Dataset Information

Incidence of Major Bleeding in Patients with Pulmonary Thromboembolism Treated with Fixed Dose Alteplase 100 mg.

ABSTRACT:

Background

Acute pulmonary thromboembolism (PTE) is a critical cardiopulmonary condition associated with high mortality and morbidity. In massive PTE, recently referred to as high risk PTE, the routine protocol for thrombolysis with recombinant tissue plasminogen activator (alteplase) is 100 mg over 2 hours. However, there are concerns about bleeding in patients with low body weight (< 50 kg), elderly patients, and Asians.

Method

We performed a retrospective study in patients who were diagnosed with intermediate or high risk PTE, and who were treated with a fixed dose of alteplase (100 mg) in a single center at Chungbuk National University Hospital between July 2008 and April 2018.

Results

A total of 42 patients were reviewed, 4 patients dropped out, and 38 patients were included in the analysis. There were 18 males (47.4%), and the average age of the patients was 70.68 years (± standard deviation 13.15). Major bleeding was seen in 10/38 patients (26.3%), and 30/38 patients (78.9%) were successfully discharged.

Conclusion

The major bleeding risk was higher in our study (26.3%) than in a previously published meta-analysis (9.24%). Therefore, we suggest reducing the dose of alteplase in patients who are elderly, Asian, or have cardiovascular disease. Further prospective studies of efficacy and bleeding rate after low dose alteplase should be considered.

SUBMITTER: Bae DH

PROVIDER: S-EPMC7445310 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Incidence of Major Bleeding in Patients with Pulmonary Thromboembolism Treated with Fixed Dose Alteplase 100 mg.

Bae Dae Hwan DH Lee Won Jae WJ Shin Yoon Mi YM

Journal of Korean medical science 20200824 33

<h4>Background</h4>Acute pulmonary thromboembolism (PTE) is a critical cardiopulmonary condition associated with high mortality and morbidity. In massive PTE, recently referred to as high risk PTE, the routine protocol for thrombolysis with recombinant tissue plasminogen activator (alteplase) is 100 mg over 2 hours. However, there are concerns about bleeding in patients with low body weight (< 50 kg), elderly patients, and Asians.<h4>Method</h4>We performed a retrospective study in patients who ...[more]

PMID: 32830464

Similar Datasets

Project description:BACKGROUND:Statins may reduce the risk of first and recurrent venous thromboembolism (VTE). No data are available on their potential benefit in patients treated with the oral anticoagulant rivaroxaban. METHODS:The EINSTEIN DVT/PE and EINSTEIN Extension studies compared rivaroxaban with standard of care (n=8280) and placebo (n=1188), respectively. The incidences of recurrent VTE and major bleeding per 100 patient-years for exposure (or not) to statins were calculated. A Cox proportional hazards model was constructed, stratified by index event and intended treatment duration, with statin use as a time-dependent variable, for each treatment group (rivaroxaban vs enoxaparin/vitamin K antagonist or placebo) and adjusted for relevant variables. RESULTS:In EINSTEIN DVT/PE, 1509 (18.3%) patients used statins during the at-risk period, and 6731 (81.7%) did not. Overall, 2.6 recurrent VTEs occurred per 100 patient-years with statin use compared with 3.8 per 100 patient-years without statins (adjusted hazard ratio [HR] 0.76; 95% confidence interval [CI] 0.46-1.25). HRs for recurrent VTE were similar for concomitant use of rivaroxaban-statin and enoxaparin/VKA-statin. Major bleeding events occurred in 3.0 per 100 patient-years with statin use compared with 2.3 per 100 patient-years without statins (adjusted HR 0.77; 95% CI 0.46-1.29). Due to adjustments in the Cox regression model, the direction of this HR is in contrast to the crude comparison. In EINSTEIN Extension, no recurrent VTEs occurred with statin use in the rivaroxaban group compared with 1.6 per 100 patient-years without statins. In the placebo group, 12.2 recurrent VTEs occurred per 100 patient-years with statin use compared with 13.2 per 100 patient-years without (adjusted HR 0.81; 95% CI 0.35-1.86). CONCLUSIONS:The effect of statins in this secondary analysis of the EINSTEIN VTE treatment program is consistent with other studies that suggest a reduced risk of recurrent VTE, but conclusive evidence of this benefit is lacking. Statins are simple to use, inexpensive, very safe and do not cause bleeding. Therefore, the potential effect on reducing recurrent VTE, which is in the range of that of acetylsalicylic acid, deserves evaluation in a large randomized trial. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov: EINSTEIN PE, NCT00439777; EINSTEIN DVT, NCT00440193; EINSTEIN Extension, NCT00439725.

Project description:BackgroundBleeding is the most dreaded complication of anticoagulant therapy for acute venous thromboembolism (VTE). Limited data exist about patient characteristics, time course and outcomes of major bleeding, according to the bleeding site.MethodsWe used the data from the Registro Informatizado Enfermedad TromboEmbólica (RIETE) registry (03/2001-07/2018) and identified patients who suffered from major bleeding during anticoagulation. We assessed patient characteristics, time course, and 30-day outcomes including mortality, re-bleeding, and VTE recurrences, according to bleeding site.ResultsAmong 78,136 patients with VTE receiving anticoagulation, 2244 (2.9%) suffered from major bleeding (gastrointestinal in 800, intracranial in 417, hematoma in 410, genitourinary in 222, retroperitoneal in 145; other sites in 250). There were variations in baseline characteristics, including older age (P < 0.001) and predominance of women (70.2% [95% confidence interval [CI]]: 65.6-74.6% versus 50.5%, 95% CI: 48.2-52.9, P < 0.001) in patients with hematoma, compared with other patients. Overall, 82.7% of hematomas and 81.4% of retroperitoneal bleeds occurred in the first 90 days after the diagnosis of the VTE event, compared with only 50.6% of intracranial bleeds. Across the bleeding subgroups, 30-day all-cause mortality rates were highest in patients who suffered from intracranial bleeding (41.0%; 99% confidence interval [CI]: 34.8-47.4%), and lowest in patients who suffered from hematoma (17.8%; 99% CI: 13.2-23.2%). Patients who suffered from a major bleeding event in the first 30 days after VTE had significantly higher odds at 90-day follow-up to develop mortality (including from bleeding), recurrent VTE, and recurrent major bleeding (all Ps < 0.001). Variations were observed in the results according to the bleeding site.ConclusionsMajor bleeding is a serious complication in VTE patients. Patient characteristics, time course and outcomes varied substantially according to the bleeding site. Additional studies are needed to tease out the impact of patient risk factors, treatment regimens, and a potential distinct effect from the site of bleeding.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02832245 (RIETE registry).

Dataset Information

Incidence of Major Bleeding in Patients with Pulmonary Thromboembolism Treated with Fixed Dose Alteplase 100 mg.

Background

Method

Results

Conclusion

Publications

Incidence of Major Bleeding in Patients with Pulmonary Thromboembolism Treated with Fixed Dose Alteplase 100 mg.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets