The Take Home: AHA Scientific Sessions
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The American Heart Association Scientific Sessions were held Nov. 5 to 7 in Chicago, the first time they were conducted in-person since 2019.
Healio and Cardiology Today covered the meeting on-site and spoke to a number of key opinion leaders — including Geoffrey Barnes, MD, MSc, from the University of Michigan; Cardiology Today Prevention Section Editor Roger S. Blumenthal, MD, from the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease; Martha Gulati, MD, MS, FACC, FAHA, FASPC, from Smidt Heart Institute at Cedars-Sinai; Anu Lala, MD, from Icahn School of Medicine at Mount Sinai; Cardiology Today Editorial Board Member Jagmeet P. Singh, MD, DPhil, from Massachusetts General Hospital and Harvard Medical School; and Matthew I. Tomey, MD, FACC, FSCAI, from Icahn School of Medicine at Mount Sinai — to get their assessments of the most important developments from the meeting.
Editor’s Note: All coverage from the AHA Scientific Sessions can be f ound here .
SPORT
Gulati: As we all know, sometimes our patients have more trust in supplements vs. prescription medications. It is important to be able to communicate with our patients when supplements are advertised on their label as protecting the heart or lowering cholesterol. This study found a very small dose of rosuvastatin lowered LDL and total cholesterol effectively, whereas none of the other supplements did. The percent LDL reduction with rosuvastatin was greater than all supplements and placebo (P < .001). Mean percent decrease in LDL for rosuvastatin was –37.9% (95% CI –42.1 to –33.6). The difference in LDL reduction with rosuvastatin compared with placebo was –35.2% (95% CI, –41.3 to –29.1; P < .001). None of the dietary supplements demonstrated a significant decrease in LDL compared with placebo; however, garlic showed a significant increase in LDL of 7.8% (95% CI, 1.7-13.8; P = .01).
Sometimes people think physicians have been somehow “bought” by pharmaceutical companies. Statins are generic drugs; there is nothing to gain by prescribing them. People need to understand that prescription medications are well studied. What has not been well studied to date is supplements. Supplements are not safe just because they are sold over-the-counter; they are not regulated. If I can say an alternative is available that can do something, I will guide a patient appropriately. We want to know if something our patients are taking is safe and effective. The reality is these kinds of trials are not that common, so this is a very practical trial. It is a good start.
PRECISE
Tomey: PRECISE was a well-designed, carefully executed and highly pragmatic trial in which physicians retained authority to direct care with or without the information provided by a “precision strategy” integrating the PROMISE minimal-risk score and, for elevated-risk patients, cardiac CT, with or without CT-derived fractional flow reserve (HeartFlow).
The study was well powered to detect a difference in an interesting primary composite endpoint combining death, nonfatal MI and catheterization without obstructive CAD.
Outcomes differed starkly with a precision strategy vs. usual care, with a significant 71% reduction in the primary composite endpoint (4.2% vs. 11.3%; HR = 0.35; 95% CI, 0.25-0.5; adjusted HR = 0.29; 95% CI, 0.2-0.41; P < .001; win ratio = 2.81; 95% CI, 1.36-6.41). This difference appeared to be explained by a marked reduction in catheterization without obstructive CAD (2.6% vs. 10.2%; aHR = 0.18; 95% CI, 0.12-1.3).
It is important to stipulate that this was a study of stable patients with symptomatic suspected CAD and not ACS. Chest pain is a common complaint brought by patients to their physician or cardiologist. The approach we take to evaluation of this complaint has substantial implications for patient symptoms, patient safety, patient outcomes and resource utilization. In this context, PRECISE is a trial of great importance.
One might say that the precision strategy led to more “actionable” catheterizations — there was, in fact, more revascularization in the precision strategy arm. This finding is all the more interesting when juxtaposed with the absence of evidence for reduction in death, nonfatal MI or frequent angina.
It was encouraging to see that the precision strategy led to greater utilization of medical therapies including lipid-lowering medication and antiplatelet therapy.
