-
1.
Effectiveness of Adaptive Statistical Iterative Reconstruction for 64-Slice Dual-Energy Computed Tomography Pulmonary Angiography in Patients With a Reduced Iodine Load: Comparison With Standard Computed Tomography Pulmonary Angiography.
Lee, JW, Lee, G, Lee, NK, Moon, JI, Ju, YH, Suh, YJ, Jeong, YJ
Journal of computer assisted tomography. 2016;(5):777-83
Abstract
OBJECTIVE The aim of the study was to assess the effectiveness of the adaptive statistical iterative reconstruction (ASIR) for dual-energy computed tomography pulmonary angiography (DE-CTPA) with a reduced iodine load. MATERIALS AND METHODS One hundred forty patients referred for chest CT were randomly divided into a DE-CTPA group with a reduced iodine load or a standard CTPA group. Quantitative and qualitative image qualities of virtual monochromatic spectral (VMS) images with filtered back projection (VMS-FBP) and those with 50% ASIR (VMS-ASIR) in the DE-CTPA group were compared. Image qualities of VMS-ASIR images in the DE-CTPA group and ASIR images in the standard CTPA group were also compared. RESULTS All quantitative and qualitative indices, except attenuation value of pulmonary artery in the VMS-ASIR subgroup, were superior to those in the VMS-FBP subgroup (all P < 0.001). Noise and signal-to-noise ratio of VMS-ASIR images were superior to those of ASIR images in the standard CTPA group (P < 0.001 and P = 0.007, respectively). Regarding qualitative indices, noise was significantly lower in VMS-ASIR images of the DE-CTPA group than in ASIR images of the standard CTPA group (P = 0.001). CONCLUSIONS The ASIR technique tends to improve the image quality of VMS imaging. Dual-energy computed tomography pulmonary angiography with ASIR can reduce contrast medium volume and produce images of comparable quality with those of standard CTPA.
-
2.
Platelet reactivity in patients with venous thrombosis who use rosuvastatin: a randomized controlled clinical trial.
Biedermann, JS, Cannegieter, SC, Roest, M, van der Meer, FJ, Reitsma, PH, Kruip, MJ, Lijfering, WM
Journal of thrombosis and haemostasis : JTH. 2016;(7):1404-9
-
-
Free full text
-
Abstract
UNLABELLED Essentials Statins, especially rosuvastatin, may reduce venous thrombosis risk, but the mechanism is unclear. We performed a randomized trial investigating the effect of rosuvastatin on platelet reactivity. Thromboxane-A2 mediated platelet aggregation was measured before and after rosuvastatin therapy. Rosuvastatin did not inhibit thromboxane-mediated platelet aggregation in venous thrombosis patients. SUMMARY Background Statins may exert a protective effect against the risk of venous thrombosis (VT), but the mechanism is unclear. Objectives In this open-label, randomized clinical trial (www.clinicaltrials.gov NCT01613794), we aimed to determine the ex vivo effect of rosuvastatin on platelet reactivity in patients with a history of VT. Methods Platelet reactivity, in platelet reaction units (PRUs), was measured at baseline and after 28 days with VerifyNow, which uses arachidonic acid to determine thromboxane-mediated platelet aggregation, in 50 consecutive patients included in our study (25 receiving rosuvastatin and 25 without intervention). Results Forty-seven of 50 (94.0%) consecutively enrolled patients had two valid PRU measurements. The mean PRUs in rosuvastatin users were 609 at baseline and 613 at the end of the study (mean change 5; 95% confidence interval [CI] - 18 to 27). The mean PRUs in non-users were 620 at baseline and 618 at the end of the study (mean change - 2; 95% CI - 15 to 12). The mean difference in PRU change between users and non-users was 6 (95% CI - 20 to 33). After exclusion of patients who used antiplatelet medication, or had thrombocytopenia, similar results were obtained, i.e. no apparent effect of rosuvastatin on PRUs, with a mean difference in PRU change between users and non-users of - 1 (95% CI - 20 to 19). Conclusions Rosuvastatin does not affect platelet reactivity when arachidonic acid is used as an agonist in patients with a history of VT.
-
3.
The High Risk of Contrast-induced Nephropathy in Patients with Suspected Pulmonary Embolism Despite Three Different Prophylaxis: A Randomized Controlled Trial.
