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Efficacy of rivaroxaban for pulmonary embolism

Efficacy of rivaroxaban for pulmonary embolism Background: Previous clinical trials have addressed that rivaroxaban is effective for the treatment of patients with pulmonary embolism (PE). This study will systematically assess its efficacy and safety for PE. Methods: We will carry out this study by searching the following electronic databases from inception to March 1, 2019 without language restrictions: Cochrane Library, EMBASE, PUBMED, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. In addition, we will also search clinical trial registries, dissertations, and conference abstracts to avoid any missing potential studies. All randomized controlled trials of rivaroxaban for patients with PE will be fully considered. Two researchers will independently perform literature selection, data collection, and methodological quality assessment. If it is appropriate, outcome data will be pooled by using a fixed-effect model or random-effect model, and meta-analysis will be considered for operation. Results: All efficacy and safety of rivaroxaban for PE will be assessed through all primary and secondary outcomes. The primary outcomes are all-cause mortality and major bleeding. The secondary outcomes are recurrent venous thromboembolism, duration of hospital stay, quality of life, patient satisfaction, and adverse events. Conclusion: The findings of this study will summarize updated evidence on the efficacy and safety of rivaroxaban for patients with PE. Ethics and dissemination: It is not necessary to inquire ethical approval for this study, because it will not analyze any individual patient data. The results of this study will be published through peer-reviewed journals. Systematic review registration: PROSPERO CRD42019126095. Abbreviations: PE = pulmonary embolism, TSQM-II = Treatment Satisfaction Questionnaire for Medication version II, VTE = venous thromboembolism. Keywords: efficacy, pulmonary embolism, rivaroxaban, systematic review 1. Introduction is about 69 per 100,000 every year. Most importantly, its associated mortality risk is reported to more than 20% and 65% of Venous thromboembolism (VTE), which consists of deep vein [8–10] deaths happening within 1 hour. Furthermore, such mortality thrombosis and pulmonary embolism (PE), is a very tricky [11] risk may still persist with 5%, and lasts up to 12 months. [1–4] condition at clinic. It is often associated with very high Standard therapy for PE comprises of warfarin, a dose- [1,4] mortality and morbidity in patients with such condition. It has [12–14] adjusted vitamin K antagonist. It is an oral anticoagulant been reported that about 20% patients with VTE died before or for the treatment of PE. However, its anticoagulation effect one day after they diagnosed with VTE. Furthermore, about 11% cannot work as immediate-acting parenteral agent until after 4–5 of the VTE survivors still may die due to the variety of [15–17] days treatment. Additionally, it also requires strict dietary, [5,6] complications within 3 months. Of such condition, PE is a and regular monitor for anticoagulation effect to keep interna- potential life-threatening disease, especially acute PE that requires [18] tional normalized rate (INR) within the range of 2.0–3.0. urgent intervention. It is also the third leading reason of death in Rivaroxaban is a specific developed oral anticoagulant with patients with cardiovascular diseases, following coronary heart [19] rapid onset of action. It is also a direct Factor Xa inhibitor, [7] attack, and stroke. It has been estimated that the incidence of PE [19,20] which does not need for routine INR monitoring. A numerous clinical trials have reported that rivaroxaban is effective This study is supported by Shaanxi Key R&D Program (No. 2017SF-207). The [21,22] for patients with PE. Furthermore, although a systematic funder did not involve in this study. review has addressed to assess the benefits of rivaroxaban for PE The authors have no conflicts of interest to disclose. involving observational studies only, and search date up to a b Department of Respiratory Medicine, Department of Critical Medicine, Yulin [23] November 2016, lots of high quality randomized controlled No. 2 Hospital, Yulin, Shaanxi, China. [24–38] trials (RCTs) were published after that study. Thus, this Correspondence: Ning Xu, Department of Critical Medicine, Yulin No. 2 updated study will systematically evaluate the efficacy and safety of Hospital, Cross of Wenhua South Road and Kangan Road, Yuyang District, Yulin, 719000, China (e-mail: ningxu198405@yeah.net). rivaroxaban for PE, and will provide its latest updated evidence. Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the Creative Commons 2. Methods Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 2.1. Study registration Medicine (2019) 98:16(e15224) This study has been registered on PROSPERO Received: 20 March 2019 / Accepted: 21 March 2019 (CRD42019126095). The systematic review protocol will be http://dx.doi.org/10.1097/MD.0000000000015224 1 Jia et al. Medicine (2019) 98:16 Medicine Table 1 Search strategy used in Cochrane Library database. Number Search terms 1 Mesh descriptor: (pulmonary embolism) explode all trees 2 Mesh descriptor: (venous thrombosis) explode all trees ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ 3 ([pulmonary ] or [embolism ] or [thrombo-embolism ] or [thromboembolism ] or [infarct ] or [venous or deep vein ] or [thrombos ] or [phlebothrombos ]):ti, ab, kw 4Or1–3 5 Mesh descriptor: (rivaroxaban) explode all trees ∗ ∗ ∗ ∗ 6 ([rivaroxaban ] or [xarelto ] or [anticoagulant medication ] or [blood thinner ]):ti, ab, kw 7Or5–6 8 MeSH descriptor: (randomized controlled trials) explode all trees ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ 9 ([random ] or [allocation ] or [placebo ] or [sham ] or [blind ] or [control trial ] or [RCT ] or [clinical trials ]):ti, ab, kw 10 Or 8–9 11 4 and 7 and 10 reported in accordance with the Preferred Reporting Items for registries, dissertations, and conference abstracts will also be Systematic Reviews and Meta-Analysis Protocol statement searched. The detailed search strategy of Cochrane Library is [39] guidelines. demonstrated in Table 1. Similar strategies will be made and utilized to any other electronic databases. 2.2. Eligibility criteria 2.2.1. Types of studies. This study will only consider RCTs. 2.4. Study selection Any other studies will be not considered, such as nonclinical Two researchers will perform all study selection independently. studies, noncontrolled trials, crossover studies, non-RCTs, and Any conflict regarding the study selection between two quasi-RCTs. researchers will be solved by a third researcher through 2.2.2. Types of participants. Participants with a diagnosis of PE discussion. At the first stage, they will review the titles and will be included regardless of race, gender, sex, and their abstracts of all records to identify any potential studies based on economic status. the predefined eligibility criteria. At the second stage, full-texts of all potential relevant studies will be read for further judgments. 2.2.3. Types of interventions The whole study selection procedure will abide to the PRISMA 2.2.3.1. Experimental interventions. We will include any forms guidelines, and will be showed in PRISMA flowchart. of rivaroxaban monotherapy. Any combination of rivaroxaban and other treatments will not be considered. 2.5. Data extraction and management A standard data extraction form will be created before the data 2.2.3.2. Control interventions. Apart from rivaroxaban, thera- collection. Two researchers will independently collect all the pies in control group can be any treatments. important information and extract data from each eligible study. 2.2.4. Type of outcome measurements Any conflicts between two researchers will be settled down by 2.2.4.1. Primary outcomes. All-cause mortality; consulting a third researcher. The extracted information includes: Major bleeding (as assessed by simplified Pulmonary Embo- general characteristics of eligible studies (e.g., first author name, lism Severity Index score, or other instruments). published year, country, sample size, eligibility criteria, and so on), details of patients (e.g., sex, age, and so on), details of treatments 2.2.4.2. Secondary outcomes. Recurrent venous thromboem- (e.g., drug, dosage, frequency, route, and so on), and outcomes bolism; (e.g., primary, secondary, and other outcome measurements). Duration of hospital stay; Quality of life (as evaluated by Global Quality of Life Scale or 2.6. Missing data other tools); Any missing data will be required by contacting primary authors Patient satisfaction (as measured by generic Treatment with emails. If we cannot receive those data, we will only analyze Satisfaction Questionnaire for Medication version II or other available data, and will discuss it. scales); Adverse events (any expected and unexpected adverse events). 2.7. Methodological quality assessment 2.3. Search strategy Cochrane risk of bias tool will be used to evaluate the methodological quality for each eligible trial. It will be divided Cochrane Library, EMBASE, PUBMED, Web of Science, into 7 aspects, and each aspect will be classified as low risk, Cumulative Index to Nursing and Allied Health Literature, unclear, or high risk. Two independent researchers will perform Allied and Complementary Medicine Database, Chinese Bio- the whole process of methodological quality assessment. If there medical Literature Database, and China National Knowledge are disagreements, a third researcher will help to resolved them by Infrastructure will be searched from inceptions to March 1, 2019 discussion. without language restrictions. Additionally, clinical trial 2 Jia et al. Medicine (2019) 98:16 www.md-journal.com [2] Bartholomew JR. Update on the management of venous thromboembo- 2.8. Strategy for data synthesis lism. Cleve Clin J Med 2017;84(Suppl 3):39–46. 