Pulmonary Embolism Thrombolysis Treatment and Its Complications JAMA

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This clinical investigation that was published in The Journal of the American Medical Association (JAMA) on June 18, 2014, was a collaboration of efforts from PubMed, the Cochrane Library, EMBASE, EBSCO, Web of Science, and CINAHL since its inception from April 10, 2014. The goal of the study was to determine the risks and complications involved with thrombolytic therapy compared with anticoagulation in acute pulmonary embolism.

Complexity

Pulmonary embolism (PE) is an important cause of morbidity and mortality with more than 100,000 US cases annually and as many as 25% of patients presenting with sudden death. Pulmonary embolism is associated with increased mortality rates for up to 3 months after the index PE event. Multiple studies and meta-analyses have evaluated the role of thrombolytic therapy in PE with largely discordant results.

Several recent trials have evaluated the role of thrombolytics in PE for the patients without definitive results, particularly for the end-point of mortality. Thus, this clinical investigation performed a meta-analysis of all randomized trials of thrombolytic therapy in PE. It aimed to ascertain associations of thrombolytic therapy with bleeding risk and potential mortality benefits, with special attention paid to the subpopulation of patients presenting with intermediate-risk PE.

**Study Selection**
Eligible studies were randomized clinical trials comparing thrombolytic therapy vs anticoagulant therapy in pulmonary embolism patients. Sixteen trials comprising 2115 individuals were identified. Eight trials comprising 1775 patients specified inclusion of patients with intermediate-risk pulmonary embolism.

**Main Outcomes and Measures**
The primary outcomes were all-cause mortality and major bleeding. Secondary outcomes were risk of recurrent embolism and intracranial hemorrhage (ICH). Peto odds ratio (OR) estimates and associated 95% CIs were calculated using a fixed-effects model.

**Data Analysis**
Associations with lower mortality were derived largely from use of thrombolytics for patients with intermediate-risk PE in the contemporary era (2009-2014). In intermediate-risk pulmonary embolism trials, thrombolysis was associated with lower mortality and more major bleeding events.

In a subgroup analysis of patients older than 65 years, there was a nonsignificant association with lower mortality, however, there was an association with greater risk of major bleeds for the same subgroup.

Date Created

2014-04-10

Last Modified

2014-06-18

Version

2014-06-18

Update Frequency

Never

Temporal Coverage

1970-2014

Spatial Coverage

United States

Source

John Snow Labs => The Journal of the American Medical Association (JAMA)

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

PubMed, the Cochrane Library, Excerpta Medica dataBASE (EMBASE), EBSCO, Web of Science, Cumulative Index to Nursing and Allied Health Literature (CINAHL)

Keywords

Thrombolytic Therapy, Thrombolytics, Treatment of Pulmonary Embolism, Thrombolytic Agents, Pulmonary Embolism Complications, Anticoagulant Long-term Management, Pulmonary Embolism Treatment, JAMA Studies, Long-term Oral Anticoagulation Therapy, Anticoagulant Therapy Outcomes

Other Titles

Thrombolytic Therapy for Pulmonary Embolism and Its Complications, Thrombolytics Treatment for Pulmonary Embolism and Its Complications, Thrombolysis Treatment of Pulmonary Embolism and Its Complications, Thrombolytics Agent for Pulmonary Embolism and Its Complications, Thrombolysis Treatment for Pulmonary Embolism Complications

NameDescriptionTypeConstraints
Outcome_of_InterestDescription of the risk outcomes or complications from the use of Thrombolytics or Anticoagulant agents.stringrequired : 1
Number_of_Studies_ReportingDescription of the number of studies reported.integerrequired : 1 level : Ratio
Number_of_Events_Thrombolytic_GroupDescription of the number of outcome events that took place for the patients that received the Thrombolytics.integerrequired : 1 level : Ratio
Number_of_Patients_Thrombolytic_GroupDescription of the number of patients who received the Thrombolytics agents.integerrequired : 1 level : Ratio
Percentage_of_Absolute_Event_Rate_Thrombolytic_GroupDescription of the total or absolute outcome event rate from the patients who received the Thrombolytics agent.numberrequired : 1 level : Ratio
Number_of_Events_Anticoagulant_GroupDescription of the number of outcome events that took place for the patients that received the Anticoagulants.integerrequired : 1 level : Ratio
Number_of_Patients_Anticoagulant_GroupDescription of the number of patients who received the Anticoagulant agents.integerrequired : 1 level : Ratio
Percentage_of_Absolute_Event_Rate_Anticoagulant_GroupDescription of the total or absolute outcome event rate from the patients who received the Anticoagulant agent.numberrequired : 1 level : Ratio
Number_Needed_to_TreatDescription of the dosage required to achieve the therapeutic effect of either the thombolytic or anticoagulant agent.integerlevel : Ratio
Number_Needed_to_HarmDescription of the dosage required to reach the adverse effects of either the thombolytic or anticoagulant agent.integerlevel : Interval
ProbabilityDescribes the null hypothesis value that is defined as the probability of obtaining a result equal to or "more extreme" than what was actually observed.string-
Outcome_of_InterestNumber_of_Studies_ReportingNumber_of_Events_Thrombolytic_GroupNumber_of_Patients_Thrombolytic_GroupPercentage_of_Absolute_Event_Rate_Thrombolytic_GroupNumber_of_Events_Anticoagulant_GroupNumber_of_Patients_Anticoagulant_GroupPercentage_of_Absolute_Event_Rate_Anticoagulant_GroupNumber_Needed_to_TreatNumber_Needed_to_HarmProbability
Major Bleeding169810619.243610543.4218<.001
All-cause Mortality162310612.174110543.89590.
Intracranial Hemorrhage (ICH)151510241.46210190.19780.
Intracranial Hemorrhage (ICH)151510241.46210190.19780.
Intracranial Hemorrhage (ICH)151510241.46210190.19780.
Intracranial Hemorrhage (ICH)151510241.46210190.19780.
Intracranial Hemorrhage (ICH)151510241.46210190.19780.
Intracranial Hemorrhage (ICH)151510241.46210190.19780.
Intracranial Hemorrhage (ICH)151510241.46210190.19780.
Intracranial Hemorrhage (ICH)151510241.46210190.19780.