From Gladiatorial Debates to Papal Address, Rome to Host ESC 2016 Congress

August 22, 2016

ROME, ITALY — It is as if planners for the European Society of Cardiology (ESC) 2016 Congress wanted to outdo themselves, after previously introducing "Meet the Legends" sessions for members not sufficiently wowed at "Meet the Experts." This year attendees can, in a fashion, "Meet the Pontiff." The ESC announced last week that Pope Francis will give an address on Wednesday of the meeting, incentive like no other for attendees to hang around for the shortened last day of the program.

ESC Highlights: Introduction

Although the popular hot-line sessions don't kick off until Sunday, there is lots scheduled for Saturday, from educational sessions and symposia to posters, rapid-fire oral abstracts, debates, and "mini-quiz" sessions on the 2015 ESC guidelines and other topics.

The debates held throughout the Congress include several in which leading voices in the field will argue, in gladiatorial fashion, whether PCSK9 inhibitors and an angiotensin receptor-neprilysin inhibitor (ARNI) should be scoring more points in their respective clinical arenas.

In a midday Saturday debate on the ARNI agent, a PARADIGM trial leader will face off against another respected scientist on whether "ACE inhibitors should be replaced by LCZ696 (sacubitril/valsartan; Entresto, Novartis) as first-line therapy for heart failure." Then on Monday, two thought leaders, including one from the highly anticipated international outcomes trial FOURIER, will clash on whether "PCSK9 inhibitors are ready for daily life."

Sunday, August 28

The hot-line sessions, all of which take place in the main auditorium at the venue, Fiera di Roma, will be led at 11:00 by the DANISH trial, a randomized assessment of implantable cardioverter defibrillators (ICD) with or without cardiac resynchronization therapy (CRT) in a projected 1000 patients with noninschemic NYHA 2–3 heart failure and an LVEF <35%. The primary end point is all-cause mortality over 5 years.

The same hot-line session will feature the CHART-1 randomized trial of an injection of bone-marrow–derived mesenchymal cardiopoietic cells vs a sham control procedure. Conducted at >30 European centers, it had an estimated 240 patients with NYHA class 2–4 heart failure, LVEF <35%, and a history of worsening heart failure on medical therapy.

Also in the session, a cell-therapy trial in a different population, "Safety and efficacy of intravenous infusion of ischemia tolerant allogeneic mesenchymal stem cells in patients with nonischemic cardiomyopathy," and two implantable-device remote monitoring studies, including REM-HF and the prematurely terminated MORE-CARE.

A "scores-and-outcomes" registry session , starting at 14:00, is slated to feature a longitudinal study of a planned 1250 patients undergoing invasive evaluation for possible CAD, cerebrovascular disease, or peripheral vascular disease. Called CASABLANCA, the study is assessing whether assessment during catheterization of "novel" cardiac and renal biomarkers, especially by high-sensitivity troponin assay and tests for cystatin-C, can predict cardiac or renal injury over 1 year.

Planned for the first "preventive strategies" hot-line session at 16:30: the ANTARCTIC trial, described as a comparison of tailored-dose prasugrel (Effient/Efient; Eli Lilly/Daiichi Sankyo) guided by a standard platelet-function point-of-care assay vs conventional prasugrel dosing in patients with PCI-treated STEMI or NSTEMI. The trial enrolled a target of 880 patients at least 75 years of age, following them for a composite of cardiovascular events, urgent revascularization, stent thrombosis, and bleeding over 1 year.

Also on the bill, the SAVE randomized, open-label comparison of treatment with continuous positive airway pressure vs standard care in a planned 2500 patients with moderate to severe obstructive sleep apnea along with established coronary or cerebrovascular disease. Patients are being followed for CV death, nonfatal MI, nonfatal stroke, hospitalization for heart failure, unstable angina, or transient ischemic attack. Recruitment centers span the world, from Australia to China, India, Spain, and Brazil.

The same hot-line session is planned to include the NIPPON study of "optimal dual antiplatelet treatment duration following placement of a drug-eluting stent [Nobori, Terumo] with bioabsorbable polymer and abluminal coating" and the NACIAM trial on "early use of N-acetylcysteine with glyceryl trinitrate" in ST-segment-elevation MI [STEMI] patients undergoing PCI.

Monday, August 29

An 8:30 "atrial-fibrillation" registry session is slated to include an analysis based on the prospective ORBIT-AF II registry including patients with newly diagnosed AF and recently started on a direct oral anticoagulant. Enrollment is ongoing with a goal of about 15,000 patients and a projected completion for primary-outcome results (major bleeding events) in early 2018. The ORBIT-AF-II presentation in Rome is titled "Association of inappropriate dosing of non–vitamin K oral anticoagulants and risk of adverse events."

The "prevention and lipids" hot line at 11:00 is planned to include the OPTICARE randomized assessment of "expanded educational and behavioral intervention programs" after standard cardiac rehabilitation compared with standard cardiac rehab alone. There are two experimental interventions explored in the three-arm trial, one focusing on a series of telephone-based coaching sessions starting after standard rehab and the other including an exercise program and emphasizing lifestyle and risk-factor evaluation and tailored intervention.