2.8.1. Measurement of treatment effect. As for dichotomous [3] Zhang Z, Tang L, Hu Y. Progress in the research on venous values, we will record them as risk ratio with 95% confidence thromboembolism. J Huazhong Univ Sci Technol Med Sci 2017;37: intervals (CIs). As for continuous values, we will record them as 811–5. mean difference or standardized mean difference with 95% CIs. [4] Winter MP, Schernthaner GH, Lang IM. Chronic complications of venous thromboembolism. J Thromb Haemost 2017;15:1531–40. 2.8.2. Data synthesis. We will judge heterogeneity by using I [5] White RH. The epidemiology of venous thromboembolism. Circulation test. If I is less than 50%, low heterogeneity is regarded. Then, 2003;107:I4–8. [6] Tagalakis V, Patenaude V, Kahn SR, et al. Incidence of and mortality we will use a fixed-effect model to synthesize the data. from venous thromboembolism in a real-world population: the Q-VTE Meanwhile, meta-analysis will be carried out by using RevMan Study Cohort. Am J Med 2013;126:832e813–821. version 5.3 software. If I is more than 50%, high heterogeneity is [7] Goldhaber SZ, Bounameaux H. Pulmonary embolism and deep vein considered, and subgroup analysis will be conducted. If there is thrombosis. Lancet 2012;379:1835–46. low heterogeneity after subgroup analysis, we will pool the data [8] Silverstein MD, Heit JA, Mohr DN, et al. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based by using a random-effect model, and we will also carry out meta- study. Arch Intern Med 1998;158:585–93. analysis. If there is still high heterogeneity after subgroup [9] Stein PD, Henry JW. Prevalence of acute pulmonary embolism analysis, we will not synthesize the data, and only a narrative among patients in a general hospital and at autopsy. Chest 1995;108: summary will be reported. 978–81. [10] Anderson FAJr, Wheeler HB, Goldberg RJ, et al. A population-based 2.8.3. Subgroup analysis. Subgroup analysis will be carried out perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch based on the different treatments, controls, and outcomes. Intern Med 1991;151:933–8. [11] Kearon C. Natural history of venous thromboembolism. Circulation 2.8.4. Sensitivity analysis. Sensitivity analysis will also be 2003;107: I22-30. performed to check the robustness of pooled results by [12] Ansell J, Hirsh J, Poller L, et al. The pharmacology and management of eliminating the impact of low-quality studies. the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126:204S–33S. 2.8.5. Reporting bias. The funnel plot and Egger’s test will be [13] Aujesky D, Roy PM, Verschuren F, et al. Outpatient versus inpatient performed to evaluate the reporting bias if at least 10 trials are treatment for patients with acute pulmonary embolism: an interna- included. tional, open-label, randomised, non-inferiority trial. Lancet 2011;378: 41–8. [14] Zondag W, Mos ICM, Creemers-Schild D, et al. Outpatient treatment in 3. Discussion patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost 2011;9:1500–7. Although a previous relevant study has been published in [15] Jones M, McEwan P, Morgan CL, et al. Evaluation of the pattern of [23] 2017, it only included observational studies up to the treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non-valvar atrial fibrillation: a record November 2016 with quite low level of evidence, and lots of [24–38] linkage study in a large British population. Heart 2005;91:472–7. high-quality RCTs have been published after that study. [16] White HD, Gruber M, Feyzi J, et al. Comparison of outcomes among This updated study protocol will only include higher level patients randomized to warfarin therapy according to anticoagulant evidence of RCTs, and will systematically assess the efficacy and control: results from SPORTIF III and V. Arch Intern Med 2007;167: safety of rivaroxaban for patients with PE. Its results will 239–45. [17] Prins MH, Bamber L, Cano SJ, et al. Patient-reported treatment summarize the latest updated evidence on assessing the efficacy satisfaction with oral rivaroxaban versus standard therapy in the and safety of rivaroxaban for PE. It may also present solid data treatment of pulmonary embolism; results from the EINSTEIN PE trial. and robust evidence either to the clinical practice, and future Thromb Res 2015;135:281–8. studies, or to the health policy makers. [18] Kearon C, Akl EA, Comerota AJ, et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed.: American College of Chest Physicians