In summary, use of a precision strategy incorporating the PROMISE minimal-risk score and CT imaging in evaluation of symptomatic suspected CAD appears to substantially decrease the likelihood of bringing patients to the catheterization laboratory only to find no obstructive CAD.
A hypothesis-generating finding of relevance is that the precision strategy also led to greater utilization of medications that may modulate the natural history of atherosclerosis. This finding, if true, serves to bolster an argument for integration of anatomic investigations (such as CT) capable of identifying atherosclerotic plaque independent of the presence of discernible ischemia on other noninvasive tests common in usual care. The available 12-month follow-up of PRECISE might preclude recognition of longer-term benefits of such anti-atherosclerotic medical therapy.
STRONG-HF
Lala: The investigators behind the STRONG-HF study should be commended on conducting a study focused on strategy. Medical therapy for HF across the range of ejection fraction has evolved dramatically, yet we know implementation is sorely lacking. The population was more diverse than other studies at least with respect to race and gender, and two-thirds had EF less than or equal to 40%.
Compared with those in the usual care group, patients in the high-intensity care group (with uptitration of medical therapy within 6 weeks after discharge) experienced lower rates of readmission for HF or mortality at 180 days (15.2% vs. 23.3%; adjusted risk difference, 8.1 percentage points; 95% CI, 2.9-13.2; P = .0021; RR = 0.66; 95% CI, 0.5-0.86) as well as improvement in quality of life as measured by the EQ-VAS score (a more generalized [quality of life] instrument than the Kansas City Cardiomyopathy Questionnaire, which is HF-specific) and measurements of congestion including weight loss, improvement in NYHA class, jugular venous pressure, edema and natriuretic peptide levels.
The trial was stopped early due to clinical benefit seen across subgroups including EF and renal function.
This study adds undeniable evidence showing us the time is now to implement the therapies discovered to benefit our patients. This means improving equitable access to care and creating workflows to allow for the close and frequent follow-up needed following hospital discharge for HF.
PROMINENT
Blumenthal: Most of us expected that pemafibrate (Kowa Pharmaceuticals), a peroxisome proliferator-activated receptor-alpha modulator, might lower CV events in a population of patients with high triglycerides and low HDL with moderate elevations in LDL. However, that was not borne out in the PROMINENT trial of patients with type 2 diabetes and elevated triglycerides, and there was no reduction in apolipoprotein B.
The primary efficacy endpoint of nonfatal MI, ischemic stroke, coronary revascularization or death from CV causes occurred in 572 patients assigned pemafibrate (3.6 per 100 person-years) vs. 560 assigned placebo (3.51 per 100 person-years; HR = 1.03; 95% CI, 0.91-1.15; P = .67).
While there was a signal of a possible decrease in nonalcoholic fatty liver disease, there was a modest increased risk for renal events and venous thromboembolic events. So far, we have not found any significant CV event reduction from adding a fibrate to a moderate-intensity statin.
For persons with elevated triglycerides, we need to focus more on better glycemic control via better lifestyle habits and judicious use of metformin, SGLT2 inhibitors, GLP-1 receptor agonists and icosapent ethyl (Vascepa, Amarin).
PROGRESSIVE-AF
Singh: This is a terrific study that reaffirms our understanding of atrial fibrillation — that it is a progressive disorder and if left unchecked can progress from paroxysmal to persistent AF. Jason Andrade, FRCPC, MD, and colleagues followed a total of 303 patients over 3 years — half of which were randomly assigned to cryoballoon ablation and the other half to an antiarrhythmic medication.
The early follow-up of this study presented a couple of years ago had shown that cryoablation in the initial treatment of symptomatic paroxysmal AF resulted in a significant lowered recurrence of atrial arrhythmias within the first year, as compared with antiarrhythmic drug therapy alone. The current extended follow-up study for 3 years shows that these early effects of an ablation translate into better longer-term outcomes, with reduced AF recurrences and a significantly lower incidence of the development of persistent AF. There is no conjecture here, as all the patients had implanted loop recorders, capable of continuous rhythm monitoring.
