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Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018
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Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
A major overhaul of cholesterol clinical practice guidelines, including the first concrete guidance on the use of PCSK9 inhibitors, greeted attendees at the American Heart Association (AHA) Scientific Sessions 2018, held November 10 to 12 in Chicago.
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
This year, the AHA moved to a leaner 3-day format but maintained a full line-up of clinical trial findings. Among the key presentations this year:
New Guidance on Management of Blood Cholesterol
REDUCE-IT: 'A New Era' in CVD Prevention With High-Dose EPA
VITAL: No CVD or Cancer Benefit From Vitamin D, Omega-3
New Guideline on Physical Activity for Americans as Young as 3
TRED-HF: Drug Withdrawal Inadvisable in 'Recovered' Dilated Cardiomyopathy
DECLARE-TIMI 58: Dapagliflozin Cuts Heart Failure in Diabetes
ODYSSEY OUTCOMES: Alirocumab Cost-effective at $6000 a Year
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
New AHA/ACC Cholesterol Guideline Expands Role of LDL Targets
The AHA/American College of Cardiology (ACC) 2018 guideline on the management of blood cholesterol preserves key ideas from the original guideline put forth in 2013 and puts renewed focus on cherished principles that had been given a back seat in 2013. The update also provides clear guidance on the use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, namely evolocumab (Repatha) and alirocumab (Praluent). The 2018 guideline retains one of the most controversial innovations of the 2013 document — a scoring system for 10-year atherosclerotic cardiovascular disease (ASCVD) risk — but has modified it to include more population-based data than before. But more fundamentally, it seems to slash the ASCVD risk calculator's influence as a trigger for statin therapy. The AHA/ACC 2018 guideline on the management of blood cholesterol, endorsed by at least 10 other medical societies, was published in the Journal of the American College of Cardiology and in Circulation to coincide with release here at the AHA sessions.
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
REDUCE-IT: 'A New Era' in CVD Prevention With High-Dose EPA
Final results of the REDUCE-IT trial show that a high-dose purified form of the omega-3 oil, eicosapentaenoic acid (EPA), in patients with elevated triglycerides who have CVD or diabetes and one other risk factor has significant benefit. The EPA product used in the study was icosapent ethyl (Vascepa). Previously reported top-line results showed a 25% relative risk reduction in major adverse cardiovascular events. "The 25% reduction in the primary end point revealed previously is itself very impressive, but now we are reporting detailed results showing large consistent reductions on multiple end points and statistics which show that these results are extremely statistically significant and robust," said lead author Deepak Bhatt, MD, Brigham and Women's Hospital, Boston. "The primary end point had a P value of .00000001 — that is seven zeros. And the key secondary end point of hard events CV death/MI/stroke was .0000001 — that is six zeros," Bhatt said. "I've never seen that degree of statistical significance before in all my years of doing clinical trials, so nobody can say this is the play of chance. This is a great outcome for patients and should definitely change clinical practice going forward."
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
VITAL: No CVD or Cancer Benefit From Vitamin D, Omega-3
More research finds no significant benefit from vitamin D supplementation for the prevention of CVD or cancer, and little benefit from omega-3 supplements, as both therapies missed their primary end points. The Vitamin D and Omega-3 Trial (VITAL) is one of the largest randomized, placebo-controlled trials to examine these associations in a diverse population. The two primary outcome measures were invasive cancer of any type and major CV events. Neither the participants who received vitamin D3 at 2000 IU per day nor those who received 1 g of marine n-3 fatty acids (omega-3) per day showed a significantly lower incidence of either outcome over 5 years of follow-up compared with those receiving placebo. Based on past research, these findings weren't that surprising, said lead author JoAnn Manson, MD, Brigham and Women's Hospital and Harvard Medical School, Boston. The news was a bit more optimistic for some of the secondary outcomes, with a 28% reduction in risk for MI alone in the full group receiving omega-3 and a 77% reduction in MI risk among black participants in the omega-3 group. There was also "a signal for reduction in cancer death" for the participants who received vitamin D, said Manson.
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
New HHS Guideline on Physical Activity for Americans
The second edition of the Physical Activity Guidelines for Americans were unveiled here. The document includes, for the first time, recommendations on physical activity for those starting as young as 3 years of age, and reviews the evidence supporting a variety of newly established benefits of physical activity across a variety of populations. "Our overarching vision is to transform the present sick care system into a health-promoting system," said Admiral Brett Giroir, MD, Assistant Secretary for Health, US Department of Health and Human Services. "The new guideline is a unique opportunity to implement this vision directly to affect every single person across the country." The new recommendations first advocate simply "moving more and sitting less," Giroir said. One change aims to make meeting the guidelines easier by removing the assertion in the previous guideline that only activity in at least 10-minute increments would count toward the 150- to 300-minute goal, he noted. "The new guidelines demonstrate based on the best science, everyone can dramatically improve their health just by moving, anytime, anywhere, and by any means that get you active."
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
TRED-HF: Drug Withdrawal Inadvisable in 'Recovered' Dilated Cardiomyopathy
Withdrawal of heart failure drug therapy from patients deemed to have "recovered" from dilated cardiomyopathy resulted in a relapse rate of 40% in the TRED-HF study. The study involved 51 patients with a previous diagnosis of nonischemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) of 40% or less, who were being treated with at least one HF medication and who had a current LVEF of 50% or greater and a left ventricular end diastolic volume indexed to body surface area within normal range, no HF symptoms, and plasma N-terminal pro B-type natriuretic peptide (NT-pro-BNP) concentration below 250 ng/L. "Our results suggest that improvement in function in patients with dilated cardiomyopathy represents remission rather than permanent recovery, and that withdrawal of therapy should not usually be attempted until predictors of relapse are defined, there is a better understanding of the importance of specific therapies, and monitoring is in place," said lead investigator Brian Halliday, PhD, Imperial College London. "In answer to our question of whether we can withdraw therapy in these patients, our advice is 'don't do it'," Halliday added.
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
DECLARE-TIMI 58: Dapagliflozin Cuts Heart Failure in Diabetes
Dapagliflozin (Farxiga/Forxiga) showed a nonsignificant trend toward a reduced rate of major adverse cardiac events (MACE) but significantly reduced hospitalization for heart failure in the DECLARE-TIMI 58 trial in patients with type 2 diabetes. "What we're seeing in this trial is a similar theme to other major trials of sodium glucose cotransporter-2 (SGLT2) inhibitors — a significant reduction in heart failure hospitalization and renal events," said lead author Stephen Wiviott, MD, Brigham and Women's Hospital and Harvard Medical School, Boston. "DECLARE-TIMI 58, however, differs from the other [cardiovascular outcomes] trials in that it enrolled a much broader and healthier population, including 10,000 patients without pre-existing cardiovascular disease but with multiple risk factors, as well as 7000 patients with pre-existing cardiovascular disease."
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
CIRT: Methotrexate Fails to Cut CV Events in Secondary Prevention
Low-dose methotrexate proved no better than placebo at reducing key inflammatory markers or CV events in high-risk patients on statin therapy with stable atherosclerosis in the prematurely halted Cardiovascular Inflammation Reduction Trial (CIRT). Observational data suggesting fewer CV events in patients with arthritis raised hopes that the generic, anti-inflammatory drug might deliver similar effects as the more costly monoclonal antibody canakinumab (Ilaris). In the CANTOS trial, canakinumab tamped down inflammation by targeting interleukin (IL)-1β and reduced MACE and lung cancer. Yet when the same trialists randomly assigned a similar set of more than 4000 patients in CIRT, 170 patients on methotrexate and 167 patients on placebo had a nonfatal MI/stroke or CV death (P = .91). Patients treated with methotrexate also had an unexpected increase in cancers, primarily nonbasal cell skin cancer (31 vs 10 events; P = .002). "To find out at the end of this study that low-dose methotrexate did not lower what we believe to be a critical pathway in atherosclerosis, the IL-1 to IL-6 pathway, but also did not lower cardiovascular event rates for me is a very informative negative control," said chief investigator Paul Ridker, MD, Brigham and Women's Hospital and Harvard University, Boston.
