ESC 2016: Bare-Metal Flashbacks, Coronary Imaging Comparisons, Heart Team Hype, and His Holiness

 

“There are two different ways of writing history: one is to persuade men to virtue and the other is to compel men to truth.” - Robert Graves, I, Claudius

(UPDATED) Dubbed the “Eternal City,” one of Europe’s busiest tourist hubs is bracing to soak up another 30,000-odd visitors this weekend when the 2016 European Society of Cardiology (ESC) Congress kicks off in Rome, Italy. Attendees who can pry themselves away from the Trevi fountain can expect a jam-packed program, including no less than 28 “hotline” presentations, attendees from two-thirds of the world’s nations, and a closing address from the city’s most famous neighbor: His Holiness Pope Francis.

The meeting opens Saturday, with rapid-fire abstracts, posters, and a number of country-specific guideline sessions, as well as a wide range of clinical symposia.

The first of the six hotline sessions—two sessions with as many as ten trials per day on Sunday, Monday, and Tuesday—begin Sunday: the morning session is devoted to heart failure, while the afternoon’s is focused on Preventive Strategies. Monday’s hotlines are grouped as “Prevention and Lipids” and “Coronary Artery Disease and Imaging,” while Tuesday’s are “Coronary Artery Disease and Stenting” plus “Preventive Strategies.”

Top Trials

Speaking with TCTMD, François Schiele, MD, PhD (Université de Franche Comté, Besançon, France), an ESC spokesperson and member of the ESC press committee, acknowledged that some trials will likely make a bigger splash than others. Among his picks for interventional trials most likely to have an impact on clinical practice—regardless of how they turn out—Schiele pointed to the following.

• NorSTENT, a comparison of long-term effects of new-generation DES versus contemporary BMS on mortality, morbidity, revascularization, and quality of life. “To be honest, I was very surprised to see this study,” Schiele said, coming as it does more than a decade and a half after RAVEL, the first randomized controlled trial to show superiority of a drug-eluting versus bare-metal stent. NorSTENT, however, is a 9,000-patient trial comparing the latest-generation BMS to modern DES. “This could be a very hot discussion,” he continued. For one, RAVEL compared a now defunct DES to a “very poor stent,” the BX Velocity, which was associated with very high rates of restenosis as compared with BMS today. Second, the cost differential between DES and BMS still remains substantial. “It’s completely crazy,” he said. “A drug-eluting stent today is still three to four times more costly—could understand that initially, but now, why are DES so much higher than BMS when most of the [cost] is due to the balloon, and to the stent itself,” as well as the sterilization and packaging. “But putting the drug on is probably not so costly,” he added.

• BASKET-SAVAGE, similarly, is looking at BMS versus DES in saphenous vein grafts. Schiele acknowledged this study as being a bit out of step with current practicein coronary bypass surgery, with internal mammary artery grafts now favored.

• Two OCT trials. The first is DOCTORS, looking at whether optical coherence tomography (OCT) can optimize results of stenting—Schiele is a co-author—while a second OCT trial, led by Ik-Kyung Jang, MD (Harvard University, Boston, MA), is looking at whether patients with ACS caused by plaque erosion can safely be treated with antithrombotic therapy only, with no stenting. These two studies should help further pin down the potential value of OCT in clinical practice, he said. “Maybe OCT can gain some official [role] in the treatment of ACS, because that is not the case so far,” Schiele mused. “This is important because we still don’t know the answer to this question with IVUS, even after 20 years, so maybe we will know this with OCT.”

• PRAGUE-18, a randomized comparison of ticagrelor versus prasugrel in ST elevation myocardial infarction. “This is a study of 1,230 patients in STEMI, and it could be interesting because this is a pending question as to whether prasugrel is better than ticagrelor in this setting. Maybe this can answer the question,” Schiele said.

• CONSERVE, a comparison of direct catheterization versus selective catheterization guided by coronary computed tomography in patients with stable suspected coronary artery disease. “This is a very huge question,” Schiele observed. “How to follow-up these patients and when to follow-up these patients and what to do.”

• Two other trials, CE-MARC 2 and PACIFIC, are also testing imaging strategies in the diagnosis and management of patients with suspected ischemic heart disease.

An Eternity of Hotlines

There is a much broader range of topics beyond intervention in this year’s hotlines, of course—there are, after all, 28 of them (30 were originally promised, but two appear to have been pulled). ESCAPE is a phase III trial looking at the potential effect of the PCSK9 inhibitor alirocumab on the frequency of lipoprotein apheresis in patients with heterozygous familial hypercholesterolemia. Then there’s ANNEXA-4: Andexanet alfa for reversal of Factor Xa inhibitors in patients with acute major bleeding. The trial results are coming hot on the heels of news that the FDA is not yet ready to approve the agent in the United States.

