Background: The choice of the imaging modality for diagnosis of pulmonary embolism (PE) could be influenced by provider, patient or hospital characteristics, or over time. However, little is known about the choice of the diagnostic modalities in practice. The aim of this study was to evaluate the variations in the use of imaging modalities for patients with acute PE. Methods: Using the data from Registro Informatizado Enfermedad TromboEmbolica (RIETE), a prospective international registry of patients with venous thromboembolism (March 2001–January 2019), we explored the imaging modalities used in patients with acute PE. The imaging modalities included computed tomography pulmonary angiography, ventilation/perfusion scanning, pulmonary angiography, a combination of these tests, or PE signs and symptoms plus imaging-confirmed proximal deep vein thrombosis but no chest imaging. Results: Among 38 025 patients with confirmed PE (53.1% female, age: 67.3±17 years), computed tomography pulmonary angiography was the dominant modality of diagnosis in all RIETE enrollees (78.2% [99% CI, 77.6–78.7]); including pregnant patients (58.9% [99% CI, 47.7%–69.4%]) and patients with severe renal insufficiency (62.5% [99% CI, 59.9–65.0]). A greater proportion of patients underwent ventilation/perfusion scanning in larger hospitals compared with smaller hospitals (13.1% versus 7.3%, P <0.001). The use of computed tomography pulmonary angiography varied between 13.3% and 98.3% across the countries, and its use increased over time (46.5% in 2002 to 91.7% in 2018, P <0.001). Conclusions: In a large multinational PE registry, variations were observed in the use of imaging modalities according to patient or institutional factors and over time. However, computed tomography pulmonary angiography was the dominant modality of diagnosis, even in pregnancy and severe renal insufficiency. The safety, costs, and downstream effects of these tests on PE-related and non-PE-related outcomes warrant further investigation.
Our objective was to develop a prognostic stratification tool that enables patients with cancer and pulmonary embolism (PE), whether incidental or symptomatic, to be classified according to the risk of serious complications within 15 days.The sample comprised cases from a national registry of pulmonary thromboembolism in patients with cancer (1075 patients from 14 Spanish centres). Diagnosis was incidental in 53.5% of the events in this registry. The Exhaustive CHAID analysis was applied with 10-fold cross-validation to predict development of serious complications following PE diagnosis.About 208 patients (19.3%, 95% confidence interval (CI), 17.1-21.8%) developed a serious complication after PE diagnosis. The 15-day mortality rate was 10.1%, (95% CI, 8.4-12.1%). The decision tree detected six explanatory covariates: Hestia-like clinical decision rule (any risk criterion present vs none), Eastern Cooperative Group performance scale (ECOG-PS; <2 vs ⩾2), O2 saturation (<90 vs ⩾90%), presence of PE-specific symptoms, tumour response (progression, unknown, or not evaluated vs others), and primary tumour resection. Three risk classes were created (low, intermediate, and high risk). The risk of serious complications within 15 days increases according to the group: 1.6, 9.4, 30.6%; P<0.0001. Fifteen-day mortality rates also rise progressively in low-, intermediate-, and high-risk patients: 0.3, 6.1, and 17.1%; P<0.0001. The cross-validated risk estimate is 0.191 (s.e.=0.012). The optimism-corrected area under the receiver operating characteristic curve is 0.779 (95% CI, 0.717-0.840).We have developed and internally validated a prognostic index to predict serious complications with the potential to impact decision-making in patients with cancer and PE.
Current guidelines from the American College of Chest Physicians recommend that patients with venous thromboembolism (VTE) be treated initially with heparin, followed by long-term treatment with anti-vitamin K (AVK) drugs (Büller et al, 2004). However, even after adequate anticoagulant therapy some 3–5% of patients have recurrence of their VTE (Douketis et al, 2000; Prandoni et al, 2002; Veeger et al, 2005). The computerised registry of patients with venous thromboembolism (RIETE) is an ongoing, multicentre, observational registry of consecutive patients with acute VTE (Monreal et al, 2003; Trujillo-Santos et al, 2006). We compared the clinical characteristics, treatment patterns and 3-month outcome in patients with new VTE (group 1), those with recurrent VTE after termination of AVK (group 2), and those with recurrent VTE during AVK therapy (group 3). Consecutive patients with symptomatic, acute deep vein thrombosis (DVT) or pulmonary embolism (PE), confirmed by objective tests are enrolled in RIETE. The following parameters are recorded: patient's baseline characteristics; risk factors for VTE; the treatment received upon diagnosis; and the outcome within 3 months. Fatal PE, in the absence of autopsy, was defined as death shortly after PE, in the absence of any alternative cause of death. Fatal bleeding was defined as any death occurring shortly after a major bleed. Bleeding complications were classified as 'major', if they were overt and required a transfusion of 2 units of blood or more, or were retroperitoneal or intracranial. During the observation period, special attention was paid to any signs or symptoms suggesting either VTE recurrences or bleeding complications. Each episode of clinically suspected recurrent DVT or PE was documented by repeat objective tests. The statistical package for the social sciences (spss) version 11.5 (SPSS Inc., Chicago, IL, USA) was used to calculate odds ratios and corresponding 95% confidence intervals, and a P-value <0·05 was considered to be statistically significant. Of the 15 862 patients with acute VTE who had been followed for 3 months as of July 2006, 2538 (16%) had a prior episode of VTE. In 177 (7·0%) the current episode developed during AVK therapy. Ninety-nine further patients taking AVK for other reasons (i.e. atrial fibrillation and heart diseases) were not considered in this analysis. Thus, there were 13 324 patients in group 1; 2361 in group 2 and 177 in group 3. Patients in group 3 were more frequently males, younger, and had more often cancer than those in group 1 (Table I). Although thrombophilia testing was not performed as part of the study, 31 patients receiving AVK were positive (54%), the most common abnormality being the presence of antiphospholipid antibodies. During initial therapy these patients received unfractionated heparin and/or had a vena cava filter more often, but the use of AVK for long-term therapy was less common. During the observation period, group 3 patients had an increased incidence of recurrent VTE, fatal PE, fatal bleeding, and overall death compared with those in group 1. Patients in group 3 were more often males, younger, weighed less, and had cancer more often than those in group 2. The majority of patients in both of these groups were initially treated with low-molecular-weight heparin (LMWH), but those in group 3 received unfractionated heparin and/or a vena cava filter more often. As for long-term therapy, the use of AVK was less frequent in those who were already taking the drug when VTE developed. They also had an increased incidence of recurrent VTE, fatal PE, fatal bleeding and overall death. Twelve (6·8%) patients in group 3 had a VTE recurrence during the observation period: six were on AVK therapy and six received LMWH. Three of the six patients with new recurrences, while on AVK had an International Normalised Ratio (INR) >2·0. Eight patients had signs of DVT and four had PE (which was fatal in two). One of the fatal PE cases presented with recurrent PE 2 months after insertion of a vena cava filter, and died 3 d later, probably as a result of formation of thrombus on the proximal side of the filter with subsequent pulmonary emboli. The traditional point of view is that VTE patients who have already had a recurrence are at higher risk of having yet more (Luk et al, 2001). Our data confirm that the patients with recurrent VTE during AVK have an increased incidence of further recurrences, but they also have an increased incidence of fatal bleeding and fatal PE. By contrast, those who were not taking AVK when VTE recurred had a similar outcome to patients with no prior VTE. One in every three patients with recurrent VTE despite AVK, had cancer. According to the results of the comparison of LMWH versus oral anticoagulant therapy for long-term anticoagulation in cancer patients with VTE trial these patients would probably benefit from long-term therapy with LMWH instead of AVK (Lee et al, 2003). However, there is a substantial percentage of non-cancer patients for whom no specific therapy has proved to be superior. Some patients were found to have antiphospholipid antibodies, and would probably benefit from AVK therapy with a higher target of INR (Cherian & Gertner, 2005). Finally, for those who had a sub-therapeutical INR at recurrence the best therapeutical approach would probably consist of a more accurate dose of AVK (Hull et al, 1982). Several therapeutical strategies are available for these patients, including unfractionated heparin, LMWH, higher intensity oral anticoagulation and vena cava filter, but there is little information on the most effective and safe therapeutical strategies for these patients. As an observational study, RIETE is not designed to answer questions regarding the relative efficacy and safety of different modalities of therapy. RIETE provides data on the treatment of VTE in a real-world situation with an unselected patient population, in contrast to the rigorously controlled conditions of randomised clinical studies. Data from the registry are hypothesis-generating and provide feedback from real-world clinical situations, which is invaluable when designing new randomised clinical studies. We conclude that patients with recurrent VTE despite AVK have a worse prognosis, with an increased incidence of both further recurrences and bleeding complications. Adequate clinical trials are needed to ascertain which would be the most effective and safe therapy for these patients. We express our gratitude to Sanofi-Aventis Spain for supporting this Registry with an unrestricted educational grant and the Registry Coordinating Center, S & H Medical Science Service, for their logistic and administrative support. The project has been partially supported by Red Respira from the Instituto Carlos III (RedRespira-ISCiii-RTIC-03/11). We would like to thank Salvador Ortíz, Prof. Universidad Autónoma de Madrid and Statistical Advisor S & H Medical Science Service for the statistical analysis of the data presented in this article. Members of the RIETE Group Spain: Arcelus, J.I., Barba, R., Blanco, A., Barrón, M., Bugés, J., Casado, I., Conget, F., Del Molino, F., Del Toro, J., Epelde, F., Falgá, C., Fernández-Capitán, C., Gallego, P., García-Bragado, F., Grau, E., Guijarro, R., Guil, M., Gutiérrez, J., Gutiérrez, M.R., Hernández, L., Jiménez, D., Laserna, E., Lecumberri, R., Lobo, JL., López, F., López, L., López, I., Madridano. O., Maestre, A., Martín-Villasclaras, J.J., Monreal, M., Montes, J., Naufall, M.D., Nieto, J.A., Núñez, M.J., Orue, M.T., Otero, R., Pérez, J.L., Rabuñal, R., Román, P., Ruiz-Giménez, N., Sahuquillo, J.C., Samperiz, A.L., Sánchez, J.F., Sánchez, R., Soler, S., Tiberio, G., Todolí, J.A., Tolosa, C., Trujillo, J., Uresandi, F., Valdés, M., Valle, R. & Vela, J. France: Mismetti, P., Rivron-Guillot, K. & Boccalon, M. Italy: Di Micco, P., Enea, I., Moretti, V., Poggio, R., Quintavalla, R., Tiraferri, E. & Visonà A.
Corrected by: Erratum to: “Venous thromboembolism in patients with intracranial haemorrhage” by Lobo et al. (Thromb Haemost 2011; 106: 750-752)Thromb Haemost 2011; 106(12): 1234-1234DOI: 10.1160/TH2011120002