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Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

Cardiologists from around the world came together to hear the latest developments in their field at the European Society of Cardiology (ESC) 2018 Congress, held August 25 through 29 in Munich, Germany.

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

Among the major clinical trial presentations:

  • ASCEND: Time to rethink omega-3 and aspirin for primary prevention in diabetes?
  • ARRIVE: An aspirin a day fails to lower CV risk in long-term prevention study
  • PURE: PURE diet score supports 7 foods — dairy and meat included
  • MITRA-FR: MitraClip comes up empty-handed in functional mitral regurgitation
  • POET: Switch to oral antibiotics safe, convenient in stable left-sided endocarditis
  • MARINER: No benefit with rivaroxaban after discharge in medically ill patients
  • SCOT-HEART: CTCA linked to less death, nonfatal MI in stable chest pain
  • MATRIX: Transradial access benefits maintained at 1 year in ACS

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

Omega-3 Supplements: No Effect on Vascular Events in ASCEND

The largest and longest placebo-controlled randomized trial of omega-3 fatty acid (as found in fish oil) supplementation has found no effect on serious vascular events, cancer, or mortality. The ASCEND trial looked specifically at primary prevention in diabetes patients, a group considered to be at high risk of developing vascular disease. The study included 15,480 UK patients with diabetes (age ≥ 40 years) without prior cardiovascular disease and randomly assigned them in a 2 × 2 factorial design to omega-3 fatty acids vs placebo or aspirin vs placebo. "On the basis of these results I believe that there is no justification for using a 1-g dose of omega-3 fatty acids for the prevention of cardiovascular disease and that the current guideline recommendations should be reconsidered," concluded co-lead investigator, Louise Bowman, MD, associate professor at the clinical trial service unit of the University of Oxford, United Kingdom. The results were presented at a Hotline Session here and simultaneously published in the New England Journal of Medicine.

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

ASCEND: Aspirin Not Needed for Primary Prevention in Diabetes

The benefit of aspirin on reducing vascular events did not outweigh the increased risk for serious bleeding in this analysis of the large primary prevention trial in patients with diabetes. In this analysis of the ASCEND trial, aspirin significantly reduced the risk for serious vascular events by 12% but also significantly increased the risk for major bleeding by 29%. No effect on gastrointestinal or any other cancer was seen. "I think we now have to consider very carefully whether aspirin is necessary," concluded co-lead investigator, Jane Armitage, MD, professor of clinical trials and epidemiology and honorary consultant in public health medicine at the University of Oxford, United Kingdom. "In our trial, patients generally had good control of blood sugar, blood pressure and cholesterol and a high percentage of nonsmokers, so under these circumstances I would say that aspirin is not needed," she concluded.

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

Daily Aspirin Fails to Lower CV Risk in Long-term, Primary Prevention ARRIVE Trial

Aspirin at a daily dose of 100 mg did not reduce the long-term risk for cardiovascular (CV) or cerebrovascular events in a trial that randomly assigned more than 12,000 nondiabetic adults with multiple CV risk factors but no history of CV events. Nor was the risk for stroke reduced. But daily aspirin was associated with more gastrointestinal bleeding, although such events were few. The ARRIVE trial, initiated a decade ago, sought to answer long-standing questions about whether aspirin is cardioprotective in a primary prevention setting, in this case in patients thought to be at moderate CV risk. J. Michael Gaziano, MD, Brigham and Women's Hospital, Boston, Massachusetts, said the lack of aspirin effect likely stems from the trial having entered what turned out to be a lower-risk population than its design anticipated. "I do believe that there are patients whose risk calculus is sufficient to warrant aspirin as part of the armamentarium," Gaziano said. "The use of aspirin remains a decision that should involve a thoughtful discussion between the patient and clinician."

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

PURE Diet Score Recommends 7 Foods, Including Dairy and Meat

A diet quality score based on the PURE study, which advocates eating more of seven key foods — fruits, vegetables, nuts, legumes, fish, dairy, and nonprocessed red meat — has been linked to lower mortality and CV events in three independent data sets. The PURE healthy diet score may be seen as controversial by some because a few elements, namely the inclusion of dairy and meat, differ from most other current dietary advice. "You need nutrition beyond fruit and vegetables — dairy and red meats both have many nutrients not found in fruits and vegetables. We looked at the whole diet," said PURE investigator Andrew Mente, PhD, Population Health Research Institute at McMaster University, Hamilton, Ontario, Canada. "Yes, the inclusion of dairy and unprocessed meat does conflict with current Western guidelines, but we are not suggesting people consume outrageous amounts of these items — three servings of dairy and one and a half servings of unprocessed red meat per day are what our data suggest is beneficial," Mente said.

