John Mandrola, MD


August 22, 2016

When asked which medical meeting is my favorite, I don't hesitate. It's the European Society of Cardiology (ESC) Congress. Just the fact that they call it a "congress" is cool.

No disrespect to American meetings, but I live here; I pretty much know how US cardiologists roll.

The best part about ESC is the international influence. Their slogan, "where the world of cardiology comes together," is not hyperbole. ESC is vastly international. It's thrilling to learn how colleagues from other continents think about heart disease.

The ESC numbers are impressive: 5 days of sessions, 150 topics, 11,000 abstracts, and more than 30,000 healthcare professionals from over 140 countries. And this year's congress in Rome, Italy features a huge bonus: ESC president Prof Fausto Pinto announced that Pope Francis will attend the closing ceremonies. "His holiness wishes to say a few words to the dedicated healthcare professionals in attendance as congress delegates."

Late-breaking science at ESC will include six clinical hot-line sessions, two basic and translational hot-line sessions, four clinical-trial-update sessions, and five registry updates.

In Rome, the ESC will release clinical practice guidelines concerning the prevention of cardiovascular disease and the treatment of dyslipidemia, atrial fibrillation, and heart failure. They will also present a position paper on cardioncology. In the AF-treatment guideline update, five of the six presentations include the phrase, "the atrial-fibrillation heart team approach to . . . ." That's new, and interesting.

One of the five heart-failure guideline-update sessions I am looking forward to is a session on the "importance of comorbidities." This issue gets too little notice. Uncommon is the patient who presents with LCZ696-tolerant blood pressure and no comorbidities.

Hot Lines: The hot-line sessions get started on Sunday with a potential shocker. It's been more than a decade since we've had a randomized controlled trial of ICDs for primary prevention.

The DANISH trial is a randomized, controlled, multicenter study to assess the efficacy of ICDs in patients with nonischemic systolic heart failure. This trial could either upend or confirm current guideline recommendations for ICD therapy in patients with nonischemic cardiomyopathy (NICM).

Remember, not a single trial has demonstrated a statistically significant mortality benefit from ICD in patients with NICM.[1] Two small trials of ICD use in NICM were stopped early because of futility[2,3]. In the DEFINITE trial, more than 450 patients with NICM, LVEF <36%, and nonsustained VT were randomized to ICD or medical therapy. The numerically lower mortality in the ICD arm did not reach statistical significance. And, although the SCD-HeFT[4] trial showed an overall mortality benefit of ICD therapy, nearly half the cohort had ischemic cardiomyopathy. In a prespecified subgroup analysis of SCD-HeFT, neither ischemic nor nonischemic subgroups met statistical significance. The P value for the nonischemic group was 0.06. DANISH, therefore, is a damn important trial.

Following the DANISH trial in that session, two studies will test the value of remote monitoring of implantable devices in patients with heart failure. I predict positive results. This session finishes with two studies of regenerative therapy for heart failure. Thus far, stem-cell therapy has promised much more than it has delivered.

Preventive strategies are the topic of four studies in the second hot-line session. In the NIPPON study, Japanese researchers are studying the optimal dual antiplatelet treatment (DAPT) duration following implantation of a permanent drug-eluting stent with a bioabsorbable polymer and abluminal coating. Good. We need more information on DAPT. In the ANTARCTIC trial, French investigators will tell us how the strategy of tailored platelet-function monitoring in elderly patients stented for an ACS compared with standard-dose prasugrel (Effient, Lilly/Daiichi-Sankyo). If positive, this may resurrect platelet-function testing, which was largely abandoned after the GRAVITAS trial failed to show a benefit for adjusting the clopidogrel dose in patients with high on-treatment platelet reactivity after PCI.[5]

Of the five lipid and prevention studies presented in the third hot-line session, the one that most interests me involves no medications or procedures. Cardiac rehab after ACS has changed little from the preinternet days. When the OPTICARE[6] trial is presented, we will learn how an expanded educational and behavioral intervention regimen compares with the standard cardiac rehab program. I may be wrong, but improving human behavior will likely prove far more useful for heart health than manipulating surrogate markers. Two other studies presented during this session will assess apheresis of lipoproteins. One study will look at the effect of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab (Praluent, Sanofi/Regeneron) on the frequency of apheresis, and the other will investigate apheresis as a novel treatment for refractory angina.

The fourth hot-line session addresses the issue of imaging for coronary artery disease. The stand-out could be the CE-MARC 2 trial.[7] This multicenter trial in patients with suspected CAD will compare 3T cardiac-MR-guided care, single photon-emission computed tomography (SPECT)–guided care, or guideline-directed care based on the pretest likelihood of disease. The primary (efficacy) end point is the occurrence of unnecessary angiography defined as a normal (>0.8) invasive fractional flow reserve. Importantly, safety, cost efficacy, and quality of life will be measured out to 3 years. In this session, Prof Jean-Philippe Collet (Groupe Hospitalier Pitié-Salpêtrière, Paris, France) will present a study called AMERICA, which asks the provocative question of whether doctors need to systematically detect and image multivascular atherothrombosis in patients with CAD or just treat the CAD. It's likely to be an important study since Journal of the American College of Cardiology editor in chief Dr Valentin Fuster (Icahn School of Medicine at Mount Sinai, New York) will be the discussant.

One theme I'll be paying attention to in the imaging session is the difference between anatomic atherosclerosis and active coronary artery disease. These aren't the same; lots of people have detectable atherosclerosis but no symptoms or significant ischemia. Increasingly sensitive imaging tests will detect abnormalities of the vessel; treatment of these shadows may or may not change outcomes. I worry these tests may overdiagnose CAD and may lead to more procedures. (Full disclosure: this is an area of research I am working on.)

What surprises me most about the fifth hot-line session on coronary stenting is the lack of studies on fully bioabsorbable stents. Two studies compare drug-eluting stents against bare-metal stents in multiple scenarios. Another trial tests culotte vs T-stenting for treatment of coronary bifurcation lesions. Of the five studies in this session, my young interventional cardiologist partner said he was most interested in the PRAGUE-18 trial, which is a randomized clinical trial comparing ticagrelor (Brilinta, AstraZeneca) vs prasugrel in patients with STEMI. Both drugs have bested clopidogrel in studies on patients with ACS, but this is the first trial to directly compare them.

The final hot-line session centers on the prevention of thrombosis. The ENSURE-AF[8] study tests the utility of edoxaban (Savaysa, Daiichi-Sankyo) for cardioversion. The importance of this study extends beyond the use of edoxaban. Namely, if edoxaban compares favorably with warfarin, it adds to the evidence that periprocedural novel oral anticoagulant (NOAC) treatment precludes the need for preshock transesophageal echo. In another presentation during this session, Dr Stuart Connolly (McMaster University, Hamilton, ON) will present the ANNEXA-4 study, which evaluates andexanet alfa (AndexXa, Portola Pharmaceuticals) for reversal of factor Xa inhibitors in patients with acute major bleeding. This will be big news, given that the FDA recently delayed an approval decision for the factor Xa antidote. Finally, I love studies that inform the decision to stop treatment. The REVERSE II study will verify whether use of a new clinical decision rule identifying patients diagnosed with unprovoked blood clots can identify those who can safely stop oral anticoagulant therapy after 5 to 7 months of treatment.

We will have a strong team of news and features writers to cover ESC, including colleagues from Medscape Neurology and Endocrine/Diabetes.

The Twitter feed will be humming as well. Follow us at @theheartorg.

See you in Rome.



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