Schiele also highlighted SAVE, a study looking at sleep apnea treatment and cardiovascular endpoints, as well as REVERSE II, a multinational, 3,300-patient, phase IV study looking at the use of the "Men Continue and HERDOO2" clinical decision rules to identify low-risk unprovoked venous thromboembolism patients in whom anticoagulants can be discontinued after 6 months of treatment.

“This is clearly needed to know when we can stop anticoagulation,” Schiele said. “And it’s not so often that we have a study regarding deep vein thrombosis and pulmonary embolism, so this kind of study could be important too.”

He also pointed to two trials of cell therapy-based approaches to heart failure, two studies of remote monitoring in heart failure, and the DANISH randomized controlled trial looking at the impact of implantable cardioverter defibrillators on mortality in patients with nonischemic systolic heart failure—all in the opening hotline session on Sunday.

Beyond the Late Breakers

In addition to the late-breaking hotlines, the program also contains four clinical trial update sessions, featuring new data and follow-up from 25 different international studies.

Fittingly, for a city perhaps best known for its crumbling colosseum, at this year’s meeting eight featured debates will be held in the “Gladiator’s Arena.” These will tackle everything from futile procedures, to stress testing in stable CAD, to SPRINT blood pressure targets, and optimal thromboembolic protection after TAVR. In a new twist, members of the audience will—figuratively—throw the losing debater to the lions by voting on who had the best arguments.

The ESC is also releasing several new guidelines at this year’s Congress, including new atrial fibrillation guidelines on August 28 and new dyslipidemia guidelines on August 29. A third “position paper” on cardio-oncology is also being released during the meeting. On the final day of the meeting, a special session is recapping highlights from these three guidance documents, as well as two sets of ESC guidelines, on prevention and heart failure, released at meetings earlier this year.

Perhaps taking a page from TCTMD’s in-depth feature on this topic, the “spotlight” for this year’s meeting is “The Heart Team,” with at least 15 sessions dedicated to this theme. To TCTMD, program committee chair Geneviève Derumeaux, MD (Louis Pradel University Hospital, Lyon, France), explained that the choice of the heart team focus goes far beyond procedures typically performed by surgeons and interventional cardiologists. “Many diseases and pathologic conditions affect the heart,” she said in an email. “Therefore, we need to raise awareness among cardiologists about these conditions and to facilitate the cross talk between different specialists, but more generally speaking, between the different healthcare providers.” The impetus, she continued, is to emphasize the “importance of teamwork and interactions between all professionals and specialties involved in the fight against cardiovascular disease” as well as highlight the “cross-collaboration spirit of the ESC and its constituent bodies.”

This approach in part explains the rationale for the addition of several new tracks to this year’s program, covering three areas: surgery, stroke, and e-cardiology.

All three areas “are important partners of the heart team concept,” Derumeaux said. “This is obvious for the surgeons but neurologists share [with cardiologists the need to address] the same underlying pathophysiology and now the same type of treatment to fight consequences of stroke.

As for e-cardiology, the program includes presentations on telemedicine, big data, and electronic pill counts but also extends to what Derumeaux described as “specialized computer methods in cardiovascular image processing, computational knowledge discovery, artificial intelligence, intelligent data analysis, biosignal processing, signal modelling, predictive models development, e-health and mobile applications, as well as communications within and between hospitals.”

Of special interest to interventional cardiologists, this year’s Andreas Gruentzig Lecture will be given by Jean Fajadet, MD (Clinique Pasteur, Toulouse, France), and entitled: “From balloon to bioresorbable scaffold: a 40-year journey in coronary intervention.” Appealing to what one assumes might be a broader audience, the ESC has also managed to lure what must be its biggest-name speaker of all time: Pope Francis.

“The Pope’s visit is recognition of the significant efforts by the European Society of Cardiology and medical professionals worldwide to advance prevention, diagnosis, and treatment of heart disease,” ESC President Fausto Pinto, MD, PhD (University of Lisbon, Portugal), commented in a large-font press statement emailed to reporters last week. “We are honored to welcome Pope Francis.”

Public Recitals to Large Audiences*

The ESC program committee received over 11,000 abstracts for this year’s meeting. They are expecting well over 30,000 attendees, hoping to top last year’s number of 32,758 in London and potentially the ESC record of 32,897, when the meeting was held in Paris.

This is the first time that the Congress has been held “in” Rome and, as with Paris, the convention center is actually located in an adjoining village, Ponte Galeria, some 22 kilometers from Rome’s central train station. Program registration includes 10 one-way public transportation tickets for attendees hoping to get in or out from Rome proper. The Congress has also arranged for direct transportation from the city center to the convention center via a specialized service, leaving from three points on the outskirts of the old city.

TCTMD reporters will be covering ESC Congress 2016 from Rome. Follow the TCTMD news team on Twitter, check out breaking news on our site, and make sure you are subscribed to our newsletter: just ask us here. By all means—if you think there is news I should know about, let me know. I’ll be on-site in Rome and on Twitter as @shelleywood2.

*Another gratuitous I, Claudius quote.