Aymara Fernandez De La Vara, MD

Clinical question: Is fecal microbiota transplantation (FMT) an efficacious and safe treatment approach for patients with recurrent Clostridium difficile infection (CDI)?

Background: FMT restores the normal composition of gut microbiota and is recommended when antibiotics fail to clear CDI. To date, only case series and open-labeled clinical trials support the use of FMT.

Study design: Randomized, controlled, double-blinded clinical trial.


Setting: Academic medical centers.

The primary endpoint was resolution of diarrhea without anti-CDI therapy after 8 weeks of follow-up. In the donor FMT group, 90.9% achieved clinical cure, compared with 62.5% in the autologous group. Patients who developed recurrent CDI were free of further disease after subsequent donor FMT.

The study included only patients who experienced three or more recurrences but excluded immunocompromised and older patients (older than 75 years of age).

Bottom line: Donor stool administered via colonoscopy was more effective than autologous FMT in preventing further CDI episodes.

Citation: Kelly CR, Khoruts A, Staley C, et al. Effect of fecal microbiota transplantation on recurrence in multiply recurrent Clostridium difficile infection: a randomized trial. Ann Intern Med. 2016;165(9):609-616.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.

Clinical question: Is fecal microbiota transplantation (FMT) an efficacious and safe treatment approach for patients with recurrent Clostridium difficile infection (CDI)?

Background: FMT restores the normal composition of gut microbiota and is recommended when antibiotics fail to clear CDI. To date, only case series and open-labeled clinical trials support the use of FMT.

Study design: Randomized, controlled, double-blinded clinical trial.


Setting: Academic medical centers.

The primary endpoint was resolution of diarrhea without anti-CDI therapy after 8 weeks of follow-up. In the donor FMT group, 90.9% achieved clinical cure, compared with 62.5% in the autologous group. Patients who developed recurrent CDI were free of further disease after subsequent donor FMT.

The study included only patients who experienced three or more recurrences but excluded immunocompromised and older patients (older than 75 years of age).

Bottom line: Donor stool administered via colonoscopy was more effective than autologous FMT in preventing further CDI episodes.

Citation: Kelly CR, Khoruts A, Staley C, et al. Effect of fecal microbiota transplantation on recurrence in multiply recurrent Clostridium difficile infection: a randomized trial. Ann Intern Med. 2016;165(9):609-616.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.

Clinical question: Is fecal microbiota transplantation (FMT) an efficacious and safe treatment approach for patients with recurrent Clostridium difficile infection (CDI)?

Background: FMT restores the normal composition of gut microbiota and is recommended when antibiotics fail to clear CDI. To date, only case series and open-labeled clinical trials support the use of FMT.

Study design: Randomized, controlled, double-blinded clinical trial.


Setting: Academic medical centers.

The primary endpoint was resolution of diarrhea without anti-CDI therapy after 8 weeks of follow-up. In the donor FMT group, 90.9% achieved clinical cure, compared with 62.5% in the autologous group. Patients who developed recurrent CDI were free of further disease after subsequent donor FMT.

The study included only patients who experienced three or more recurrences but excluded immunocompromised and older patients (older than 75 years of age).

Bottom line: Donor stool administered via colonoscopy was more effective than autologous FMT in preventing further CDI episodes.

Citation: Kelly CR, Khoruts A, Staley C, et al. Effect of fecal microbiota transplantation on recurrence in multiply recurrent Clostridium difficile infection: a randomized trial. Ann Intern Med. 2016;165(9):609-616.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.

Clinical question: How does edoxaban compare with enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing cardioversion?

Background: Studies on non–vitamin K antagonist oral anticoagulants (NOACs) for patients with nonvalvular atrial fibrillation undergoing cardioversion are limited.

Study design: Multicenter, prospective, randomized trial.

Setting: Nineteen countries at 239 study sites.

