Our cardiologist blogger highlights PARTNER-2, HOPE-3, and sessions on women in cardiology at ACC.16.
It hardly seemed like spring-more like a very harsh Chicago winter. The wind was chilling my bones. The snowflakes clung to my eyelashes. Yet, like thousands of others who braved the weather to learn about exciting new developments in the world of cardiology, I waited patiently in the long line of taxicabs queued up to get into McCormick place. Inside, one would never have known it was a frigid 20 degrees outside. A sea of people flooded the main tent where the opening session of the scientific sessions was followed by the first in a series of very exciting late breaking clinical trials.
By far, the trial that received the most publicity, controversy, and discussion among attendees and in the press was the HOPE-3 trial. This was a large randomized controlled trial with a 2X2 factorial design (rosuvastatin 10mg vs placebo and candesartan 16 mg/HCTZ 12.5 mg vs placebo) of 12,705 participants who did not have cardiovascular disease but were at intermediate risk. Intermediate risk was defined as men over the age of 55y and women over the age of 65y with at least one additional risk factor (elevated waist-to-hip ratio, history of low level HDL-C, current or recent tobacco use, dysglycemia, family history of premature coronary artery disease, mild renal dysfunction). Looking at major adverse cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke), the blood pressure combination pill only reduced events in those with hypertension (the highest tertile of systolic blood pressure, [SBP >143.5 mmHg], a prespecified endpoint). Rosuvastatin lowered the risk of the primary endpoint by 24% (CI 0.64-0.91, p=0.002) in the overall trial. This trial resulted in not 1, not 2, but 3 NEJM articles, which were published simultaneously with the late-breaker presentation.
The data are not novel-blood pressure and cholesterol lowering are effective. But, this landmark trial’s most important contribution was its demonstration that a polypill (containing combination blood pressure and cholesterol lowering agents) could result in high rates of compliance and a lowering of adverse cardiovascular events.
Another late breaking clinical trial that had standing room only was the intermediate risk TAVR group or PARTNER 2 trial. This trial randomly assigned 2032 intermediate-risk patients (as defined by STS score of at least 4%) to TAVR or surgical replacement (SAVR) with a primary endpoint, at 2 years, of death from any cause or disabling stroke. The study was powered for noninferiority and TAVR was similar to surgical AVR in these patients (P=0.001). TAVR resulted in larger aortic-valve areas and lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. By demonstrating non-inferiority of TAVR to SAVR in lower risk patients, the late breaking trial sets the stage for a change in our current guidelines-that is expanded indications for TAVR to patients at lower surgical risk than ever before.
Copyright Aila Images/Shutterstock.comTo take a break from the hustle and bustle of the main tent and the overflowing expo hall, I headed to the Women in Cardiology session. This year, I had the honor of co-chairing the session with such well-known women in cardiology as Dr. Athena Poppas (the chair of the scientific sessions program committee) and Dr. Sarah Clarke (the president of the British Cardiovascular Society). One of the most striking presentations was by Dr. Pamela Douglas (past president of the ACC), which highlighted the disparities in the U.S. between male and female cardiologists’ practice patterns and salaries. Women were much more likely to be specialized in general/noninvasive cardiology (53% vs. 28%) and less likely to be in an interventional subspecialty with an independent association between sex and lower salary. Statistical modeling showed that the mean salary for women was approximately $32,000 lower than what was actually observed. Another fascinating presentation by Dr. Cindy Grines, an interventional cardiologist, highlighted the trials and tribulations of being a female interventionalist in an era where only 2.8% of all percutaneous coronary interventions are performed by women in the subspecialty.
I spent the rest of my time between sessions meeting old mentors and catching up with friends from fellowship whenever I could spare a minute. As I left the windy city for Denver, Colorado on the last day of the meeting, I was happy to be going back to spring blossoms and clear skies. I was even happier, however, to have attended a meeting so full of great science. And, I know I wasn’t the only one-I heard many people murmuring to themselves, “The program this year is one of the best we have had at the ACC!”
Yusuf S, Lonn E, Pais P, et al, for the HOPE-3 investigators. Blood-pressure and cholesterol lowering in persons without cardiovascular disease. April 2, 2016 DOI: 10.1056/NEJMoa1600177
Leon MB, Smith CR, Mack MJ, et al for the PARTNER 2 Investigators. Transcatheter or surgical aortic valve replacement in intermediate-risk patients. NEJM. April 2, 2016. DOI: 10.1056/NEJMoa1514616 http://www.nejm.org/doi/full/10.1056/NEJMoa1514616#t=articleBackground