scholarly journals Real-life data of direct anticoagulant use, bleeding risk and venous thromboembolism recurrence in chronic thromboembolic pulmonary hypertension patients: an observational retrospective study

2020 ◽  
Vol 10 (1) ◽  
pp. 204589401987354 ◽  
Author(s):  
Sert Sena ◽  
Mutlu Bulent ◽  
Kocakaya Derya ◽  
Kaptan Deniz ◽  
Ataş Halil ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Venous Thromboembolism ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Real Life ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Bleeding Events ◽  
Warfarin Group ◽  
Thromboembolic Pulmonary Hypertension ◽  
Recurrent Vte

Introduction Lifelong anticoagulation is the cornerstone of the chronic thromboembolic pulmonary hypertension (CTEPH) treatment regardless of the additional pulmonary endarterectomy, balloon pulmonary angioplasty, or medical treatment alone. Aim of this study was to evaluate the rate of oral anticoagulant preferences and document direct oral anticoagulants’ (DOACs’) safety, efficacy in the CTEPH population. Methods Patients’ demographic data obtained from database between September 2011 and April 2018. In-hospital events, death, venous thromboembolism (VTE) recurrence, bleeding events and anticoagulant therapy transition were recorded. Results We reviewed 501 CTEPH patients who observed 9.0 ± 8.5 years. All-cause death, all bleeding, recurrent VTE was observed in 15.6%, 31% and 12%. Forty-one patients (8.2%) were diagnosed as inoperable. Of all, 15.2% of operable patients remained as residual. All-cause mortality rates were 13.8% (57 pts.) in the warfarin group as compared with 9.7% (13 pts.) in rivaroxaban group (HR: 1.61, 95% CI, 0.89–2.99; p: 0.11). Higher bleeding events occurred with warfarin group (27.1%) as compared with rivaroxaban (24.6%; HR: 1.28, 95% CI, 0.86–1.88; p: 0.22). Major bleeding was significantly higher with warfarin group (HR: 1.94, 95% CI, 1.05–3.62; p: 0.03). Subgroup analysis of all-cause death revealed that this significance dominated by the rate of death according to bleeding events; warfarin versus those seen with rivaroxaban (4.85% vs. 2.2%; HR: 4.75, 95% CI: 1.12–20.16; p = 0.03). The rate of recurrent VTE was found 8.9% in the rivaroxaban group, 10.9% in warfarin group (HR: 1.21, 95% CI, 0.64–2.23; p: 0.55). Conclusion DOACs could be a safe and effective alternative for lifelong anticoagulant therapy in CTEPH patients. Rivaroxaban produced similar rates of thromboembolism and non-relevant bleeding compared to those associated with warfarin. The main difference was found with major bleeding that it was mainly associated with the death rate according to major bleeding. Using DOACs might be a more reasonable way to prevent bleeding events without increasing thromboembolic risk.

scholarly journals Association Between Anticoagulation Outcomes and Venous Thromboembolism History in Chronic Thromboembolic Pulmonary Hypertension

2021 ◽  
Vol 8 ◽  
Author(s):  
Yong-Jian Zhu ◽  
Yu-Ping Zhou ◽  
Yun-Peng Wei ◽  
Xi-Qi Xu ◽  
Xin-Xin Yan ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Venous Thromboembolism ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Prior History ◽  
Anticoagulation Treatment ◽  
Increased Risk ◽  
Thromboembolic Pulmonary Hypertension ◽  
History Of ◽  
Recurrent Vte ◽  
Potential Factors