evidence-based clinical practice Author contributions guidelines. Chest 2012;141:e419S–96S. [19] Perzborn E, Roehrig S, Straub A, et al. Rivaroxaban: a new oral factor Xa Conceptualization: Juan Jia, Ning Xu. inhibitor. Arterioscler Thromb Vasc Biol 2010;30:376–81. Data curation: Juan Jia, Shi-min Xue, Ning Xu. [20] Sarich TC, Peters G, Berkowitz SD, et al. Rivaroxaban: a novel oral anticoagulant for the prevention and treatment of several thrombosis- Formal analysis: Juan Jia, Shi-min Xue. mediated conditions. Ann NY Acad Sci 2013;1291:42–55. Funding acquisition: Ning Xu. [21] The EINSTEIN InvestigatorsOral rivaroxaban for symptomatic venous Investigation: Ning Xu. thromboembolism. N Engl J Med 2010;363:2499–510. Methodology: Juan Jia, Shi-min Xue. [22] The EINSTEIN-PE InvestigatorsOral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012;366:1287–97. Project administration: Ning Xu. [23] Kohn CG, Fermann GJ, Peacock WF, et al. Association between Resources: Juan Jia, Shi-min Xue. rivaroxaban use and length of hospital stay, treatment costs and early Software: Shi-min Xue. outcomes in patients with pulmonary embolism: a systematic review of Supervision: Ning Xu. real-world studies. Curr Med Res Opin 2017;33:1697–703. Validation: Juan Jia, Shi-min Xue, Ning Xu. [24] Groetzinger LM, Miller TJ, Rivosecchi RM, et al. Apixaban or rivaroxaban versus warfarin for treatment of submassive pulmonary Visualization: Juan Jia, Shi-min Xue, Ning Xu. embolism after catheter-directed thrombolysis. Clin Appl Thromb Writing – original draft: Juan Jia, Shi-min Xue, Ning Xu. Hemost 2018;24:908–13. Writing – review & editing: Juan Jia, Shi-min Xue, Ning Xu. [25] Shen ZF. Clinical efficacy and safety of rivaroxaban in the treatment of acute pulmonary embolism. Chin Community Physician 2018;34: 47–8. References [26] Cai XY, Sun J. Clinical observation of rivaroxaban in the treatment of middle-risk pulmonary embolism. World Med Inf Dig 2018;18: [1] Coon WW. Venous thromboembolism. Prevalence, risk factors, and 101–4. prevention. Clin Chest Med 1984;5:391–401. 3 Jia et al. Medicine (2019) 98:16 Medicine [27] Liang S. Therapeutic effect of comprehensive nursing intervention [34] Tang KW, Mo GQ, Pan YC. Clinical efficacy of low molecular weight combined with rivaroxaban in patients with acute pulmonary thrombo- heparin combined with rivaroxaban in the treatment of acute pulmonary embolism combined with deep venous thrombosis of lower extremity. embolism. J Clin Ration Drug Use 2018;11:55–6. Heilongjiang Med 2018;42:1025–6. [35] Ren JF, Si QJ. Study on the efficacy and safety of different regimens of [28] Liang LD, Lin MK, Zhou W, et al. The effect of rivaroxaban combined rivaroxaban in the prevention and treatment of elderly patients with with low-division heparin calcium in the treatment of advanced lung thromboembolic diseases. Chin J Geriatr Cardiovasc Cerebrovasc Dis cancer with pulmonary embolism. Chin J Gerontol 2018;38:4385–7. 2018;20:367–70. [29] Sun GL, Qiao W, Gao SJ. Clinical effect of rivaroxaban in the treatment [36] Jiang G, Zhang WD, Peng ML. Clinical significance of rivaroxaban in the of pulmonary embolism. Chin Prescr Drugs 2018;16:66–7. treatment of acute intermediate-risk pulmonary thromboembolism [30] Ye GS. Effect of rivaroxaban on pulmonary embolization anticoagulant combined with deep venous thrombosis of lower extremity. Chin J therapy, incidence of adverse reactions and effects on vascular Respir Crit Care 2018;17:172–7. endothelial function in patients. Chin Pract Med 2018;13:93–4. [37] Wu X, Cui WN, Wang SM, et al. Effects of rivaroxaban on D-dimer level [31] Wei XL, Guli KD. Observing the clinical efficacy of rivaroxaban in the and quality of life in patients with acute pulmonary embolism. Chin Lab treatment of patients with pulmonary embolism. Chin Foreign Med Diagn 2018;22:230–3. Treat 2018;37:105–6. [38] Huang XG, Wang LY, Chen XL. Therapeutic effect of rivaroxaban on [32] Huang H, Huang XD, Lin CQ. Therapeutic effect of rivaroxaban on acute pulmonary embolism after stroke. Chin J Pract Nerv Dis acute pulmonary embolism. China Mod Pharm Appl 2018;12:88–90. 2017;20:32–5. [33] Tian H, Wang H, Wang YP, et al. Clinical observation of rivaroxaban in [39] Shamseer L, Moher D, Clarke M, et al. Preferred reporting items for the treatment of venous thromboembolism. Chin Foreign Med Res systematic review and meta-analysis protocols (PRISMA-P) 2015: 2018;16:45–7. elaboration and explanation. BMJ 2015;349:g7647. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Medicine Pubmed Central

Efficacy of rivaroxaban for pulmonary embolism

Jia, Juan; Xue, Shi-min; Xu, Ning
Medicine , Volume 98 (16) – Apr 19, 2019
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Pubmed Central
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Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc.