Turedi, S, Erdem, E, Karaca, Y, Tatli, O, Sahin, A, Turkmen, S, Gunduz, A
Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2016;(10):1136-1145
-
-
Free full text
-
Abstract
OBJECTIVE The objective was to compare the protective effects of N-acetylcysteine (NAC) plus normal saline (NS), sodium bicarbonate (NaHCO3 ) plus NS, and NS alone in the prevention of contrast-induced nephropathy (CIN) after computed tomography pulmonary angiography (CTPA) in emergency patients. METHODS This study was planned as a randomized, controlled clinical research. Patients undergoing contrast-enhanced CTPA on suspicion of pulmonary embolism (PE) in the emergency department and with at least one risk factor for development of CIN were included in one of three different prophylaxis groups. The groups received 3 mL/kg intravenous (IV) NAC+NS or NaHCO3 +NS solution or NS alone 1 hour before CTPA and 1 mL/kg IV per hour for a minimum of 6 hours after CTPA. CIN was evaluated as the primary outcome and moderate or severe renal insufficiency and in-hospital mortality as secondary outcomes. RESULTS A total of 257 patients were enrolled in the study. The total level of CIN development was 23.7% (61/257), the level of moderate and severe renal failure was 12.5% (32/257), and the in-hospital mortality rate was 12.8% (33/257). Rates of CIN development in the drug groups were 23.5% in the NAC group (20/85), 21.2% (18/85) in the NaHCO3 group, and 26.4% in the NS group (23/87). Rates of development of moderate or severe renal insufficiency were 9.4% in the NAC group (8/85), 10.6% in the NaHCO3 group (9/85), and 17.2% in the NS group (15/87). In-hospital mortality rates were 12.9% in the NAC group (11/85), 11.8% in the NaHCO3 group (10/85), and 13.8% in the NS group (12/87). No difference was determined between the drug groups in terms of CIN, moderate or severe renal injury, or hospital mortality. CONCLUSIONS Our results indicate that there is a high risk of CIN in patients with suspected PE despite three different types of prophylaxis being administered, and no statistically significant differences were observed among prophylactic NAC, NaHCO3 , and NS in prevention of CIN following contrast-enhanced CTPA.
-
4.
Indirect comparison and cost-utility of dabigatran etexilate and rivaroxaban in the treatment and extended anticoagulation of venous thromboembolism in a UK setting.
Jugrin, AV, Hösel, V, Ustyugova, A, De Francesco, M, Lamotte, M, Sunderland, T
Journal of medical economics. 2016;(1):1-10
Abstract
BACKGROUND Acute venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is traditionally managed with a short course of parenteral anticoagulation followed by 3-6 months of a vitamin-K antagonist. Non-vitamin K oral anticoagulants (NOACs) do not require routine monitoring and dose adjustment, thus potentially provide an alternative treatment option. METHODS AND RESULTS Because of the lack of head-to-head clinical studies, an indirect comparison was conducted of dabigatran etexilate and rivaroxaban based on the respective phase III clinical trial. The derived relative safety and efficacy estimates were used to evaluate the cost-utility of dabigatran compared with rivaroxaban in the treatment and secondary prevention of VTE. The results of the indirect comparison showed no significant difference between dabigatran and rivaroxaban in avoiding recurrent VTE following index PE, index DVT, or DVT/PE combined, in treatment and extended anticoagulation. Dabigatran has significantly less major or clinically relevant bleeds (MCRBE) compared to rivaroxaban in treatment after index DVT and treatment after DVT or PE combined, but was not significantly different from rivaroxaban after index PE or in extended anticoagulation. In cost-utility deterministic analyses, dabigatran was projected dominant in all analyzed settings, given its marginally lower total cost and marginally higher QALYs gained compared to rivaroxaban. Probabilistic analyses results showed a high likelihood of dabigatran being considered good value for money in the UK, in treatment and in secondary prevention of VTE. CONCLUSION The cost-effectiveness evaluations showed that dabigatran can be considered the dominant treatment strategy compared to rivaroxaban in the patients' sub-groups considered, given the projected marginally higher clinical benefits and lower treatment costs.
-
5.
