Trial Files Throwback: Why don't we target a hemoglobin of 130 g/L in CKD? Why don't we do Swans anymore? And how long should we monitor for afib post cryptogenic stroke?!

Oct 6, 2025

Join us on November 5th, 2025, from 4-5 pm for a free crash course on acute kidney injury.

Speaker details: Dr. Mike Fralick is a Clinician Scientist who works in Toronto and Sault Ste. Marie.

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Why is targeting a hemoglobin of 130 g/L a bad idea for CKD?

A Trial of Darbepoetin Alfa in T2DM and CKD

The TREAT Trial. NEJM (November 2009)

Bottom Line: This randomized clinical trial evaluated the impact of darbepoetin alfa on clinical outcomes in 4,038 patients with type 2 diabetes, chronic kidney disease, and anemia across 623 sites in 24 countries. Participants were assigned to darbepoetin (target hemoglobin ~13 g/dL) or placebo with rescue therapy if hemoglobin fell below 9.0 g/dL. Over a median follow-up of 29.1 months, the composite outcome of death or cardiovascular event occurred in 31.4% of the darbepoetin group and 29.7% of placebo (hazard ratio 1.05, 95% CI 0.94–1.17, P=0.41), and death or ESRD in 32.4% vs. 30.5% (hazard ratio 1.06, 95% CI 0.95–1.19, P=0.29). Stroke risk was significantly higher with darbepoetin (5.0% vs. 2.6%; hazard ratio 1.92, 95% CI 1.38–2.68, P<0.001).

LINK TO ARTICLE (TREAT)


Why is a Swan catheter generally a bad idea for patients hospitalized with heart failure?

Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness

The ESCAPE Trial. JAMA (October 2005)

Bottom line: This randomized clinical trial evaluated the effect of pulmonary-artery catheter (PAC)–guided therapy versus clinical assessment alone on outcomes in patients hospitalized with severe symptomatic and recurrent heart failure across 26 centers in the United States and Canada. A total of 433 participants were assigned to PAC-guided management (n=215) or clinical assessment alone (n=218) (mean age, 56 years; 73% men; mean ejection fraction 19%). The primary outcome was days alive and out of hospital during 6 months of follow-up, with a mean of 133 days in the PAC group and 135 days in the clinical-assessment group (HR, 1.00 (95% CI, 0.82–1.21; P = .99)). Mortality occured in 43 patients vs 38 patients (OR, 1.26 (95% CI, 0.78-2.03; P = .35). Adverse events occurred more frequently with PAC use (47 [21.9%] vs 25 [11.5%]; P = .04) The investigators concluded that routine use of PAC did not improve survival or reduce rehospitalization, but was associated with increased complications.

LINK TO ARTICLE (ESCAPE)


For patients with cryptogenic stroke, what is the benefit of 30 day monitoring for afib?

Atrial Fibrillation in Patients with Cryptogenic Stroke

The EMBRACE Trial. NEJM (June 2014)

Bottom Line: This randomized clinical trial evaluated whether 30-day monitoring with an event-triggered recorder (intervention group) increases detection of atrial fibrillation in patients with cryptogenic stroke compared to a conventional 24-hour monitor (control group). A total of 572 participants with cause-undetermined cryptogenic stroke, without known AF, were randomized. The primary endpoint was newly detected atrial fibrillation lasting 30 seconds or longer within 90 days after randomization. The primary endpoint was detected in 45 of 280 patients (16.1%) in the intervention group, as compared with 9 of 277 (3.2%) in the control group (absolute difference, 12.9 percentage points; 95% confidence interval [CI], 8.0 to 17.6; P<0.001; number needed to screen, 8). The investigators concluded that noninvasive ambulatory ECG monitoring for a target of 30 days markedly increases the yield of AF detection after cryptogenic stroke versus standard practice of short-duration ECG monitoring.

LINK TO ARTICLE (EMBRACE)


Trial Files Issue #2025-21