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0025-7974
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10.1097/MD.0000000000015224
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Abstract

Background: Previous clinical trials have addressed that rivaroxaban is effective for the treatment of patients with pulmonary embolism (PE). This study will systematically assess its efficacy and safety for PE. Methods: We will carry out this study by searching the following electronic databases from inception to March 1, 2019 without language restrictions: Cochrane Library, EMBASE, PUBMED, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. In addition, we will also search clinical trial registries, dissertations, and conference abstracts to avoid any missing potential studies. All randomized controlled trials of rivaroxaban for patients with PE will be fully considered. Two researchers will independently perform literature selection, data collection, and methodological quality assessment. If it is appropriate, outcome data will be pooled by using a fixed-effect model or random-effect model, and meta-analysis will be considered for operation. Results: All efficacy and safety of rivaroxaban for PE will be assessed through all primary and secondary outcomes. The primary outcomes are all-cause mortality and major bleeding. The secondary outcomes are recurrent venous thromboembolism, duration of hospital stay, quality of life, patient satisfaction, and adverse events. Conclusion: The findings of this study will summarize updated evidence on the efficacy and safety of rivaroxaban for patients with PE. Ethics and dissemination: It is not necessary to inquire ethical approval for this study, because it will not analyze any individual patient data. The results of this study will be published through peer-reviewed journals. Systematic review registration: PROSPERO CRD42019126095. Abbreviations: PE = pulmonary embolism, TSQM-II = Treatment Satisfaction Questionnaire for Medication version II, VTE = venous thromboembolism. Keywords: efficacy, pulmonary embolism, rivaroxaban, systematic review 1. Introduction is about 69 per 100,000 every year. Most importantly, its associated mortality risk is reported to more than 20% and 65% of Venous thromboembolism (VTE), which consists of deep vein [8–10] deaths happening within 1 hour. Furthermore, such mortality thrombosis and pulmonary embolism (PE), is a very tricky [11] risk may still persist with 5%, and lasts up to 12 months. [1–4] condition at clinic. It is often associated with very high Standard therapy for PE comprises of warfarin, a dose- [1,4] mortality and morbidity in patients with such condition. It has [12–14] adjusted vitamin K antagonist. It is an oral anticoagulant been reported that about 20% patients with VTE died before or for the treatment of PE. However, its anticoagulation effect one day after they diagnosed with VTE. Furthermore, about 11% cannot work as immediate-acting parenteral agent until after 4–5 of the VTE survivors still may die due to the variety of [15–17] days treatment. Additionally, it also requires strict dietary, [5,6] complications within 3 months. Of such condition, PE is a and regular monitor for anticoagulation effect to keep interna- potential life-threatening disease, especially acute PE that requires [18] tional normalized rate (INR) within the range of 2.0–3.0. urgent intervention. It is also the third leading reason of death in Rivaroxaban is a specific developed oral anticoagulant with patients with cardiovascular diseases, following coronary heart [19] rapid onset of action. It is also a direct Factor Xa inhibitor, [7] attack, and stroke. It has been estimated that the incidence of PE [19,20] which does not need for routine INR monitoring. A numerous clinical trials have reported that rivaroxaban is effective This study is supported by Shaanxi Key R&D Program (No. 2017SF-207). The [21,22] for patients with PE. Furthermore, although a systematic funder did not involve in this study. review has addressed to assess the benefits of rivaroxaban for PE The authors have no conflicts of interest to disclose. involving observational studies only, and search date up to a b Department of Respiratory Medicine, Department of Critical Medicine, Yulin [23] November 2016, lots of high quality randomized controlled No. 2 Hospital, Yulin, Shaanxi, China. [24–38] trials (RCTs) were published after that study. Thus, this Correspondence: Ning Xu, Department of Critical Medicine, Yulin No. 2 updated study will systematically evaluate the efficacy and safety of Hospital, Cross of Wenhua South Road and Kangan Road, Yuyang District, Yulin, 719000, China (e-mail: ningxu198405@yeah.net). rivaroxaban for PE, and will provide its latest updated evidence. Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the Creative Commons 2. Methods Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 2.1. Study registration Medicine (2019) 98:16(e15224) This study has been registered on PROSPERO Received: 20 March 2019 / Accepted: 21 March 2019 (CRD42019126095). The systematic review protocol will be http://dx.doi.org/10.1097/MD.0000000000015224 1 Jia et al. Medicine (2019) 98:16 Medicine Table 1 Search strategy used in Cochrane Library database. Number Search terms 1 Mesh descriptor: (pulmonary embolism) explode all trees 2 Mesh descriptor: (venous thrombosis) explode all trees ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ 3 ([pulmonary ] or [embolism ] or [thrombo-embolism ] or [thromboembolism ] or [infarct ] or [venous or deep vein ] or [thrombos ] or [phlebothrombos ]):ti, ab, kw 4Or1–3 5 Mesh descriptor: (rivaroxaban) explode all trees ∗ ∗ ∗ ∗ 6 ([rivaroxaban ] or [xarelto ] or [anticoagulant medication ] or [blood thinner ]):ti, ab, kw 7Or5–6 8 MeSH descriptor: (randomized controlled trials) explode all trees ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ 9 ([random ] or [allocation ] or [placebo ] or [sham ] or [blind ] or [control trial ] or [RCT ] or [clinical trials ]):ti, ab, kw 10 Or 8–9 11 4 and 7 and 10 reported in accordance with the Preferred Reporting Items for registries, dissertations, and conference abstracts will also be Systematic Reviews and Meta-Analysis Protocol statement searched. The detailed search strategy of Cochrane Library is [39] guidelines. demonstrated in Table 1. Similar strategies will be made and utilized to any other electronic databases. 2.2. Eligibility criteria 2.2.1. Types of studies. This study will only consider RCTs. 2.4. Study selection Any other studies will be not considered, such as nonclinical Two researchers will perform all study selection independently. studies, noncontrolled trials, crossover studies, non-RCTs, and Any conflict regarding the study selection between two quasi-RCTs. researchers will be solved by a third researcher through 2.2.2. Types of participants. Participants with a diagnosis of PE discussion. At the first stage, they will review the titles and will be included regardless of race, gender, sex, and their abstracts of all records to identify any potential studies based on economic status. the predefined eligibility criteria. At the second stage, full-texts of all potential relevant studies will be read for further judgments. 2.2.3. Types of interventions The whole study selection procedure will abide to the PRISMA 2.2.3.1. Experimental interventions. We will include any forms guidelines, and will be showed in PRISMA flowchart. of rivaroxaban monotherapy. Any combination of rivaroxaban and other treatments will not be considered. 2.5. Data extraction and management A standard data extraction form will be created before the data 2.2.3.2. Control interventions. Apart from rivaroxaban, thera- collection. Two researchers will independently collect all the pies in control group can be any treatments. important information and extract data from each eligible study. 2.2.4. Type of outcome measurements Any conflicts between two researchers will be settled down by 2.2.4.1. Primary outcomes. All-cause mortality; consulting a third researcher. The extracted information includes: Major bleeding (as assessed by simplified Pulmonary Embo- general characteristics of eligible studies (e.g., first author name, lism Severity Index score, or other instruments). published year, country, sample size, eligibility criteria, and so on), details of patients (e.g., sex, age, and so on), details of treatments 2.2.4.2. Secondary outcomes. Recurrent venous thromboem- (e.g., drug, dosage, frequency, route, and so on), and outcomes bolism; (e.g., primary, secondary, and other outcome measurements). Duration of hospital stay; Quality of life (as evaluated by Global Quality of Life Scale or 2.6. Missing data other tools); Any missing data will be required by contacting primary authors Patient satisfaction (as measured by generic Treatment with emails. If we cannot receive those data, we will only analyze Satisfaction Questionnaire for Medication version II or other available data, and will discuss it. scales); Adverse events (any expected and unexpected adverse events). 