Background: The association between anticoagulation outcomes and prior history of venous thromboembolism (VTE) in chronic thromboembolic pulmonary hypertension (CTEPH) has not been established. This study aimed to compare the efficacy and safety of anticoagulation treatment in CTEPH patients with and without prior history of VTE.Methods: A total of 333 CTEPH patients prescribed anticoagulants were retrospectively included from May 2013 to April 2019. The clinical characteristics were collected at their first admission. Incidental recurrent VTE and clinically relevant bleeding were recorded during follow-up. The Cox proportional regression models were used to identify potential factors associated with recurrent VTE and clinically relevant bleeding.Results: Seventy patients (21%) without a prior history of VTE did not experience recurrent VTE during anticoagulation. Compared to CTEPH patients without a prior history of VTE, those with a prior history of VTE had an increased risk of recurrent VTE [2.27/100 person-year vs. 0/100 person-year; hazard ratio (HR), 8.92; 95% confidence interval (CI), 1.18–1142.00; P = 0.029] but a similar risk of clinically relevant bleeding (3.90/100 person-year vs. 4.59/100 person-year; HR, 0.83; 95% CI, 0.38–1.78; P = 0.623). Multivariate Cox analyses suggested that a prior history of VTE and interruption of anticoagulation treatments were significantly associated with an increased risk of recurrent VTE, while anemia and glucocorticoid use were significantly associated with a higher risk of clinically relevant bleeding.Conclusions: This study is the first to reveal that a prior history of VTE significantly increases the risk of recurrent VTE in CTEPH patients during anticoagulation treatment. This finding should be further evaluated in prospective studies.

scholarly journals The anticoagulant effects of warfarin and the bleeding risk associated with its use in patients with chronic thromboembolic pulmonary hypertension at a specialist center in Japan: a retrospective cohort study

2017 ◽  
Vol 7 (3) ◽  
pp. 684-691 ◽  
Author(s):  
Takayuki Jujo-Sanada ◽  
Nobuhiro Tanabe ◽  
Seiichiro Sakao ◽  
Toshihiko Sugiura ◽  
Ayumi Sekine ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Bleeding Risk ◽  
Incidence Rates ◽  
Pulmonary Endarterectomy ◽  
Bleeding Events ◽  
Thromboembolic Pulmonary Hypertension ◽  
Recurrent Vte ◽  
Clinical Records ◽  
Observation Period

Patients with chronic thromboembolic pulmonary hypertension (CTEPH) require lifelong anticoagulation therapy. However, the bleeding risk and recurrence of venous thromboembolism (VTE) in CTEPH patients who are administered warfarin have not been adequately evaluated. The purpose of this study was to evaluate the risk of clinically relevant bleeding, recurrent VTE, and clinical worsening in patients with CTEPH who were administered warfarin. The clinical records of 72 patients with CTEPH who regularly visited our institution and were administered warfarin were retrospectively reviewed between 1 January 2011 and 31 December 2015. We investigated the incidence of clinically relevant bleeding events, recurrent VTE, and hospitalization for the deterioration of pulmonary hypertension or right heart failure (RHF) during the observation period. The mean observation period for the 72 patients was 3.60 ± 1.60 person-years. Clinically relevant bleeding, RHF, and recurrent VTE occurred in 21 (29.2%), eight (11.1%), and three (4.2%) of 72 patients, respectively, and the incidence rates for these events were 8.1%/person-year, 3.1%/person-year, and 1.2%/person-year, respectively. The incidence rates for the major and non-major bleeding events were 5.0%/person-year and 3.9%/person-year, respectively. The incidence of clinically relevant bleeding events was 20.8%/person-year during medical treatment with a soluble guanylate cyclase stimulator. One of 35 patients (2.9%) during the post-pulmonary endarterectomy period experienced hemoptysis during observation period (> 6 months after pulmonary endarterectomy). No bleeding events occurred during the post-balloon pulmonary angioplasty period. In conclusion, warfarin effectively prevents VTE recurrence in CTEPH patients, but its effects may be associated with a considerable bleeding risk.

scholarly journals Risk of major bleeding during extended oral anticoagulation in patients with first unprovoked venous thromboembolism: a systematic review and meta-analysis protocol

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Faizan Khan ◽  
Miriam Kimpton ◽  
Tobias Tritschler ◽  
Grégoire Le Gal ◽  
Brian Hutton ◽  
...  
Keyword(s):  
Systematic Review ◽  
Venous Thromboembolism ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Bleeding Events ◽  
Major Bleeding Events

