Brigham and Women’s Hospital was well-represented at this year’s American Heart Association (AHA) Scientific Sessions, Nov. 16 to 20, in Dallas through various presentations, late-breaking clinical trials and awards. In addition, Eliott Antman, MD, senior investigator in the Thrombolysis in Myocardial Infarction (TIMI) Study Group, AHA president elect, will be inducted as AHA president in summer 2014.
There were a handful of late-breaking clinical trials that attracted the attention of cardiologists and media alike. A major trial, known as ENGAGE AF-TIMI 48, showed that high- and low-dose edoxaban were at least as effective in preventing stroke or systemic embolism (blood clot), while significantly reducing bleeding and cardiovascular death, compared to warfarin.
“Our study findings represent good news for patients and health care providers,” said Robert Giugliano, MD, SM, FACC, FAHA, BWH Cardiovascular Division, lead study author. “We believe that once-daily edoxaban represents a new, effective, safe and convenient treatment to prevent stroke for many patients with atrial fibrillation, with the benefits of less bleeding and cardiovascular death, compared to standard therapy with warfarin.”
Led by the BWH TIMI Study Group and Harvard Medical School, the study was the largest (21,105 participants) and longest (2.8 years average follow-up) trial of a novel anticoagulant to date in patients with atrial fibrillation (irregular heart rate).
Researchers recruited participants with atrial fibrillation who were at moderate-to-high risk for stroke. The trial was conducted at 1,393 centers in 46 countries. The primary goals of the study were to assess the combined outcome of stroke or systemic embolism (primary efficacy outcome), as well as bleeding.
During the treatment period, the rate of stroke or systemic embolism was 1.50 percent per year for participants on warfarin, and 1.18 percent per year for those on high-dose edoxaban. This represents a 21 percent reduction in the risk of stroke or systemic embolism with high-dose edoxaban compared to warfarin.
Moreover, annualized rates of major bleeding were 3.43 percent with warfarin and 2.75 percent with high-dose edoxaban, representing a 20 percent reduction in bleeding. There were also fewer cardiovascular deaths with edoxaban compared to warfarin: high-dose edoxaban 2.74 percent per year compared to warfarin 3.17 percent per year.
Another study, known as the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial, demonstrated that spironolactone did not reduce the primary outcome of cardiovascular death, heart failure hospitalization, nor surviving a cardiac arrest in patients with heart failure and preserved ejection fraction (pump function). However, it did reduce the major burden faced by these patients—the risk of repeated hospitalizations for heart failure.
The TOPCAT trial, led by a clinical research team under the direction of Marc A. Pfeffer, MD, PhD, BWH Division of Cardiovascular Medicine, Department of Medicine, in collaboration with the New England Research Institutes, is the first randomized, double-blind trial to assess the effect of spironolactone on clinical outcomes in these patients with heart failure and preserved ejection fraction.
The trial enrolled 3,445 participants from 270 medical centers in six countries. Patients randomized to spironolactone were less likely to be hospitalized for heart failure compared to those on placebo. At the end of the study, 206 out of 1722 patients on spironolactone (12 percent) had been hospitalized for heart failure, compared to 245 of 1723 patients (14 percent) given placebo. There were no statistically significant differences between the groups in deaths or hospitalizations from any cause.
“When treating our patients, clinicians are always balancing risks and benefits,” said Akshay S. Desai, MD, MPH, advanced heart failure specialist, BWH Division of Cardiovascular Medicine, Department of Medicine, study author. “The results of TOPCAT will help inform clinicians as they make treatment decisions for this understudied population.”
In addition to significant studies, BWHers made their presence known at the AHA Scientific Sessions through a slew of honors:
Annarosa Leri, MD, BWH Department of Anesthesiology, Perioperative and Pain Medicine, and BWH Division of Cardiovascular Medicine, presented the George E. Brown Memorial Lecture. Established in 1935, the George E. Brown Memorial Lecture was created to honor the memory of Brown, who was part of one of the small groups that was responsible for the formation of the AHA Section for the Study of the Peripheral Circulation, and was elected the first Chairman of the Section.
Marc Pfeffer, MD, PhD, BWH Division of Cardiovascular Medicine, Department of Medicine was presented with the James B. Herrick Award—the Council on clinical Cardiology’s highest honor. The annual award is given to a physician whose scientific achievements have contributed profoundly to the advancement and practice of clinical cardiology. In bestowing the award, the council noted that Pfeffer’s discoveries “have transformed the treatment of heart disease worldwide.”
Paul Ridker, MD, director, BWH Center for Cardiovascular Disease Prevention, was the recipient of the Distinguished Scientist Award, which the AHA annually presents to a prominent scientist whose contributions to research have advanced the understanding of cardiovascular disease and stroke. Prior to this award, Ridker was named the recipient of both a Clinician Scientist Award (1992-1997) and an Established Investigator Award (1997-2002) by the AHA. Jonathan Seidman, MD, was also a recipient of the Distinguished Scientist Award. Seidman is the Henrietta B. and Frederick H. Bugher Professor of Cardiovascular Genetics at Harvard Medical School. Along with Christine Seidman, MD, he co-runs the Seidman Laboratory, located within the Department of Genetics at Harvard Medical School and the Cardiovascular Division of BWH.