During 36 months of follow-up, 1.9% of participants in the ablation group and 7.4% of participants in the drug therapy group had an episode of persistent AF (HR = 0.25; 95% CI, 0.09-0.7).
Recurrent atrial tachyarrhythmia occurred in 56.5% of participants in the ablation group and 77.2% of participants in the antiarrhythmic drug group (HR = 0.51; 95% CI, 0.38-0.67).
Median percentage of time in AF was 0% in the ablation group and 0.24% in the antiarrhythmic drug group.
At 3 years, 5.2% of participants in the ablation group and 16.8% of participants in the antiarrhythmic drug group had been hospitalized (RR = 0.31; 95% CI, 0.14-0.66).
This study goes to show that early catheter ablation can be disease-modifying, reduce progression of AF and improve the quality of life of patients. The study also shows that ablation does not completely prevent AF recurrences, with over 56.5% of the patients in the ablation group showing recurrences of atrial tachyarrhythmias over the extended 3-year follow-up. With that being said, drug therapy, even though not as effective as ablation, can still serve as a useful adjunct in the management of patients with AF. Maybe the right long-term strategy is not an either/or, but a hybrid approach with early ablation, and if needed, antiarrhythmics added later on, especially if we want to prevent the continued progression of AF over a lifetime.
BEST-CLI
Barnes: The BEST-CLI results are quite striking and important for clinical practice. When patients with chronic limb-threatening ischemia (CLTI) have a good saphenous vein conduit, that appears to be a better revascularization strategy than endovascular intervention. The benefit is driven primarily by the lower rate of repeat intervention or amputation. This echoes findings that we have seen in the coronary artery bypass arena, where the use of native vessels to bypass occluded coronary arteries is often associated with fewer repeat interventions compared with PCI.
In cohort one, consisting of 1,434 patients who had an adequate saphenous vein conduit for surgical bypass, the primary outcome of death or a major adverse limb event occurred in 42.6% of the surgery group and 57.4% of the endovascular group (HR = 0.68; 95% CI, 0.59-0.79; P < .001). In cohort two, consisting of 396 patients without an adequate saphenous vein conduit, there was no difference between the groups in incidence of the primary outcome (surgery, 42.8%; endovascular, 47.7%; HR = 0.79; 95% CI, 0.58-1.06; P = .12).
The benefit found with saphenous vein revascularization in cohort one (as compared to endovascular intervention) was not seen when alternative revascularization conduits (eg, prosthetic, nonsaphenous veins) were used. This suggests that a less-invasive approach of endovascular revascularization may be preferable for patients who do not have suitable saphenous veins.
Overall, this trial highlights the high rate of mortality and morbidity for patients with CLTI peripheral artery disease. We need to invest more effort into identifying PAD at an earlier stage and initiating treatments to prevent CLTI from developing in the first place. Further studies on how best to implement ankle-brachial index screening for at-risk patients would be of high value, especially for patients most likely to be impacted by CLTI (eg, Black patients, those with diabetes, those at lower socioeconomic status). The disparities in PAD and CLTI treatments and outcomes are a major concern.
Of note is the high burden of hypertension, hyperlipidemia and diabetes in this population. Despite being in a clinical trial, only 70% were on a statin and only two-thirds were on aspirin. We need to improve the use of medical management for patients with PAD, no matter what stage of severity. We also need to develop more therapies targeted specifically for patients with PAD that have PAD-related outcome benefits (eg, prevention of progression to CLTI, prevention of amputation or revascularization).
With regard to the quality of life data, importantly, quality of life measures before the procedure are quite low, suggesting significant morbidity for patients. However, it’s good to know that these quality of life measures all improved dramatically after intervention. While the difference in cohort one was statistically significant, I do not believe that reaches a clinical threshold. So, I would not tell a patient that they are more or less likely to get a quality of life benefit with surgical vs. endovascular revascularization. Rather, any revascularization is likely to significantly improve their quality of life.
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