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

MITRA-FR: MitraClip Comes Up Empty-Handed in Functional Mitral Regurgitation

Treatment with the MitraClip device on top of optimal medical therapy failed to shift outcomes in MITRA-FR, the first prospective randomized study to examine percutaneous mitral-valve repair in patients with functional mitral regurgitation. At 1 year, there was no difference in the primary composite endpoint of all-cause death or unplanned hospitalization for heart failure between the MitraClip and medical therapy–alone groups. This lack of benefit was consistent for the individual components of the endpoint and in per protocol analyses. While the study confirmed prior observations that the MitraClip is safe and effective, it was unable to show that correction of functional mitral regurgitation changes the prognosis, Professor Jean-François Obadia, MD, Louis Pradel Hospital, Bron Cedex, France, said in a Hotline Session here. "This leads us to think that very probably the main cause of the disease is more the underlying cardiomyopathy and that the mitral regurgitation is more a marker of [severity] than a cause of the disease," he said.

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

POET: Switch to Oral Antibiotics Safe in Left-Sided Endocarditis

The largest randomized, controlled trial in infective endocarditis has shown that stabilized patients with left-sided endocarditis can be safely switched from intravenous to oral antibiotics, sparing them weeks of in-hospital treatment. Partial oral antibiotic therapy in the POET trial was as good as intravenous-only therapy for the primary composite endpoint of all-cause death, unplanned cardiac surgery, embolic events, or relapse of bacteremia at 6 months. The findings were consistent across subgroups, including type of bacteria, native vs prosthetic heart valves, and surgically vs conservatively treated patients. "Based on these results, more than 50% of all patients with endocarditis may be candidates [for] partial oral antibiotic treatment," said study author Henning Bundgaard, MD. American Heart Association Past-President Mariell Jessup, MD, said, "To have a precedent in a study like this that shows that you could, in theory, choose some patients to go home on pills is terrific. It could save a lot of money and make patients less miserable."

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

GLOBAL-LEADERS: Extended Ticagrelor Monotherapy After Stenting Misses Endpoint

A novel antiplatelet regimen of extended ticagrelor monotherapy with aspirin added just for the first month after stenting narrowly failed to show superiority over standard treatment in the GLOBAL LEADERS trial. Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to standard 1-year dual antiplatelet therapy followed by 1 year of aspirin monotherapy in terms of the composite endpoint of all-cause mortality or new Q-wave myocardial infarction at 2 years. However, at 1 year there was a clear reduction of the primary endpoint in the ticagrelor group, and there was an issue with adherence to ticagrelor in the second year; this could have contributed to the less impressive result at 2 years, said Patrick Serruys, MD, Erasmus Medical Center, Rotterdam, the Netherlands. "The idea behind that concept was to try and replace aspirin for secondary prevention by a drug which is more specific and reliable antiplatelet therapy. We believe that if a potent antiplatelet drug like ticagrelor is used it may be possible to drop the aspirin," said Serruys. "We were very close to showing superiority. But ticagrelor will not get approval for this based on this study, unfortunately, because the 1-year timepoint wasn't the primary endpoint. Overall, our results do not support a change to standard clinical practice, and we need more convincing data."

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

ATTR-ACT: Tafamidis Reduces Mortality in Amyloid Cardiomyopathy

Treatment with tafamidis (Vyndaqel, Pfizer) led to a reduction in all-cause mortality, CV hospitalizations, and functional decline compared with placebo in a study of patients with transthyretin amyloid cardiomyopathy. Transthyretin amyloid cardiomyopathy is a rare disease caused by deposition of amyloid fibrils in the myocardium. It is more common in older men and has a very poor prognosis. "This is a terrible disease," said principal investigator Claudio Rapezzi, MD, University of Bologna, Italy. "The mean duration of survival is no more than 2.5 years from the time of diagnosis." Tafamidis is still investigational but has orphan drug designation from the European Medicines Agency and fast track designation from the US Food and Drug Administration. If approved, it would be the first such treatment for transthyretin amyloid cardiomyopathy. Actually, said Rapezzi, this condition "is less rare than underdiagnosed," and "it can be easily diagnosed when suspected, so the first point is fostering the suspicion." Tafamidis is "effective and safe and offers hope for patients whose life expectancy and quality of life are extremely limited," Rapezzi said.