Reducing contrast medium volume and tube voltage in CT angiography of the pulmonary artery.
Mourits, MM, Nijhof, WH, van Leuken, MH, Jager, GJ, Rutten, MJ
Clinical radiology. 2016;(6):615.e7-615.e13
Abstract
AIM: To evaluate image quality after contrast medium (CM) and tube voltage reduction in computed tomography angiography (CTA) of the pulmonary artery. MATERIALS AND METHODS Thirty-three patients referred for CTA of the pulmonary artery for suspected pulmonary embolism were included. Patients were randomly assigned to Protocol I (100 ml of 350 mg iodine/ml iodinated CM; n=16) or Protocol II (50 ml of 350 mg iodine/ml iodinated CM; n=17). Dual-energy CT (80 kV and 140 kV) was performed in all patients. An averaged weighted series equivalent to a 120 kV image acquisition was reconstructed. The mean attenuation value of CM was measured at eight positions in the pulmonary trunk and pulmonary arteries. Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) were calculated. Qualitative assessment of the vascular enhancement was performed independently by two experienced radiologists using a three-point scale. Mean attenuation values, image noise, CNR, and SNR of images with 50 ml CM and images with 100 ml CM were compared and mean attenuation values, image noise, CNR, and SNR in 80 kV images and 120 kV images were compared. For qualitative analysis, interobserver variability was analysed using Cohen's kappa statistics. RESULTS The mean attenuation values in Protocol I and Protocol II were not significantly different at 80 kV (634.6±168.3 versus 537.9±146.7 HU; p=0.088) and 120 kV (482.8±127.7 versus 410.4±106.0 HU; p=0.085). The mean attenuation value at 80 kV was significantly higher than the mean attenuation value at 120 kV in Protocols I and II (p<0.001). The CNR and SNR were higher at 120 kV than at 80 kV in both protocols (p=0.000-0.019); however, there were no significant differences in the CNR and SNR between both protocols (p=0.600-0.952). Qualitative (subjective) analysis showed no statistical significant difference between Protocols I and II (p=0.524-1.000). CONCLUSION Low tube voltage (80 kV) CTA using 50 ml CM is not inferior to CTA at 120 kV using 100 ml CM.
-
6.
Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial.
Prins, MH, Bamber, L, Cano, SJ, Wang, MY, Erkens, P, Bauersachs, R, Lensing, AW
Thrombosis research. 2015;(2):281-8
Abstract
INTRODUCTION Rivaroxaban is an oral, direct Factor Xa inhibitor, approved for the treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT) and the secondary prevention of recurrent PE and DVT as a fixed-dose, monotherapy regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. Approval in this indication was supported by results from EINSTEIN PE, a large, randomised, open-label study that compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy in patients with acute symptomatic PE with or without DVT. MATERIALS AND METHODS Patient-reported treatment satisfaction was evaluated in a predefined subanalysis of EINSTEIN PE to enable monitoring and optimisation of patient-reported outcomes and, therefore, patient compliance. As part of EINSTEIN PE, 2,397 patients in seven countries were asked to complete a validated measure of treatment satisfaction, the Anti-Clot Treatment Scale (ACTS) throughout the duration of treatment (up to 12 months). RESULTS Patients reported greater satisfaction in the rivaroxaban treatment arm as compared with the enoxaparin/VKA treatment arm. Treatment with rivaroxaban was reported as being significantly less burdensome than enoxaparin/VKA therapy, and the benefits of treatment were significantly greater. CONCLUSION Rivaroxaban treatment resulted in improved treatment satisfaction compared with enoxaparin/VKA in PE patients, particularly in reducing patient-reported anticoagulation burden.
-
7.
Six Months vs Extended Oral Anticoagulation After a First Episode of Pulmonary Embolism: The PADIS-PE Randomized Clinical Trial.