2.7. Methodological quality assessment 2.3. Search strategy Cochrane risk of bias tool will be used to evaluate the methodological quality for each eligible trial. It will be divided Cochrane Library, EMBASE, PUBMED, Web of Science, into 7 aspects, and each aspect will be classified as low risk, Cumulative Index to Nursing and Allied Health Literature, unclear, or high risk. Two independent researchers will perform Allied and Complementary Medicine Database, Chinese Bio- the whole process of methodological quality assessment. If there medical Literature Database, and China National Knowledge are disagreements, a third researcher will help to resolved them by Infrastructure will be searched from inceptions to March 1, 2019 discussion. without language restrictions. Additionally, clinical trial 2 Jia et al. Medicine (2019) 98:16 www.md-journal.com [2] Bartholomew JR. Update on the management of venous thromboembo- 2.8. Strategy for data synthesis lism. Cleve Clin J Med 2017;84(Suppl 3):39–46. 2.8.1. Measurement of treatment effect. As for dichotomous [3] Zhang Z, Tang L, Hu Y. Progress in the research on venous values, we will record them as risk ratio with 95% confidence thromboembolism. J Huazhong Univ Sci Technol Med Sci 2017;37: intervals (CIs). As for continuous values, we will record them as 811–5. mean difference or standardized mean difference with 95% CIs. [4] Winter MP, Schernthaner GH, Lang IM. Chronic complications of venous thromboembolism. J Thromb Haemost 2017;15:1531–40. 2.8.2. Data synthesis. We will judge heterogeneity by using I [5] White RH. The epidemiology of venous thromboembolism. Circulation test. If I is less than 50%, low heterogeneity is regarded. Then, 2003;107:I4–8. [6] Tagalakis V, Patenaude V, Kahn SR, et al. Incidence of and mortality we will use a fixed-effect model to synthesize the data. from venous thromboembolism in a real-world population: the Q-VTE Meanwhile, meta-analysis will be carried out by using RevMan Study Cohort. Am J Med 2013;126:832e813–821. version 5.3 software. If I is more than 50%, high heterogeneity is [7] Goldhaber SZ, Bounameaux H. Pulmonary embolism and deep vein considered, and subgroup analysis will be conducted. If there is thrombosis. Lancet 2012;379:1835–46. low heterogeneity after subgroup analysis, we will pool the data [8] Silverstein MD, Heit JA, Mohr DN, et al. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based by using a random-effect model, and we will also carry out meta- study. Arch Intern Med 1998;158:585–93. analysis. If there is still high heterogeneity after subgroup [9] Stein PD, Henry JW. Prevalence of acute pulmonary embolism analysis, we will not synthesize the data, and only a narrative among patients in a general hospital and at autopsy. Chest 1995;108: summary will be reported. 978–81. [10] Anderson FAJr, Wheeler HB, Goldberg RJ, et al. A population-based 2.8.3. Subgroup analysis. Subgroup analysis will be carried out perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch based on the different treatments, controls, and outcomes. Intern Med 1991;151:933–8. [11] Kearon C. Natural history of venous thromboembolism. Circulation 2.8.4. Sensitivity analysis. Sensitivity analysis will also be 2003;107: I22-30. performed to check the robustness of pooled results by [12] Ansell J, Hirsh J, Poller L, et al. The pharmacology and management of eliminating the impact of low-quality studies. the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126:204S–33S. 2.8.5. Reporting bias. The funnel plot and Egger’s test will be [13] Aujesky D, Roy PM, Verschuren F, et al. Outpatient versus inpatient performed to evaluate the reporting bias if at least 10 trials are treatment for patients with acute pulmonary embolism: an interna- included. tional, open-label, randomised, non-inferiority trial. Lancet 2011;378: 41–8. [14] Zondag W, Mos ICM, Creemers-Schild D, et al. Outpatient treatment in 3. Discussion patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost 2011;9:1500–7. Although a previous relevant study has been published in [15] Jones M, McEwan P, Morgan CL, et al. Evaluation of the pattern of [23] 2017, it only included observational studies up to the treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non-valvar atrial fibrillation: a record November 2016 with quite low level of evidence, and lots of [24–38] linkage study in a large British population. Heart 2005;91:472–7. high-quality RCTs have been published after that study. [16] White HD, Gruber M, Feyzi J, et al. Comparison of outcomes among This updated study protocol will only include higher level patients randomized to warfarin therapy according to anticoagulant evidence of RCTs, and will systematically assess the efficacy and control: results from SPORTIF III and V. Arch Intern Med 2007;167: safety of rivaroxaban for patients with PE. Its results will 239–45. [17] Prins MH, Bamber L, Cano SJ, et al. Patient-reported treatment summarize the latest updated evidence on assessing the efficacy satisfaction with oral rivaroxaban versus standard therapy in the and safety of rivaroxaban for PE. It may also present solid data treatment of pulmonary embolism; results from the EINSTEIN PE trial. and robust evidence either to the clinical practice, and future Thromb Res 2015;135:281–8. studies, or