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

BASKET-SMALL: Drug-Coated Balloon in Line With DES in Small De Novo Lesions

In patients with small de novo coronary lesions, drug-coated balloon (DCB) angioplasty was comparable to the preferred treatment strategy of second-generation drug-eluting stents (DES), in the noninferiority BASKET-SMALL 2 trial. In a per protocol analysis, 12-month major adverse CV events (MACE) were similar among patients treated with a paclitaxel-coated balloon (SeQuent Please, B. Braun Melsungen) and DES (7.57% vs 7.52%; P = .0217 for noninferiority). Results were also similar in a full-population analysis, according to findings reported here and published simultaneously in the Lancet. "We have a potential benefit of leaving behind an intact vessel without armor, without a stent," said study author Raban Jeger, MD, University Hospital Basel, Switzerland. "Therefore, we don't expect any thrombotic events, and no prolonged dual antiplatelet therapy is necessary. In drug-coated balloons, you just need 4 weeks of dual antiplatelet therapy." Discussant Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, New York City, said DCB "is safe and comparable to DES in terms of MACE and offers an important alternative in patients with small-vessel disease. This important potential benefit of not having a permanent implant in our patients with diffuse long lesions is tremendous."

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

COMMANDER HF Quashes Oral Anticoagulation Hopes in HF Sans AF

Long-term oral anticoagulation (OAC) with rivaroxaban (Xarelto, Bayer/Janssen) had no apparent effect on risk for death, myocardial infarction (MI), or stroke in the COMMANDER HF randomized trial of 5000+ patients with a recent episode of worsening heart failure (HF). Nor was there a significant difference in a primary safety endpoint reflecting fatal or serious bleeding, although less critical bleeding considered manageable was significantly more common with the factor Xa inhibitor than with placebo. The trial tested whether blocking possible thrombin-mediated mechanisms of HF progression, including inflammation, endothelial dysfunction, and thrombosis, would improve clinical outcomes in patients with HF in sinus rhythm, which has been called the heart failure thrombin hypothesis, noted Faiez Zannad, MD, PhD, Centre Hospitalier Universitaire de Nancy, France. But the results of COMMANDER HF are solid and unambiguous in showing a lesser role, if any, for thrombin in HF progression. "We have closed that door, the hypothesis was proven wrong. Thrombin inhibition — anticoagulation — doesn't seem to be effective in patients with worsening heart failure," said Zannad.

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

MARINER: No Drop in Death, VTE With Rivaroxaban After Discharge in Medically Ill Patients

The MARINER randomized trial found no benefit of treatment with rivaroxaban (Xarelto, Bayer/Janssen) over placebo in reducing a composite endpoint of symptomatic venous thromboembolism (VTE) or death in patients at increased risk for VTE after discharge from a medical hospitalization. Major bleeding was low and not significantly increased with treatment. "In conclusion, our trial did not show a significant benefit of this rivaroxaban regimen started at hospital discharge with regard to the composite outcome of fatal or symptomatic venous thromboembolism in medically ill patients," Alex C. Spyropoulos, MD, the Donald and Barbara Zucker School of Medicine, Northwell Health at Lennox Hill Hospital, New York, and colleagues write in a paper published in the New England Journal of Medicine, to coincide with the presentation here. However, they add, given the relatively low incidence of events despite their strategy to enrich the trial with a high-risk population, and a lack of effect seen on VTE-related death, "the usefulness of extended thromboprophylaxis remains uncertain. Future studies should more accurately identify deaths caused by thrombotic mechanisms and focus on the patients who are at highest risk and may benefit from anticoagulant prophylaxis."