Couturaud, F, Sanchez, O, Pernod, G, Mismetti, P, Jego, P, Duhamel, E, Provost, K, dit Sollier, CB, Presles, E, Castellant, P, et al
JAMA. 2015;(1):31-40
Abstract
IMPORTANCE The optimal duration of anticoagulation after a first episode of unprovoked pulmonary embolism is uncertain. OBJECTIVES To determine the benefits and harms of an additional 18-month treatment with warfarin vs placebo, after an initial 6-month nonrandomized treatment period on a vitamin K antagonist. DESIGN, SETTING, AND PARTICIPANTS Randomized, double-blind trial (treatment period, 18 months; median follow-up, 24 months); 371 adult patients who had experienced a first episode of symptomatic unprovoked pulmonary embolism (ie, with no major risk factor for thrombosis) and had been treated initially for 6 uninterrupted months with a vitamin K antagonist were randomized and followed up between July 2007 and September 2014 in 14 French centers. INTERVENTIONS Warfarin or placebo for 18 months. MAIN OUTCOMES AND MEASURES The primary outcome was the composite of recurrent venous thromboembolism or major bleeding at 18 months after randomization. Secondary outcomes were the composite at 42 months (treatment period plus 24-month follow-up), as well as each component of the composite, and death unrelated to pulmonary embolism or major bleeding, at 18 and 42 months. RESULTS After randomization, 4 patients were lost to follow-up, all after month 18, and 1 withdrew due to an adverse event. During the 18-month treatment period, the primary outcome occurred in 6 of 184 patients (3.3%) in the warfarin group and in 25 of 187 (13.5%) in the placebo group (hazard ratio [HR], 0.22; 95% CI, 0.09-0.55; P = .001). Recurrent venous thromboembolism occurred in 3 patients in the warfarin group and 25 patients in the placebo group (HR, 0.15; 95% CI, 0.05-0.43); major bleeding occurred in 4 patients in the warfarin group and in 1 patient in the placebo group (HR, 3.96; 95% CI, 0.44 to 35.89). During the 42-month entire study period (including the study treatment and follow-up periods), the composite outcome occurred in 33 patients (20.8%) in the warfarin group and in 42 (24.0%) in the placebo group (HR, 0.75; 95% CI, 0.47-1.18). Rates of recurrent venous thromboembolism, major bleeding, and unrelated death did not differ between groups. CONCLUSIONS AND RELEVANCE Among patients with a first episode of unprovoked pulmonary embolism who received 6 months of anticoagulant treatment, an additional 18 months of treatment with warfarin reduced the composite outcome of recurrent venous thrombosis and major bleeding compared with placebo. However, benefit was not maintained after discontinuation of anticoagulation therapy. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00740883.
-
8.
Development of a tool to identify patients' preference for vitamin K antagonist or direct oral anticoagulant therapy.
Zolfaghari, S, Harenberg, J, Froelich, L, Wehling, M, Weiss, C
Seminars in thrombosis and hemostasis. 2014;(1):121-8
-
-
Free full text
-
Abstract
Direct oral anticoagulants (DOACs) were developed for the treatment of thromboembolic diseases to overcome limitations of vitamin K antagonists (VKA). International guidelines on atrial fibrillation acknowledge patients' for antiembolic therapy with VKA or DOAC as relevant decision criteria. The objective assessment of patients' preference social interactions and psychological factors are hard to measure albeit representing important contributors. After a series of structured interviews and pilot studies assessing the preparedness to use DOAC as an anticoagulant and the motivation of patients to participate in clinical studies with DOAC, seven items were identified from several questionnaires by regression analysis. Those items were seen the best to describe the willingness to change anticoagulation from VKA to DOAC. By their use, we aim to develop a tool for the objective identification of the patients' preferences for VKA or for DOAC to increase adherence to therapy and to reduce anticoagulant undertreatment. German-speaking patients were asked to fill out a questionnaire consisting of biographic data and the seven selected items, and 180 patients completed the questionnaire so far. Of these, 90 patients were on treatment with VKA (group 1), 57 patients changed anticoagulation from VKA to DOAC (group 2), 29 patients were DOAC naive patients (group 3), and 4 patients changed from DOAC to VKA (group 4). Overall, 94 patients received VKA, 29 patients received dabigatran, 50 patients received rivaroxaban, and 7 patients received apixaban as an anticoagulant. Eight patients were younger than 40 years, 35 patients were aged between 40 and 59 years, 53 patients were aged between 60 and 70 years, and 84 patients were aged older than 70 years. Indication for anticoagulation were atrial fibrillation (n = 106), pulmonary embolism (n = 24), deep vein thrombosis (n = 40), artificial heart valve replacement (n = 8), or other diseases (n = 2). Based on the results of the analysis, a score will be suggested to identify the preference of patients for anticoagulation with VKA or DOAC. This tool may be useful for practitioners and health-care professionals to support patient adherence to therapy, and thereby increase treatment effectiveness.