The session also will feature the ESCAPE randomized trial of alirocumab (Praluent, Sanofi/ Regeneron) vs placebo looking at effects on reducing the number of LDL apheresis sessions in a 12-week period in adults with heterozygous familial hypercholesterolemia already undergoing apheresis therapy. The trial entered 62 patients at 13 centers in Germany and the US.

It also includes a trial described as "comparing the effect of long-term exposure to lower LDL-C, lower SBP, or both on the risk of cardiovascular disease; the HIJ-PROPER trial on "LDL-cholesterol targeting with pitavastatin and ezetimibe for patients with acute coronary syndrome and dyslipidemia"; and another randomized study of apheresis, but in patients with "refractory angina with raised lipoprotein(a)."

The day's debates include a confrontation at 14:00 over whether antiplatelets are "all we need" in transcatheter aortic-valve implantation (TAVI) or whether there remains a role for anticoagulants. A prominent interventionalist and leader in the OBSERVANT registry and BRAVO-3 trial will argue in favor of antiplatelets alone, and another leading name and ADVANCE and NOTION investigator will be the antagonist.

The "coronary artery disease and imaging" hot-line session at 16:30 is scheduled to lead off with the ongoing international CONSERVE trial comparing direct referral to cardiac catheterization to selective catheterization determined by the results of coronary CT angiography (CTA). The trial had an estimated enrollment of 1500 patients with suspected stable CAD and no history of CHD and is following them for a year for major adverse cardiac events (MACE) primarily and MACE plus major bleeding secondarily.

To be presented shortly afterward, the PACIFIC trial has explored a similar issue while comparing several noninvasive techniques for evaluating suspected CAD in 210 patients vs cardiac catheterization that includes measurements of fractional flow reserve. Those noninvasive approaches are coronary CTA, single photon-emission computed tomography (SPECT) myocardial perfusion imaging, quantitative positron-emission tomography (PET), and the hybrid evaluations CTA/SPECT perfusion and CTA/PET.

The CE-MARC 2 randomized trial compared management for suspected CAD guided by cardiac magnetic resonance (CMR) at 3 Tesla vs SPECT imaging vs criteria specified in National Institutes for Clinical Excellence (NICE) guidelines for guidance by CT calcium scores, SPECT, or contrast angiography depending on pretest CAD likelihood. The primary end point is "unnecessary invasive coronary angiography" at 1 year.

The session also includes an observational study in the DOCTOR series that asks, "Does optical coherence tomography optimize results of stenting?" and AMERICA, on the "systematic [Doppler ultrasound] detection and management of multivascular involvement of atherothrombosis in coronary patients" vs conservative management.

Tuesday August 30

At a 10:00 general assembly session, voting ESC members can watch the "Transfer of Presidency" from Prof Fausto J Pinto (Lisbon University Medical School, Portugal) to Prof Jeroen J Bax (Leiden University, the Netherlands), who will carry the baton until 2018. After an address from the new president, they can then make their way over to the 11:00 "coronary artery disease and stenting" hot-line session where they can check out the PRAGUE-18 presentation. That trial randomized 1226 patients undergoing PCI for acute STEMI to receive adjunctive prasugrel or ticagrelor (Brilique/Brilinta, AstraZeneca) and followed them primarily for a 7-day composite end point that included CV events, serious bleeding, and target vessel revascularization.

Accompanying that trial on the bill: the NorStent "comparison of long-term effects of new-generation drug-eluting stents (DES) vs contemporary bare-metal stents on mortality, morbidity, revascularization, and quality of life"; the BASKET-SAVAGE trial of "drug-eluting vs bare-metal stents in saphenous vein grafts," which was terminated prematurely; the BBK2 comparison of "culotte vs T-stenting for treatment of coronary bifurcation lesions" following patients for percent-stenosis at 9 months; and a trial asking whether "patients with acute coronary syndromes caused by plaque erosion can be treated with antithrombotic therapy without stenting."

The later second "preventive strategies" hot-line session starts with the ENSURE-AF that tested the factor Xa inhibitor edoxaban (Lixiana/Savaysa, Daiichi-Sankyo) vs enoxaparin followed by warfarin in the setting of planned electrical cardioversion of nonvalvular AF. About 2200 patients were randomized at a projected 284 sites in the US, Europe, Russia, Ukraine, and Israel to one of the two anticoagulation strategies, which they adhered to for up to 49 days before the procedure.

It also includes the open-label ANNEXA-4 study of the factor Xa reversal agent andexanet alfa (AndexXa, Portola Pharmaceuticals) in patients with acute major bleeding on oral or parenteral factor Xa inhibitors, including enoxaparin and edoxaban, apixaban (Eliquis, Bristol-Myers Squibb), or rivaroxaban (Xarelto, Janssen). With a projected enrollment of 270, it's estimated date of completion for the primary end point (stopping the major bleed within 24 hours of antidote administration) isn't for another 6 years.

Also in that session: the REVERSE II study, a "multinational validation of the Men Continue and HERDOO2 [clinical decision] rule to identify low-risk unprovoked venous thromboembolism patients who can discontinue anticoagulants," and YEARS, "Safety and efficiency of a simplified diagnostic management algorithm for 3500 patients with clinically suspected acute pulmonary embolism."

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