to the health policy makers. [18] Kearon C, Akl EA, Comerota AJ, et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed.: American College of Chest Physicians evidence-based clinical practice Author contributions guidelines. Chest 2012;141:e419S–96S. [19] Perzborn E, Roehrig S, Straub A, et al. Rivaroxaban: a new oral factor Xa Conceptualization: Juan Jia, Ning Xu. inhibitor. Arterioscler Thromb Vasc Biol 2010;30:376–81. Data curation: Juan Jia, Shi-min Xue, Ning Xu. [20] Sarich TC, Peters G, Berkowitz SD, et al. Rivaroxaban: a novel oral anticoagulant for the prevention and treatment of several thrombosis- Formal analysis: Juan Jia, Shi-min Xue. mediated conditions. Ann NY Acad Sci 2013;1291:42–55. Funding acquisition: Ning Xu. [21] The EINSTEIN InvestigatorsOral rivaroxaban for symptomatic venous Investigation: Ning Xu. thromboembolism. N Engl J Med 2010;363:2499–510. Methodology: Juan Jia, Shi-min Xue. [22] The EINSTEIN-PE InvestigatorsOral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012;366:1287–97. Project administration: Ning Xu. [23] Kohn CG, Fermann GJ, Peacock WF, et al. Association between Resources: Juan Jia, Shi-min Xue. rivaroxaban use and length of hospital stay, treatment costs and early Software: Shi-min Xue. outcomes in patients with pulmonary embolism: a systematic review of Supervision: Ning Xu. real-world studies. Curr Med Res Opin 2017;33:1697–703. Validation: Juan Jia, Shi-min Xue, Ning Xu. [24] Groetzinger LM, Miller TJ, Rivosecchi RM, et al. Apixaban or rivaroxaban versus warfarin for treatment of submassive pulmonary Visualization: Juan Jia, Shi-min Xue, Ning Xu. embolism after catheter-directed thrombolysis. Clin Appl Thromb Writing – original draft: Juan Jia, Shi-min Xue, Ning Xu. Hemost 2018;24:908–13. Writing – review & editing: Juan Jia, Shi-min Xue, Ning Xu. [25] Shen ZF. Clinical efficacy and safety of rivaroxaban in the treatment of acute pulmonary embolism. Chin Community Physician 2018;34: 47–8. References [26] Cai XY, Sun J. Clinical observation of rivaroxaban in the treatment of middle-risk pulmonary embolism. World Med Inf Dig 2018;18: [1] Coon WW. Venous thromboembolism. Prevalence, risk factors, and 101–4. prevention. Clin Chest Med 1984;5:391–401. 3 Jia et al. Medicine (2019) 98:16 Medicine [27] Liang S. Therapeutic effect of comprehensive nursing intervention [34] Tang KW, Mo GQ, Pan YC. Clinical efficacy of low molecular weight combined with rivaroxaban in patients with acute pulmonary thrombo- heparin combined with rivaroxaban in the treatment of acute pulmonary embolism combined with deep venous thrombosis of lower extremity. embolism. J Clin Ration Drug Use 2018;11:55–6. Heilongjiang Med 2018;42:1025–6. [35] Ren JF, Si QJ. Study on the efficacy and safety of different regimens of [28] Liang LD, Lin MK, Zhou W, et al. The effect of rivaroxaban combined rivaroxaban in the prevention and treatment of elderly patients with with low-division heparin calcium in the treatment of advanced lung thromboembolic diseases. Chin J Geriatr Cardiovasc Cerebrovasc Dis cancer with pulmonary embolism. Chin J Gerontol 2018;38:4385–7. 2018;20:367–70. [29] Sun GL, Qiao W, Gao SJ. Clinical effect of rivaroxaban in the treatment [36] Jiang G, Zhang WD, Peng ML. Clinical significance of rivaroxaban in the of pulmonary embolism. Chin Prescr Drugs 2018;16:66–7. treatment of acute intermediate-risk pulmonary thromboembolism [30] Ye GS. Effect of rivaroxaban on pulmonary embolization anticoagulant combined with deep venous thrombosis of lower extremity. Chin J therapy, incidence of adverse reactions and effects on vascular Respir Crit Care 2018;17:172–7. endothelial function in patients. Chin Pract Med 2018;13:93–4. [37] Wu X, Cui WN, Wang SM, et al. Effects of rivaroxaban on D-dimer level [31] Wei XL, Guli KD. Observing the clinical efficacy of rivaroxaban in the and quality of life in patients with acute pulmonary embolism. Chin Lab treatment of patients with pulmonary embolism. Chin Foreign Med Diagn 2018;22:230–3. Treat 2018;37:105–6. [38] Huang XG, Wang LY, Chen XL. Therapeutic effect of rivaroxaban on [32] Huang H, Huang XD, Lin CQ. Therapeutic effect of rivaroxaban on acute pulmonary embolism after stroke. Chin J Pract Nerv Dis acute pulmonary embolism. China Mod Pharm Appl 2018;12:88–90. 2017;20:32–5. [33] Tian H, Wang H, Wang YP, et al. Clinical observation of rivaroxaban in [39] Shamseer L, Moher D, Clarke M, et al. Preferred reporting items for the treatment of venous thromboembolism. Chin Foreign Med Res systematic review and meta-analysis protocols (PRISMA-P) 2015: 2018;16:45–7. elaboration and explanation. BMJ 2015;349:g7647.

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Medicine – Pubmed Central

Published: Apr 19, 2019

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