Abstract Background The optimal duration of anticoagulation after a first unprovoked venous thromboembolism (VTE) remains controversial. Deciding to stop or continue anticoagulant therapy indefinitely after completing 3 to 6 months of initial treatment requires balancing the long-term risk of recurrent VTE if anticoagulation is stopped against the long-term risk of major bleeding if anticoagulation is continued. However, knowledge of the long-term risk for major bleeding events during extended anticoagulation in this patient population is limited. We plan to conduct a systematic review and meta-analysis to quantify the risk for major bleeding events during extended oral anticoagulation in patients with first unprovoked VTE. Methods Electronic databases including MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials will be systematically searched with the assistance of an information specialist (from inception to March 1, 2019) to identify randomized controlled trials and prospective cohort studies reporting major bleeding during extended oral anticoagulation in patients with first unprovoked VTE, who have completed at least 3 months of initial anticoagulant therapy. Study selection, risk of bias assessment, and data extraction will be performed independently by at least two investigators. The number of major bleeding events and person-years of follow-up will be used to calculate the rate (events per 100 person-years) with its 95% confidence interval for each study cohort, during clinically relevant time periods of extended anticoagulant therapy. Results will be pooled using random effect meta-analysis. Discussion The planned systematic review and meta-analysis will provide reliable estimates of the risk for major bleeding events during extended anticoagulation. This information will help inform patient prognosis and assist clinicians with balancing the risks and benefits of treatment to guide management of unprovoked VTE. Systematic review registration PROSPERO CRD42019128597.

P4672Current outcome of chronic thromboembolic pulmonary hypertension in Spain

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Martinez Santos ◽  
A Aurtenetxe Perez ◽  
M J Lopez Gude ◽  
J A Barbera ◽  
M Lopez Meseguer ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Survival Rates ◽  
Real Life ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Invasive Procedure ◽  
Percutaneous Treatment ◽  
Mortality Data ◽  
Balloon Pulmonary Angioplasty ◽  
Thromboembolic Pulmonary Hypertension ◽  
The Impact

Abstract Background Chronic thromboembolic pulmonary hypertension (CTEPH) treatment has evolved over the last decade. Increasing evidence regarding new therapeutic developments has shown clinical benefit among these patients in different scenarios. However, there is scarce information about the long-term impact of these achievements in a real-life population on a national scale. We aimed to analyze the impact of current CTEPH therapies on survival in Spain. Methods We prospectively collected epidemiological, clinical and prognostic data from CTEPH patients consecutively included in the Spanish REHAP registry from January 1, 2007, to December 31, 2017. All-cause mortality data were gathered during this period. Results Eight hundred thirteen patients were included. The mean age was 61 (15) years and 58.1% were women. Out of the 813 patients, 537 (66%) were referred to an expert PH-center. Overall, 245 (30.1%) patients were selected for surgery and 52 (6.4%) for percutaneous treatment and 452 (60.5%) received medical treatment exclusively with specific PH drugs. Survival rates of patients who underwent an invasive procedure (pulmonary thrombendarterectomy or balloon pulmonary angioplasty) were remarkably high. Figure 1. Cumulative survival from date Conclusions Patients who underwent pulmonary thrombendarterectomy or balloon pulmonary angioplasty associated a better outcome. Acknowledgement/Funding We gratefully acknowledge all investigators of the REHAP Registry. We express our gratitude to Actelion, Ferrer, GlaxoSmithKline (GSK) and Merck Sharp

scholarly journals Impact of residual pulmonary obstruction on the long-term outcome of patients with pulmonary embolism

2017 ◽  
Vol 49 (5) ◽  
pp. 1601980 ◽  
Author(s):  
Raffaele Pesavento ◽  
Lucia Filippi ◽  
Antonio Palla ◽  
Adriana Visonà ◽  
Carlo Bova ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Pulmonary Hypertension ◽  
Venous Thromboembolism ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
First Episode ◽  
Long Term Outcome ◽  
Recurrent Venous Thromboembolism ◽  
Thromboembolic Pulmonary Hypertension ◽  
The Impact ◽  
Lung Scanning