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

Lorcaserin Is Safe, 'Moves Needle' for Weight Loss in CAMELLIA

Added to a background of diet and exercise, the obesity drug lorcaserin (Belviq, Eisai) led to modest weight loss compared with placebo and did not increase the risk for MACE in the CAMELLIA-TIMI 61 CV outcomes study, which lasted a median of 3.3 years, in 12,000 overweight and obese patients with established CV disease, type 2 diabetes, or CV risk factors. "It was safe; this is the first time, in a rigorous outcome study, that we've been able to demonstrate cardiovascular safety…for a pharmacologic weight loss agent," said lead author, Erin A. Bohula, from the Brigham and Women's Hospital, Boston, Massachusetts. This supports the role of lorcaserin "as an adjunct to lifestyle modification for long-term weight management even in patients at high cardiovascular risk," she observed. Of interest, the rate of new-onset diabetes was 19% lower in the active treatment group than in the placebo group among those who had prediabetes at baseline (around a third of the study population).

Image from Darbe Rotach/Medscape

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

SCOT-HEART: CT Angiography Linked to Less Death, Nonfatal MI in Stable Chest Pain

Adding CT coronary angiography (CTCA) to standard care in patients with stable chest pain leads to a significant reduction in rates of death from coronary heart disease (CHD) or nonfatal myocardial infarction (MI) after 5 years, without increasing coronary intervention rates, the SCOT-HEART trial has found. The trial involved more than 4000 patients with stable chest pain who were randomly assigned to CTCA plus standard care or standard care alone and followed up for almost 5 years. Performing CTCA during diagnostic testing was associated with a 41% reduction in the combined primary endpoint: rates of death from CHD and nonfatal MI. David E. Newby, MD, professor of cardiology at the University of Edinburgh, United Kingdom, who led the study, said CTCA "made a difference," adding: "Show me another imaging test that is shown to reduce the rates of MI. There isn't one. So why aren't we using it first line?" He also noted that there was no overall difference in rates of coronary angiography or coronary revascularization, with CTCA even linked to a reduction in intervention after 1 year of follow-up. He also showed data indicating that patients who had CTCA alongside standard care were more likely to be initiated on statin therapy than those who had standard care alone, suggesting that greater awareness of a patient's condition led to better care.

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

HIGH-STEACS: High Sensitivity Troponin Does Not Improve MI Outcomes

The first randomized controlled trial of the latest high-sensitivity cardiac troponin I assay in patients with suspected acute coronary syndrome showed the test increased detection of those with myocardial injury, but only a third of the patients reclassified had a diagnosis of MI, and outcomes at 1 year did not improve. But while the length of hospital stay was doubled in the patients reclassified with the new test, it was halved in those without myocardial injury and was reduced by one third across the whole trial population, suggesting that clinicians were more confident ruling out MI with potential benefits for healthcare providers, said Nicholas L. Mills, from the University of Edinburgh, United Kingdom. "This test can be extremely helpful, but mainly for ruling out MI rather than ruling it in. We need further research to optimize the way we use this test to help us rule in MI more effectively," said Mills. "This trial has shown this test is useful, but not in the way we thought it might be. We were hoping to show it was better at identifying patients with MI and therefore reducing outcomes in these patients. We didn't find this to be the case, but we did find it was very useful in risk-stratifying patients and identifying low-risk patients who can be managed in the outpatient setting," said Mills.

Image from iStock

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

MATRIX: Transradial Access Benefits Maintained at 1 Year in ACS

The early benefits of using transradial rather than transfemoral access during invasive treatment of patients with acute coronary syndrome (ACS) persist at 1 year, according to final results of the MATRIX trial. The risk for MACE at 1 year was similar between patients assigned to treatment via radial or femoral access. The radial-access group, however, had 13% fewer net adverse clinical events (NACE), defined as non–coronary artery bypass graft-related major bleeding or MACE. "Radial access reduced the 1-year NACE rates, owing to a durable effect on CV death and bleeding complications," said principal investigator Marco Valgimigli, MD, University of Bern, Switzerland. CV mortality was 2.1% in the radial-access group vs 3.0% in the femoral-access group, and major Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding was 2.1% vs 2.9% (for both outcomes, rate ratio, 0.71; 95% confidence interval, 0.54 - 0.93). Myocardial infarction, stent thrombosis, and stroke rates did not differ significantly between patients in the two groups. MATRIX is the largest trial to compare radial vs femoral access and the first to report 1-year outcomes, observed Valgimigli.

Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

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Top News From ESC 2018: Slideshow

Steve Stiles; Patrice Wendling; Lisa Nainggolan; Darbe Rotach; Miquel Gonzalez; Liam Davenport; Marlene Busko; Megan Brooks; Susan Jeffrey | September 12, 2018 | Contributor Information

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