ESC: Diagnostic Testing in the Spotlight

— HS-troponin I and CT-based fractional flow reserve among top trials expected

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LONDON -- The PLATFORM trial on CT-derived fractional flow reserve (FFR) for revascularization decisions and results from the BACC trial on an algorithm with high-sensitivity troponin I for rapid diagnosis of myocardial infarction are in the spotlight at the European Society of Cardiology meeting.

That is what leading cardiologists told MedPage Today when asked which trials they most anticipated at the conference, which kicks off here on Saturday.

Richard C. Becker, MD, chief of cardiovascular health and disease and director of the Heart, Lung, and Vascular Institute at the University of Cincinnati:

BACC: "The advance of diagnostic testing is particularly important in cardiovascular disease. In the case of HS-troponin, an ability to rapidly secure a diagnosis of myocardial infarction will prompt initiation of evidence-based care paths and potentially improve patient outcomes, while concomitantly reducing length of hospital stay."

CIRCUS: "Inflammation is thought to underlie many of the pivotal steps of atherosclerosis, thrombosis, and maladaptive processes following acute myocardial infarction. While neutrophils have been a focus of investigation, lymphocytes, T-lymphocytes in particular, are increasingly recognized as playing an important role in cardiovascular disease and its major clinical phenotypes. Cyclosporine, a T-lymphocyte inhibitor that also exhibits anti-apoptotic effects, is being employed in the CIRCUS trial to test the 'inflammation hypothesis' in the acute MI setting."

ELIXA: "The GLP (glucagon-like peptide)-1 receptor responds to a meal by decreasing glucagon release from pancreatic alpha cells and increasing insulin release from pancreatic beta cells. Lixisenatide is a GLP-1 agonist that may attenuate the maladaptive metabolic environment that accompanies ACS and, unlike exogenous insulin administration, have a favorable impact on early patient outcomes."

Kim A. Williams Sr., MD, chief of cardiology at Rush University Medical Center in Chicago and president of the American College of Cardiology:

"For me, PLATFORM (hoping that FFR by CTA will become mainstream soon) is number one, followed by LEADLESS II (expecting the marked reduction in pacemaker complications with less hardware insertion), and IMPROVE-IT's diabetes analysis (looking for further reduction of risk in this high-event group)."

Jeffrey Michel, MD, a cardiologist at Baylor Scott and White Healthcare in Temple, Texas:

PLATFORM: "CTA has held enormous promise but failed to live up to high expectations (PROMISE trial). The holy grail would be combined anatomic and functional assessment. Will CTA-FFR pan out?"

"BACC is important because we are all nervously awaiting high-sensitivity troponin assays as they begin seeing us in clinical practice. Will they increase the number of MI diagnoses or simply muddy the waters further. Everyone is concerned about the apparent low positive predictive value and high false discovery rate of the test in clinical practice."

ALBATROSS: "There have been a long list of failures in the search for additional agents to further reduce the morbidity and mortality of AMI. Will aldosterone be that agent?"

W. Douglas Weaver, MD, of the Henry Ford Hospital in Detroit and a past president of the American College of Cardiology:

CIRCUS: "This was a well designed trial to look at reperfusion injury; a smaller preliminary study was very positive."

Vivek Reddy, MD, director of cardiac arrhythmia services at the Mount Sinai Health System in New York City:

"Effect of empirical left atrial appendage isolation on long-term procedure outcome in patients with long-standing persistent atrial fibrillation undergoing catheter ablation: results from BELIEF -- [this] is a concept that has been talked about quite a bit in the literature, but this will be the first randomized controlled trial to look at this."

"CUPID 2: a phase IIb trial investigating the efficacy and safety of the intracoronary administration of AAV1/SERCA2a in patients with advanced heart failure -- a very exciting potential therapy for treating heart failure patients. [There was] promising data in CUPID 1, now we will see how this bigger trial does."

Sanjay Rajagopalan, MBBS, co-director of the University of Maryland Heart Center in Baltimore:

"ELIXA, TECOS, and ARTS-HF are definitely exciting studies that are worth mentioning."

"I am hoping that there would be additional analysis as part of ELIXA and TECOS that may provide some additional insights on subsets in these two trials. Aldosterone blockade using non-steroidal analogues [in ARTS-HF] may be an advantage and may be safer. This is the excitement around molecules such as finerenone."

Another key trial slated for presentation at the conference is the PATHWAY 2 trial comparing treatments in drug-resistant hypertension, said Genevieve Derumeaux, MD, PhD, of Hôpital Louis Pradel in Lyon, France, and chair of conference program committee, in an ESC press release.

"We have been disheartened by the results of renal denervation in resistant hypertension and this study will bring hope to the field," she noted in the press release.