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
ODYSSEY OUTCOMES: Alirocumab Cost-effective at $6000 a Year
Treatment with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab (Praluent) is cost-effective at $6319 a year when the willingness-to-pay threshold is the generally accepted $100,000 per quality-adjusted life-year (QALY), according to cost-effectiveness findings for alirocumab, based on data from the ODYSSEY OUTCOMES trial. "My hope is that this analysis might move the needle and provide evidence for what the cost should be, as opposed to just pricing drugs based on what the market might tolerate," said Deepak Bhatt, MD, Brigham and Women's Hospital Heart and Vascular Center, Boston. Research should "see what the value is, and that's what the price should be — not higher," he added. Currently, pricing of the two PCSK9 inhibitors approved by the US Food and Drug Administration — alirocumab and evolocumab (Repatha) — is far from transparent, he noted. Amgen recently lowered the list price of evolocumab by 60%, from more than $14,000 a year to $5850 a year. Alirocumab currently costs between $4500 and $8000 per year, but the actual price is "very opaque" because of hidden rebates, said Bhatt.
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
PIONEER-HF: In-Hospital ARNI Shows Biomarker Benefit vs ACE-I
Findings from the PIONEER-HF trial bolster support for the strategy of initiating sacubitril/valsartan (Entresto) in stabilized patients who had presented with acute decompensated HF, regardless of previous angiotensin-converting-enzyme (ACE) inhibitor use or previous HF diagnosis, said Eric Velazquez, MD, Yale University, New Haven, Connecticut, after unveiling the results. In the trial, levels of a prognostically important biomarker fell quickly after the stabilized patients were started in hospital on either sacubitril/valsartan or enalapril. But the drop in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, sustained for the trial's 8 weeks, was significantly deeper in the group on sacubitril/valsartan. That newer angiotensin receptor-neprilysin inhibitor (ARNI) also showed no signs of being less safe than the venerable ACE inhibitor in this setting. In an exploratory analysis, the risk for rehospitalization for HF significantly declined in the sacubitril/valsartan group, compared with the enalapril group, during the 8-week study, although it wasn't powered for clinical outcomes.
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
REGROUP Lifts Cloud Over Endoscopic Vein Harvesting for CABG
In the hands of experts, there was no difference in rates of major adverse cardiac events between endoscopic vein-graft harvesting and open vein-graft harvesting nearly 3 years after on-pump coronary artery bypass surgery (CABG) in the Randomized Endo-Vein Graft Prospective (REGROUP) trial. The primary end point of death, MI, or revascularization occurred in 13.9% of patients with endoscopic vein harvesting (EVH) and in 15.5% of patients with open vein harvesting (OVH) at a median follow-up of 2.78 years (hazard ratio [HR], 1.12; 95% confidence interval [CI], 0.83 - 1.51; P = .47). Rates were lower with EVH for the individual components of death (6.4% vs 8%), MI (4.7% vs 5.9%), and revascularization (5.4% vs 6.1%). As expected, patients also experienced fewer harvest-site complications. "Endoscopic harvest performed by an expert may be considered the preferred vein harvesting modality," said Marco Zenati, MD, Veterans Affairs Boston Healthcare System and Harvard Medical School, Boston.
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
A yoga-based cardiac rehabilitation program was safe and improved quality of life after MI but fell short of offering significant clinical gains in a randomized trial from India. Yoga is becoming more popular all over the world and has the potential to become a low-cost alternative to conventional rehabilitation programs, said study author Dorairaj Prabhakaran, MD, DM, Centre for Chronic Disease Control, New Delhi. "In the United States, the minority population, women, and the elderly actually do not take up conventional rehabilitation because they find it difficult, particularly the physical activity component," he said. "So we can introduce some of the gentler poses, meditation, and breathing exercises, which they might find more acceptable."