The impact of residual pulmonary obstruction on the outcome of patients with pulmonary embolism is uncertain.We recruited 647 consecutive symptomatic patients with a first episode of pulmonary embolism, with or without concomitant deep venous thrombosis. They received conventional anticoagulation, were assessed for residual pulmonary obstruction through perfusion lung scanning after 6 months and then were followed up for up to 3 years. Recurrent venous thromboembolism and chronic thromboembolic pulmonary hypertension were assessed according to widely accepted criteria.Residual pulmonary obstruction was detected in 324 patients (50.1%, 95% CI 46.2–54.0%). Patients with residual pulmonary obstruction were more likely to be older and to have an unprovoked episode. After a 3-year follow-up, recurrent venous thromboembolism and/or chronic thromboembolic pulmonary hypertension developed in 34 out of the 324 patients (10.5%) with residual pulmonary obstruction and in 15 out of the 323 patients (4.6%) without residual pulmonary obstruction, leading to an adjusted hazard ratio of 2.26 (95% CI 1.23–4.16).Residual pulmonary obstruction, as detected with perfusion lung scanning at 6 months after a first episode of pulmonary embolism, is an independent predictor of recurrent venous thromboembolism and/or chronic thromboembolic pulmonary hypertension.

P5594Comparison of non-vitamin K antagonist oral anticoagulants versus vitamin K antagonist on changes in pulmonary vascular resistance in patients with chronic thromboembolic pulmonary hypertension

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Hosokawa ◽  
K Abe ◽  
H Tsutsui
Keyword(s):  
Pulmonary Hypertension ◽  
Pulmonary Vascular Resistance ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Vitamin K Antagonist ◽  
Thromboembolic Pulmonary Hypertension ◽  
Clinical Worsening

Abstract Background/Introduction Chronic thromboembolic pulmonary hypertension (CTEPH) requires a lifelong anticoagulation therapy. However, the efficacy or safety of non-vitamin K antagonist oral anticoagulants (NOACs) have not been established in CTEPH. Purpose We aimed to evaluate the effects of NOACs on the changes in pulmonary vascular resistance (PVR) and their adverse events such as bleeding and clinical worsening in CTEPH. Methods We retrospectively compared the changes in PVR among CTEPH patients taking vitamin-K antagonists (VKA) (n=38) and those taking NOACs (n=46) to evaluate the effectiveness of NOACs for the prophylaxis of thrombotic disease progression in CTEPH. Also, we extracted incidence of clinically relevant bleeding and clinical worsening in CTEPH as an exploratory outcome measures. Clinical worsening in CTEPH was defined as composite outcome of death from any cause, lung transplantation and worsening pulmonary hypertension that resulted in hospitalization, addition of specific drug for pulmonary hypertension, or rescue pulmonary endarterectomy or balloon pulmonary angioplasty. Clinically relevant bleeding was defined as composite major bleeding and/or clinically relevant non-major bleeding, which is defined as bleeding associated with the need for medical intervention, contact with a physician, interruption of anticoagulation therapy, discomfort or impairment of activities of daily life. Results The changes in PVR (VKA group; −0.17±0.82 woods unit/year, NOACs group; −0.44±0.89 woods unit/year, p=0.32) were comparable between VKA and NOACs groups. The incidence of clinical worsening in CTEPH (VKA group; 1.8% per patient-year, NOACs group; 0% per patient-year) and clinically relevant bleeding (VKA group; 2.8% per patient-year, NOACs group; 2.8% per patient-year) was comparable between the VKA and NOACs groups. D-dimer levels (VKA group; 0.58±0.22 μg/ml, NOACs group; 0.67±0.47 μg/ml, p=0.41) were also comparable between the groups. Conclusions Our study revealed that NOACs had a similar effectiveness in the prevention of thrombotic disease progression in CTEPH as compared with VKA. The result suggest that NOACs might have similar efficacy and safety as VKA in daily clinical practice. Acknowledgement/Funding Japan Agency for Medical Research and Development

