This year’s scientific sessions of the American Heart Association (AHA) have been disruptive to common dogma. The Presidential Address was preceded by select songs from the Broadway musical, Hamilton. Not surprising, one of the song’s lyrics, “I want to be in the room where it happens,” caught my attention. We all want to be where the discussions are happening and that is precisely what the current President of AHA was keen to ensure. There was diversity in the program and faculty. In particular, early career professionals and women were well represented and had a seat at the table. More than that, conventionally, AHA focused on basic sciences. This year there was emphasis on clinical cardiology as well with the presentation of much anticipated late breaking clinical trials (LBCT) like ISCHEMIA, Impella and IABP in acute myocardial infarction and shock, GALILEO and RECOVERY studies.
The details of these trials were divulged through multiple platforms including social media, blogs and society websites. We read commentaries from reputable thought leaders such as the statement released by the President of the Society of Cardiovascular Angiography and Interventions (SCAI) regarding the ISCHEMIA trial. Each of these LBCT, however, heralded another important concept that Dr. Bob Harrington highlighted in his speech, evidence matters. For a change, filling in the evaluation forms at the conclusion of the sessions meant something more to me as a clinical cardiologist and weren’t just part of the routine to obtain my CME credits.
- ISCHEMIA Trial: $100 million was spent to tell many of us what we already knew. Revascularization in stable disease does not reduce hard endpoints. So, why spend all that money? The answer was simple. We now have robust evidence to quote to referring physicians and patients telling them that optimal medical therapy (OMT) works just as well. Central to this are the numerous referrals to revascularize coronary arteries in otherwise asymptomatic patients before non-cardiac surgery. It also brought into focus the meaning of OMT which extends beyond anti-angina. It should include disease modifiers like more stringent lipid lowering agents, antiplatelet agents and better control of diabetes. Examining the data furnished by the investigators, it was disappointing to learn that OMT outside North America was in fact poor. Finally, core lab adjudication of every piece of information from EKG to angiograms set a new standard for research.
- IMPELLA vs IABP in Acute Myocardial Infarction with Cardiogenic Shock Study: I was trained in Michigan, hometown to General Motors and CHIP (Complex High Risk Percutaneous Interventions). My patients often need mechanical circulatory support. Yet, reviewing the results of this observational study that extracted data from the NCDR registry revealed more bleeding and deaths in the Impella arm. I want to help my patients as do all other CHIP operators. Given these results, I had to question practice not guided by evidence. At this point the nuances of registry data don’t permit solid recommendations. It may help. It may harm. We are in desperate need for a well-executed and funded randomized study.
- GALILEO Trial: This trial examined the role of Rivaroxaban comparted to dual anti-platelet therapy in patients who have undergone trans-catheter aortic valve replacement (TAVR). There were higher bleeding events and higher thromboembolic events in the Rivaroxaban arm. With the premature termination of this trial, we are at a loss to what the ideal treatment of patients after TAVR. The data behind the use of dual anti-platelet agents is weak. We know all novel anti-coagulants are safer than the vitamin K antagonists, but we don’t know if we can use them for atrial fibrillation in patients post-TAVR. Why? The most notable difference is the mean age in GALILEO was 80 years which is much higher than that in ROCKET AF. Once again, we need the evidence to guide practice in the elderly which is lacking on many fronts especially with regards to anticoagulation.
- RECOVERY Study: This study demonstrated an improved survival out to 8 years in those with asymptomatic very severe aortic stenosis who undergo surgical aortic valve replacement. Can these results be extended to TAVR? I remain optimistic, but I know we need the evidence and that is expected to reach completion in 2021.
Finally, I am a clinician. I want to be in the room where it happens for my patients. They deserve best practices guided by evidence…Yes Mr. President, evidence matters.
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