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
Empagliflozin May Reduce LV Mass in Patients With CVD, Diabetes
Treatment with the SGLT2 inhibitor empagliflozin (Jardiance) is associated with beneficial effects on left ventricular (LV) structure and function in patients with stable CVD and type 2 diabetes, new research suggests. The results might provide some insight into why previous studies have shown a positive association between SGLT2 inhibition and heart failure (HF) outcomes, the investigators note. The randomized EMPA-Heart Cardiolink-6 trial, which involved almost 100 patients, showed significantly reduced LV mass in those who received empagliflozin 10 mg/day for 6 months, compared with those who received matching placebo. The oral drug was also associated with a significant reduction in systolic blood pressure and an increase in hematocrit levels. "These benefits were seen in a normotensive population, with preserved ejection fraction, without known heart failure, and on top of standard-of-care therapies," lead author Subodh Verma, MD, St. Michael's Hospital and University of Toronto, told attendees during a late-breaking science session.
Image courtesy of Phillip Cuculich, MD
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
ENCORE-VT Takes Noninvasive VT Ablation to Next Level
The nascent field of stereotactic radiation for ventricular tachycardia (VT) took a significant step forward with the prospective phase 1/2 ENCORE-VT study, confirming remarkable case series results. Targeting arrhythmogenic scar tissue with a single fraction of 25 Gy radiation for a median of just 15 minutes reduced VT and premature ventricular contraction episodes by 94% at 6 months among 18 evaluable adults with treatment-refractory VT — over half of whom presented with VT storm. The median number of VT episodes dropped from 119 to three (P < .001), reported Phillip Cuculich, MD, Washington University, St. Louis. From a patient-safety standpoint, this is very much a leap forward, added Cuculich, pictured here (left) with colleague and ENCORE-VT lead author Clifford Robinson, MD, a radiation oncologist at Washington University (right).
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
Novel Agent Lowers Lp(a), Meets All End Points in Phase 2
A novel antisense agent is relatively safe and highly effective in lowering levels of lipoprotein(a) in patients with both elevated Lp(a) and established CVD, a study has shown. The dose-finding phase 2b trial examined five regimens in more than 200 patients with CVD and Lp(a) levels of at least 60 mg/dL. Treatment with the subcutaneous injectable drug known as AKCEA-APO(a)-LRX (Akcea Therapeutics/Ionis Pharmaceuticals) was associated with a dose-dependent effect on these levels from baseline to weeks 25 to 27, meeting the primary end point. In addition, for the patients receiving the highest active dose evaluated, 20 mg/week, there was a mean 80% reduction in Lp(a) from baseline. Lead author Sotirios Tsimikas, MD, Ionis Pharmaceuticals and University of California, San Diego, noted that this is especially dramatic compared with currently available treatments, including PCSK-9 inhibitors. "Looking at current therapies, PCSK-9 inhibitors lower Lp[a] by about 15% to 25% and niacin can lower it by 20% to 30%, so this is two to three times more potent than what's currently available to lower Lp(a)," Tsimikas said.
Top News From AHA 2018: Slideshow
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
Steve Stiles; Patrice Wendling; Deborah Brauser; Susan Hughes; Marlene Busko; Megan Brooks; Fredy Perojo; Susan Jeffrey | November 26, 2018 | Contributor Information
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Steve Stiles
theheart.org | Medscape Cardiology News Editor
Susan Hughes
Medscape Neurology, Senior Journalist
Marlene Busko
Freelance Journalist
Megan Brooks
Freelance Journalist
Fredy Perojo
Medscape Photo Editor
Susan Jeffrey
theheart.org | Medscape Cardiology, Executive News Editor
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