamin); Barillari, G. (Giovanni); Ruiz-Ruiz, J. (Justo); Lorente-Ruiz, M. (M.); Verhamme, P. (Peter); Vázquez, F.J. (Fernando Javier); Weinberg, I. (Ido); Monreal, M. (Manuel)Introduction Treatment of venous thromboembolism (VTE) in cancer patients with thrombocytopenia is challenging due to perceived higher risk of bleeding. Material and methods We used the RIETE registry to compare the 10- and 30-day outcomes in cancer patients with acute VTE, according to platelet count at baseline. Results As of December 2018, 15,337 cancer patients with VTE were included: 166 (1.1%) had <50 × 109 platelets/L (severe thrombocytopenia), 711 (4.6%) had 50–99 × 109/L (mild thrombocytopenia) and 14,460 (94.3%) had ≥100 × 109/L (normal count). Most patients in all subgroups received initial therapy with low-molecular-weight heparin (LMWH), but 62% of those with severe thrombocytopenia received <150 IU/kg/day LMWH, 42% received <100 IU/kg/day. The mortality rate progressively decreased with increasing platelet counts (12%, 9.4% and 3.3% respectively at 10 days, 27%, 18% and 9.4% at 30 days), but the major bleeding rates did not (1.2%, 2.5% and 1.3% respectively at 10 days, 2.4%, 4.4% and 2.2% at 30 days). On multivariable analysis, patients with severe thrombocytopenia had a similar risk for major bleeding at 10 days (OR 0.84; 95%CI 0.20–3.49) and at 30 days (OR 0.90; 95%CI 0.32–2.49), but those with mild thrombocytopenia were at increased risk both at 10 days (OR 2.11; 95%CI 1.27–3.49) and at 30 days (OR 1.91; 95%CI 1.29–2.84). Conclusions Cancer patients with acute VTE and baseline thrombocytopenia often receive initial lower-than recommended doses of LMWH. Although caution is required, this practice seems to be safe in patients with severe thrombocytopenia. Nonetheless, there was an inverse correlation between baseline platelet count and mortality
- Outcome of Cancer-Associated Venous Thromboembolism Is More Favorable among Patients with Hematologic Malignancies than in Those with Solid Tumors(Thieme, 2022) Lecumberri, R. (Ramón); Ruiz-Artacho, P. (Pedro); Tzoran, I. (Inna); Brenner, B. (Benjamin); Farge-Bancel, D. (Dominique); Ay, C. (Cihan); Rosa, V. (Vladimir); Francisco, I. (Iria); Hernández-Blasco, L.M. (Luis M.); Trujillo-Santos, J. (Javier); Monreal, M. (Manuel)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 with hematologic versus 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 analyses 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 (46 vs. 55%) 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. Conclusion 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.