Epidemiology and socioeconomic consequences of venous thromboembolism

ESC CardioMed ◽  
2018 ◽  
pp. 2747-2751
Author(s):  
Alexander T. Cohen ◽  
Marjolein P. A. Brekelmans ◽  
Carlos Martinez
Keyword(s):  
Pulmonary Hypertension ◽  
Venous Thromboembolism ◽  
Recurrent Events ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Incidence Rates ◽  
Post Thrombotic Syndrome ◽  
Disease Associations ◽  
Thromboembolic Pulmonary Hypertension ◽  
Surgical Conditions ◽  
Socioeconomic Consequences

Venous thromboembolism (VTE) is a common disease with numerous well-characterized risk factors and many different clinical manifestations. There is great variation in the epidemiology and socioeconomic impact depending on the disease associations and the site of the thrombosis. The regional rates vary and in Western countries the incidence rate for first events is in the order of 100–250 per 100,000 person-years, attack rates (new and recurrent events) are about 250 per 100,000 person-years. The annual prevalence (a cross-sectional view) is about 400 per 100,000 population. Following hospitalization for medical or surgical conditions, the rates are higher and these events contribute to around half the population attributable risk. During periods of active cancer the incidence rates are very high. Post-thrombotic syndrome complicates 20–50% of deep vein thrombosis cases and is severe in 5–10%. Chronic thromboembolic pulmonary hypertension contributes significantly to the burden of VTE. Around 0.4–4% of patients with pulmonary embolism will eventually develop chronic thromboembolic pulmonary hypertension. Incidence rates for first episodes and attack rates have been widely studied, but incidence rates of recurrent events, post-thrombotic syndrome, and chronic thromboembolic pulmonary hypertension have not and generally only the cumulative incidence has been characterized. VTE mortality is significant particularly in the first 3 months, following that it is strongly related to the underlying diseases. The socioeconomic consequences of VTE are significant with respect to disability and costs.

Treatment of venous thromboembolism with rivaroxaban in relation to body weight

2016 ◽  
Vol 116 (10) ◽  
pp. 739-746 ◽  
Author(s):  
Maria C. Vedovati ◽  
Antoni Riera-Mestre ◽  
Martin H. Prins ◽  
Katharina Mueller ◽  
Alexander T. Cohen ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Treatment Period ◽  
Major Bleeding ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards Model ◽  
Fixed Dose ◽  
Bleeding Events ◽  
Hazard Ratios ◽  
Increased Risk ◽  
Recurrent Vte

SummaryThe pharmacokinetics of oral rivaroxaban are highly predictable and only affected to a limited extent by bodyweight; therefore, dose adjustments for bodyweight are not required. However, this raises concerns among physicians for potential under- or overdosing. This substudy of the randomised EINSTEIN DVT and EINSTEIN PE trials, which compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy, aimed to determine the incidence of major bleeding in patients with a low bodyweight and recurrent venous thromboembolism (VTE) in patients with a high bodyweight during rivaroxaban or enoxaparin/VKA therapy. More than 8,000 patients with objectively diagnosed deepvein thrombosis or pulmonary embolism were included. Adjusted hazard ratios for recurrent VTE and bleeding were calculated using the Cox proportional hazards model. Analyses were performed for both the first 21 days of treatment and the whole treatment period. For rivaroxaban recipients, there was no association between bodyweight or body mass index (BMI) and risk of recurrent VTE (ptrend=0.87 and 0.62, respectively), major bleeding (ptrend=0.24 and 0.36, respectively) or clinically relevant bleeding (ptrend=0.17 and 0.63, respectively). Major bleeding events were numerically lower in rivaroxaban patients across all bodyweight and BMI categories. Hazard ratios for rivaroxaban vs enoxaparin/VKA were similar in all bodyweight and BMI categories, both during the first 21 days and the whole treatment period. The fixed-dose rivaroxaban regimen is not associated with an increased risk of major bleeding or recurrent VTE in patients with either a low or high bodyweight. A high BMI was not associated with an increased risk of recurrent VTE during anticoagulation.Note: This study was presented at the 25th Congress of the International Society on Thrombosis and Haemostasis; June, 2015, Toronto, Canada. Trial registration: EINSTEIN DVT (NCT00440193), EINSTEIN PE (NCT00439777).

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