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ASCENT COPD Trial: Effect of Aclidinium Bromide on Major Cardiovascular Events and Exacerbations in High-Risk Patients With COPD

ASCENT COPD trial

2019, ASCENT-COPD Trial: Effect of Aclidinium Bromide on Major Cardiovascular Events and Exacerbations in High-Risk Patients With Chronic Obstructive Pulmonary Disease; The ASCENT-COPD Randomized Clinical Trial. Source: JAMA

PReVENT Trial (2018): Low vs Intermediate Tidal Volume Strategy in ICU Patients

Source: JAMA

MOPETT: Low-dose tPA for submassive PE

2013, Low-dose tPA for submassive PE, AJC

EINSTEIN PE: Rivaroxaban for Acute PE

2012, Rivaroxaban for Acute Pulmonary embolism, NEJM

FLAME: LABA + LAMA vs LABA + ICS for COPD

 

2016, Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD, NEJM

REDUCE: Short-term vs Conventional Glucocorticoid Therapy in Acute Exacerbations of COPD

 

 

2013, 5 days vs 14 days Glucocorticoid Therapy in Acute Exacerbations of COPD, JAMA

NELSON: CT Screening For Lung Cancer in High Risk Population

 

Full trial results to follow the publication. This abstract format was presented at the WCLC 2018.

EXTRA Trial: Omalizumab in Severe Allergic Asthma Visual Abstract

extra trial visual abstract on use omalizumab in allergic asthma

Omalizumab is an anti-IgE monoclonal antibody that was coined to prevent asthma exacerbations in patients with severe allergic asthma. The hypothesis was tested in the EXTRA trial in which Omalizumab was added to patients with severe allergic asthma who were already on ICS and LABA therapy. The results showed 25% relative reduction in asthma exacerbations in patients using Omalizumab compared to placebo. The above visual abstract summarizes the primary findings of the trail.

Source

WARFASA Trial: Aspirin for preventing VTE Recurrence

warfasa trial on use of aspirin for preventing venous thromboembolism recurrence

Summarized by / Author: Usama bin Nasir, MD

Contribution To Literature:

WARFASA trial established role of aspirin for prevention of recurrent VTE in patients who have completed 6-18 months course of anticoagulation and were no longer on it.

Guidelines Adaptation

According to ACCP (CHEST) Antithrombotic Therapy for VTE Disease 2016 guidelines, in patients with an unprovoked proximal DVT or PE who are stopping anticoagulant therapy and do not have a contraindication to aspirin, aspirin over no aspirin to prevent recurrent VTE (Grade 2B) is recommended.

Study Design

It was a multicenter, randomized, double-blind, placebo-controlled that took place and involved enrollment from 2004 to 2010. 403 patients were enrolled and distributed among the study groups. Median follow up period was 2 years.

 

Inclusion criteria:

  • Age ≥18 years
  • Completed therapy with 6-18 months of vitamin K antagonist for first, symptomatic, unprovoked, objectively confirmed proximal DVT, PE, or both

Exclusion criteria:

Important exclusion criteria included

  • Cancer or major thrombophilia
  • Indication for long-term anticoagulation
  • Atherosclerotic disease requiring antiplatelet therapy
  • Active bleeding

Primary outcomes:

  • Recurrent VTE was significantly decreased in patients on aspirin compared to patients on placebo. (HR 0.58; 95% CI 0.36-0.93; P=0.02)

Secondary outcomes:

  • Bleeding (4 events in each group) and death rates (HR 1.04; 95% CI 0.32-3.42; P=0.95) were similar in both groups.

Interpretation:

The WARFASA trial successfully established role of aspirin in prevention of VTE recurrence. Another trial that was done during same time period was the ASPIRE trial. The ASPIRE trial results were non-significant but the important difference between the trials was that in WARFASA all patients completed minimum of 6 months oral anticoagulation. Recurrent rates of VTE after 3-6 months of OAC for unprovoked VTE can reach up to 11% (2) once the anticoagulation is stopped therefore starting aspirin is important and carries grade 2B recommendation per CHEST 2016 guidelines.

References:

  1. Becattini C, Agnelli G, Schenone A, et al. Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med. 2012;366(21):1959-67. Source
  2. Prandoni P, et al. “The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients.”Haematologica 2007. 92(2):199-205.
  3. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest 2016;149:315-352.

ProACT Trial: Procalcitonin-Guided Antibiotics for Lower Respiratory Tract Infection

Procalcitonin has proven to be a great marker for guiding antibiotics treatment in patients with concern for lower respiratory tract infections. However, it’s not yet established how much does clinicians adhere to using the antibiotic therapy based on procalcitonin results. The ProACT trial recently got published in NEJM. It showed that despite it’s usefulness, clinicians still base their antibiotic use on clinical suspicion. Take a look at our visual abstract for the findings.

IMPACT Trial: Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD

impact trial visual abstract on single versus dual inhaler therapy in COPD

Source: NEJM

PEITHO Trial: Fibrinolysis for patients with intermediate-risk pulmonary embolism

peitho trial studied the use of fibrinolytics in intermediate risk pulmonary embolism

Source: NEJM

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