Meeting Report: ACC 2013 Scientific Sessions

APRIL 01, 2013
ACC 2013 Scientific Sessions
San Francisco, CA

The American College of Cardiology’s (ACC) 62nd Scientific Sessions featured over 2100 abstracts and 22 late-breaking clinical trials across 5 sessions. More than 22,000 people attended the 3-day conference, which focused on the transformation of cardiovascular care from discovery to delivery.

Cardiology Review is highlighting 8 study presentations from ACC 2013: PEITHO, ASTRONAUT, SELECT-ACS, REMINDER, CHAMPION-PHOENIX, ACRIN PA 4005, RED-HF, and RELAX.

Reduction of Events by Darbepoetin in Heart Failure

The Reduction of Events with Darbepoetin Alfa in Heart Failure (RED-HF) trial tested darbepoetin alfa (Aranesp) in heart failure (HF) patients with anemia. This phase 3 trial started in 2006 and enrolled 2278 patients with symptomatic systolic HF and anemia. Patients were randomized in a 1:1 ratio to darbepoetin alfa or placebo. The trial was designed to evaluate whether the treatment of anemia could improve morbidity and mortality in systolic HF patients.

Results showed no difference between the treatment and placebo arms in the composite end point of time to death from any cause or first hospital admission for worsening HF (hazard ratio [HR], 1.01; 95% confidence interval [CI], 0.90-1.13). The goal in the treatment group was a target hemoglobin of at least 13.0 g/dL. The primary end point was a composite of time to death from any cause or first hospitalization for worsening HF in subjects with HF and anemia.

No new safety issues emerged in RED-HF. In June 2011 the FDA advised tailored dosing for erythropoieisis-stimulating agents in patients with chronic kidney disease (CKD) because of an increased risk of cardiovascular events. This action followed reports of an increased risk of stroke for diabetic patients with CKD who were not yet on dialysis and were taking darbepoetin (see 2009 TREAT trial:

Pulmonary Embolism Thrombolysis Study

Analysis of the Pulmonary Embolism Thrombolysis Study (PEITHO), the largest trial of thrombolysis for intermediate- risk pulmonary embolism (PE) ever done, shows that the addition of tenecteplase to standard treatment with heparin in patients with intermediate-risk PE significantly reduced the primary end point of death or hemodynamic collapse within 7 days of randomization. However, the benefit came with a significantly increased risk of major hemorrhage.

Study coauthor Stavros Konstantinides, MD, of the University of Mainz, Germany, said, “There is a price to pay, and we would not say that everybody in this group should receive thrombolysis.” He said that an analysis by age was performed, and showed that age might be an important factor. Patients less than 75 years of age had most of the benefit and a tendency toward fewer hemorrhagic strokes. Dr Konstantinides said the dose of drug that was used could be lowered in older patients, and alternative ways to deliver thrombolytics could be explored.

PEITHO was conducted in 1006 patients, mean age 70 years, in 13 countries (Europe and Israel) from 2007 to mid-2012. Patients were randomized to heparin plus placebo or heparin plus a weight-adapted bolus of tenecteplase.

The primary end point was reduced by 56% in patients treated with tenecteplase and heparin, compared with the heparin-only group (2.6% in the tenecteplase group vs 5.6% in the placebo group; P = 0.015). However, major bleeding was significantly increased with tenecteplase: 6.3% vs 1.5% in the placebo group (P <0.001). There were 10 hemorrhages in the tenecteplase group and 1 in the placebo group.

Tenecteplase is not FDA approved for acute PE. Dr. Konstantinides said further research is needed to better identify patients who will benefit most with less risk of bleeding.

PEITHO was sponsored by Assistance Publique-Hopitaux de Paris and funded by the French Ministry of Health, the German Ministry of Education and Research, and by a grant from Boehringer Ingelheim to the sponsor.

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