Synopsis: This trial compared edoxaban with enoxaparin-warfarin. The study was stratified by cardioversion approach, anticoagulant experience, selected edoxaban dose, and region. There were 2,199 patients, mean age was 64, mean CHA2DS2-VASc score was 2.6, and mean therapeutic time on warfarin was 70.8%.

The primary efficacy endpoint was a composite of stroke, systemic emboli, myocardial infarction, and cardiovascular mortality, which occurred in 5 (1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio, 0.46; 95% CI, 0.12-1.43).

The primary safety endpoint was major and clinically relevant nonmajor bleeding for patients receiving at least one dose of the study drug, occurring in 16 (1%) of 1,067 patients given edoxaban versus 11 (1%) of 1,082 patients given enoxaparin-warfarin (OR, 1.48; 95% CI, 0.64-3.55).

Bottom line: In patients with nonvalvular atrial fibrillation undergoing cardioversion, edoxaban had low rates of major bleeding and thromboembolism similar to enoxaparin-warfarin therapy.

Citation: Goette A, Merino JL, Ezekowitz MD, et al. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016;388(10055):1995-2003.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.

Clinical question: How does edoxaban compare with enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing cardioversion?

Background: Studies on non–vitamin K antagonist oral anticoagulants (NOACs) for patients with nonvalvular atrial fibrillation undergoing cardioversion are limited.

Study design: Multicenter, prospective, randomized trial.

Setting: Nineteen countries at 239 study sites.

Synopsis: This trial compared edoxaban with enoxaparin-warfarin. The study was stratified by cardioversion approach, anticoagulant experience, selected edoxaban dose, and region. There were 2,199 patients, mean age was 64, mean CHA2DS2-VASc score was 2.6, and mean therapeutic time on warfarin was 70.8%.

The primary efficacy endpoint was a composite of stroke, systemic emboli, myocardial infarction, and cardiovascular mortality, which occurred in 5 (1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio, 0.46; 95% CI, 0.12-1.43).

The primary safety endpoint was major and clinically relevant nonmajor bleeding for patients receiving at least one dose of the study drug, occurring in 16 (1%) of 1,067 patients given edoxaban versus 11 (1%) of 1,082 patients given enoxaparin-warfarin (OR, 1.48; 95% CI, 0.64-3.55).

Bottom line: In patients with nonvalvular atrial fibrillation undergoing cardioversion, edoxaban had low rates of major bleeding and thromboembolism similar to enoxaparin-warfarin therapy.

Citation: Goette A, Merino JL, Ezekowitz MD, et al. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016;388(10055):1995-2003.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.

Clinical question: How does edoxaban compare with enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing cardioversion?

Background: Studies on non–vitamin K antagonist oral anticoagulants (NOACs) for patients with nonvalvular atrial fibrillation undergoing cardioversion are limited.

Study design: Multicenter, prospective, randomized trial.

Setting: Nineteen countries at 239 study sites.

Synopsis: This trial compared edoxaban with enoxaparin-warfarin. The study was stratified by cardioversion approach, anticoagulant experience, selected edoxaban dose, and region. There were 2,199 patients, mean age was 64, mean CHA2DS2-VASc score was 2.6, and mean therapeutic time on warfarin was 70.8%.

The primary efficacy endpoint was a composite of stroke, systemic emboli, myocardial infarction, and cardiovascular mortality, which occurred in 5 (1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio, 0.46; 95% CI, 0.12-1.43).

The primary safety endpoint was major and clinically relevant nonmajor bleeding for patients receiving at least one dose of the study drug, occurring in 16 (1%) of 1,067 patients given edoxaban versus 11 (1%) of 1,082 patients given enoxaparin-warfarin (OR, 1.48; 95% CI, 0.64-3.55).

Bottom line: In patients with nonvalvular atrial fibrillation undergoing cardioversion, edoxaban had low rates of major bleeding and thromboembolism similar to enoxaparin-warfarin therapy.

Citation: Goette A, Merino JL, Ezekowitz MD, et al. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016;388(10055):1995-2003.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.