-
9.
Prospective randomised comparison of diagnostic confidence and image quality with normal-dose and low-dose CT pulmonary angiography at various body weights.
Szucs-Farkas, Z, Megyeri, B, Christe, A, Vock, P, Heverhagen, JT, Schindera, ST
European radiology. 2014;(8):1868-77
-
-
Free full text
-
Abstract
OBJECTIVES To find a threshold body weight (BW) below 100 kg above which computed tomography pulmonary angiography (CTPA) using reduced radiation and a reduced contrast material (CM) dose provides significantly impaired quality and diagnostic confidence compared with standard-dose CTPA. METHODS In this prospectively randomised study of 501 patients with suspected pulmonary embolism and BW <100 kg, 246 were allocated into the low-dose group (80 kVp, 75 ml CM) and 255 into the normal-dose group (100 kVp, 100 ml CM). Contrast-to-noise ratio (CNR) in the pulmonary trunk was calculated. Two blinded chest radiologists independently evaluated subjective image quality and diagnostic confidence. Data were compared between the normal-dose and low-dose groups in five BW subgroups. RESULTS Vessel attenuation did not differ between the normal-dose and low-dose groups within each BW subgroup (P = 1.0). The CNR was higher with the normal-dose compared with the low-dose protocol (P < 0.006) in all BW subgroups except for the 90-99 kg subgroup (P = 0.812). Subjective image quality and diagnostic confidence did not differ between CT protocols in all subgroups (P between 0.960 and 1.0). CONCLUSIONS Subjective image quality and diagnostic confidence with 80 kVp CTPA is not different from normal-dose protocol in any BW group up to 100 kg. KEY POINTS • 80 kVp CTPA is safe in patients weighing <100 kg • Reduced radiation and iodine dose still provide high vessel attenuation • Image quality and diagnostic confidence with low-dose CTPA is good • Diagnostic confidence does not deteriorate in obese patients weighing <100 kg.
-
10.
Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism.
van Bellen, B, Bamber, L, Correa de Carvalho, F, Prins, M, Wang, M, Lensing, AW
Current medical research and opinion. 2014;(5):829-37
Abstract
OBJECTIVE The phase III EINSTEIN DVT and EINSTEIN PE trials demonstrated the potential of oral rivaroxaban for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). The length of initial hospitalization in patients presenting with either symptomatic DVT or PE was assessed using hospitalization records from these trials. METHODS Analyses were carried out in the intention-to-treat population, using non-parametric and parametric statistical methods. RESULTS Overall, 52% (1781/3434) of EINSTEIN DVT patients and 90% (4328/4821) of EINSTEIN PE patients were admitted to hospital. The proportion of hospitalized patients with a length of stay of five or fewer days receiving rivaroxaban was 54% compared with 31% for enoxaparin/vitamin K antagonist (VKA) in patients with DVT. For patients with PE, the corresponding values were 45% and 33%. Stays of 6-10 days were observed in 29% of rivaroxaban-treated patients compared with 45% of enoxaparin/VKA-treated patients for DVT. For patients with PE, these values were 39% and 46% in the rivaroxaban and enoxaparin/VKA groups, respectively. Overall, length of stay was significantly shorter in the rivaroxaban group, compared with the enoxaparin/VKA group across all analyses performed (p < 0.0001). Across regions, the observed admission rates and length of stay duration varied greatly: Asia had the longest overall hospitalization rates, whereas the lowest rates were reported in North America, Australia and New Zealand. Nevertheless, a consistent trend was observed: length of hospital stay in patients with DVT or PE receiving rivaroxaban was shorter than, or at least similar to, patients receiving enoxaparin/VKA. CONCLUSION A single-drug regimen with rivaroxaban may reduce the burden on healthcare systems and patients, and provides effective and well tolerated treatment. The studies shared an open-label design that allowed comparison of initial hospitalization, but limitations include the well monitored clinical trial setting in which decisions on admission and discharge could vary from real-world management.